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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K243753

510(k) cleared

cobas liat Bordetella panel nucleic acid test

Roche Molecular Systems, Inc. · Nov 20, 2025 · K243753

FDA cleared the cobas liat Bordetella panel nucleic acid test from Roche Molecular Systems, Inc. on Nov 20, 2025 under K243753, a dual track 510(k). The device falls under product code OZZ, Bordetella Pertussis Dna Assay System, regulated at 21 CFR 866.3980 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Dec 5, 2024. The decision came 350 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Roche Molecular Systems, Inc. has 6 other decisions in the tracker over the last 12 months: K260021 (cobas® BV/CV), K260917 (cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems), K253756 (cobas liat CT/NG nucleic acid test), K253759 (cobas liat CT/NG/MG nucleic acid test).

Questions & Answers

What did FDA clear under K243753?

K243753 is the FDA 510(k) for cobas liat Bordetella panel nucleic acid test, submitted by Roche Molecular Systems, Inc.. FDA's decision date was Nov 20, 2025, under product code OZZ (Bordetella Pertussis Dna Assay System).

Who makes the cobas liat Bordetella panel nucleic acid test?

Roche Molecular Systems, Inc., based in Pleasanton, CA, is the applicant of record for K243753.

How long did the K243753 review take?

FDA received the submission on Dec 5, 2024 and issued its decision on Nov 20, 2025, 350 days later.

← All decisions in November 2025