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FDA Grants 510(k) Clearances to BioMérieux, Roche, Philips, Diasorin, Others in June

NEW YORK – The US Food and Drug Administration in June granted 510(k) marketing clearance to a number of in vitro diagnostic products including tests to aid in treating drug-resistant infections, as well as two digital pathology systems and a multiplex panel to identify the causes of fungemia.

BioMérieux secured FDA clearance for an automated antimicrobial susceptibility testing system to aid the development of patient-specific sepsis treatments. The French firm's Vitek Reveal AST System qualitatively determines antimicrobial susceptibility via an array of sensors that can detect volatile organic compounds that are emitted by growing bacteria. Along with the instrument, the FDA cleared BioMérieux's Vitek Reveal GN AST Assay for the determination of susceptibility of Gram-negative bacteria from positive blood culture.

BioMérieux also got the agency's go-ahead for a pair of tests that are used to determine the susceptibility of Candida species to antifungal agents. The firm's Vitek 2 AST Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) test is used for the quantitative determination of susceptibility of C. krusei, C. parapsilosis, and C. tropicalis to the antifungal drug voriconazole (Pfizer's Vfend). Its Vitek 2 AST Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) test is used for the quantitative determination of susceptibility of C. albicans, C. glabrata, C. parapsilosis, C. tropicalis, C. guilliermondii, and C. krusei to the antifungal drug anidulafungin (Pfizer's Eraxis). Both tests are designed for use on BioMérieux's Vitek 2 and Vitek 2 Compact instruments.

Basel, Switzerland-based Roche received the green light for the Roche Digital Pathology Dx whole-slide imaging system that includes the firm's Ventana DP 200 six-slide brightfield slide scanner, digital pathology workflow software, and a display. The system is used to aid the review and interpretation of digital images of scanned pathology slides for primary diagnosis.

Roche also secured the agency's go-ahead for an electrochemiluminescence immunoassay that is used to measure folate concentrations to aid the diagnosis and treatment of anemia. The Elecsys Folate III assay is used for the quantitative determination of folate in erythrocytes, and it is designed for use on Roche's Cobas E 801 analyzer.

Amsterdam-based Philips got the nod for an automated digital pathology system for creating, viewing, and managing digital images from surgical pathology slides. The Philips IntelliSite Pathology Solution 5.1 is used to aid the review and interpretation of whole-slide images, and it is comprised of the company's image management system, slide scanners, and display.

Diasorin secured 510(k) clearance for a molecular panel that is used for the detection of 16 pathogens that are commonly associated with fungal bloodstream infections. The Saluggia, Italy-based firm's Liaison Plex Yeast Blood Culture Assay is a qualitative nucleic acid test that is used for the simultaneous detection and identification of the causes of fungemia. It is the firm's second syndromic panel that is cleared for use on the firm's Liaison Plex instrument, following the Liaison Plex Respiratory Flex Assay.

Brea, California-based Beckman Coulter, a Danaher company, gained clearance for an updated version of a thyroglobulin assay that is used to help monitor patients for persistent, recurrent, or metastatic disease in patients who have differentiated thyroid cancer, have had thyroid surgery, and lack serum thyroglobulin antibodies. The Access Thyroglobulin chemiluminescent assay is used for the quantitative determination of thyroglobulin levels in serum and plasma, and it is designed for use on Beckman Coulter's Access Immunoassay instruments.

Meantime, CorDx got the FDA's go-ahead for a rapid antigen test for COVID-19. The firm's CorDx Tyfast COVID-19 Ag Rapid Test is a lateral flow immunoassay that is used for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in anterior nasal swab samples from individuals who have signs and symptoms of COVID-19. It is designed for over-the-counter use by individuals ages 14 years and older, and individuals ages 2 years and older when tested by an adult. The firm had received FDA Emergency Use Authorization for the test in late 2022 when it was called the CorDx COVID-19 Ag Test.

Hangzhou, China-based VivaChek Biotech secured clearance for its BioSieve ToxiSmart FIA Reader fluorescence instrument and BioSieve Fentanyl FIA Test Kit fluorescence immunoassay. The instrument and assay are used together for the qualitative point-of-care detection of fentanyl in urine.

Lastly, Hangzhou AllTest Biotech received FDA clearance for updated versions of its tests for drugs of abuse. The firm's AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are lateral flow immunoassays that are used for the qualitative and simultaneous detection of 14 drugs in urine.

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