Cleared Traditional

DADE PROTEIN C CLOTTING ASSAY (K903468) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903468 · Baxter Healthcare Corp · Hematology device
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Feb 1991
Decision
209d
Days
Class 2
Risk

K903468 is an FDA 510(k) clearance for the DADE PROTEIN C CLOTTING ASSAY. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on February 26, 1991 after a review of 209 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K903468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1990
Decision Date February 26, 1991
Days to Decision 209 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 113d · This submission: 209d
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 70
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K903468.
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
IL TEST PROCLOT ASSAY STYSTEM
K912711 · Instrumentation Laboratory CO · Oct 1991
FREE PROTEIN S REAGENT CAT. NO. 5363
K904247 · Helena Laboratories · Jan 1991
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
K896174 · Helena Laboratories · Mar 1990
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
K897136 · Helena Laboratories · Feb 1990