China's Clinical Mass Spectrometry Sector: 54 Companies Secure Over 200 Medical Device Registrations

Sep 21, 2023 16:47 CST Updated 16:47

Roche

Oncology Drug Research, Development, and Manufacturing

With Views, With Attitude

This is the Life Science Industry Observer Official Account's Issue #775-3Article

Author: Yanzhao Jun

Source: KRIS Mass Spectrometry Platform

On January 10, 2023, diagnostic giant Roche released the research and development progress of its mass spectrometry testing products for the first time, drawing widespread attention from the global biopharmaceutical health field to clinical mass spectrometry. The clinical mass spectrometry sector, with a potential market of 2.9 billion Swiss francs, has become a hot topic. For more details, please refer to the historical article: 2023 JPM Review | Roche Diagnostics Focuses on Clinical Mass Spectrometry, Building an Automated High-Throughput Mass Spectrometry Pipeline.

On July 27, 2023, Roche released the latest progress of its mass spectrometry project in its semi-annual report. The model of the mass spectrometer is i601, an integrated solution for full automation and intelligence, enabling seamless sample-to-result operation. The Roche i601 still relies on the technical platform of its global strategic partner, Hitachi (HITACHI). Hitachi's Chromaster 5610, M8000LC-3QDMS, and other chromatography and triple quadrupole mass spectrometry analyzers entered the Chinese market long ago. The i601 should be a fully automated high-throughput mass spectrometry system specifically OEM-produced for Roche. The instrument’s automation meets the needs of conventional laboratories for fast and predictable turnaround times, achieving complete automation from sample preparation to random-access results. It plans to analyze over 60 analytes to meet market and user demands. The system is expected to debut in CE Europe by the end of 2024, with FDA approval in the United States anticipated in 2025.

Mass spectrometry (MS) is a platform analytical technology for separating and detecting the mass-to-charge ratio of charged particles. From its birth in the early 20th century to the present, it has been over a century. In more than 100 years of the development history of mass spectrometry, more than a dozen Nobel Prizes have been awarded for research related to the birth, development, and applications of mass spectrometry technology.

Joseph John Thomson (Joseph John Thomson, 1906 Nobel Prize in Physics, revealed the movement of charges in gases)

Wilhelm Carl Werner Otto Fritz Franz Wien (Winner of the 1911 Nobel Prize in Physics for elucidating the laws of thermal radiation)

Francis William Aston (Francis William Aston, 1922 Nobel Prize in Chemistry, applied mass spectrometry to discover isotopes)

Wolfgang Paul (1989 Nobel Prize in Physics, inventor of ion trap technology) Hans Georg Dehmelt (1989 Nobel Prize in Physics, inventor of ion trap technology)

John Bennet Fenn (2002 Nobel Prize in Chemistry, invented Electrospray Ionization)

Koichi Tanaka (2002 Nobel Prize in Chemistry, inventor of Matrix-Assisted Laser Desorption/Ionization)

Robert Curl Jr. (1996 Nobel Prize in Chemistry, discovery of C60)

Harold Kroto (Nobel Prize in Chemistry 1996, discovery of C60)

Richard Smalley (1996 Nobel Prize in Chemistry, discovered C60)

Yuan Tseh Lee (1996 Nobel Prize in Chemistry, Molecular Beam)

Tu Youyou (2015 Nobel Prize in Physiology or Medicine, Discovery of Artemisinin)

……

From J.J. Thomson’s development of the first mass spectrometer in 1912 to identify neon and its isotopes, to the breakthrough in biomacromolecule mass spectrometry analysis in 2002, and subsequently its widespread clinical application across China, mass spectrometry technology has undergone over a century of development.

In 1906, British physicist Joseph J. Thompson was awarded the Nobel Prize in Physics for his research on anode rays, also known as electrons. His work also laid the foundation for mass spectrometry technology, and thus J.J. Thompson is considered by many to be the father of mass spectrometry.

British scientist Francis William Aston, with the help of the mass spectrometer he designed, discovered the existence of isotopes and elucidated the whole number rule of isotopes, for which he was awarded the 1922 Nobel Prize in Chemistry. His work also laid the foundation for the later development of atomic energy science.

German physicists Wolfgang Paul and Hans G. Dehmelt invented the ion trap technology in the 1950s, which uses charged quadrupole rods to capture ions, and they were awarded the 1989 Nobel Prize in Physics.

American analytical chemist John B. Fenn and Japanese scientist Koichi Tanaka for their respective contributions to the development of electrospray and MALDI ionization technologies,ObtainedThe 2002 Nobel Prize in Chemistry. These two technologies have greatly expanded the application scope of the combination of mass spectrometry and liquid chromatography, directly promoting the research on biomacromolecules.

In the context of precision medicine, the previous treatment approach of using a single drug for everyone regardless of age or gender is gradually changing. Precision medicine focuses on different populations, different diseases, different time periods, as well as an individual’s genome, proteome, metabolome, lifestyle, and environmental factors, to comprehensively determine a personalized treatment plan.

Therefore, the precise detection in laboratories is particularly crucial. Currently, the two most widely used technology platforms are the molecular platform and the mass spectrometry platform. The relationship between these two platforms is like a person's two legs—both are indispensable, and missing one would make it impossible to obtain complete information. Since the outbreak of the pandemic, the molecular platform has been more frequently utilized, including sequencing and PCR. What problems can these technologies address? They can detect whether there are mutations in the gene sequence, identify the location of the mutations, and examine modifications such as methylation.

Testing data can inform clinicians of what might occur. Changes are driven by a genetic basis, and the second aspect is the transcriptome. Genetic changes merely indicate the potential for change, primarily reflected at the DNA level. Whether such changes are expressed through transcription—whether there's variation in RNA—is typically examined using transcriptomics technology, which falls under molecular diagnostics. Something may potentially happen, but has it actually occurred? This also depends on whether a phenotype has emerged. Phenomics reveals what is currently happening. Further analysis of related products clarifies if it truly occurred and identifies specific pathological changes. Combining both aspects enables precise diagnosis, providing robust support for precision medicine.

Precisely because of the aforementioned advantages, the potential applications of clinical mass spectrometry in testing and diagnosis are becoming increasingly widespread. Mass spectrometry analysis technology has been listed by authoritative foreign institutions as one of the most significant innovative technologies in recent decades. Currently, 70% of clinical medical decisions rely on laboratory test data and laboratory reports; in other words, the contribution of laboratory data to clinical medical decision-making has exceeded 70%. The role of mass spectrometry technology in this regard is even more critical, especially for precision medicine.

Mass spectrometry is like a molecular balance, which can accurately qualify and quantify molecules. Moreover, the establishment of reference methods for the detection of many substances usually relies on mass spectrometry. Mass spectrometry can simultaneously analyze multiple analytes, allowing one sample to be tested for many indicators with high throughput, relatively low cost, and high sensitivity. Whether for scientific research or clinical use, it has considerable value.

