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Roche Diagnostics, Beckman Coulter, Sekisui Diagnostics, Others Receive FDA Clearances in April

NEW YORK (360Dx) – During April, the US Food and Drug Administration cleared in vitro diagnostic tests from Roche Diagnostics, Beckman Coulter, Cepheid, Genmark Diagnostics and others, according to the agency's website.

Roche Diagnostics received clearance for its Elecsys TSH electrochemiluminescence immunoassay, which is used for the diagnosis of thyroid and pituitary disorders while running on the firm's Cobas e immunoassay analyzer.

The FDA cleared Sekisui Diagnostics' Sekure Creatine Kinase Assay, which measures creatine kinase activity in serum and plasma on the firm's SK500 clinical chemistry system. The measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases, such as progressive Duchenne-type muscular dystrophy.

InDevr received clearance for its FluChip-8G Influenza A+B Assay, a multiplex RT-PCR diagnostic test used for the detection and differentiation of seasonal influenza A/H3N2, seasonal influenza A/H1N1pdm09, and non-seasonal influenza A subtypes other than seasonal H1N1pdm09 or H3N2.

The FDA cleared IXensor's PixoTest POCT System, consisting of a point-of-care analyzer and A1c test kit used to measure glycated hemoglobin and to monitor long-term glycemic control in people previously diagnosed with diabetes mellitus.

Cepheid, a Danaher company, received clearance for incorporating enhanced algorithms into a definition file used in determining a number for test results — specifically results that are Staphylococcus aureus (SA) positive, methicillin-resistant Staphylococcus aureus (MRSA) positive, SA negative, and MRSA negative — using the firm's Xpert MRSA/SA Blood Culture Assay.

Microbiologics got clearance for the Cepheid Xpert C. difficile/Epi Control Panel for use as external assayed positive and negative quality controls to monitor the performance of in vitro nucleic acid testing procedures. The procedures are used in the detection of Clostridium difficile by the Cepheid Xpert C. difficile/Epi assay running on the GeneXpert Dx System.

Beckman Coulter was granted clearance for its MicroScan Dried Gram-Negative MIC/Combo Panel, used to determine antimicrobial agent susceptibility of colonies grown on solid media of aerobic and facultative anaerobic gram-negative bacilli. The submission is specifically associated with the addition to the test panel of the antimicrobial eravacycline (Xerava) at concentrations of 0.016 to 32 µg/mL.

In April, the FDA also cleared Ortho Clinical Diagnostics' Vitros XT MicroSlides multitest technology, which allows labs to run two tests simultaneously on one MicroSlide; Bio-Rad Laboratories' IH-500 automated random access system for blood typing and screening; Aggredyne's AggreGuide A-100 ADP Assay, a cartridge used to measure the effect of antiplatelet medications that target P2Y12, a platelet receptor; and CoaguSense's second-generation prothrombin time/international normalized ratio monitoring system for patients on warfarin (Coumadin).

GenMark Diagnostics was granted 510(k) clearance for an assay to detect gram-negative bacteria in blood cultures. The firm said that the clearance of its third BCID panel paves the way for a customizable approach to sepsis MDx.