Cleared Traditional

K003158 - ROCHE DIAGNOSTICS CK-MB

K003158 is an FDA 510(k) clearance for ROCHE DIAGNOSTICS CK-MB, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code JHW cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K003158 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
69d
Days
Class 2
Risk

K003158 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS CK-MB. Classified as U.v. Method, Cpk Isoenzymes (product code JHW), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 18, 2000 after a review of 69 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 Corp. devices

FDA 510(k) Submission Details - K003158

510(k) Number K003158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2000
Decision Date December 18, 2000
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
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 25
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