Mass spectrometry technology is widely used in clinical applications abroad, including genetic metabolic diseases, hormones, nutrition, toxicology, forensic science, microbial identification, and the detection of infectious disease tumor markers. Large laboratories like Quest Diagnostics offer over 400 mass spectrometry tests, and Mayo Clinic provides more than 300 such tests. In China, there is still a gap; the number of hospitals offering these services is limited, and even those that do typically provide only a small range of tests. Fudan University Zhongshan Hospital, as a leading name in Chinese clinical mass spectrometry, currently offers more than 100 clinical mass spectrometry tests, primarily focusing on TDM, hormone, and vitamin testing.This is the gap compared to foreign countries, which also reflects a significant room for improvement in the application of clinical mass spectrometry in China. Currently, there are still some challenges in the application of clinical mass spectrometry in Chinese hospitals.

Challenge One: Compliance

According to the current management regulations for medical devices, all instruments and reagents used in laboratories should have a registration certificate. This is necessary for compliance. Currently, many mass spectrometry projects do not have a registration certificate and are generally conducted using self-developed (LDTs) methods, which raises some compliance issues. Of course, at present, some manufacturers have long been aware of this issue and have started producing and registering related kits. They have already obtained registration certificates, including those for pre-processing, kits, chromatography columns, and instruments. With a registration certificate, this technology can be carried out legally and without any worries.

A complete mass spectrometry analysis system includes a chromatograph, mass spectrometer, software, chromatography column, reagent kits, sample preparation, and mobile phase. To ensure quality, it is also necessary to use calibrators, quality control materials, internal standards, and corresponding consumables. The method must be validated before use. In fact, currently, there are not many manufacturers with a relatively complete set of registered products. According to the requirements of more standardized laboratories, there are still some concerns about their use. Some are still using LDTs (Laboratory Developed Tests), so hospitals should choose manufacturers that can provide a full range of compliant products, ensuring no worries during hospital use. Of course, hospitals can also contribute their mature experience and collaborate with manufacturers to develop some forward-looking reagent kits.

Challenge Two: Sample Pretreatment

Although mass spectrometry is highly sensitive, specific, and performs well in analysis, it also requires a very high standard for sample preprocessing. If the preprocessing is not done properly, the variation in subsequent test results can be significant, leading to considerable differences between operators. Automating sample preprocessing would greatly help ensure consistent, stable, and reliable test results. Sample preprocessing has been used extensively and over long periods abroad. Due to its high sensitivity, the requirements for sample handling are also very strict, making sample preprocessing the biggest challenge affecting analytical quality. To ensure testing quality and reduce result variations caused by operational discrepancies between individuals, automated preprocessing would be an excellent choice. Implementing these in clinical settings would be highly beneficial for testing and quality assurance.

Challenge Three: Quality Control

Mass spectrometry technology is different from other analytical methods. It has its own characteristics in terms of quality control requirements, and the reference ranges also vary. Currently, there are not many programs available for inter-laboratory quality assessment.

Mass spectrometry is different from biochemistry and immunoassays. For immunoassays, you may be required to perform a weak positive control daily and two negative controls. For biochemistry, performing quality control at two or three concentration levels is sufficient. However, mass spectrometry has distinct requirements. For instance, calibration points should include at least six to eight points, and quality control points must cover low, medium, and high concentrations. Additionally, factors such as matrix effects of the calibrator, extraction efficiency, sensitivity, accuracy, and precision of the kit must meet the requirements. Do the stability of samples and reagents meet quality standards? These are all requirements for product quality.

Challenge Four: Traceability System

Generally, to establish traceability for a product, it is best to have both reference methods and reference materials. Internationally, the best practice for traceability involves having both reference methods and reference materials, which is quite common. However, it is regrettable that in the practical application of clinical mass spectrometry for many indicators, there are neither reference materials nor reference methods. There are even cases where technologies with lower analytical performance are used to evaluate its standards. Therefore, peers need to work together to establish more reference methods and develop more reference materials. This will greatly help the application and promotion of mass spectrometry. When developing methods independently, it is also necessary to consider the issue of traceability of the test to ensure quality and proper traceability.

Challenge Five: Clinical Reference Range

Because mass spectrometry is relatively new, the testing indicators cannot refer to the original immunological or biochemical methods. The principles behind these two types of analyses are completely different. Biochemical and immunological methods use spectroscopy for indirect quantification, whereas mass spectrometry directly measures the mass for quantification. Therefore, the reference ranges for these two methods are definitely different. When applying this in clinical practice, closer collaboration with clinicians is needed to establish the reference range for mass spectrometry methods. It’s also important to correlate test results with clinical manifestations to better interpret clinical outcomes. This requires extensive cooperation and exploration with clinicians. Of course, some projects may have reference ranges established abroad, but whether they are suitable for the Chinese population needs to be verified and confirmed in practice. Generally, according to international conventions, each laboratory should establish its own reference range. This reference range can only serve as a guide. Therefore, before implementing this technology, laboratories must consider the reference range and address how clinicians will interpret the test results.

Challenge Six: Inter-laboratory Quality Assessment

The National Health Commission's Clinical Laboratory Center and the clinical laboratory centers of various provinces and cities in China have already launched some external quality assessment (EQA) projects using mass spectrometry methodologies. Examples include steroids, vitamins, homocysteine, etc. However, the overall number of projects is still insufficient, and there remains a significant gap compared to other countries. For instance, Quest Diagnostics, a major laboratory abroad, offers over 400 mass spectrometry testing projects, while Mayo Clinic provides more than 300 such projects. According to current laws and regulations, each project must have a corresponding EQA program. There is still considerable room for growth, so it is essential to establish more EQA programs to maintain standardization across the industry and ensure reliable results. Medical institutions and third-party laboratories that adopt this technology can collaborate to improve this process. Despite some challenges ahead, mass spectrometry is uniquely suited for detecting trace substances with very low concentrations. It also provides precise quantification, high throughput, and, once fully automated, will allow for effective quality control under compliance. The application prospects remain very promising.

In recent years, with the increasing application of mass spectrometry technology in the field of clinical testing, the installation of mass spectrometers and the establishment of clinical mass spectrometry laboratories have become the choice of many medical institutions and third-party medical testing laboratories. Compared with conventional biochemical immune systems, mass spectrometry analysis and detection systems have stricter requirements for laboratory environments, require more auxiliary equipment, consumables, and reagent types, involve more complex manual operation steps, and demand higher technical skills from operators.

Mass spectrometry technology has been widely used in various industries, with its application in the medical field initially starting in drug development and therapeutic drug monitoring. With the rapid advancement of ion source technology and mass analyzer technology, mass spectrometry has become one of the most promising technologies in clinical research. Over the past two decades, mass spectrometry has also played an increasingly important role in the field of clinical testing. In addition to the widespread use of matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) in the microbiology field, the significant role of liquid chromatography-tandem mass spectrometry (LC-MS/MS) in clinical testing has become increasingly prominent.

