Cleared Traditional

RAMP MYOGLOBIN ASSAY (K012040) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012040 · Response Biomedical Corp. · Chemistry device
Download Printable Device Report (PDF)
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 45
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K012040.
Access Myoglobin
K231832 · Beckman Coulter, Inc. · Sep 2023
QUANTEX MYOGLOBIN
K042982 · Instrumentation Laboratory CO · Dec 2004
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
K991796 · Diagnostic Products Corp. · Jun 1999
MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
K991277 · Diagnostic Products Corp. · Apr 1999
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
K984065 · Dade Behring, Inc. · Dec 1998
MYOGLOBIN FLEX REAGENT CARTRIDGE
K984191 · Dade Behring, Inc. · Dec 1998