Cleared Traditional

K914818 - DADE ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO...

K914818 is the FDA 510(k) clearance for DADE ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO... by Baxter Diagnostics, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K914818 · Baxter Diagnostics, Inc. · Hematology device
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Jan 1992
Decision
82d
Days
Class 2
Risk

K914818 is an FDA 510(k) clearance for the DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on January 15, 1992 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K914818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1991
Decision Date January 15, 1992
Days to Decision 82 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
31d faster than avg
Panel avg: 113d · This submission: 82d
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 K914818.
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
IL TEST PROCLOT ASSAY STYSTEM
K912711 · Instrumentation Laboratory CO · Oct 1991
STACLOT(R) PROTEIN S TEST KIT
K913424 · American Bioproducts Co. · Oct 1991
LIATEST PROTEIN S KIT
K912468 · American Bioproducts Co. · Oct 1991