LC-MS/MS technology has high specificity and can simultaneously distinguish and accurately quantify various endogenous and exogenous small molecules. On the one hand, it serves as an important supplement to clinical biochemical and immunoassay methods, providing solutions for clinically urgent projects that currently cannot be detected. On the other hand, it plays a significant role in the standardization of clinical testing, such as identifying interfering substances, differentiating between different subcomponents of the same type of substance, and improving the consistency of test results across different analytical systems.

Inductively Coupled Plasma Mass Spectrometry (ICP-MS) is gradually replacing atomic absorption technology and is widely used in clinical settings for the assessment of nutritional status of various essential trace elements and screening for heavy metal poisoning. In addition, high-resolution mass spectrometry has been preliminarily applied in clinical diagnosis and differential diagnosis such as amyloidosis typing and M-proteinemia classification. In the 2022 Medical Equipment Equipping Standards for Maternal and Child Health Care Institutions (WST 793—2022) issued by China's National Health Commission, the LC-MS/MS system appears as an additional device for tertiary hospitals in the category of biophysical and physicochemical testing equipment.

An increasing number of LC-MS/MS and ICP-MS devices are obtaining medical device registration certificates, which will all drive mass spectrometry technology to rapidly enter clinical settings. However, mass spectrometry analysis and detection systems also face significant challenges in clinical applications. Compared with routine biochemical immunoassays, they impose stricter requirements on laboratory environmental conditions, necessitate a wider variety of auxiliary equipment, consumables, and reagents, involve more complex manual operation steps, and demand higher technical proficiency from personnel.

The construction and operation of clinical mass spectrometry laboratories should comply with relevant laws, regulations, and requirements such as the "Administrative Measures for Clinical Laboratories in Medical Institutions." Clinical mass spectrometry laboratories can carry out special tests that cannot be detected by conventional biochemical immunoassay methods. For some tests, there are currently no registered commercial reagents available. When using laboratory-developed methods for testing, reference should be made to Article 53 of the "Regulations on the Supervision and Administration of Medical Devices" (implemented on June 1, 2021). The diagnostic and treatment services provided by clinical mass spectrometry laboratories should also comply with national and local regulations.

Mass spectrometry is the preferred method for many critical assay items. However, the operation of clinical mass spectrometry laboratories is more complex compared to conventional testing platforms. Therefore, it is essential to strengthen the quality system construction and daily quality management of clinical mass spectrometry laboratories to ensure medical safety. Laboratories can refer to the "Criteria for Accreditation of Quality and Competence of Medical Laboratories" (GB/T 22576.1) by the China National Accreditation Service for Conformity Assessment, the "Basic Standards for Medical Testing Laboratories (Trial)" and the "Management Regulations for Medical Testing Laboratories (Trial)" issued in Document No. [2016] 37 by the National Health Commission of China, the "Interim Measures for the Management of Medical Testing Laboratories," the "General Principles for the Design of Clinical Laboratories" (GB/T 20469-2006), the "Requirements for Inter-laboratory Quality Assessment of Clinical Laboratories" (GB/T 20470-2006), and the "General Requirements for Laboratory Biosafety" (GB 19489-2004) to establish quality systems and management requirements. Additionally, they can refer to the mass spectrometry-related clauses in the College of American Pathologists' laboratory accreditation checklist to improve relevant procedures.

Mass spectrometry instruments used to issue clinical testing reports should possess a Medical Device Registration Certificate of the People's Republic of China, with the manufacturing date falling within the validity period of the certificate. The appropriate type of mass spectrometer should be selected based on the requirements of the clinical testing projects. (1) Liquid Chromatography-Triple Quadrupole Mass Spectrometry (LC-QQQ-MS): Laboratories conducting endogenous metabolite tests such as vitamins, amino acids, bile acids, catecholamines, steroid hormones, neurotransmitters, β-amyloid protein, and drug concentration monitoring should be equipped with LC-QQQ-MS instruments. (2) Inductively Coupled Plasma Mass Spectrometry (ICP-MS): Laboratories performing inorganic element testing (such as iodine, zinc, selenium, etc.) should be equipped with ICP-MS instruments. (3) Gas Chromatography-Mass Spectrometry: Laboratories carrying out organic acid testing should be equipped with gas chromatography-mass spectrometry instruments. (4) High-Resolution Mass Spectrometry: Laboratories conducting toxin and drug screening, protein identification, and other testing projects can additionally be equipped with high-resolution mass spectrometry instruments on the basis of LC-QQQ-MS.

Basic Components of Mass Spectrometer

Analytical instruments must be qualified and calibrated, and their performance verified to meet requirements before use. A verification cycle should be established based on the equipment's service life. Instruments should have clear operational status labels and be managed by designated personnel, with records kept for usage, maintenance, and repairs.

When using the instrument, the technician needs to perform daily maintenance on components such as the mass spectrometry ion source; before starting the sample injection, the following key points should be checked: confirm the type of ion source and ensure correct installation; verify that the chromatographic column model and installation direction are correct; check that the mobile phase is correctly prepared, with sufficient volume, and within the validity period. The preparation of the mobile phase must record the preparation date, preparer, and other information; check that the waste liquid bucket is not full and applicable (it needs to be replaced when the liquid level reaches 90%); inspect the sample chamber and clean the tested samples; start the system, purge the bubbles from the HPLC system tubing, and check the status and parameters of the mass spectrometer for normalcy; invoke the project method to balance the instrument, and conduct a system suitability test to evaluate the instrument's condition by observing system pressure, instrument status, retention time of analyte chromatographic peaks, and the response value of the mass spectrometer. Correctly set the type of sample plate and ensure that the sample positions in the sample tray match those in the sequence table. After meeting the requirements, proceed with the formal sample injection.

After using the instrument, the technician needs to flush the instrument according to the detected substance and mobile phase. Regularly analyze the system suitability results of the instrument, review the instrument's status, and promptly perform maintenance or repairs if there are any signal abnormalities. Periodically wipe and clean the instrument's surface and certain components to remove dirt or dust.

According to the "Recommendations for Clinical Application of Liquid Chromatography-Mass Spectrometry," the quality control measures for analytical instruments can be divided into system suitability testing and periodic quality monitoring. System Suitability Testing: It is recommended to perform system suitability testing at least before each analytical batch, after preventive maintenance, after the instrument is depressurized, or when there are issues with system equilibrium, to ensure the detection system is functioning properly. Periodic Quality Monitoring: After major repairs, maintenance, or relocation of the instrument, it is necessary to evaluate whether the performance indicators of the instrument remain consistent with those before the repair, maintenance, or relocation, and to assess the degree of deviation in clinical sample test results before and after.

