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DiaSorin, Abbott, BioMérieux, QuidelOrtho Gain FDA 510(k) Clearances in March

NEW YORK – The US Food and Drug Administration in March granted 510(k) marketing clearances for a molecular diagnostics platform, multiplex respiratory assays, a test to identify mild brain injury, and a test to assess patients for hemorrhage or thrombosis, among others.

Saluggia, Italy-based DiaSorin secured 510(k) clearance in March for its Liaison Plex molecular diagnostics instrument and Liaison Plex Respiratory Flex Assay. The instrument uses nanoparticle chemistry technologies for direct DNA detection and PCR amplification, and the company is incorporating a flexible testing model that allows labs to pay for tiers of results. The Liaison Plex Respiratory Flex Assay is used to identify up to 14 categories of viruses or virus subtypes and five bacterial targets such as SARS-CoV-2, other coronaviruses, influenza viruses, respiratory syncytial virus, and Bordetella species.

Abbott also got a green light for a test that is used at a patient's bedside to help identify patients who have mild brain injury. The firm's I-Stat TBI is a cartridge-based 15-minute test that is used to measure in blood the biomarkers ubiquitin C-terminal hydrolase L1 and glial fibrillary acidic protein. The test is designed for use with the firm's portable I-Stat Alinity analyzer.

French diagnostics firm BioMérieux also gained clearance for its multiplex PCR test for common causes of respiratory illnesses and sore throat infections, as well as an assay that is used to determine whether Gram-positive microorganisms are susceptible to the antimicrobial Xenlata (Lefamulin). The BioFire Spotfire Respiratory/Sore Throat (R/ST) assay is used for the detection of 15 viruses, viral subtypes, and bacteria, with results in about 15 minutes. The test is designed for use on the firm's SpotFire molecular analyzer. The Vitek 2 AST-Gram Positive Lefamulin (≤0.03 - ≥4 µg/mL) assay is used to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae, and it is designed for use with the company's Vitek 2 and Vitek 2 Compact analyzers.

San Diego-based QuidelOrtho secured FDA clearance and a CLIA waiver for its QuickVue COVID-19 antigen test. The lateral flow immunoassay is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples from patients within five days of symptom onset.

Thermo Fisher Scientific subsidiary Oxoid Limited got the agency's go-ahead for its semi-quantitative test, Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5, to determine an individual's susceptibility to the antimicrobial rezafungin against Candida albicans, C. glabrata, C. parapsilosis, and C. tropicalis.

Boston-based Haemonetics got a nod for its hemostasis assay that is used to assess patients for hemorrhage or thrombosis before, during, or after procedures such as cardiovascular surgery, minimally invasive valve replacements or repairs, and liver transplantation. The firm's Citrated: K, KH, RTH, FFH assay is a cartridge-based test that is used for the semi-quantitative determination in 3.2 percent citrated whole blood of citrated kaolin, citrated kaolin with heparinase, citrated rapidTEG with heparinase, and citrated functional fibrinogen with heparinase. The cartridge is designed for use with the firm's TEG 6s Hemostasis Analyzer in laboratories and at the point of care.

Lastly, three firms secured clearances for lateral flow immunoassays for the detection in urine of fentanyl use. The agency granted clearances for Instanosis' Instastrip Fentanyl Rapid Test and Instastrip Fentanyl Dipstick Test, Co-Innovation Biotech's Rapid Fentanyl (FYL) Test Strip and Rapid Fentanyl (FYL) Test Dipcard, and Assure Tech's FaStep Fentanyl Rapid Test Device (Urine) and FaStep Rapid Fentanyl Urine Test (Urine).

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