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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 / May 2026 / K253759

510(k) cleared

cobas liat CT/NG/MG nucleic acid test

Roche Molecular Systems, Inc. · May 15, 2026 · K253759

FDA cleared the cobas liat CT/NG/MG nucleic acid test from Roche Molecular Systems, Inc. on May 15, 2026 under K253759, a dual track 510(k). The device falls under product code QEP, Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections, regulated at 21 CFR 866.3393 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Nov 25, 2025. The decision came 171 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), K243753 (cobas liat Bordetella panel nucleic acid test).

Questions & Answers

What did FDA clear under K253759?

K253759 is the FDA 510(k) for cobas liat CT/NG/MG nucleic acid test, submitted by Roche Molecular Systems, Inc.. FDA's decision date was May 15, 2026, under product code QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections).

Who makes the cobas liat CT/NG/MG nucleic acid test?

Roche Molecular Systems, Inc., based in Pleasanton, CA, is the applicant of record for K253759.

How long did the K253759 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on May 15, 2026, 171 days later.

← All decisions in May 2026

Sources