Cleared Traditional

K042924 - ARCHITECT STAT MYO IMMUNOASSAY

K042924 is an FDA 510(k) clearance for ARCHITECT STAT MYO IMMUNOASSAY, manufactured by Fisher Diagnostics. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K042924

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
Combination Product No
PCCP Authorized No
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.

DDR Device Classification - Class 2, Special Controls

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 39
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