Cleared Traditional

K812431 - FACTOR VIII DEFICIENT PLASMA #B8D

K812431 is the FDA 510(k) clearance for FACTOR VIII DEFICIENT PLASMA #B8D by Sigma Chemical Co.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K812431 · Sigma Chemical Co. · Hematology device
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Sep 1981
Decision
29d
Days
Class 2
Risk

K812431 is an FDA 510(k) clearance for the FACTOR VIII DEFICIENT PLASMA #B8D. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 29 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K812431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1981
Decision Date September 23, 1981
Days to Decision 29 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
84d faster than avg
Panel avg: 113d · This submission: 29d
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 K812431.
DADE FACTOR ASSAY REFERENCE PLASMA
K820085 · American Dade · Feb 1982
LANCER COAGENT HUMAN FACTOR 1X PLASMA
K812974 · Sherwood Medical Co. · Nov 1981
LANCER COAGENT HUMAN VACTOR VIII PLASMA
K812975 · Sherwood Medical Co. · Nov 1981
VON WILLEBRAND FACTOR ASSAY
K802356 · Bio/Data Corp. · Dec 1980
HELENA FACTOR XII DEFICIENT
K792656 · Helena Laboratories · Jan 1980
HELENA FACTOR IX DEFICIENT SUBSTRATE
K792475 · Helena Laboratories · Dec 1979