The detection projects should prioritize commercial kits that have obtained a medical device registration certificate; manage them as routine reagent kits, establish SOPs for purchase, acceptance, storage, and use, and maintain accurate records of inventory, storage, usage, and expiration dates; the system suitability of the kit should be demonstrated on the instrument intended for this project, and the data from the methodological evaluation must meet the requirements of clinical guidelines.

Currently, for test items without commercialized reagent kits, laboratory-developed methods can be established according to the recommendations in "Suggestions for Clinical Application of Liquid Chromatography-Mass Spectrometry" and "Development and Validation of Clinical Testing Methods Using Liquid Chromatography Tandem Mass Spectrometry." Laboratory-developed methods can use commercially available calibrators. When commercial calibrators are unavailable, self-prepared calibrators may be considered, with the matrix of the homemade calibrator being as similar as possible to clinical samples or verified to be unaffected by matrix effects. Purchased calibrators are usually in powder form or high-concentration solutions and cannot be used directly; they should be further processed into calibration solutions through weighing, mixing, dilution, etc. Certified reference materials are highly recommended for use as calibrators. If certified reference materials are unavailable, substances developed by authoritative metrology and reference material development institutions or substances with clear assigned values should be selected as far as possible. The completeness of the analysis certificate content should be confirmed and retained. The purity, grade, specifications, and source of standards and reagents involved in the analytical process must meet experimental requirements. Batch changes of homemade calibrators should establish corresponding acceptance criteria to avoid introducing systematic errors. Internal standards can correct matrix effects and deviations generated during sample extraction, chromatographic separation, and ionization processes. Internal standards should be non-endogenous substances not present in the sample, and structural analogs or stable isotope-labeled internal standards can be used. Stable isotope-labeled (deuterium-labeled, 13C-labeled) internal standards are recommended, with a mass-to-charge ratio difference greater than 3 and purity meeting analytical requirements, preferably above 98%. Other reagents should meet the purity requirements for use in chromatography and mass spectrometry instruments. The performance of homemade reagents should be scientifically justified, and methodological evaluation data must comply with clinical guideline requirements or meet intended use.

Preferably choose commercial quality control products. If commercial quality controls are unavailable, self-preparation can be considered. Generally, three concentration levels of quality controls (high, medium, and low) need to be prepared, selecting appropriate quality control levels based on the concentration distribution of the analyte. The matrix of the quality control product should be identical or as close as possible to the sample to be tested. Self-made quality control products can use pooled patient samples or pooled samples with added expected concentrations of the analyte.

For projects without commercial reagents available, in-house methods can be adopted along with comprehensive methodological evaluation. For projects with registered commercial reagents available, commercial reagents should be the first choice, and performance verification should be conducted on the laboratory system. It is recommended to use third-party quality control materials; for self-made quality control materials, uniformity, stability, etc., should be assessed.

All consumables involved in the processes of sample collection, pre-treatment, and sample analysis (such as centrifuge tubes, solid-phase extraction plates, and chromatography columns) should have established SOPs for procurement, inspection upon receipt, storage, and usage. Accurate records of inventory in/out, usage, maintenance, and performance must be maintained. Variations in the manufacturer or batch of consumables may impact experimental results; therefore, if there is a change in consumables, relevant validation experiments must be conducted.

Clinical Mass Spectrometry Technology Plays an Increasingly Important Role in the Detection of Hormones, Drugs, Vitamins, and Amino Acids. The Mass Spectrometry Detection of Large Molecule Peptides and Proteins Has Also Received Widespread Attention. Although the Development Path of Clinical Mass Spectrometry Technology Still Faces Many Challenges, Through Continuous Efforts, It Is Believed That Clinical Mass Spectrometry Technology Will Have a Brighter Future.

Liquid Chromatography-Mass Spectrometry (LC-MS) analysis is composed of two parts: liquid chromatography analysis and mass spectrometry analysis. Liquid chromatography analysis can separate analytes based on differences in compound polarity, while mass spectrometry analysis can accurately detect the mass-to-charge ratio (m/z) of analytes. It features high sensitivity and specificity, enabling not only precise detection of trace compounds but also differentiation between analytes and their structural analogs or isomers, significantly improving detection accuracy. Mass spectrometry technology allows for simultaneous detection of multiple compounds, which helps improve work efficiency and reduce testing costs. The combination of LC-MS analysis achieves quantitative or qualitative analysis with numerous advantages such as excellent specificity, high sensitivity, wide linear range, capability to simultaneously detect multiple compounds, and faster detection speed.

Early LC-MS analysis was mainly used in fields such as drug analysis and food testing. In the 1990s, LC-MS analysis began to enter the field of clinical medical testing abroad, and around 2010, LC-MS analysis technology also started to be applied in clinical medical testing in China, playing an important role in precision diagnosis and treatment, medication guidance, and health assessment. For test items lacking universal analytical methods, the development of LC-MS analysis methods is relatively flexible. Therefore, many LC-MS analyses are carried out through laboratory-developed projects. After years of exploration and development, medical testing experts and scholars have accumulated rich practical experience in applying LC-MS analysis to hormone detection, vitamin detection, therapeutic drug monitoring, amino acid detection, toxic substance screening, peptide substance analysis, and more. Additionally, LC-MS analysis is also beginning to show promise in large-molecule protein analysis.

In terms of the clinical application of LC-MS, other countries started earlier than China and have broader applications. In North America, LC-MS has become an indispensable part of routine clinical diagnosis and treatment, playing a significant role in the analysis of small molecule analytes, peptide analysis, protein analysis, clinical toxicology, and microbial pathogen identification.

Mass spectrometry-based proteomics research generally follows two strategies: top-down and bottom-up. After more than a decade of development, mass spectrometry-based proteomics has been widely applied with the support of open-access databases. Most existing protein biomarkers used for diagnosis have evolved from traditional immunoassays. Compared to small molecule quantification, protein quantification in mass spectrometry-based proteomics faces significant challenges, such as technical complexity, time-consuming optimization, high costs, lack of reference materials and internal standards, and incomplete regulation. Examples include the quantitative detection of insulin-like growth factor, thyroglobulin, and antibody drugs. In non-targeted protein analysis, the use of high-resolution mass spectrometry can help identify disease-causing proteins and discover new disease-related proteins. For instance, in the analysis of monoclonal immunoglobulin disorders, mass spectrometry offers higher sensitivity compared to gel electrophoresis and immunofixation electrophoresis and can exclude interference caused by medications. Protein analysis represents one of the new directions in clinical LC-MS applications abroad. Despite its high analytical difficulty, the clever utilization of mass spectrometry advantages can facilitate in-depth research into disease onset and progression, promoting precision diagnostics, thus garnering widespread attention.

