Cleared Traditional

K230648 - Access hsTnI

K230648 is an FDA 510(k) clearance for Access hsTnI, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K230648 · Beckman Coulter, Inc. · Chemistry device
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Dec 2023
Decision
270d
Days
Class 2
Risk

K230648 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 December 4, 2023 after a review of 270 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

FDA 510(k) Submission Details - K230648

510(k) Number K230648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2023
Decision Date December 04, 2023
Days to Decision 270 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
182d slower than avg
Panel avg: 88d · This submission: 270d
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 71
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K230648.
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
Alinity i STAT High Sensitivity Troponin-I
K230994 · Abbott Laboratories Diagnostics Division · May 2023
Alinity i STAT High Sensitivity Troponin-I
K202525 · Abbott Laboratories Diagnostics Division · May 2022
Elecsys Troponin T Gen 5
K201441 · Roche Diagnostics · Sep 2021