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Siemens Healthineers, Thermo Fisher Scientific, Acon, Hologic, Others Gain FDA Clearances in November

NEW YORK – The US Food and Drug Administration in November granted 510(k) clearances for an immunoassay for C-reactive protein, tests to detect overdose of antidepressants or use of certain opioids, and tests for the infectious diseases COVID-19, chlamydia, and Trichomonas vaginalis.

Erlangen, Germany-based Siemens Healthineers got the agency's go-ahead for an immunological test used to measure C-reactive protein. The firm's CardioPhase hsCRP is an in vitro diagnostic reagent that is for the quantitative determination of C-reactive protein in serum, heparinized plasma, and EDTA plasma through particle enhanced immunonephelometry, and it is designed for use on the BN II and BN ProSpec System instruments. The results are used to aid evaluations of infection, tissue injury, inflammatory disorders, and related diseases, as well as determine through high-sensitivity C-reactive protein measurements the risk of cardiovascular disease and the risk of recurrent events in patients with stable coronary disease or acute coronary syndromes.

Thermo Fisher Scientific's Microgenics business obtained clearance for an enzyme immunoassay used to identify the presence of tricyclic antidepressants during a suspected overdose. The Alinity C Tricyclic Antidepressants Reagent Kit is used for qualitative or semiquantitative determination of tricyclic antidepressants in serum or plasma with a cutoff concentration of 300 ng/mL. The semiquantitative results are used to determine the appropriate dilution of a specimen for confirmatory testing or establish control procedures in laboratories. The test is designed for use with Abbott Laboratories' Alinity C System instruments.

Acon Laboratories secured 510(k) clearance for an over-the-counter rapid antigen test for COVID-19. The San Diego-based firm's Flowflex COVID-19 Antigen Home Test is a lateral flow immunoassay that is used to detect SARS-CoV-2 virus nucleocapsid protein antigen in anterior nasal swab samples within six days of onset of signs or symptoms of COVID-19 with a second test performed 48-72 hours after a negative result.

Marlborough, Massachusetts-based Hologic gained FDA 510(k) clearance for updates to a pair of infectious disease nucleic acid amplification tests. The firm secured clearance for use of its Aptima Chlamydia trachomatis assay on the firm's Panther instruments. The test for qualitative detection of chlamydia ribosomal RNA was previously cleared for use on Hologic's Tigris DTS instruments.

The firm also gained an updated clearance to allow performance of its Aptima Trichomonas vaginalis assay with a broader range of samples. The firm previously gained clearance for performance of the qualitative test for T. vaginalis ribosomal RNA on its Panther instruments with clinician-collected endocervical or vaginal swab samples and specimens collected in PreservCyt Solution, and the updated clearance allows performance of the test on those instruments with patient-collected vaginal swab samples and urine from male or female patients.

Meanwhile Ark Diagnostics got the agency's go-ahead for a urine-based immunoassay for the opioid hydrocodone. The Fremont, California-based firm's Ark Hydrocodone Assay is used for qualitative detection or semi-quantitative estimation of hydrocodone and its metabolites in urine with a cutoff concentration of 300 ng/mL. The semi-quantitative results are used by laboratories to determine an appropriate specimen dilution for confirmatory testing or establish quality control procedures.

Becton Dickinson got the green light for a blood collection system used to collect capillary whole blood samples from patients ages 18 years and older and deliver anticoagulated samples for measurement of hemoglobin and hematocrit. The Franklin Lakes, New Jersey-based firm's BD MiniDraw Capillary Blood Collection System with BD MiniDraw Hemoglobin & Hematocrit Capillary Blood Collection Tube is designed for use with Sysmex's XN-series hematology analyzer instruments.

Lastly, Chelmsford, Massachusetts-based First Light Diagnostics also secured FDA 510(k) clearance for a blood-based immunoassay to detect B. anthracis. The SensiTox B. anthracis Toxin Test is designed for use on First Light's Multipath benchtop immunofluorescence analyzer instrument, with results in 20 minutes. The US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) supported development of the assay.

For 360Dx's FDA 510(k) tracker, click here.