September FDA 510(k) Clearances Spotlight: Abbott, Siemens, Beckman Coulter, Roche, and Others Secure Approvals for Key IVD Assays and Platforms

In September, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for hematology and immunoassay analyzers, biologics infection panels, and ancillary monitoring and treatment assays for cancer patients.

Abbott Obtains Four 510(k) Clearances in September: Afinion 2 and Alere Afinion AS100 Analyzers Approved for Multiplex Testing with Afinion Kits; Afinion HbA1c Assay Quantifies Glycated Hemoglobin in Venous and Capillary Whole Blood, a Marker of Long-Term Metabolic Control in Diabetes Patients.

The company's TBI chemiluminescent immunoassay has also received 510(k) clearance, which can help assess adults with suspected mild traumatic brain injury within 12 hours after injury. The assay is designed for Abbott's Architect I1000SR system to quantitatively detect glial fibrillary acidic protein and ubiquitin carboxy-terminal hydrolase L1 in plasma and serum, and to provide semi-quantitative analysis of the test results.

Abbott also received separate approvals for a pair of cassettes designed for blood testing on the company's point-of-care I-Stat Alinity platform. The I-Stat G cassette, used with the I-Stat system, quantitatively measures glucose in blood to assist in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders. The I-Stat G3+ cassette, used with the I-Stat 1 system, quantitatively measures pH, partial pressure of oxygen, and partial pressure of carbon dioxide to assist in the diagnosis, monitoring, and treatment of respiratory, metabolic, and acid-base disorders.

T2 Biosystems Receives Approval for Test to Help Diagnose Anthrax, Tularemia, Melioidosis, Plague, Typhus, and Other Biothreat Agent InfectionsA test from T2 Biosystems has been approved to help diagnose anthrax, tularemia, melioidosis, pneumonic plague, typhus, and plague in patients showing symptoms and signs of infection by biothreat agents or those at risk of exposure to these agents. The company’s T2Biothreat Panel is a nucleic acid-based multiplex qualitative detection method used to identify Bacillus anthracis, Francisella tularensis, Burkholderia pseudomallei, Burkholderia mallei, Yersinia pestis, and Rickettsia infections from K2EDTA whole blood samples.

FDA Clears Siemens' Updated Test for Measuring Treatment Response in Patients with Epithelial Ovarian Cancer and Detecting Residual Ovarian Cancer Post First-Line Therapy

Siemens Healthineers has also received 510(k) clearance for an assay that aids in diagnosing heart failure. The ADVIA Centaur NT-proBNP II Assay is used for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in serum and plasma, specifically designed for use with the ADVIA Centaur XP system.

Beckman Coulter's Updated Immunoassay for Measuring Thyroid Antibodies Receives 510(k) Clearance for Auxiliary Diagnosis of Hashimoto's Disease, Nontoxic Goiter, and Basedow's Disease. The company’s Access Thyroglobulin Antibody II assay is a paramagnetic particle chemiluminescent immunoassay used for the quantitative determination of thyroglobulin antibody levels in serum and plasma. It is designed for use with Beckman Coulter’s Access Immunoassay systems.

Cepheid's real-time PCR assay for identifying Group B Streptococcus infection in pregnant women has also received 510(k) clearance. Its Xpert Xpress GBS test kit can be used for vaginal or rectal swab samples, allowing prenatal testing during labor. The kit is designed for use with Cepheid’s GeneXpert Dx and GeneXpert Infinity systems.

At the same time, Thermo Fisher Scientific's assay for helping monitor and treat patients with gastroenteropancreatic neuroendocrine tumors has also received 510(k) clearance. Its Brahms CgA II Kryptor automated immunofluorescence assay is used for the quantitative determination of chromogranin A concentration in serum and is designed for use with the company’s Brahms Kryptor Compact Plus analyzer.

Two immunometric assays from Roche have received 510(k) clearance for the quantitative determination of thyroglobulin in serum and plasma. The Elecsys Tg II assay is intended to aid in monitoring for residual, recurrent, or metastatic disease in patients with differentiated thyroid cancer following thyroidectomy, while the Elecsys Anti-Tg assay is used to assist in detecting autoimmune thyroid diseases.

Meanwhile, Biokit's serological assay for herpesvirus infection has also been approved. The Architect HSV-1 IgG is a chemiluminescent microparticle immunoassay for the qualitative detection of IgG antibodies to herpes simplex virus type 1 in serum and plasma, specifically designed for Abbott Laboratories' Architect i System.

Instrumentation Laboratory's fully automated chemiluminescence benchtop analyzer ACL TOP 970 CL and two chemiluminescent immunoassays have received FDA clearance. The HemosIL CL Anticardiolipin IgM assay and the HemosIL CL Anti-ß2 Glycoprotein-I IgM assay are used for the quantitative detection of IgM antibodies in 3.2% or 3.8% citrated plasma, aiding in the diagnosis of antiphospholipid syndrome.

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