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THE TAPE

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 / October 2025 / K252393

510(k) cleared

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

Ortho-Clinical Diagnostics, Inc. · Oct 29, 2025 · K252393

FDA cleared the VITROS Immunodiagnostic Products hs Troponin I Reagent Pack from Ortho-Clinical Diagnostics, Inc. on Oct 29, 2025 under K252393, a traditional 510(k). The device falls under product code MMI, Immunoassay Method, Troponin Subunit, regulated at 21 CFR 862.1215 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jul 31, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Ortho-Clinical Diagnostics, Inc. has one other decision in the tracker over the last 12 months: K254295 (Sofia Lyme FIA; Sofia 2 Campylobacter FIA).

Questions & Answers

What did FDA clear under K252393?

K252393 is the FDA 510(k) for VITROS Immunodiagnostic Products hs Troponin I Reagent Pack, submitted by Ortho-Clinical Diagnostics, Inc.. FDA's decision date was Oct 29, 2025, under product code MMI (Immunoassay Method, Troponin Subunit).

Who makes the VITROS Immunodiagnostic Products hs Troponin I Reagent Pack?

Ortho-Clinical Diagnostics, Inc., based in Rochester, NY, is the applicant of record for K252393.

How long did the K252393 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Oct 29, 2025, 90 days later.

← All decisions in October 2025

Sources