Cleared Traditional

K931906 - NEW STACHROM PROTEIN C TEST KIT

K931906 is the FDA 510(k) clearance for NEW STACHROM PROTEIN C TEST KIT by American Bioproducts Co.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K931906 · American Bioproducts Co. · Hematology device
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Nov 1993
Decision
206d
Days
Class 2
Risk

K931906 is an FDA 510(k) clearance for the NEW STACHROM PROTEIN C TEST KIT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on November 5, 1993 after a review of 206 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 American Bioproducts Co. devices

Submission Details

510(k) Number K931906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1993
Decision Date November 05, 1993
Days to Decision 206 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
93d slower than avg
Panel avg: 113d · This submission: 206d
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 126
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K931906.
PROTEIN C REAGENT, COAGULOMETRIC
K924425 · Behring Diagnostics, Inc. · Jan 1995
HEMOLAB PROTEIN C CHROMOGENIC ASSAY
K934210 · Biomerieux Vitek, Inc. · Dec 1994
MDA PROTEIN ASSAY
K925617 · Organon Teknika Corp. · Jan 1994
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