Cleared Traditional

ARCHITECT STAT High Sensitivity Troponin-I (K191595) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence.

K191595 · Abbott Laboratories Diagnostics Division · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
88d
Days
Class 2
Risk

K191595 is an FDA 510(k) clearance for the ARCHITECT STAT High Sensitivity Troponin-I. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Abbott Laboratories Diagnostics Division (Abbott Park, US). The FDA issued a Cleared decision on September 13, 2019 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories Diagnostics Division devices

Submission Details

510(k) Number K191595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2019
Decision Date September 13, 2019
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MMI Immunoassay Method, Troponin Subunit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01608100 Completed Interventional Industry-sponsored

Evaluation of a New Cardiac Biomarker Assay

Design Validation Protocol for the Evaluation of ARCHITECT STAT High Sensitive Troponin I Assay

1101
Patients (actual)
12
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Acute Coronary Syndrome; Acute Myocardial Infarction
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Fred S Apple, PhD
Sponsor Abbott Diagnostics Division (industry)
Started 2012-06-01 → Primary completion 2014-08-01 → Completed 2014-09-01
Primary outcome
Clinical Performance - Area Under the Curve
Secondary outcome
Prognosis
View full study on ClinicalTrials.gov

Regulatory Peers - MMI Immunoassay Method, Troponin Subunit

All 93
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K191595.
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
K252393 · Ortho-Clinical Diagnostics, Inc. · Oct 2025
Access hsTnI
K243483 · Beckman Coulter, Inc. · Aug 2025
Access hsTnI
K242870 · Beckman Coulter, Inc. · Jun 2025
i-STAT hs-TnI cartridge with the i-STAT 1 System
K240984 · Abbott Point of Care, Inc. · Jan 2025
Atellica® IM High-Sensitivity Troponin I (TnIH)
K241165 · Siemens Healthcare Diagnostics, Inc. · Jul 2024
PATHFAST®hs-cTnI-II
K231974 · Phc Corporation · Mar 2024