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LabCorp, Sysmex, Diazyme, and Others Receive FDA Clearances for Assays, Diagnostic Systems in October

NEW YORK (360Dx) – Laboratory Corporation of America, Sysmex, and Diazyme Laboratories were among the companies that received US Food and Drug Administration clearances in October for their in vitro diagnostic tests, according to the FDA website.

The FDA cleared LabCorp's Extended Lipid Panel Assay for quantitative determination in human serum and plasma of total cholesterol, high density lipoprotein cholesterol, and triglycerides in human serum and plasma, as well as of apolipoprotein B in human serum, running on the LipoScience Vantera Clinical Analyzer.

Meantime, Sysmex received clearance for its UD-10 Fully Automated Urine Particle Digital Imaging Device for locating, digitally storing, and displaying microscopic images captured from urine specimens. The device locates and presents particles and cellular elements based on size ranges. The images are displayed for review and classification by a qualified clinical laboratory technologist on the firm's urinalysis data manager. This device is intended for in vitro diagnostic use in conjunction with a urine particle counter for screening patient populations in clinical laboratories, the FDA said.

The FDA cleared Diazyme Laboratories' enzymatic assay for the detection of 1,5- anhydroglucitol in serum or plasma for the intermediate monitoring of glycemic control in people with diabetes.

Also, Phamatech was granted clearance for its QuickScreen Pro Multi Drug Screening test for the detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methadone, methamphetamine, opiates, oxycodone, and other drugs of abuse and prescription medications.

PixCell Medical Technologies was granted clearance for its HemoScreen Hematology Analyzer, a system used to enumerate and classify a range of parameters in capillary and venous whole blood. The analyzer can be used in clinical laboratories or point-of-care settings to test adults and children at least 2 years old.

The Binding Site Group received clearance for its Optilite High Sensitivity C-Reactive Protein kit. It measures C-reactive protein in serum using the firm's Optilite analyzer and is used for evaluation of conditions associated with inflammation in otherwise healthy individuals.

The Immunalysis Ethyl Alcohol Enzyme Assay was cleared for the analysis of ethyl alcohol, or ethanol, in human urine, serum, or plasma with automated clinical chemistry analyzers. Clinicians measure ethanol in the diagnosis and treatment of alcohol intoxication and poisoning.

Immuno Concepts received clearance for the Histofluor Rodent LKS Fluorescent Antibody Test System for the detection of IgG autoantibodies by manual fluorescent microscopy or by the firm's Image Navigator Fluorescence SemiAutomated Microscope.  The test system is used to detect anti-mitochondrial, antiparietal cell, and anti-smooth muscle autoantibodies associated with type I autoimmune hepatitis, primary biliary cholangitis, and pernicious anemia or autoimmune gastritis in conjunction with other lab and clinical findings.

And EliTech Group received clearance for a sample-to-result diagnostic instrument and an assay to detect and differentiate herpes simplex viruses 1 and 2.

Other tests which received clearance last month include Abbott's next-generation Influenza A & B 2 and Strep A 2 molecular assays, which enable fast time-to-result for molecular influenza A & B and Strep A testing at the point of care.

Inova Diagnostics received clearance for a fecal extraction device designed for use with the firm's Quanta Flash Calprotectin assay, and Ansh Labs' PicoAMH ELISA diagnostic test was cleared as an aid in determining a patient’s menopausal status.

PerkinElmer received clearance for its NeoBase 2 Non-Derivatized MSMS kit for testing newborns for metabolic disorders with a single dried blood spot.

Late in October, the FDA cleared the Ortho Clinical Diagnostics Vitros XT 7600 Integrated System, which enables high-throughput clinical chemistry and immunoassay testing for mid- and high-volume labs.