Cleared Traditional

K924884 - IL TEST(TM) PRO-CHROM

K924884 is an FDA 510(k) clearance for IL TEST(TM) PRO-CHROM, 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 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

FDA 510(k) Submission Details - K924884

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.

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 151
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