Cleared Traditional

K132571 - ELECSYS CK-MB STAT IMMUNOASSAY

K132571 is the FDA 510(k) clearance for ELECSYS CK-MB STAT IMMUNOASSAY by Roche Diagnostics. It is a Class 2 Chemistry device (product code JHY) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K132571 · Roche Diagnostics · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 2013
Decision
64d
Days
Class 2
Risk

K132571 is an FDA 510(k) clearance for the ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 18, 2013 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics devices

Submission Details

510(k) Number K132571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2013
Decision Date October 18, 2013
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHY Colorimetric Method, Cpk Or Isoenzymes
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 - JHY Colorimetric Method, Cpk Or Isoenzymes

All 17
Devices cleared under the same product code (JHY) and FDA review panel - the closest regulatory comparables to K132571.
Dimension Vista MMB Assay
K143720 · Siemens Healthcare Diagnostics · Sep 2015
ELECSYS CK-MB STAT IMMUNOASSAY
K140404 · Roche Diagnostics · May 2014
SPIFE CK KIT, MODEL 3332, 3333
K022757 · Helena Laboratories · Oct 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
K022654 · Roche Diagnostics Corp. · Aug 2002
ELECSYS CK-MB STAT
K974421 · Boehringer Mannheim Corp. · Dec 1997
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
K961412 · Bayer Corp. · Jun 1996