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ARCHITECT STAT High Sensitivity Troponin-I

by Abbott Laboratories Diagnostics Division

510(k) K191595

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 NumberK191595 Date13 Sep 2019ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 862.1215
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The ARCHITECT STAT High Sensitivity Troponin-I is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of cardiac troponin I (cTnI) in human plasma. It is designed for use on the ARCHITECT system with dipotassium (K2) EDTA anticoagulant.

The device is supplied as an in vitro diagnostic reagent for use in clinical laboratory settings. It has received FDA 510(k) clearance (K191595) and is traceable to the National Institute of Standards and Technology (NIST).

Other devices from Abbott Laboratories Diagnostics Division

Questions

AI-generated answers, 24 Sep 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 ARCHITECT STAT High Sensitivity Troponin-I used for?

    It is used for the quantitative determination of cardiac troponin I (cTnI) in human plasma as an in vitro diagnostic reagent in clinical laboratory settings, aiding in the assessment of myocardial injury when measured on the ARCHITECT system with K2 EDTA anticoagulant.

  • How is the ARCHITECT STAT High Sensitivity Troponin-I supplied and what type of assay is it?

    The device is supplied as an in vitro diagnostic reagent in the form of a chemiluminescent microparticle immunoassay (CMIA) designed for use on the ARCHITECT system, requiring human plasma samples with dipotassium (K2) EDTA as the anticoagulant for accurate measurement.

  • What regulatory clearance does the ARCHITECT STAT High Sensitivity Troponin-I have and what is its traceability?

    It has received FDA 510(k) clearance under submission K191595 and is traceable to the National Institute of Standards and Technology (NIST), ensuring standardization and reliability of measurements across testing sites.