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FDA Grants 510(k) Clearances to Roche Diagnostics, Abbott, Siemens Healthineers, Others in February

NEW YORK – The US Food and Drug Administration in February cleared the marketing of in vitro diagnostic tests and systems from Roche Diagnostics, Abbott, Siemens Healthineers, Thermo Fisher Scientific, and others, according to the agency's website.

Roche Diagnostics received three clearances, including one for its Cobas Influenza A/B and RSV nucleic acid test running on the Cobas Liat system. The automated, multiplex, real-time, RT-PCR assay detects and discriminates between influenza A virus RNA, influenza B virus RNA, and respiratory syncytial virus RNA in swabs from patients with respiratory infection symptoms.

The company also got FDA clearance for its Tina-quant C-Reactive Protein IV test, an immunoturbidimetric assay for measurement of C-reactive protein in serum and plasma on Roche's Cobas c systems. The test is used to evaluate the amount of injury to body tissues.

The FDA cleared Roche's Elecsys Anti-TSHR immunoassay for the measurement of autoantibodies to thyroid stimulating hormone receptor in human serum using a human thyroid stimulating monoclonal antibody. The measurement is used to assess patients suspected of Graves' disease. The electrochemiluminescence immunoassay runs on Roche's Cobas e 601 immunoassay analyzers.

Abbott received five clearances associated with its i-Stat Chem8+ cartridge running on the company's iStat 1 system, including for the measurement of glucose and creatinine in the point-of-care or clinical lab setting. Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Further, the FDA cleared use of the i-Stat Chem8+ cartridge running on the i-Stat 1 system to measure hematocrit for the determination and monitoring of total red cell volumes, which can be associated with conditions that include anemia and erythrocytosis.

The agency also granted clearance for use of the Abbott cartridge and system for the measurement of sodium, potassium, chloride, and blood urea nitrogen. In a separate clearance, the FDA gave the go-ahead to market the system for measurement of total carbon dioxide used in the diagnosis, monitoring, and treatment of disorders associated with changes in body acid base balance.

The FDA also cleared the i-Stat Chem8+ cartridge and i-Stat 1 system for conducing ionized calcium measurements used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.

In February, Siemens Healthineers got the go-ahead for use of its Advia Centaur BR assay to measure cancer antigen CA 27.29 using the Advia Centaur, Advia Centaur XP, and Advia Centaur XPT systems. The test is used to monitor patients previously treated for Stage II or Stage III breast cancer, and to manage breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

BioMérieux got the nod to market its Vitek 2 AST-GN Polymyxin B quantitative assay for antimicrobial susceptibility testing of Gram-negative bacilli and for use with the Vitek 2 and Vitek 2 Compact systems. Polymyxin B, an antibiotic marketed by Global Pharma Tek and others as Poly-Rx, is active against most strains of Pseudomonas aeruginosa.

Thermo Fisher Scientific's Life Technologies business received clearance for its Applied Biosystems 3500 Dx Genetic Analyzer and the Applied Biosystems 3500xL Dx Genetic Analyzer. Both are used to detect fluorescently labeled DNA by capillary electrophoresis for sequencing and fragment analysis using FDA-cleared and approved assays.

ARK Diagnostics got the go-ahead for its ARK Fentanyl II immunoassay for the measurement of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL on automated clinical chemistry lab analyzers.

In other FDA-related regulatory news during February, blood culture collection firm Kurin got the nod for its novel push-button needle, and the FDA issued an emergency use authorization for a test from the US Centers for Disease Control and Prevention for the novel coronavirus, COVID-19.

Also, the FDA authorized marketing of Asuragen’s AmplideX Fragile X Dx and Carrier Screen Kit, the first genetic test for fragile X syndrome.