Cleared Traditional

K833892 - COATEST FACTOR VIII

K833892 is the FDA 510(k) clearance for COATEST FACTOR VIII by Kabivitrum, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K833892 · Kabivitrum, Inc. · Hematology device
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Jan 1984
Decision
82d
Days
Class 2
Risk

K833892 is an FDA 510(k) clearance for the COATEST FACTOR VIII. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Kabivitrum, Inc. (Walker, US). The FDA issued a Cleared decision on January 30, 1984 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 Kabivitrum, Inc. devices

Submission Details

510(k) Number K833892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1983
Decision Date January 30, 1984
Days to Decision 82 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
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 127
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K833892.
RISTOCETIN COFACTOR ASSAY
K840329 · Helena Laboratories · Apr 1984
PROTOPATH FACTOR IX ASSAY
K834050 · American Dade · Feb 1984
PROTOPATH FACTOR VIII ASSAY
K834051 · American Dade · Feb 1984
FACTOR II DEFICIENT SUBSTRATE PLASMA
K834031 · Helena Laboratories · Dec 1983
VON WILLEBRAND FACTOR ASSAY
K823453 · General Diagnostics · Jan 1983
FACTOR VIII RELATED ANTIGEN ROCKET EID
K823267 · Helena Laboratories · Dec 1982