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BioMérieux, DiaSorin, GenMark, and Others Receive FDA Clearances in December

NEW YORK (360Dx) – During December, a month in which legislators from the House and Senate released a new version of a draft bill incorporating the US Food and Drug Administration's ideas for diagnostics regulation, BioMérieux, DiaSorin, and GenMark Diagnostics were among the companies that received clearances for their in vitro diagnostic tests, according to the FDA website.

BioMérieux got the nod for its Vitek MS mass spectrometry system that uses MALDI-TOF MS to identify microorganisms cultured from human specimens. Clinicians can use the Vitek MS system to diagnose bacterial, yeast, and mold infections.

DiaSorin received clearance for its Liaison Calprotectin chemiluminescent immunoassay used to measure fecal calprotectin, a neutrophilic protein that's a marker of mucosal inflammation. The assay, performed on the Liaison XL analyzer, can be used in the diagnosis of inflammatory bowel diseases — specifically Crohn’s disease and ulcerative colitis — and to differentiate inflammatory bowel disease from irritable bowel syndrome. The firm simultaneously received clearance for the Liaison Quantitative Stool Extraction and Test device for use in preparing human stool specimens for testing in the calprotectin assay.

Further, Diasorin's assay to detect pathogens that cause pertussis, or whooping cough, received clearance for an additional claim in December.

Thermo Fisher Scientific's Phadia AB received clearance for the EliA RF IgM immunoassay for measuring IgM class rheumatoid factor antibodies in serum and plasma to diagnose rheumatoid arthritis while operating on the Phadia 2500/5000 instrument. The firm also received clearance for the EliA SmDP, an assay used to measure IgG antibodies specific for Sm protein antibodies in diagnosing systemic lupus erythematosus.

Thermo Fisher was also granted clearance for its Thermo Scientific QMS Plazomicin Immunoassay.

The FDA cleared Lin-Zhi International's LZI Fentanyl Enzyme Immunoassay for the detection of norfentanyl in human urine at a cutoff of 5 ng/mL.  The assay is designed for prescription use with some automated clinical chemistry analyzers. It provides a preliminary analytical result that must be confirmed by a more specific alternative chemical method, such as gas or liquid chromatography or mass spectrometry.

The FDA also cleared an Ark Diagnostics immunoassay for the detection of tramadol in urine at a cutoff of 100 ng/mL. The assay is used by prescription only and conducted in labs with automated clinical chemistry analyzers. 

Sekisui Diagnostics won FDA clearance for the Acucy Influenza A & B test with the Acucy system and the Influenza A & B control kit. The test consists of a rapid chromatographic immunoassay for detection of influenza A and B viral nucleoprotein antigens. Negative test results using the assay are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay, the FDA said.

Axis-Shield Diagnostics got clearance for the Advia Centaur Calcitonin assay used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.

YD Diagnostics was granted clearance for marketing of its UriScan 10ACR urine strips run on the UriScan Optima urine analyzer to measure blood, acetoacetic acid, protein, nitrite, glucose, pH, specific gravity, leucocytes, albumin, and creatinine, and to calculate the albumin to creatinine ratio. Such measurements are used in the evaluation of renal, urinary, and metabolic disorders.

Meantime, GenMark Diagnostics received clearance for a molecular diagnostic panel assay to detect fungal pathogens from blood cultures of patients with suspected bloodstream infections. It also received clearance for its ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel.

The FDA cleared Becton Dickinson's BD Max enteric viral panel, a molecular diagnostic test for the detection and differentiation of pathogens that cause viral gastroenteritis. And it cleared Hycor Biomedical's Noveos allergy testing system and a related assay for dust mite allergen detection.