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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 / July 2026 / K260917

510(k) cleared

cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems

Roche Molecular Systems, Inc. · Jul 8, 2026 · K260917

FDA cleared the cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems from Roche Molecular Systems, Inc. on Jul 8, 2026 under K260917, a traditional 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 Mar 19, 2026. The decision came 111 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), K253756 (cobas liat CT/NG nucleic acid test), K253759 (cobas liat CT/NG/MG nucleic acid test), K243753 (cobas liat Bordetella panel nucleic acid test).

Questions & Answers

What did FDA clear under K260917?

K260917 is the FDA 510(k) for cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems, submitted by Roche Molecular Systems, Inc.. FDA's decision date was Jul 8, 2026, under product code QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections).

Who makes the cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems?

Roche Molecular Systems, Inc., based in Pleasanton, CA, is the applicant of record for K260917.

How long did the K260917 review take?

FDA received the submission on Mar 19, 2026 and issued its decision on Jul 8, 2026, 111 days later.

← All decisions in July 2026

Sources