Cleared Traditional

K920012 - IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY S...

K920012 is the FDA 510(k) clearance for IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY S... by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K920012 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
223d
Days
Class 2
Risk

K920012 is an FDA 510(k) clearance for the IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM. 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 August 12, 1992 after a review of 223 days - an extended review 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: 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 K920012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1992
Decision Date August 12, 1992
Days to Decision 223 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
110d slower than avg
Panel avg: 113d · This submission: 223d
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 K920012.
IL TEST(TM) PROTEIN S
K930327 · Instrumentation Laboratory CO · Apr 1993
IL TEST(TM) PRO-CHROM
K924884 · Instrumentation Laboratory CO · Jan 1993
NEW STACHROM ANTIPLASMIN
K921449 · American Bioproducts Co. · Sep 1992
RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA
K920981 · Medical Diagnostic Technologies, Inc. · Apr 1992
DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY
K914818 · Baxter Diagnostics, Inc. · Jan 1992
IL TEST PROCLOT ASSAY STYSTEM
K912711 · Instrumentation Laboratory CO · Oct 1991