Cleared Traditional

K002467 - COALIZA PROTEIN S-FREE

K002467 is the FDA 510(k) clearance for COALIZA PROTEIN S-FREE by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K002467 · Instrumentation Laboratory CO · Hematology device
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Oct 2000
Decision
63d
Days
Class 2
Risk

K002467 is an FDA 510(k) clearance for the COALIZA PROTEIN S-FREE. 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 October 13, 2000 after a review of 63 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.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K002467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2000
Decision Date October 13, 2000
Days to Decision 63 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
50d faster than avg
Panel avg: 113d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 118
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K002467.
PROTEIN S AC
K022290 · Dade Behring, Inc. · Aug 2002
IL TEST PROS
K011424 · Instrumentation Laboratory CO · Jun 2001
IL TEST FREE PROTEIN S
K010379 · Instrumentation Laboratory CO · Apr 2001
PROTEIN C REAGENT
K002541 · Dade Behring, Inc. · Sep 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K000649 · Dade Behring, Inc. · Apr 2000
IL TEST VON WILLEBRAND FACTOR
K992704 · Instrumentation Laboratory CO · Nov 1999