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DiaSorin, PerkinElmer, Roche, Others Nab FDA 510(k) Clearances in November

NEW YORK – The US Food and Drug Administration granted 510(k) clearances for tests from DiaSorin, PerkinElmer, Roche, and others in November, according to the agency's website.

Saluggia, Italy-based DiaSorin got the nod for its Simplexa Congenital CMV Direct assay, an qPCR test for congenital cytomegalovirus infections using saliva swabs or urine samples from infants less than 21 days old. The company also secured authorization for the related Simplexa Congenital CMV Positive Control Pack.

PerkinElmer nabbed clearance for its Eonis SCID-SMA kit, an qPCR assay for the simultaneous detection of severe combined immunodeficiency (SCID) and spinal muscular atrophy (SMA). The Waltham, Massachusetts-based firm said last month that the kit was the first FDA-authorized assay for SMA screening in newborns, and the SMA portion of the assay went through the agency's de novo regulatory pathway while the SCID portion went through 510(k) clearance. The test is intended for use on Thermo Fisher Scientific's QuantStudio Dx qPCR instrument.

Basel, Switzerland-based Roche got the green light for its blood-based Cobas HCV hepatitis C test, a quantitative PCR assay designed for use on the company's Cobas 5800, 6800, and 8800 instruments. The test uses fully automated sample preparation followed by PCR amplification and detection.

Meantime, Brea, California-based Beckman Coulter Diagnostics, part of Danaher, got clearance for its fully automated DxI 9000 Access Immunoassay Analyzer for quantitative, semi-quantitative, or qualitative determination of analyte concentrations in bodily fluids as well as clearance for its Access TSH (3rd IS) paramagnetic particle chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone levels in blood and plasma.

Durham, North Carolina-based HemoSonics secured clearance for its QStat Cartridge to provide point-of-care hemostasis data during trauma and liver transplantation procedures. The cartridge is designed for use with the ultrasound-based Quantra Hemostasis Analyzer, which uses sonic estimation of elasticity via resonance (SEER) sonorheometry to measure coagulation properties in blood samples. The firm said last month the Quantra Hemostasis System can aid bleeding management decisions in operating rooms, emergency departments, and intensive care units.

ProciseDx got a go-ahead for its Procise CRP immunoassay for the quantitative determination of C-reactive protein in human serum. The San Diego-based firm's test, which is designed for use with the ProciseDx Analyzer, is intended to aid evaluation of injuries to body tissues, infections, and inflammatory disorders.

French firm Sebia also picked up 510(k) clearance for its FLC Kappa kit and FLC Lambda kit, both of which aid diagnosis in adults of multiple myeloma and AL amyloidosis in conjunction with other laboratory and clinical findings. The ELISA kits are used for quantification of free light chains in serum using antibodies targeting anti-Kappa and anti-Lambda free light chains.

And Lincolnshire, Illinois-based Sysmex America secured clearance for its XW-100 Automated Hematology Analyzer, an electrical resistance-type blood cell counter that is intended for CLIA-waived use to classify and quantify 12 hematology parameters of whole blood anticoagulated with K2/K3 EDTA, including basic complete blood count, three-part white blood cell differential, and mean corpuscular volume.