Roche Diagnostics, Beckman Coulter, BioMérieux, Mesa Biotech Receive FDA 510(k) Clearances in November – 360Dx

30December 2020

New York City ─ The United States Food and Drug Administration in November gave a few 510(k) clearances for in vitro diagnostic companies, according to the firm’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, germs, and hyaline casts; and the qualitative determination of non-squamous epithelial cells, crystals, yeasts, pathological casts, mucus, and sperm in urine. The gadget has a maximum theoretical throughput of as much as 116 samples per hour, the FDA said.

Danaher’s Beckman Coulter was provided the consent 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, blood stream, joints, and abdominal area.

The Brea, California-based business’s MicroScan Dried Gram-Negative MIC/Combo Panels are used in the determination of quantitative and/or qualitative antimicrobial representative 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 snatched a 510(k) clearance for its FilmArray Global Fever Panel External Control Package, which consists of favorable and unfavorable external controls. The external control set is used with the firm’s FilmArray Global Fever Panel, which spots leptospirosis, malaria, chikungunya fever, and dengue fever. Both the favorable and unfavorable external controls are offered in FilmArray Control Injection Vials. The Favorable Control Injection Vial consists of dried synthetic DNA segments in buffer and stabilizer to assess the presence of each assay on the panel. The Unfavorable Control Injection Vial consists of no DNA and is non-reactive with the panel’s assays.

In other regulatory news throughout November, Mesa Biotech got 510(k) clearance and a CLIA waiver, which it announced in December, for its Accula Strep A molecular test.Source: 360dx. com

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