Cleared Traditional

K922201 - COAMATE PROTEIN C CHROMOGENIC ASSAY

K922201 is an FDA 510(k) clearance for COAMATE PROTEIN C CHROMOGENIC ASSAY, manufactured by Chromogenix AB. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K922201 · Chromogenix AB · Hematology device
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Dec 1992
Decision
210d
Days
Class 2
Risk

K922201 is an FDA 510(k) clearance for the COAMATE PROTEIN C CHROMOGENIC ASSAY. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Chromogenix AB (Molndal, SE). The FDA issued a Cleared decision on December 7, 1992 after a review of 210 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 Chromogenix AB devices

FDA 510(k) Submission Details - K922201

510(k) Number K922201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1992
Decision Date December 07, 1992
Days to Decision 210 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 113d · This submission: 210d
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 156
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K922201.
NEW STACHROM PROTEIN C TEST KIT
K931906 · American Bioproducts Co. · Nov 1993
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
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