Cleared Traditional

K042576 - COATEST SP FVIII

K042576 is an FDA 510(k) clearance for COATEST SP FVIII, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K042576 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
71d
Days
Class 2
Risk

K042576 is an FDA 510(k) clearance for the COATEST SP FVIII. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 2, 2004 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042576

510(k) Number K042576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2004
Decision Date December 02, 2004
Days to Decision 71 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 113d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 Hematology devices follow this clearance model.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 183
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K042576.
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CRYOCHECK CLOT C
K040987 · Precision Biologic, Inc. · Jun 2004
HEMOSIL VON WILLEBRAND ACTIVITY
K040843 · Instrumentation Laboratory CO · Apr 2004
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
K032139 · Corgenix, Inc. · Apr 2004
K042576 · COATEST SP FVIII
Download PDF FDA Summary Instrumentation Labor…