Cleared Traditional

K924884 - IL TEST(TM) PRO-CHROM

K924884 is the FDA 510(k) clearance for IL TEST(TM) PRO-CHROM by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K924884 · Instrumentation Laboratory CO · Hematology device
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Jan 1993
Decision
108d
Days
Class 2
Risk

K924884 is an FDA 510(k) clearance for the IL TEST(TM) PRO-CHROM. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on January 14, 1993 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K924884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1992
Decision Date January 14, 1993
Days to Decision 108 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
5d faster than avg
Panel avg: 113d · This submission: 108d
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 K924884.
MDA PROTEIN ASSAY
K925617 · Organon Teknika Corp. · Jan 1994
NEW STACHROM PROTEIN C TEST KIT
K931906 · American Bioproducts Co. · Nov 1993
IL TEST(TM) PROTEIN S
K930327 · Instrumentation Laboratory CO · Apr 1993
NEW STACHROM ANTIPLASMIN
K921449 · American Bioproducts Co. · Sep 1992
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM
K920012 · Instrumentation Laboratory CO · Aug 1992
RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA
K920981 · Medical Diagnostic Technologies, Inc. · Apr 1992