Cleared Traditional

K162526 - Creatine Kinase-MB

K162526 is an FDA 510(k) clearance for Creatine Kinase-MB, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code JHW cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K162526 · Roche Diagnostics · Chemistry device
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May 2017
Decision
259d
Days
Class 2
Risk

K162526 is an FDA 510(k) clearance for the Creatine Kinase-MB. Classified as U.v. Method, Cpk Isoenzymes (product code JHW), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on May 26, 2017 after a review of 259 days - an extended review 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: 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.

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FDA 510(k) Submission Details - K162526

510(k) Number K162526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2016
Decision Date May 26, 2017
Days to Decision 259 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
171d slower than avg
Panel avg: 88d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHW Device Classification - Class 2, Special Controls

Product Code JHW U.v. Method, Cpk 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 - JHW U.v. Method, Cpk Isoenzymes

All 23
Devices cleared under the same product code (JHW) and FDA review panel - the closest regulatory comparables to K162526.
WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
K023744 · Wiener Laboratories Saic · Jan 2003
ROCHE DIAGNOSTICS CK-MB
K003158 · Roche Diagnostics Corp. · Dec 2000
ELECSYS CK-MB
K961501 · Boehringer Mannheim Corp. · Jun 1996
LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN
K944325 · Princeton BioMeditech Corp. · Feb 1995
CREATINE KINASE MB DETERMINATION (UV)
K942958 · Biochemical Trade, Inc. · Nov 1994
AXSYM CK-MB
K935924 · Abbott Laboratories · Jun 1994