Cleared Traditional

K864481 - COAGULATION INTRINSIC DEFICIENT PLASMAS

K864481 is the FDA 510(k) clearance for COAGULATION INTRINSIC DEFICIENT PLASMAS by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K864481 · Instrumentation Laboratory CO · Hematology device
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Jan 1987
Decision
53d
Days
Class 2
Risk

K864481 is an FDA 510(k) clearance for the COAGULATION INTRINSIC DEFICIENT PLASMAS. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on January 5, 1987 after a review of 53 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K864481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1986
Decision Date January 05, 1987
Days to Decision 53 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
60d faster than avg
Panel avg: 113d · This submission: 53d
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 118
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K864481.
IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)
K870353 · American Dade · Feb 1987
IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)
K870354 · American Dade · Feb 1987
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA
K864480 · Instrumentation Laboratory CO · Jan 1987
COAGULATION EXTRINSIC DEFICIENT PLASMAS
K864497 · Instrumentation Laboratory CO · Jan 1987
ASSERA-PLATE VWF KIT
K861417 · American Bioproducts Co. · Jun 1986
ASSERA-PLATE PROTEIN C KIT
K861475 · American Bioproducts Co. · Jun 1986