Submission Details
| 510(k) Number | K252393 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 31, 2025 |
| Decision Date | October 29, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Oct 2025
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K252393 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products hs Troponin I Reagent Pack, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on October 29, 2025, 90 days after receiving the submission on July 31, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.
Device Classification
| Product Code | MMI — Immunoassay Method, Troponin Subunit |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1215 |
Manufacturer
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