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BioMérieux, Beckman Coulter, Siemens Healthineers, Others Get 510(k) Clearances in November

NEW YORK – The US Food and Drug Administration cleared in vitro diagnostic tests and systems in November from BioMérieux, Beckman Coulter, Siemens Healthineers, Thermo Fisher Scientific, and others, according to the agency's website.

BioMérieux received clearance for its ETest Delafloxacin system — a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The ETest can be used to determine the minimum inhibitory concentration of delafloxacin (Melinta, Baxdela) against a number of microorganisms.

Beckman Coulter got clearance for its Access PCT chemiluminescent immunoassay for measuring procalcitonin levels using its Access immunoassay systems. Within its indications for use of the immunoassay, the FDA noted that measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients for progression to severe sepsis and septic shock on their first day of intensive care. In parallel, the FDA cleared Beckman's Access PCT Calibrators to calibrate the Access PCT assay for the quantitative measurement of PCT.

In a separate clearance, Beckman got the nod for its MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem, which determines quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. Specifically, the clearance related to updated breakpoints for Enterobacteriaceae and Pseudomonas aeruginosa in association with the antimicrobial meropenem (Pfizer, Merrem).

Also, the FDA cleared Siemens Healthineers' Advia Centaur Cortisol chemiluminescent immunoassay for the quantitative determination of cortisol in serum, plasma, and urine, using the firm's Advia Centaur XP system. Cortisol measurements are used in the diagnosis and treatment of adrenal gland disorders.

The firm also received clearance for its chemiluminescent Advia Centaur CA 15-3 assay to detect cancer antigen CA 15-3 in human serum and plasma using the firm's Advia Centaur, Advia Centaur XP and Advia Centaur XPT systems. The Advia Centaur CA 15-3 assay is used for monitoring the course of disease and therapy in metastatic breast cancer patients and for detection of recurrence in previously treated Stage II breast cancer patients, with greater than two positive lymph nodes, or Stage III breast cancer patients.

Thermo Fisher Scientific received clearance for its Sensititre Aris HiQ System, an automated plate management device consisting of an incubator and embedded OptiRead module, which is part of the firm's Sensititre antimicrobial susceptibility testing system. The Thermo Scientific Sensititre Aris HiQ System is designed for use with the Thermo Scientific Sensititre Swin Software System. The system and software work together to read Sensititre susceptibility plates, generating minimum inhibitory concentration and interpreting breakpoint results for non-fastidious microorganisms.

DiaSorin got the nod for its Simplexa VZV Swab Direct assay for the qualitative detection of varicella-zoster virus DNA and use with the firm's Liaison MDx instrument. In November, the firm also announced that the FDA had cleared its DiaSorin's Liaison XL Zika Capture IgM Assay II for detecting Zika virus IgM antibodies.

PerkinElmer got the go-ahead for its GSP Neonatal Total Galactose kit used for the determination of total galactose concentrations in blood specimens dried on filter paper. The kit is used to screen newborns for galactosemia, which a disorder that affects how the body processes galactose. The kit runs on PerkinElmer's GSP instrument.

The FDA granted clearance to Lin-Zhi International to market its LZI Cotinine II Enzyme Immunoassay to detect cotinine in human urine.

Other products that received FDA clearances include Immunalysis' Carisoprodol Metabolite/Meprobamate Urine HEIA enzyme immunoassay, used for the analysis of the anxiety disorder therapy meprobamate, marketed by Wyeth as Equanil and Wallace Laboratories as Miltown, at a cutoff of 280 ng/mL in human urine.

Meanwhile, Sebia received clearance for its Capi 3 Immunotyping kit for the detection and characterization of monoclonal proteins in human urine and serum.

The FDA granted clearance to Seventh Sense Biosystems for its TAP Blood Collection Device, a lithium, heparin-coated, single-use product, to collect capillary blood from the upper arm of adults aged 21 or older.

NantHealth received clearance for its Omics Core technology, a whole-exome tumor-normal in vitro diagnostic that measures overall tumor mutational burden in cancer tissue and reports somatic mutations in 468 cancer-relevant genes.

And the FDA authorized Vela Diagnostics' next-generation sequencing-based HIV-1 drug resistance mutation assay for marketing through its de novo premarket review pathway.