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Sysmex, Beckman Coulter, Thermo Fisher Scientific, Others Receive FDA Clearances in January

NEW YORK (360Dx) – During January, the US Food and Drug Administration cleared in vitro diagnostic tests from Sysmex, Beckman Coulter, Thermo Fisher Scientific, and others, according to the agency's website.

Sysmex America obtained clearance for its XN-L Automated Hematology Analyzer, a multi-parameter automated differential cell counter that classifies and enumerates whole blood and body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling.

Beckman Coulter received clearance for use of its HbA1c Advanced assay on the firm's DxC 700 AU clinical chemistry analyzer. The assay is used to determine mmol/mol HbA1c and percentage HbA1c concentration in whole blood and for the diagnosis of diabetes mellitus.

The FDA granted clearance to Thermo Fisher Scientific for use of its Sensititre MIC and Breakpoint Susceptibility System for clinical susceptibility testing of non-fastidious gram-negative isolates consisting of Enterobacteriaceae, Pseudomonas aeruginosa, and other non-Enterobacteriaceae, and for testing of non-fastidious gram-positive isolates, consisting of Staphylococcus sp., Enterococcus sp., and beta hemolytic Streptococci other than S. pneumoniae.

Other firms whose products got FDA's nod last month include 23andMe, which got clearance for its genetic health risk report for a syndrome associated with a higher risk of developing hereditary colorectal cancer.

ILine Microsystems received clearance for its microINR System for use by professional healthcare providers to determine a patient's International Normalized Ratio (INR) — a measurement used to monitor patient response to warfarin oral anticoagulation therapy at the point of care.

The FDA cleared the Immunalysis Sefria PCP Oral Fluid Enzyme Immunoassay, which has a cutoff of 10 ng/mL in oral fluid accumulated with the firm's Quantisal II oral fluid collection device. The assay, which is used with clinical analyzers, is for analyzing phencyclidine (PCP) in human oral fluid.

Qualigen received clearance for use of its FastPack IP Sex Hormone Binding Globulin Immunoassay, a chemiluminescent test used to diagnose androgen disorders while running on the firm's FastPack system.

Medical device firm Kurin got the nod for its Kurin Lock blood culture collection product with a peripheral IV infusion set. PTS Diagnostics received clearance for its medical device convenience kit for quantitatively measuring the percent of glycated hemoglobin, total cholesterol, high-density lipoprotein, triglycerides, and glucose in whole blood.

And the FDA granted de novo classification for eight of the Oxford Gene Technology's Cytocell Aquarius Haematology fluorescence in situ hybridization probes for acute myeloid leukemia and myelodysplastic syndromes.

Last month also, the US Food and Drug Administration issued a request for comment on plans previously announced in the fall to modernize the 510(k) process used by many IVD manufacturers.