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Roche Diagnostics, Beckman Coulter, BioMérieux, Mesa Biotech Receive FDA 510(k) Clearances in November

NEW YORK ─ The US Food and Drug Administration in November granted a few 510(k) clearances for in vitro diagnostic companies, according to the agency's website.

The diagnostics division of Basel, Switzerland-based Roche got the green light for its Cobas u 701 analyzer, a fully automated stand-alone urine analysis system optimized for high-volume laboratories.

The analyzer is used for the quantitative determination of erythrocytes and leukocytes; the semi-quantitative determination of squamous epithelial cells, bacteria, and hyaline casts; and the qualitative determination of non-squamous epithelial cells, crystals, yeasts, pathological casts, mucus, and sperm in urine. The device has a maximum theoretical throughput of up to 116 samples per hour, the FDA said.

Danaher's Beckman Coulter was given the go-ahead for its MicroScan Dried Gram-Negative MIC/Combo Panels with the antibiotic ceftazidime (Eli Lilly's Tazidime, Pfizer's Tazicef, Teligent's Fortaz), used to treat meningitis and infections in the lower respiratory tract, skin, urinary tract, bloodstream, joints, and abdomen.

The Brea, California-based company's MicroScan Dried Gram-Negative MIC/Combo Panels are used in the determination of quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.

Further, the BioFire Defense subsidiary of Marcy-l'Étoile, France-based BioMérieux nabbed a 510(k) clearance for its FilmArray Global Fever Panel External Control Kit, which contains positive and negative external controls. The external control kit is used with the firm's FilmArray Global Fever Panel, which detects leptospirosis, malaria, chikungunya fever, and dengue fever.  

Both the positive and negative external controls are provided in FilmArray Control Injection Vials. The Positive Control Injection Vial contains dried synthetic DNA segments in buffer and stabilizer to assess the presence of each assay on the panel. The Negative Control Injection Vial contains no DNA and is non-reactive with the panel's assays.

In other regulatory news during November, Mesa Biotech obtained 510(k) clearance and a CLIA waiver, which it announced in December, for its Accula Strep A molecular test.