Clinical LC-MS applications abroad are mainly developed in-house by laboratories. Issues of standardization and quality management have always been the focus of attention, resulting in the accumulation of a wealth of mature experience. In daily medical testing work, particular attention should be paid to the accuracy of reference standards and the details of method validation for LC-MS-specific quality management; during data analysis, close attention should be given to changes in internal standard intensity, retention time, ion ratio, and signal-to-noise ratio, which serve as important criteria for quality assessment.

Over the past decade, mass spectrometry technology has taken root and flourished in the field of laboratory medicine in China. Large tertiary hospitals and independent medical laboratories have successively carried out application research. Therapeutic drug monitoring (TDM) is one of the important application directions. TDM helps optimize clinical treatment plans, improve drug efficacy, reduce toxic side effects, and meet the needs of personalized medication guidance in clinical practice. The detection methods for TDM have evolved from spectroscopy, immunoassays, and liquid chromatography to LC-MS methods. LC-MS technology is characterized by relatively simple method development, lower cost of testing reagents, high sensitivity, and the ability to detect multiple compounds (drugs) simultaneously, making it highly suitable for detecting drug concentrations. Although the dosing regimen may be the same, there is still considerable variation in blood drug concentrations between individuals; some patients' blood drug concentrations are either above or below the effective therapeutic range, which may lead to a higher probability of adverse reactions. It should be emphasized that for TDM, it is not only necessary to obtain timely and accurate results but also to focus on the clinical application of TDM results, such as adjusting medication regimens promptly based on monitoring results and improving patient treatment outcomes.

In addition to TDM, medical laboratory professionals in China have turned their attention to a broader range of other clinical applications. LC-MS technology can not only be applied in routine clinical testing but also in the establishment of reference methods and the preparation of reference materials.

The clinical application of LC-MS in China started relatively late and is still in its infancy, with many shortcomings and a considerable gap compared to advanced international levels. The promotion and application of LC-MS in clinical settings still face numerous challenges, such as high equipment costs, method standardization, personnel shortages, and limitations in management models. It requires the joint efforts of peers to continuously innovate and properly address these issues in order to better serve the broad patient population.

As more and more mass spectrometers are being produced in China, prices will gradually decrease, automation levels will continue to rise, and the miniaturization of instruments is also constantly innovating. With the enrichment of product lines and the entire industry’s growing understanding and refinement of mass spectrometry technology, many current limitations and bottlenecks will progressively be overcome. The Cres Mass Spectrometry Platform has been dedicated to promoting the application of mass spectrometry technology in Chinese clinical testing, accelerating the localization of mass spectrometry equipment production, and striving to lead industry development in the fields of oncology and non-invasive prenatal diagnosis, better serving China's precision medicine initiatives and contributing to a healthier China. The platform has always been highly optimistic about mass spectrometry technology, believing that in the near future, its clinical applications will expand significantly. Projects will multiply, and mass spectrometry technology in clinical applications has already entered a period of rapid growth.

Looking ahead, the clinical application of LC-MS will continue to evolve, achieving technological breakthroughs and expanding applications. It is believed that with the joint efforts of numerous experts, scholars, and the broader testing community, clinical mass spectrometry technology will bring more possibilities and better outcomes to medical testing.

According toNational Medical Products AdministrationData Show, which has currently obtained the medical device registration certificateMass Spectrometer and Mass SpectrometryTest KitMore than 50 manufacturing enterprises,Registration CertificateThe number exceeds 200.

The domestic production enterprises and products are as follows:

The ranking is not in any particular order and is organized by the number of registration certificates as of September 20, 2023. Names that are the same are counted only once.

Shandong Ying盛 Biotechnology Co., Ltd. Quantity: 13

High-Performance Liquid Chromatography Tandem Mass Spectrometry Detection System

Lu Mechanical Registration Approval20192220473

Succinylacetone, Amino Acids, and Carnitine Assay Kit (Tandem Mass Spectrometry Method)

NMPA Registration Certificate20193400493

Fat-Soluble Vitamin Assay Kit (Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry)

LU Medication Approval20202400103

Water-Soluble Vitamins Assay Kit (UHPLC-MS/MS)

LU MEASURING EQUIPMENT20202400129

Inductively Coupled Plasma Mass Spectrometer

Lu Medical Device Registration Approval20202220321

25-Hydroxy Vitamin D Assay Kit (High Performance Liquid Chromatography-Tandem Mass Spectrometry)

LU MEDICAL DEVICE REGISTRATION APPROVAL20212400136

Lu Mechanical Registration Approval20232400492

Cyclosporine and Tacrolimus Assay Kit (High Performance Liquid Chromatography-Tandem Mass Spectrometry)

Lu Mechanical Registration Approval20212400258

Vancomycin Assay Kit (High-Performance Liquid Chromatography-Tandem Mass Spectrometry)

LU Medication Approval20212400421

Valproic Acid and Carbamazepine Assay Kit (High-Performance Liquid Chromatography-Tandem Mass Spectrometry)

LU MEDICAL DEVICE REGISTRATION APPROVAL20212400487

Iodine Element Assay Kit (Inductively Coupled Plasma Mass Spectrometry)

Lu Medical Device Registration Approval20212400520

Potassium, Calcium, Sodium, Magnesium, Iron, Copper, Zinc, Lithium, Phosphorus Element Assay Kit (Inductively Coupled Plasma Mass Spectrometry)

Lu Mechanical Registration Approval20212400522

Methotrexate Assay Kit (High-Performance Liquid Chromatography-Tandem Mass Spectrometry)

Lu Mechanical Registration Approval20212400571

Six Steroid Hormone Assay Kit (High-Performance Liquid Chromatography-Tandem Mass Spectrometry)

Lu Medical Device Registration Approval20232400203

Hangzhou Calibr Precision Medical TestingTest Technology Co., Ltd. Quantity: 11

(Dian Diagnostics Subsidiary)

Zhejiang Dipu Diagnostics Technology Co., Ltd.

Hangzhou Calibre Quality Technology Co., Ltd.

Hunan Callippus Biotechnology Co., Ltd.

Zhejiang Disaishi Diagnostic Technology Co., Ltd.

Time-of-Flight Mass Spectrometry Detection System

Zhejiang Medical Device Registration Certificate20202220910

Liquid Chromatography Tandem Mass Spectrometry Detection System

Zhejiang Medical Device Registration Certificate20222220116

Liquid Chromatography Tandem Mass Spectrometry Detection System

Hunan Medical Device Registration Approval20232220788

25-Hydroxy Vitamin D Test Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Certificate20202400042

Hunan Medical Device Registration Approval20222402032

Five Steroid Hormone Testing Kits (Liquid Chromatography-Tandem Mass Spectrometry Method)

Zhejiang Medical Device Registration Approval20222400314

Tacrolimus/Cyclosporin A/Sirolimus Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Certificate20212400640

Fat-Soluble Vitamin Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Certificate20222401020

Hunan Medical Device Registration Approval20222402029

Valproic Acid, Carbamazepine, and Phenytoin Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Zhejiang Medical Device Registration Approval20222401060

Hunan Medical Device Registration Approval20222402126

Vanillylmandelic Acid and Creatinine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Certificate20222401175

Aldosterone and Cortisol Test Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Approval20222401229

Bile Acid Profile Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Certificate20232401387

Beijing Haosi Biotechnology Co., Ltd. NumberQuantity: 11

Jiangsu Haosi Biotechnology Co., Ltd.

