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Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2

by Mitsubishi Chemical Medience Corporation

510(k) K100130

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100130 Date16 May 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
FDA applicant
Mitsubishi Chemical Medience CO
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 PATHFAST cTnI-II Test is an immunoassay method for the quantitative measurement of cardiac Troponin I (cTnI) in heparinized or EDTA whole blood and plasma. As classified under the Immunoassay Method, Troponin Subunit category, this device aids in the detection and assessment of cardiac Troponin I levels, which are critical biomarkers for diagnosing acute myocardial infarction (AMI).

This device is supplied as a kit comprising the PATHFAST cTnI-II Test, PATHFAST cTnI Calibrators, and PATHFAST Sample Diluent 2, intended for use in clinical laboratory or point-of-care settings. The test is designed for single-use and requires no sterilization beyond manufacturer-provided packaging. It is classified as a Class II medical device under FDA regulations (862.1215) and holds a 510(k) clearance (K100130) for substantial equivalence. Storage conditions and additional regulatory details are specified in the manufacturer’s instructions.

Other devices from Mitsubishi Chemical Medience Corporation

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 PATHFAST cTnI-II Test used for?

    The PATHFAST cTnI-II Test is an immunoassay method for the quantitative measurement of cardiac Troponin I in heparinized or EDTA whole blood and plasma, aiding in the detection and assessment of cardiac Troponin I levels, which are critical biomarkers for diagnosing acute myocardial infarction (AMI).

  • How is the PATHFAST cTnI-II Test supplied?

    The device is supplied as a kit comprising the PATHFAST cTnI-II Test, PATHFAST cTnI Calibrators, and PATHFAST Sample Diluent 2, intended for use in clinical laboratory or point-of-care settings.

  • Is the PATHFAST cTnI-II Test single-use or reusable?

    The test is designed for single-use and requires no sterilization beyond manufacturer-provided packaging. Each test component should be used only once according to the manufacturer's instructions to ensure accurate results and maintain sterility.

  • What is the regulatory classification of the PATHFAST cTnI-II Test?

    The PATHFAST cTnI-II Test is classified as a Class II medical device under FDA regulations (862.1215) and holds a 510(k) clearance (K100130) for substantial equivalence. It is intended for use in clinical laboratory or point-of-care settings.