The FDA has granted Emergency Use Authorization to 443 different COVID-19 laboratory tests and collection products. Even so, 510(k) premarket clearance remains the pathway through which most new in vitro diagnostic tests and other medical devices reach the US market. In 2022, the FDA granted 510(k) clearance allowing for the marketing of 70 different lab tests or panels last year. That count doesn’t include related laboratory products like reagents, collection devices, results analysis software, or testing platforms and instruments.
Abbott and its various subsidiaries garnered the most clearances with 13, including three tests run on the firm’s Alinity m platform:
- The Alinity m STI Assay, a real-time PCR test to detect a range of sexually-transmitted infections (STIs);
- The Alinity i STAT High Sensitivity Troponin-I assay for diagnosis of myocardial infarction; and
- The Alinity m EBV quantitative test for Epstein-Barr Virus.
Abbott also got 510(k) clearance to market tests for albumin BCP2, creatinine, urea nitrogen2, Toxo IgG antibodies, β-amylase2, bilirubin, cholesterol, influenza, and strep.
Roche finished the year with 11 clearances. Eight of those products were Elecsys tests, including a new assay for early detection of Alzheimer’s disease, as well as immunoassays for testosterone 2 and IgG class antibodies to herpes simplex virus (HSV-1). The FDA also cleared three new tests for the Roche Cobas systems:
- Cobas SARS-CoV-2 Qualitative for use on the Cobas 6800/8800 Systems;
- Cobas HCV for hepatitis C;
- Cobas Influenza A/B & RSV nucleic acid for use on the Cobas Liat System;
Other companies that received multiple 510(k) clearances for new lab tests in 2022 included:
- BioFire (4 infectious disease tests);
- Becton Dickinson (3, including one test for STIs and two for bacterial pathogens);
- Cepheid (3 genetic Xpert tests run on the firm’s GeneXpert Dx System);
- Beckman Coulter (2 blood tests—one for Total lmmunoglobulin E (IgE) and one for early detection of pregnancy); and
- Swiss Precision (2 early pregnancy tests).
By clinical application, it’s not surprising that tests for infectious diseases were the most common with 10 new products receiving 510(k) clearance, followed by pregnancy detection (6), STIs (5), and cardiovascular and cancer indications (4 apiece).
See the full article in our February 2023 Laboratory Industry Report, posted in advance of PDF publication.