Hunan Haosi Biotechnology Co., Ltd.

25-Hydroxy Vitamin D Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Su Medical Device Registration Approval20202400523

Hunan Medical Device Registration Approval20212401932

25-Hydroxy Vitamin D3 Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Hunan Medical Device Registration Approval20212401391

Dried Blood Spot 25-Hydroxy Vitamin D Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Hunan Medical Device Registration Certificate No. 20222400574

Methotrexate Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

SU Med. Dev. Reg. Cert.20212401508

Hunan Medical Device Registration Approval20212401539

Assay Kit for the Determination of Multiple Fat-Soluble Vitamins (Liquid Chromatography-Tandem Mass Spectrometry Method)

Hunan Medical Device Registration Approval20212401390

5-Fluorouracil Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Hunan Medical Device Registration Approval20212401538

Sirolimus Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Hunan Medical Device Registration Approval20222400462

Tacrolimus Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Hunan Medical Device Registration Approval20222400463

Cyclosporine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Hunan Medical Device Registration Approval20222400464

Immunosuppressant 3-item Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Hunan Medical Device Registration Approval20222400575

Folic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Hunan Medical Device Registration Approval20222400936

Homocysteine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Hunan Medical Device Registration Approval20222401718

Multiple Ceramide Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Hunan Medical Device Registration Approval20232400898

Meikang Biotechnology Co., Ltd.Co., Ltd.Quantity: 9

Jiangxi Meikang Shengde Biotechnology Co., Ltd.

Meikang Shengde Medical Technology (Suzhou) Co., Ltd.

Meikang Shengde Biotechnology (Hunan) Co., Ltd.

Three Immunosuppressant Assay Kits (Liquid Chromatography-Tandem Mass Spectrometry Method)

Gan Medical Device Registration Approval20202400002

25-Hydroxy Vitamin D Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Gan Medical Device Registration Approval20202400003

Catecholamine Testing Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Gan Medical Device Registration Approval20212400156

Bile Acid Profile Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Gan Medical Device Registration Approval20212400157

Valproic Acid and Carbamazepine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Gan Medical Device Registration Approval20222400302

Steroid Hormone Testing Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Gan Medical Device Registration Approval20232400185

Liquid Chromatography-Mass Spectrometry (LC-MS)

Su Medical Device Registration Approval20192221449

Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometer

Su Medical Device Registration Approval20202220539

Liquid Chromatography-Mass Spectrometry (LC-MS)

Hunan Medical Device Registration Approval20222221209

Hunan Demite Instrument Co., Ltd. Quantity: 9

Two-dimensional liquid chromatography-tandem mass spectrometry system

Hunan Medical Device Registration Approval20232220119

High-Performance Liquid Chromatography Tandem Mass Spectrometry Detection System

Hunan Medical Device Registration Approval20232220191

Two-Dimensional Liquid Chromatography Miniature Mass Spectrometer

Hunan Medical Device Registration Approval20232220496

Risperidone Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Hunan Medical Device Registration Approval20212401912

Valproic Acid and Carbamazepine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Hunan Medical Device Registration Approval20222400937

25-Hydroxy Vitamin D Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Hunan Medical Device Registration Approval20222400940

Mycophenolic Acid Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Hunan Medical Device Registration Approval20222400941

Vancomycin Test Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Hunan Medical Device Registration Approval20232400376

Tacrolimus and Cyclosporine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Hunan Medical Device Registration Approval20232400377

Shanghai Ruikang Biotechnology Co., Ltd. NumberQuantity: 8

Shanghai Ruizhi Technology Co., Ltd.Company

Ultra-high Performance Liquid Chromatography Tandem Mass Spectrometry Detection System

Shanghai Medical Device Registration Approval20212220239

25-Hydroxy Vitamin D Test Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Shanghai Medical Device Registration Approval20212400098

Homocysteine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Shanghai Medical Device Registration Approval20212400099

Folic Acid Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Shanghai Medical Device Registration Approval20212400100

Glycocholic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Shanghai Medical Device Registration Approval20212400101

Total Triiodothyronine and Total Thyroxine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Shanghai Medical Device Registration Certificate20212400102

Vanillylmandelic Acid and Creatinine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Shanghai Medical Device Registration Certificate20212400103

Testosterone, Androstenedione, Dehydroepiandrosterone Sulfate, and 17α-Hydroxyprogesterone Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Shanghai Medical Device Registration Approval20232400190

Suzhou Wuxi Zekang Biotechnology Co., Ltd. Quantity: 8

Valproic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Su Medical Device Registration Approval20202401171

Tacrolimus Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Su Medical Device Registration Approval20212400811

Homocysteine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

JS Medical Device Registration Approval20212401393

Cyclosporine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Su Medical Device Registration Approval20212401430

25-Hydroxy Vitamin D Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

SU Med. Dev. Reg. Cert.20222400869

Quetiapine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Su Medical Device Registration Approval20222401711

Olanzapine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

JS Medical Device Registration Certificate20222401712

Lamotrigine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Su Medical Device Registration Approval20222402019

Zhejiang BioChainMedical Technology Co., Ltd. Quantity: 7

Hunan Baichen MedicalTherapy TechnologyCo., Ltd.

Hangzhou Baichen Medical Device Co., Ltd.

Valproic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Hunan Medical Device Registration Approval20222401961

Zhejiang Medical Device Registration Certificate20232401284

25-Hydroxy Vitamin D Test Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Approval20202400506

Carbamazepine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Certificate20212400542

Hunan Medical Device Registration Approval20212401480

Cortisol Test Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Zhejiang Medical Device Registration Approval20212400548

Hunan Medical Device Registration Approval20212401479

Vanillylmandelic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Certificate20232401279

Hunan Medical Device Registration Approval20222401612

Tacrolimus Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Approval20232401283

Trace Element Analyzer

Zhejiang Medical Device Registration Certificate20232221107

Hunan Medical Device Registration Approval20222221205

Guangzhou Darui Biotechnology Co., Ltd. Quantity: 6

Time-of-Flight Mass Spectrometry Detection System

Guangdong Medical Device Registration Approval20182220875

Liquid Chromatography-Tandem Mass Spectrometry System

Yue Medical Device Registration Approval20222220154

25-Hydroxy Vitamin D Assay Kit (Tandem Mass Spectrometry Method)

