Cleared Traditional

K253051 - i-STAT hs-TnI cartridge with the i-STAT...

K253051 is an FDA 510(k) clearance for i-STAT hs-TnI cartridge with the i-STAT..., manufactured by Abbott Point of Care, Inc.. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K253051 · Abbott Point of Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
262d
Days
Class 2
Risk

K253051 is an FDA 510(k) clearance for the i-STAT hs-TnI cartridge with the i-STAT Alinity System. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Abbott Point of Care, Inc. (Princeton, US). The FDA issued a Cleared decision on June 11, 2026 after a review of 262 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Point of Care, Inc. devices

FDA 510(k) Submission Details - K253051

510(k) Number K253051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2025
Decision Date June 11, 2026
Days to Decision 262 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 88d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMI Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K253051.
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