Cleared Traditional

K012040 - RAMP MYOGLOBIN ASSAY

K012040 is the FDA 510(k) clearance for RAMP MYOGLOBIN ASSAY by Response Biomedical Corp.. It is a Class 2 Chemistry device (product code DDR) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K012040 · Response Biomedical Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Dec 2001
Decision
172d
Days
Class 2
Risk

K012040 is an FDA 510(k) clearance for the RAMP MYOGLOBIN ASSAY. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Response Biomedical Corp. (Burnaby, British Columbia, CA). The FDA issued a Cleared decision on December 18, 2001 after a review of 172 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5680 - 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

Submission Details

510(k) Number K012040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2001
Decision Date December 18, 2001
Days to Decision 172 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
84d slower than avg
Panel avg: 88d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDR Myoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5680
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 - DDR Myoglobin, Antigen, Antiserum, Control

All 33
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K012040.
QUANTEX MYOGLOBIN
K042982 · Instrumentation Laboratory CO · Dec 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK
K033300 · Ortho-Clinical Diagnostics, Inc. · Nov 2003
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
K021229 · Beckman Coulter, Inc. · Jun 2002
RANDOX MYOGLOBIN
K010700 · Randox Laboratories, Ltd. · May 2001
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
K000196 · Beckman Coulter, Inc. · Feb 2000
K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR
K992976 · Kamiya Biomedical Co. · Nov 1999