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VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

by Ortho-Clinical Diagnostics, Inc.

510(k) K252393

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252393 Date29 Oct 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MMI
Device Class
Class II
Regulation
21 CFR Part 862.1215
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VITROS Immunodiagnostic Products hs Troponin I Reagent Pack is an in vitro diagnostic immunoassay reagent pack designed for the quantitative measurement of high-sensitivity cardiac troponin I (hs-cTnI) in lithium heparin plasma. It employs a streptavidin-conjugated antibody and an HRP-labeled antibody conjugate to detect hs-cTnI levels in patient samples, aiding in the assessment of myocardial injury.

This reagent pack is intended for use exclusively with the VITROS 5600 Integrated System and is supplied as a single-use component. It is classified as a Class II medical device under FDA regulations (862.1215) and holds a 510(k) clearance through a traditional review process. The device is not sterile and must be stored under controlled conditions as specified in the manufacturer’s instructions.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the VITROS hs Troponin I Reagent Pack used for?

    The VITROS hs Troponin I Reagent Pack is designed for the quantitative measurement of high-sensitivity cardiac troponin I (hs-cTnI) in lithium heparin plasma. It uses a streptavidin-conjugated antibody and an HRP-labeled antibody conjugate to detect hs-cTnI levels, helping clinicians assess myocardial injury. This is particularly useful in diagnosing acute coronary syndromes or evaluating patients with suspected heart damage.

  • Which system is this reagent pack compatible with?

    This reagent pack is exclusively intended for use with the VITROS 5600 Integrated System. It is not compatible with any other diagnostic platforms, so compatibility must be confirmed before use.

  • Is the VITROS hs Troponin I Reagent Pack sterile?

    No, the VITROS hs Troponin I Reagent Pack is not sterile. It must be handled under controlled conditions as outlined in the manufacturer’s instructions to prevent contamination. Sterility is not required for this single-use reagent pack.

  • How is the reagent pack supplied, and is it single-use?

    The reagent pack is supplied as a single-use component, meaning each pack is intended for one test cycle only. This design ensures consistency and reduces the risk of cross-contamination between samples. Discard any unused portions after opening.

  • What storage conditions are required for this reagent pack?

    The reagent pack must be stored under controlled conditions as specified in the manufacturer’s instructions. While exact details are provided in the accompanying documentation, typical requirements include protection from extreme temperatures, light exposure, and humidity. Always refer to the packaging for precise storage guidelines.