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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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 3 other decisions in the tracker over the last 12 months: K254262 (Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA), K254264 (Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA), 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