Cleared Traditional

K042924 - ARCHITECT STAT MYO IMMUNOASSAY

K042924 is the FDA 510(k) clearance for ARCHITECT STAT MYO IMMUNOASSAY by Fisher Diagnostics. It is a Class 2 Chemistry device (product code DDR) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K042924 · Fisher Diagnostics · Chemistry device
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Jan 2005
Decision
94d
Days
Class 2
Risk

K042924 is an FDA 510(k) clearance for the ARCHITECT STAT MYO IMMUNOASSAY. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on January 24, 2005 after a review of 94 days - within the typical 510(k) review window.

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 Fisher Diagnostics devices

Submission Details

510(k) Number K042924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2004
Decision Date January 24, 2005
Days to Decision 94 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
6d slower than avg
Panel avg: 88d · This submission: 94d
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 K042924.
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
K083260 · Roche Diagnostics · Oct 2009
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
K080481 · Beckman Coulter, Inc. · Feb 2009
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
K061683 · Roche Diagnostics Corp. · Jul 2006
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