Cleared Traditional

K033747 - RAMP CK-MB ASSAY

K033747 is an FDA 510(k) clearance for RAMP CK-MB ASSAY, manufactured by Response Biomedical Corp.. The device is a Class 2 Chemistry device with product code JHX cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K033747 · Response Biomedical Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
168d
Days
Class 2
Risk

K033747 is an FDA 510(k) clearance for the RAMP CK-MB ASSAY. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Response Biomedical Corp. (Burnaby, British Columbia, CA). The FDA issued a Cleared decision on May 17, 2004 after a review of 168 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.

View all Response Biomedical Corp. devices

FDA 510(k) Submission Details - K033747

510(k) Number K033747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2003
Decision Date May 17, 2004
Days to Decision 168 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 88d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHX Device Classification - Class 2, Special Controls

Product Code JHX Fluorometric 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 - JHX Fluorometric Method, Cpk Or Isoenzymes

All 42
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