Skip to main content

BioMérieux, Roche, Becton Dickinson, Others Receive FDA 510(k) Clearances in September

NEW YORK ─ The US Food and Drug Administration in September granted relatively few 510(k) clearances for in vitro diagnostic products as it continued to prioritize Emergency Use Authorizations for the coronavirus pandemic.

According to the FDA's website, it green-lighted Malvern, Pennsylvania-based Fujirebio Diagnostics to market its Lumipulse G CA15-3 chemiluminescent enzyme immunoassay to measure levels of CA 15-3 in serum or plasma on its Lumipulse G System. Clinicians use serial testing for CA15-3 in the management of patients diagnosed with stage II and stage III breast cancer.

Immucor GTI Diagnostics, based in Waukesha, Wisconsin, received 510(k) clearance for its PF4 Enhanced Assay, an enzyme linked immunosorbent assay that detects antibodies in serum or plasma that react with platelet factor 4 (PF4) complexed to polyanionic compounds. Some patients undergoing heparin therapy have these antibodies.

Marcy-l'Étoile, France-based BioMérieux nabbed clearance for its Vitek 2 AST Gram Negative Ceftazidime antimicrobial susceptibility test for gram-negative bacilli, running on the firm's Vitek 2 and Vitek 2 Compact systems.

Guangzhou, China-based Guangzhou Wondfo Biotech got the green light for its over-the-counter Wondfo T-Dip Multi-Drug Urine Test Panel, which consists of lateral flow immunochromatographic assays that detect a number of drugs at specific cut-off levels in urine. The panel detects amphetamine, buprenorphine, secobarbital, oxazepam, cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, methamphetamine, methylenedioxymethamphetamine, morphine, methadone, oxycodone, phencyclidine, propoxyphene, nortriptyline, and cannabinoids. It provides only preliminary results, and more specific mass spectrometry-based methods are recommended for confirmation, the FDA said.

Santa Clara, California-based Lin-Zhi International received clearance for its LZI Oxycodone Ill Enzyme Immunoassay to detect oxycodone in urine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

Jiangyin, China-based Jiangsu Caina Medical got the go-ahead for a blood collection needle used with a vacuum blood collection tube to collect venous blood. The device consists of a safety shield to protect against an accidental needle stick. Jiangsu Caina also received clearance for a Luer access system to link devices with luer connectors to blood collection tubes.

In other regulatory news, Roche received clearance for its Cobas RT-PCR test to detect BK virus, running on the firm's Cobas 6800 and 8800 Systems; the FDA gave the nod to Oxford Immunotec for an amendment to the pediatric age limitation for its T-Spot.TB tuberculosis test to include individuals two years of age and older; Accelerate Diagnostics received clearance for enhancements to its Accelerate Pheno system; and DiaSorin Molecular got clearance for its Simplexa Flu A/B and RSV Direct Gen II kit.

Becton Dickinson was granted 510(k) clearance in September for its BD FACSLyric Flow Cytometer with an integrated BD FACSDuet Sample Preparation System. The firm announced the clearance on Monday.