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510(k)

The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.

Roche Diagnostics got the nod for its Elecsys Anti-HAV II test for the detection of total antibodies ­­— IgG and IgM — to the hepatitis A virus.

The FDA cleared the system, comprising a blood collection device and associated test to measure long-term glucose levels in patients with diabetes. 

The clearance marks the first time that the tests have been indicated to follow a new paradigm in which two enzyme immunoassay tests can be conducted concurrently or sequentially, the FDA said.

Abbott said that its Afinion HbA1c assay used to diagnose diabetes could eventually be made available in physicians' offices through a CLIA waiver.

Included in the 510(k) clearances was one for AMS Diagnostics' Liasys 600 Electrolyte Measurement System for measuring sodium, chloride, and potassium in human serum.

The test uses turbidimetry to measure levels of fecal calprotectin, a neutrophilic protein biomarker of intestinal mucosal inflammation.

The firm is also developing a methylated DNA biomarker test — called EsoCheck Dx — for Barrett's esophagus that uses samples collected with EsoCheck.

The test, cleared for use with Quidel’s Triage MeterPro instrument, uses monoclonal antibodies that are specific for the metabolites of nine drug classes.

Applied BioCode said that it now has access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction.

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