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FDA Issues Clearances to Cepheid, Becton Dickinson, BioMérieux, Others in February

NEW YORK ─ The US Food and Drug Administration granted 510(k) clearances in February for tests from Cepheid, Becton Dickinson, BioMérieux, Sekisui Diagnostics, and Zeptometrix, according to the agency's website.

Danaher's Cepheid obtained clearance for the Xpert Xpress MVP test with the GeneXpert Instrument to diagnose vaginal infections in women presenting with symptoms consistent with bacterial vaginosis, vulvovaginal candidiasis, or trichomoniasis. The test leverages PCR technology to amplify specific DNA targets and fluorogenic target-specific hybridization probes to detect and differentiate DNA.

Zeptometrix obtained FDA clearance for its Nattrol BD Max Vaginal Panel External Controls to monitor the performance of laboratory nucleic acid testing procedures for the qualitative detection of targets on the Becton Dickinson BD Vaginal Panel with the BD Max System.

The clearance includes the Nattrol BV Negative Control containing intact and inactivated Lactobacillus crispatus, and the Nattrol BV Positive Control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae that contains the bacterial vaginosis-associated bacterium 2 sequence. The clearance further includes the Nattrol Candida/TV Positive Control containing intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis.

Meanwhile, Becton Dickinson got the nod for its BD Vacutainer UltraTouch Push Button Blood Collection Set. The multi-sample, single-use blood collection device is used to train healthcare professionals for venipuncture to obtain blood specimens from patients including those whose veins are difficult to access.

BioMérieux obtained FDA clearance for it Vitek 2 AST-Gram Positive Linezolid assay for the antimicrobial susceptibility testing of Gram-positive microorganisms with the Vitek 2 and Vitek 2 Compact systems, and it obtained a separate clearance for Vitek 2 AST Yeast Fluconazole assay for antifungal susceptibility testing of Candida species with the Vitek 2 and Vitek 2 Compact systems.

Sekisui Diagnostics got the green light for its Acetaminophen assay to measure acetaminophen in serum or plasma with the Abbott Diagnostics Architect c8000 clinical chemistry analyzer. The test is used in the diagnosis of acetaminophen overdose toxicity.