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Siemens Healthineers, Roche, Beckman Coulter, Abbott Gain FDA 510(k) Clearances in December

NEW YORK – The US Food and Drug Administration granted 510(k) clearances in December for assays from Siemens Healthineers, Roche, Beckman Coulter, Abbott, DiaSorin, and others, according to the agency's website.

Erlangen, Germany-based Siemens Healthineers nabbed clearance for its CardioPhase hsCRP prognostic test for cardiovascular disease. The test measures C-reactive protein (CRP) in serum and heparin and EDTA plasma through particle-enhanced immunonephelometry. CRP levels can be useful in detecting and evaluating infection, tissue injury, inflammatory disorders, and associated diseases. The test is designed for use on the firm's BN II and BN ProSpec systems, and the results can be used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes as a prognostic marker of recurring events in patients with stable coronary disease or acute coronary syndromes.

Basel, Switzerland-based Roche also got the go-ahead for tests to identify protein concentrations that can help rule out Alzheimer's disease as the cause for a patient's cognitive impairment. The firm's Elecsys β-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF electrochemiluminescence immunoassays are used to identify a patient's ratio of Abeta42 and pTau181 proteins, respectively, in cerebrospinal fluid samples. The test is intended for use in adults ages 55 years and older, and the ratio of proteins is used as an adjunct to other clinical diagnostic evaluations.

The firm also secured clearance for its Benzodiazepines II test for the qualitative and semiquantitative detection of benzodiazepines in urine. The test is designed for use with the firm's Cobas C instruments.

Beckman Coulter, a subsidiary of Danaher, got the nod for two blood-based paramagnetic particle chemiluminescent immunoassays for use with the firm's Access Immunoassay Systems. The Brea, California-based firm's Access Total βhCG (5th IS) for early pregnancy detection measures beta-human chorionic gonadotropin levels, and its Access Vitamin B12 assay measures vitamin B12 levels to aid the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Abbott Park, Illinois-based Abbott got 510(k) clearance for its blood-based Total Bilirubin2 assay to aid the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders by quantifying an individual's total bilirubin. In newborns, the assay also aids the diagnosis and management of neonatal jaundice and hemolytic disease. The test is designed for use with Abbott's Architect C System.

Waltham, Massachusetts-based Thermo Fisher Scientific's Microgenics business, meanwhile, gained clearance for its DRI Tricyclics Serum Tox Assay, a homogenous enzyme immunoassay for the qualitative and/or semiquantitative measurement of tricyclic antidepressants in serum, plasma, or urine of patients suspected of drug overdose. It provides preliminary analytical test results, and more specific chemical methods are needed to obtain a confirmed analytical result, the FDA noted.

Saluggia, Italy-based DiaSorin got 510(k) clearance for its Liaison Anti-HAV chemiluminescent immunoassay for detecting current or previous hepatitis A virus infections by measuring the total antibodies to the virus in human serum and sodium heparin plasma samples on the firm's Liaison analyzers.

San Francisco-based firm Cytovale got the OK for its IntelliSep prognostic blood-based test for evaluating the risk of developing sepsis with organ dysfunction in the three days following the test. The semiquantitative test measures non-microbial analytes to assess cellular host response via deformability cytometry of leukocyte biophysical properties. The test is intended for use with clinical assessments and lab findings to aid in the early detection of sepsis in adults who present to an emergency department with signs and symptoms of infection.

FDA officials also cleared ACT Genomics' ACTOnco IVD assay, a tumor profiling test that uses next-generation sequencing to identify point mutations, small insertions and deletions, ERBB2 gene amplification, and tumor mutational burden in patients with solid malignant neoplasms. The test is designed for use with the Thermo Fisher Scientific Ion GeneStudio S5 Prime System.

Also, Milan-based Sentinel Diagnostics gained FDA clearance for its Lp(a) Ultra low-density lipoprotein immunological test system for evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease. The test provides immunoturbidimetric quantitative determination of lipoprotein (a) in human serum and plasma using an automated analyzer.

French firm Diagnostica Stago also got 510(k) clearance for its STA-NeoPTimal coagulation screening test kit for use in laboratories to evaluate the extrinsic coagulation pathway and monitor oral vitamin K antagonist therapy. The test quantitatively determines prothrombin time in human citrated plasma and is designed for use on Stago's STA-R, STA Compact, and STA Satellite instruments.

Precision BioLogic also secured clearance for its Cryocheck Chromogenic Factor IX test for managing hemophilia B. The Nova Scotia-based firm's test to identify factor IX activity and deficiency in human plasma is validated for use on automated coagulation analyzers with a test range of zero to 200 percent FIX activity using one standard curve, and its frozen format allows for fast and easy preparation, the company said.

China-based Shenzhen Superbio Technology got the go-ahead for its Superbio Fentanyl Urine Detection Kit fluorescence immunoassay for qualitative detection of fentanyl in urine and its Superbio Immunofluorescence Analyzer Easy-11 assay reader. The reader is designed for use in a laboratory or at the point of care. The assay provides preliminary results, and alternative chemical testing methods are needed for confirmation, the FDA said.

The agency also granted clearance to Ortho Clinical Diagnostics for its Vitros Immunodiagnostic Products CA 125 II Reagent Pack to help monitor response to therapy for patients with epithelial ovarian cancer. The Vitros CA 125 II assay, which is designed for use with Ortho's Vitros 5600 Integrated System, is used to measure OC 125-defined antigen concentrations in human serum and plasma.

Bedford, Massachusetts-based firm Instrumentation Laboratory got clearance for its HemosIL von Willebrand Factor Antigen assay, an automated latex-enhanced immunoassay for measuring von Willebrand Factor Antigen in human citrated plasma on IL Coagulation Systems.

And Durham, North Carolina-based HemoSonics got FDA 510(k) clearance for its QPlus Cartridge, a multi-channel cartridge that is used with the Quantra Hemostasis Analyzer to measure coagulation properties in citrated venous or arterial whole blood samples. The analyzer uses sonic estimation of elasticity via resonance (SEER) sonorheometry to measure those properties during clot formation in surgical and intensive care settings. The firm said in November it had also secured 510(k) clearance for its QStat Cartridge assay for point-of-care hemostasis data during trauma and liver transplantation procedures.