Guangdong Medical Device Registration Approval20212400293

Folic Acid Assay Kit (Tandem Mass Spectrometry)

Canton Medical Device Registration Approval20212400472

Kit for the Determination of Multiple Amino Acids, Carnitine, and Succinylacetone (Tandem Mass Spectrometry Method)

National Medical Device Registration20223400972

Twenty-Gene Mutation Testing Kit for Hereditary Deafness (Time-of-Flight Mass Spectrometry)

China Medical Device Registration20233400012

Guangzhou Fenghua Bioengineering Co., Ltd. Quantity: 6

Triple Quadrupole Mass Spectrometry System

Yue Medical Device Registration Approval20182220784

Succinylacetone and Non-derivatized Multiple Amino Acids, Carnitine Assay Kit (Tandem Mass Spectrometry)

National Medical Device Registration Approval20163401324

Derivatization Reagent Kit for the Determination of Multiple Amino Acids and Carnitines (Tandem Mass Spectrometry)

NMPA Registration Certificate20163401325

25-Hydroxy Vitamin D Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Guangdong Medical Device Registration Certificate20202401385

Water-Soluble Vitamins Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Guangdong Medical Device Registration Approval20222400602

Fat-Soluble Vitamin Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Yue Medical Device Registration Approval20222400603

Nanjing Pinnacle Healthcare Technology Co., Ltd. Quantity: 6

Triple Quadrupole Mass Spectrometry System

Su Medical Device Registration Approval20202220435

25-Hydroxy Vitamin D Test Kit (Liquid Chromatography-Tandem Mass Spectrometry)

JS Medical Device Registration Certificate20212400164

Valproic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

JS Medical Device Registration Approval20222400405

Immune Suppressant Three-Item Test Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Su Medical Device Registration Approval20222402170

Homocysteine Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

SU Med Dev Reg Cert20232400765

Glycocholic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

JS Medical Device Registration Certificate20232400782

Mass Spectrometry Biotechnology Co., Ltd. Quantity: 6

25-Hydroxy Vitamin D Test Reagent (Liquid Chromatography-Tandem Mass Spectrometry)

LU MEDICAL DEVICE REGISTRATION APPROVAL20192400142

Cortisol Test Reagent (Liquid Chromatography-Tandem Mass Spectrometry Method)

Lu Mechanical Registration Approval20192400601

Fat-Soluble Vitamin Detection Reagent (Liquid Chromatography-Tandem Mass Spectrometry)

Lu Mechanical Registration Approval20222400065

Creatine and Its Metabolism-Related Substances Quality Control Materials (Tandem Mass Spectrometry Method)

Lu Mechanical Registration Approval20222400689

Three Immunosuppressant Assay Reagents (Liquid Chromatography-Tandem Mass Spectrometry)

Lu Mechanical Registration Approval20222401191

Homocysteine and Its Metabolism-Related Substances Detection Reagents (Liquid Chromatography-Tandem Mass Spectrometry)

Lu Medical Device Registration Approval20232400042

Rayleigh Spectrum (Hangzhou) Medical Technology Co., Ltd.Department

Rayzpectra (Hangzhou) Medical Device Co., Ltd.

25-Hydroxy Vitamin D Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Certificate No. 20232401008

Seven-Element Test Kit (Inductively Coupled Plasma Mass Spectrometry)

Zhejiang Medical Device Registration Certificate No. 20222401171

Quality Control Materials for Blood Elements (Inductively Coupled Plasma Mass Spectrometry)

Zhejiang Medical Device Registration Certificate No. 20232401179

Trace Element Analyzer

Zhejiang Medical Device Registration Certificate No. 20212220150

Rongzhi Biotechnology (Qingdao) Co., Ltd.

Time-of-Flight Mass Spectrometer

Shandong Medical Device Registration Certificate No. 20212220508

Gram-Positive Bacteria Identification Kit (Time-of-Flight Mass Spectrometry Method)

Shandong Medical Device Registration Certificate No. 20202401355

Identification Kit for Gram-Negative Bacilli (Time-of-Flight Mass Spectrometry)

Shandong Medical Device Registration Certificate No. 20202401349

Yeast-like Fungi Identification Kit (Time-of-Flight Mass Spectrometry)

Shandong Medical Device Registration Certificate No. 20202401350

Shenzhen BGI Co., Ltd.Limited Company

BGIBiotechnology (Wuhan) Co., Ltd.

Wuhan Huada Gene BiosciencesMedical Engineering Co., Ltd.

Shenzhen BGI Biomedical Engineering Co., Ltd.

Amino Acids and Carnitine Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

National Medical Device Registration Approval20173403180

Time-of-Flight Mass Spectrometry Detection System

E-Medical Device Registration Certificate20222223888

Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

Canton Medical Device Registration Approval20232221006

Hangzhou Pujù Medical Technology Co., Ltd.

Trace Element Analyzer

Zhejiang Medical Device Registration Certificate20212220619

Liquid Chromatography Tandem Mass Spectrometry System

Zhejiang Medical Device Registration Approval20222220115

25-Hydroxy Vitamin D Test Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Approval20222401240

Anhui Hancure Diagnostic Technology Co., Ltd.

High-Performance Liquid Chromatography Tandem Mass Spectrometry Detection System

Wan Medical Device Registration Approval20232220029

Glycocholic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Anhui Medical Device Registration Approval20222400181

25-Hydroxy Vitamin D Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Anhui Medical Device Registration Approval20222400288

Suzhou Panomics BioTech Co., Ltd.

Hunan Ruizhi Technology Co., Ltd.

Ultra-high Performance Liquid Chromatography Tandem Mass Spectrometry System

Hunan Medical Device Registration Approval20212221224

Homocysteine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Su Medical Device Registration Approval20232401300

25-Hydroxy Vitamin D Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

SU Med. Dev. Reg. Cert.20232401318

Fosun Diagnostics Technology (Shanghai) Co., Ltd.

Homocysteine Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Shanghai Medical Device Registration Approval20162400091

1,5-Anhydroglucitol Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Shanghai Medical Device Registration Approval20162400317

25-Hydroxy Vitamin D Test Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Shanghai Medical Device Registration Approval20192400093

Shanghai Meiji Yuhua Biomedical Technology Co., Ltd.

Homocysteine Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Shanghai Medical Device Registration Certificate20182400287

25-Hydroxy Vitamin D Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Shanghai Medical Device Registration Approval20182400288

1,5-Anhydroglucitol Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Shanghai Medical Device Registration Certificate20182400289

Shenzhen Huiyun Biotechnology Co., Ltd.

25-Hydroxy Vitamin D Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Guangdong Medical Device Registration Approval20222401847

Homocysteine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Canton Medical Device Registration Approval20232401152

L-Tyrosine and Taurocholic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Yue Medical Device Registration Approval20232401415

Dalian Runsheng Kangtai Medical Laboratory Co., Ltd.

