Cleared Traditional

K243483 - Access hsTnI (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243483 · Beckman Coulter, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 2025
Decision
266d
Days
Class 2
Risk

K243483 is an FDA 510(k) clearance for the Access hsTnI. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on August 1, 2025 after a review of 266 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K243483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2024
Decision Date August 01, 2025
Days to Decision 266 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
178d slower than avg
Panel avg: 88d · This submission: 266d
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 93
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K243483.
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
K252393 · Ortho-Clinical Diagnostics, Inc. · Oct 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
Access hsTnI
K222881 · Beckman Coulter, Inc. · Dec 2023