Cleared Traditional

K202525 - Alinity i STAT High Sensitivity Troponin-I

K202525 is the FDA 510(k) clearance for Alinity i STAT High Sensitivity Troponin-I by Abbott Laboratories Diagnostics Division. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 625-day FDA review.

K202525 · Abbott Laboratories Diagnostics Division · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
625d
Days
Class 2
Risk

K202525 is an FDA 510(k) clearance for the Alinity i 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 May 19, 2022 after a review of 625 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Abbott Laboratories Diagnostics Division devices

Submission Details

510(k) Number K202525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2020
Decision Date May 19, 2022
Days to Decision 625 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
537d slower than avg
Panel avg: 88d · This submission: 625d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - MMI Immunoassay Method, Troponin Subunit

All 68
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K202525.
Access hsTnI
K222881 · Beckman Coulter, Inc. · Dec 2023
Access hsTnI
K230648 · Beckman Coulter, Inc. · Dec 2023
Alinity i STAT High Sensitivity Troponin-I
K230994 · Abbott Laboratories Diagnostics Division · May 2023
Elecsys Troponin T Gen 5
K201441 · Roche Diagnostics · Sep 2021
ARCHITECT STAT High Sensitivity Troponin-I
K191595 · Abbott Laboratories Diagnostics Division · Sep 2019
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
K190675 · Siemens Healthcare Diagnostics, Inc. · May 2019