1,5-Anhydroglucitol Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Liao械注准20212400125

25-Hydroxy Vitamin D Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Liao械注准20212400126

Homocysteine Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Liao械注准20212400129

Suzhou Xinpeng Biotechnology Co., Ltd.

(Wallac Oy, a subsidiary of PerkinElmer)

Suzhou Yikun Biotechnology Co., Ltd.

Liquid Chromatography Tandem Mass Spectrometry Detection System

JS Medical Device Registration Approval20192220669

Triple Quadrupole Mass Spectrometry System

SU Med. Dev. Reg. Approval20212221279

Non-derivatized Amino Acids, Carnitine, Adenosine, Lysophosphatidylcholine, and Succinylacetone Assay Kit (Tandem Mass Spectrometry)

China Medical Device Registration Certificate20223400429

Beijing Yixin Bochuang Biotechnology Co., Ltd.

Time-of-Flight Mass Spectrometry System

Beijing Medical Device Registration Certificate No. 20162221065

Beijing Medical Device Registration Certificate No. 20192220492

Trace Element Analyzer

Beijing Medical Device Registration Certificate No. 20192220003

Beijing Medical Device Registration Certificate No. 20212220451

Chongqing Huangjia Biotechnology Co., Ltd.

Liquid Chromatography Tandem Mass Spectrometry Detection System

Yu Medical Device Registration Approval20222220144

25-Hydroxy Vitamin D Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Yu Medical Device Registration Approval20222400082

Qingdao Huiankang Bioengineering Co., Ltd.

25-Hydroxy Vitamin D Test Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Lu Medical Device Registration Approval20232400338

High-Performance Liquid Chromatography Tandem Mass Spectrometry Detection System

Lu Medical Device Registration Approval20232220805

Hunan Gurong Biotechnology Co., Ltd.

Time-of-Flight Mass Spectrometry System

Hunan Medical Device Registration Approval20222221562

Renin Detection Kit (Time-of-Flight Mass Spectrometry)

Hunan Medical Device Registration Approval20222401560

Jiangsu Simcere Medical Device Co., Ltd.

Time-of-Flight Mass Spectrometry Detection System

SU Med. Dev. Reg. Cert.20202220850

Human CYP2C19 Genotyping Kit (Time-of-Flight Mass Spectrometry)

NMPA Approved20233400263

Hefei Hehe Medical Technology Co., Ltd.

25-Hydroxy Vitamin D Test Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Anhui Medical Device Registration Approval20202400021

Vitamin A/E Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Anhui Medical Device Registration Approval20222400186

Maitville Medical Technology (Changsha) Co., Ltd.

4 Types of Steroid Hormone Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Hunan Medical Device Registration Approval20222401413

25-Hydroxy Vitamin D Test Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Hunan Medical Device Registration Approval20222401414

Taizhou Chenan Biotechnology Co., Ltd.Limited Company

Flow Cytometry Mass Spectrometer

JS Medical Device Registration Certificate No. 20232220387

Tianjin Yunjian Medical Device Co., Ltd.

Liquid Chromatography-Mass Spectrometry (LC-MS)

TJ Medical Device Registration Approval20202220258

Shanghai Runda Rongjia Biotechnology Co., Ltd.

Liquid Chromatography-Triple Quadrupole Mass Spectrometer System

Shanghai Medical Device Registration Approval20212220579

Tianjin Guoke Medical Technology Development Co., Ltd.

High-Performance Liquid Chromatography Tandem Mass Spectrometry Detection System

TJ Medical Device Registration Approval20212220103

Anhui Limu Medical Device Co., Ltd.

Liquid Chromatography-Tandem Mass Spectrometry System

Anhui Medical Device Registration Approval20222220215

Hangzhou Ji Yi Mai Te Medical Device Co., Ltd.

Triple Quadrupole Mass Spectrometry System

Zhejiang Medical Device Registration Approval20222220117

Guangzhou Keli Mass Spectrometry Medical DeviceCo., Ltd.

25-Hydroxy Vitamin D2/D3 Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Yue Medical Device Registration Approval 20192401208

Chengdu Fandi Medical Device Co., Ltd.

25-Hydroxy Vitamin D Test Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Sichuan Medical Device Registration Certificate20202400231

Guangzhou Jinqi Rui Biotechnology Co., Ltd.

25-Hydroxy Vitamin D Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Guangdong Medical Device Registration Approval20222400009

Jiangxi Tellgen Life Technology Co., Ltd.

25-Hydroxy Vitamin D Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Gan Medical Device Registration Approval20222400222

Zeda Precision (Hangzhou) Biopharmaceutical Co., Ltd.

Glycocholic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Zhejiang Medical Device Registration Certificate20222400463

Hefei XinZhi Medical Device Co., Ltd.

Free Triiodothyronine and Free Thyroxine Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Anhui Medical Device Registration Approval20232400094

Guangdong South Core Medical Technology Co., Ltd.

25-Hydroxy Vitamin D Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

Yue Medical Device Registration Approval20232401241

Zhengzhou Autobio Engineering Co., Ltd.

Fully Automatic Microbial Mass Spectrometry Detection System

Yu Medical Device Registration Approval20182220196

Zhongyuan Huiji Biotechnology Co., Ltd.Company

Fully Automatic Microbial Mass Spectrometry Detection System

Yu Medical Device Registration Approval20202220197

Guangzhou Hexin Health Source Medical Technology Co., Ltd.

Fully Automatic Microbial Mass Spectrometry Detection System

Yue Medical Device Registration Approval20202220695

Fujian Branch of Jiangsu Tianrui Instrument Co., Ltd.

Microbial Identification Time-of-Flight Mass Spectrometer

Medical Device Registration Certificate of Fujian Province20192220072

Zhuhai Meihua Medical Technology Co., Ltd.

Mass Spectrometer

Guangdong Medical Device Registration Certificate20192220521

Zhuhai Delly Biotechnology Co., Ltd.

Fully Automatic Biomass Spectrometry Detection System

Canton Medical Device Registration Approval20202221818

East-West Analytical Instruments (Tianjin) Co., Ltd.

Time-of-Flight Mass Spectrometer

Jin械注准20222220402

Maiz (Hubei) Scientific Instruments Co., Ltd.

Fully Automatic Microbial Mass Spectrometry Identification System

E-Medical Device Registration Certificate20222223655

Chengdu Tailai Medical Laboratory Co., Ltd.

Time-of-Flight Mass Spectrometry System

Sichuan Medical Device Registration Approval20232220165

Suzhou Chuanglan Biotechnology Co., Ltd.

Fully Automatic Microbial Mass Spectrometry Detection System

JS Medical Device Registration Approval20232220592

Hunan Burui Biotechnology Co., Ltd.

Human Breath Detection Mass Spectrometer

Hunan Medical Device Registration Approval20212221412

If there are any omissions, please feel free to leave a comment to supplement.

---The End---

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