Cleared Traditional

K954040 - ASSERACHROM TOTAL PROTEIN S KIT

K954040 is the FDA 510(k) clearance for ASSERACHROM TOTAL PROTEIN S KIT by American Bioproducts Co.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K954040 · American Bioproducts Co. · Hematology device
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Nov 1995
Decision
77d
Days
Class 2
Risk

K954040 is an FDA 510(k) clearance for the ASSERACHROM TOTAL PROTEIN S KIT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on November 13, 1995 after a review of 77 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 American Bioproducts Co. devices

Submission Details

510(k) Number K954040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1995
Decision Date November 13, 1995
Days to Decision 77 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 113d · This submission: 77d
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 K954040.
CHROM Z-PROTEIN C, CAT. NO. 5243
K952666 · Helena Laboratories · Jan 1996
CHROM Z-PLASMINOGEN, CAT. NO. 5244
K952669 · Helena Laboratories · Dec 1995
ASSERACHROM FREE PROTEIN S KIT
K954017 · American Bioproducts Co. · Nov 1995
PROTEIN C REAGENT, COAGULOMETRIC
K924425 · Behring Diagnostics, Inc. · Jan 1995
HEMOLAB PROTEIN C CHROMOGENIC ASSAY
K934210 · Biomerieux Vitek, Inc. · Dec 1994
MDA PROTEIN ASSAY
K925617 · Organon Teknika Corp. · Jan 1994