Cleared Special

K051752 - ROCHE ELECSYS TROPONIN T STAT (SHORT TU...

K051752 is the FDA 510(k) clearance for ROCHE ELECSYS TROPONIN T STAT (SHORT TU... by Roche Diagnostics. It is a Class 2 Chemistry device (product code MMI) cleared through the Special 510(k) pathway after a 12-day FDA review.

K051752 · Roche Diagnostics · Chemistry device
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Jul 2005
Decision
12d
Days
Class 2
Risk

K051752 is an FDA 510(k) clearance for the ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME). Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on July 11, 2005 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K051752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2005
Decision Date July 11, 2005
Days to Decision 12 days
Submission Type Special
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
76d faster than avg
Panel avg: 88d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 K051752.
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
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
K052503 · Bayer Healthcare, LLC · Dec 2005
INSTANT-VIEW TROPONIN I TEST
K042227 · Alfa Scientific Designs, Inc. · Nov 2004
ABBOTT AXSYM TROPONIN-I ADV
K041811 · Abbott Laboratories · Sep 2004
ELECSYS TROPONIN T STAT TEST
K040733 · Roche Diagnostics Corp. · May 2004