Cleared Special

K140404 - ELECSYS CK-MB STAT IMMUNOASSAY

K140404 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 Special 510(k) pathway after a 79-day FDA review.

K140404 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
79d
Days
Class 2
Risk

K140404 is an FDA 510(k) clearance for the ELECSYS CK-MB STAT 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 May 8, 2014 after a review of 79 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 devices

Submission Details

510(k) Number K140404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2014
Decision Date May 08, 2014
Days to Decision 79 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
9d faster than avg
Panel avg: 88d · This submission: 79d
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 K140404.
Dimension Vista MMB Assay
K143720 · Siemens Healthcare Diagnostics · Sep 2015
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
K132571 · Roche Diagnostics · Oct 2013
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