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Ortho Clinical Diagnostics, Siemens Healthineers, Roche, and Others Obtain FDA Clearances in October

NEW YORK ─ The US Food and Drug Administration granted 510(k) clearances in October for tests from Ortho Clinical Diagnostics, Siemens Healthineers, Roche, Becton Dickinson, and others, according to the agency's website.

Raritan, New Jersey-based Ortho got the green light for its Vitros Immunodiagnostic Products NT-proBNP II Reagent Pack to measure N-terminal pro brain natriuretic peptide. The test is used to evaluate the severity of heart failure and runs on Ortho's Vitros 3600 Immunodiagnostic system.

The FDA also gave the nod to Erlangen, Germany-based Siemens Healthineers for its N Latex FLC Kappa and Lambda IVD reagents to detect kappa and lambda free light chains in serum. The test is used to diagnose multiple myeloma on the Siemens BN Systems and Atellica CH analyzers; immunoglobulin light-chain amyloidosis on its BN Systems and Atellica CH analyzers; and monoclonal gammopathy of undetermined significance on its BN Systems analyzer.

GeneOhm Sciences Canada, part of Franklin Lakes, New Jersey-based Becton Dickinson, obtained clearance for the BD Max Vaginal Panel running on the BD Max system. The test uses real-time PCR to detect DNA biomarkers of bacterial vaginosis, vulvovaginal candidiasis Candida species, and Trichomonas vaginalis. The test uses vaginal swabs from patients with symptoms of vaginitis or vaginosis.

Basel, Switzerland-based Roche obtained clearance for its Cobas Cdiff nucleic acid test running on the firm's Cobas Liat point-of-care system. The real-time PCR test detects the toxin B gene of toxigenic Clostridioides difficile in liquid or soft stool specimens obtained from patients suspected of having C. difficile infection.

The FDA greenlighted Marcy-l'Étoile, France-based BioMérieux's Vitek 2 AST Streptococcus Cefotaxime assay for antimicrobial susceptibility testing of Streptococcus spp. for patients using cefotaxime, an antibiotic active against most strains of numerous microorganisms. The assay runs on BioMérieux's Vitek 2 and Vitek 2 compact systems.

Mountain View, California-based Hitachi Chemical Diagnostics obtained clearance for the Optigen Allergen-Specific IgE Assay 12 Allergen Bundle A to detect circulating allergen-specific IgE concentrations in serum. The allergen bundle test, which runs on the Optigen AP3600 automated instrument, consists of assays for allergies to almond, Bermuda grass, cashew, clam, crab, hazelnut, oak, salmon, sesame seed, shrimp, tuna, and walnut.

Union City, California-based Abaxis obtained FDA clearance for the Piccolo Potassium Test System for the detection of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory or point-of-care setting. The potassium measurements are used to diagnose renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis, and gastrointestinal loss. The Abaxis test runs on the firm's Piccolo blood chemistry analyzer or Piccolo Xpress chemistry analyzer.