Cleared Traditional

K884058 - COATEST PROTEIN C

K884058 is the FDA 510(k) clearance for COATEST PROTEIN C by Kabivitrum, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K884058 · Kabivitrum, Inc. · Hematology device
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Dec 1988
Decision
78d
Days
Class 2
Risk

K884058 is an FDA 510(k) clearance for the COATEST PROTEIN C. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Kabivitrum, Inc. (Alameda, US). The FDA issued a Cleared decision on December 13, 1988 after a review of 78 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 K884058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1988
Decision Date December 13, 1988
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 113d · This submission: 78d
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 K884058.
DADE PROTEIN C CHROMOGENIC ASSAY
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DADE FACTOR IX CHROMOGENIC ASSAY
K884551 · Baxter Healthcare Corp · Dec 1988
STACHROM ANTIPLASMIN TEST KIT
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STACHROM ANTIPLASMIN CONTROL
K882603 · American Bioproducts Co. · Sep 1988
CALIBRATION REFERENCE PLASMA
K874940 · Baxter Healthcare Corp · Feb 1988