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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 / K252484

510(k) cleared

cobas HCV

Roche Molecular Systems, Inc. · Nov 3, 2025 · K252484

FDA cleared the cobas HCV from Roche Molecular Systems, Inc. on Nov 3, 2025 under K252484, a traditional 510(k). The device falls under product code MZP, Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus, regulated at 21 CFR 866.3170 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Aug 7, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

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 K252484?

K252484 is the FDA 510(k) for cobas HCV, submitted by Roche Molecular Systems, Inc.. FDA's decision date was Nov 3, 2025, under product code MZP (Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus).

Who makes the cobas HCV?

Roche Molecular Systems, Inc., based in Pleasanton, CA, is the applicant of record for K252484.

How long did the K252484 review take?

FDA received the submission on Aug 7, 2025 and issued its decision on Nov 3, 2025, 88 days later.

← All decisions in November 2025

Sources