Cleared Special

K022654 - MODIFICATION TO ELECSYS CK-MB STAT

K022654 is the FDA 510(k) clearance for MODIFICATION TO ELECSYS CK-MB STAT by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code JHY) cleared through the Special 510(k) pathway after a 20-day FDA review.

K022654 · Roche Diagnostics Corp. · Chemistry device
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Aug 2002
Decision
20d
Days
Class 2
Risk

K022654 is an FDA 510(k) clearance for the MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 29, 2002 after a review of 20 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.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K022654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2002
Decision Date August 29, 2002
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 K022654.
ELECSYS CK-MB STAT IMMUNOASSAY
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K974421 · Boehringer Mannheim Corp. · Dec 1997
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K961412 · Bayer Corp. · Jun 1996
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K951638 · Organon Teknika Corp. · May 1995