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Roche, BioMérieux, Abbott Gain FDA 510(k) Clearances in October

NEW YORK – The US Food and Drug Administration granted 510(k) clearances in October for assays from Roche, BioMérieux, Abbott, and others, according to the agency's website.

Basel, Switzerland-based Roche nabbed four clearances for the month, including for a COVID-19 test and updates to three serological immunoassays used to detect infections with herpes simplex viruses 1 and 2 and cytomegalovirus. The real-time PCR-based Cobas SARS-CoV-2 Qualitative assay uses nasal or nasopharyngeal swab samples and is designed for use with the firm's Cobas 6800 and 8800 instruments. Meanwhile, the firm's Elecsys HSV-1 IgG, Elecsys HSV-2 IgG, and Elecsys CMV IgG assays are designed for use with Cobas E instruments.

French firm BioMérieux got the green light for its Vitek 2 AST-Gram Positive Cefoxitin Screen, a fully automated short-term incubation cycle antimicrobial susceptibility test used to predict mecA-mediated oxacillin resistance among Staphylococcus species. That test is designed for use on the company's Vitek 2 and Vitek 2 Compact systems.

BioMérieux's Salt Lake City, Utah-based subsidiary BioFire Diagnostics also gained FDA clearance for its BioFire Global Fever Panel, a multiplex assay designed for use with the firm's BioFire FilmArray 2.0 and FilmArray Torch PCR systems. The blood test is used to identify infections with chikungunya virus, dengue virus, Leptospira and Plasmodium species. The test also can differentiate between P. falciparum and P. vivax/ovale.

The agency also gave the go-ahead to Illinois-based Abbott's Architect CMV IgG test, a chemiluminescent microparticle immunoassay that measures IgG antibodies. The test is designed for use with the Architect i System. Abbott also gained clearances for its related Architect CMV IgG Controls.

Helena Laboratories also got an OK for its alpha-1 antitrypsin immunological test, the Spife A1AT Kit. The test results are used along with test results with other assays and clinical findings to aid in the diagnosis of alpha-1 antitrypsin deficiency, which is an inherited disorder that can lead to lung and liver damage and is a risk factor for chronic obstructive pulmonary disease.

Werfen-subsidiary Instrumentation Laboratory got the agency go-ahead for its HemosIL Liquid Anti-Xa test, which is an automated chromogenic heparin assay with synthetic chromogenic substrate and Factor Xa inactivation. When used with HemosIL Heparin Calibrators, the assay measures quantities in plasma of unfractionated heparin and low molecular weight heparin activity. When used with HemosIL Apixaban Calibrators, it measures apixaban concentrations through Factor Xa activity in patients who are on apixaban therapy and are at elevated risk of major bleeding or are undergoing a bleeding episode. Both uses of the assay are designed for use on ACL TOP Family and ACL TOP Family 50 Series instruments.

Fremont, California-based CoaguSense also nabbed FDA clearance for its Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self Testing, a portable instrument that uses a finger-stick-based blood test to detect clot formation. The instrument provides prothrombin time measurements expressed in INR units and is used to monitor patients receiving anticoagulation therapy.

And Nova Biomedical and OK BioTech both gained 510(k)s for enzymatic blood-glucose concentration test systems. The Nova Primary Glucose Analyzer System measures glucose concentrations in blood through reactions between glucose and oxygen molecules in the presence of a glucose oxidase enzyme. OK BioTech's SuperCheck Pro Blood Glucose Monitoring System is a home monitoring system that measures electrical current generated by reactions between blood and an enzyme, glucose dehydrogenase with its cofactor flavin adenine dinucleotide.