Cleared Traditional

K052503 - TROPONIN I ULTRA ASSAY AND CALIBRATOR F...

K052503 is an FDA 510(k) clearance for TROPONIN I ULTRA ASSAY AND CALIBRATOR F..., manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K052503 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
92d
Days
Class 2
Risk

K052503 is an FDA 510(k) clearance for the TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on December 14, 2005 after a review of 92 days - within the typical 510(k) review window.

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 Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K052503

510(k) Number K052503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2005
Decision Date December 14, 2005
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
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 73
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K052503.
ABBOTT AXSYM TROPONIN-I ADV
K060875 · Abbott Laboratories · Jun 2006
DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT
K053577 · Dade Behring, Inc. · Apr 2006
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
K053020 · Bayer Healthcare, LLC · Dec 2005
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
K051752 · Roche Diagnostics · Jul 2005
INSTANT-VIEW TROPONIN I TEST
K042227 · Alfa Scientific Designs, Inc. · Nov 2004
ABBOTT AXSYM TROPONIN-I ADV
K041811 · Abbott Laboratories · Sep 2004