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Thermo Fisher Scientific, Diazyme Laboratories, Rheonix, Others Obtain FDA Clearances in December

NEW YORK ─ The US Food and Drug Administration granted 510(k) clearances in December for tests from Thermo Fisher Scientific, Diazyme Laboratories, Rheonix, Accriva Diagnostics, and others, according to the agency's website.

Waltham, Massachusetts-based Thermo Fisher Scientific got the nod for the Sensititre 18 to 24 hour minimum inhibitory concentration or breakpoint susceptibility system with cefiderocol, which is active clinically and in vitro against Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Acinetobacter baumannii, and Serratia marcescens.

Thermo Fisher also obtained clearance for its Sensititre YeastOne Susceptibility System with voriconazole that includes new FDA breakpoints and indications for testing Candida spp. on the system. Voriconazole is active both clinically and in vitro against Candida albicans, Candida krusei, and Candida parapsilosis.

Poway, California-based Diazyme Laboratories got the green light for the Diazyme DZ-Lite iFlash Total beta-hCG chemiluminescent immunoassay for the quantitative measurement of total beta-human chorionic gonadotropin in serum. The assay is used for the early detection of pregnancy while running on Diazyme's DZ-Lite iFlash 1800 chemiluminescence immunoassay analyzer.

Ithaca, New York-based Rheonix obtained FDA clearance for its STI TriPlex assay on the firm's Encompass MDx workstation. The automated DNA extraction and multiplex PCR amplification test system is used for the qualitative detection of DNA from Chlamydia trachomatis, and/or Neisseria gonorrhoeae, and/or Trichomonas vaginalis in male urine specimens collected with the Rheonix Urine Specimen Collection Kit. The test is used to diagnose chlamydial urogenital disease, gonococcal urogenital disease, and trichomoniasis in men who are asymptomatic or symptomatic.

Accriva Diagnostics got the green light for the Gem Hemochron 100 System, a battery-operated, portable instrument that performs quantitative coagulation tests using whole blood. The system is used with test cartridges at the point of care for patients aged 18 years and older, and includes tests for activated clotting time and low range activated clotting time.

Pomona, California-based Immunalysis got the green light for its Sefria Methamphetamine Oral Fluid Enzyme Immunoassay for the qualitative and semi-quantitative analysis of methamphetamine in human oral fluid using clinical analyzers. The semi-quantitative mode enables laboratories to determine an appropriate dilution of the specimen for confirmation by a method such as gas chromatography/mass spectrometry or liquid chromatography/tandem mass spectrometry. The semi-quantitative mode also permits laboratories to establish quality control procedures.

The methamphetamine immunoassay provides a preliminary analytical test result, according to the FDA. A more specific alternate chemical method must be used to obtain confirmation.

Immunalysis also got the nod for the Immunalysis Sefria Oxycodone Oral Fluid Enzyme Immunoassay for the qualitative and semi-quantitative analysis of oxycodone in human oral fluid with clinical analyzers.

Arzergrande, Italy-based Vacutest Kima nabbed clearance for its Blood Collection Needles for use by trained healthcare professionals to collect blood samples for evacuated blood collection tubes. The blood collection needles have a safety mechanism that can be activated to cover the needle immediately after puncture, providing protection from accidental sticks.

In other regulatory news in December, Cincinnati, Ohio-based Meridian Bioscience obtained clearance for its Curian Campy assay for the detection of Campylobacter infection. The firm announced the clearance earlier this month.