Cleared Traditional

K921449 - NEW STACHROM ANTIPLASMIN

K921449 is an FDA 510(k) clearance for NEW STACHROM ANTIPLASMIN, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K921449 · American Bioproducts Co. · Hematology device
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Sep 1992
Decision
181d
Days
Class 2
Risk

K921449 is an FDA 510(k) clearance for the NEW STACHROM ANTIPLASMIN. 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 September 23, 1992 after a review of 181 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

FDA 510(k) Submission Details - K921449

510(k) Number K921449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1992
Decision Date September 23, 1992
Days to Decision 181 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 113d · This submission: 181d
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 155
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K921449.
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
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
DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY
K914818 · Baxter Diagnostics, Inc. · Jan 1992