Skip to main content
Premium Trial:

Request an Annual Quote

Roche's Benchtop Analyzer Receives FDA Clearance

NEW YORK (360Dx) – A benchtop analyzer from Roche Diagnostics and an immunoassay system from Shenzhen New Industries Biomedical were among the instruments and tests cleared by the US Food and Drug Administration in July, according to the agency.

The FDA granted 510(k) clearance to Roche's Cobas b 101 instrument, as well as the Cobas HbA1c test. The fully automated and self-contained benchtop instrument uses a single-use reagent disc to measure HbA1c from capillary and/or venous whole-blood samples, according to a document filed with the FDA.

Meanwhile, the Cobas HbA1c test is an in vitro diagnostic test for the quantitative measurement of glycate hemoglobin. The assay is for use with the Cobas b 101 platform, and is intended for use in a clinical laboratory or point-of-care setting.

Also receiving FDA clearance last month was the Maglumi 2000 automated immunoassay analyzer from Shenzhen New Industries Biomedical, which uses chemiluminescent technology for running IVD tests on clinical serum samples. The firm's Maglumi 2000 TSH assay for the quantitative determination of thyroid-stimulating hormone in human serum also received 510(k) clearance. The assay is for diagnosing thyroid disorders.

Lastly, Immco Diagnostics' ELISA for celiac disease was granted FDA clearance. The test is performed as a solid phase immunoassay and is intended for the qualitative or semiquantitative detection of IgA or IgG antigliadin antibodies in human serum to aid in diagnosing patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings.

Other instruments receiving FDA clearance in July include a new flow cytometer from Becton Dickinson; an expanded version of Bruker's MALDI Biotyper; and expanded indications for BioMérieux's Vitek MS MALDI-TOF Mass Spectrometery System.