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Roche, BioMérieux, Horiba Nab FDA Clearances in March

NEW YORK – The US Food and Drug Administration in March cleared the marketing of in vitro diagnostic tests from Roche Diagnostics, BioMérieux, Horiba, and others, according to the agency's website.

Roche Diagnostics received clearance for the Elecsys BRAHMS PCT electrochemiluminescence immunoassay, which runs on the firm's Elecsys and Cobas e immunoassay analyzers and measures procalcitonin levels in serum and plasma.

The test has been cleared for assessing the risk that critically ill patients on their first day of admission to the intensive-care unit, will progress to severe sepsis and septic shock. It has also been cleared for other uses, including to track changes in procalcitonin levels over time and to guide decision-making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

Roche also nabbed 510(k) clearance for its Tina-quant Hemoglobin A1cDx Gen.3 assay to diagnose diabetes and identify patients who may be at risk for developing diabetes. The in vitro diagnostic reagent system runs on the Cobas c 503 clinical chemistry analyzer.

BioMérieux's BioFire Diagnostics business received clearance for its Blood Culture Identification 2 Panel, a multiplexed test for the identification of nucleic acids associated with bacteria and yeast, and the identification of antimicrobial resistance determinants. The panel runs on the BioFire FilmArray 2.0 or FilmArray Torch diagnostics systems. Additionally, BioMérieux nabbed clearance for its Vitek 2 AST-Gram Negative Imipenem/Relebactam product, a fully automated short-term incubation cycle antimicrobial susceptibility system.

The Centers for Disease Control and Prevention received clearance for its Influenza Real-Time RT-PCR Diagnostic Panel and associated typing kits. For example, one of the kits receiving clearance, the Influenza A/B Typing Kit, contains reagents and controls used in real-time RT-PCR assays on FDA-cleared in vitro diagnostic real-time PCR instruments. The kit is used for detection of influenza virus type A or B viral RNA in upper respiratory tract clinical specimens and to provide epidemiological information for surveillance of circulating influenza viruses.

The FDA granted clearance to Horiba for its Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, and Yumizen C1200 Rheumatoid Factor reagents. Horiba's Yumizen C1200 Ferritin reagent is used to measure ferritin to diagnose diseases associated with iron metabolism, hemochromatosis, and iron deficiency anemia. Its Yumizen C1200 Transferrin reagent is used to measure transferrin to diagnose malnutrition, acute inflammation, infection, and iron deficiency anemia, and its Yumizen C1200 Rheumatoid Factor reagent is used to measure rheumatoid factor to diagnose rheumatoid arthritis.

Other firms that received 510(k) clearances last month include SSI Diagnostica, which received clearance for its ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test, a lateral flow immunochromatographic assay used to detect Streptococcus pneumoniae and Legionella pneumophila antigens in urine specimens from patients with symptoms of pneumonia. The assay is further used to diagnose infections by detection of S. pneumoniae antigen in cerebrospinal fluid.

Also, MedTest Dx was granted clearance for its Pointe Scientific Cocaine Metabolite Enzyme Immunoassay for the measurement of benzoylecgonine, a cocaine metabolite, in human urine. The assay provides a preliminary analytical test result.

Meridian Bioscience received clearance for the Curian HpSA assay used to detect Helicobacter pylori antigen in human stool and associated infection. The test was cleared for use with the Curian Analyzer.

The FDA cleared the DiaSorin Liaison Anti-HAV chemiluminescent immunoassay, which detects antibodies to hepatitis A using the firm's Liaison analyzers for laboratory diagnosis of hepatitis A infections and to determine the presence of an antibody response to Hepatitis A in vaccine recipients.

Meantime, Beckman Coulter received clearance for its MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin and, separately, for its MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin. The firm's MicroScan Dried Gram-Negative MIC/Combo Panels are used to determine the antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.

Thermo Fisher Scientific got the go-ahead for an antimicrobial susceptibility test powder, its Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol.

Nova Biomedical was granted clearance for its Stat Profile Prime Plus Analyzer used by healthcare professionals in clinical laboratory settings and at the point-of-care for measuring glucose, lactate, creatinine, and blood urea nitrogen.

Quidel received clearance for its Triage Tox Drug Screen 94600 fluorescence immunoassay for use with the firm's Triage MeterPro to detect the drugs and/or metabolites in human urine of up to nine drug assays at or above specified threshold concentrations.

Hologic received clearance for use of a ready-made reagent format for its Aptima Combo 2 assay and the Aptima Trichomonas Vaginalis assay on its Tigris and Panther diagnostic systems.

Additionally, last month the FDA cleared Siemens Healthineers' RapidPoint 500e Blood Gas Analyzer, which is used to monitor critically ill patients, including those with COVID-19, in acute care settings, and Magnolia Medical Technologies for an expanded Steripath Gen2 Initial Specimen Diversion Device line of blood contamination reduction products. Ortho Clinical Diagnostics' Vitros BRAHMS procalcitonin assay to identify bacterial infections also received 510(k) clearance from the US Food and Drug Administration.