Cleared Traditional

K954017 - ASSERACHROM FREE PROTEIN S KIT

K954017 is an FDA 510(k) clearance for ASSERACHROM FREE PROTEIN S KIT, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K954017 · American Bioproducts Co. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
80d
Days
Class 2
Risk

K954017 is an FDA 510(k) clearance for the ASSERACHROM FREE 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 80 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.

FDA 510(k) Submission Details - K954017

510(k) Number K954017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1995
Decision Date November 13, 1995
Days to Decision 80 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
33d faster than avg
Panel avg: 113d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

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 189
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K954017.
CHROM Z-F:VIII, CAT. NO. 5241
K952668 · Helena Laboratories · Feb 1996
CHROM Z-PROTEIN C, CAT. NO. 5243
K952666 · Helena Laboratories · Jan 1996
CHROM Z-PLASMINOGEN, CAT. NO. 5244
K952669 · Helena Laboratories · Dec 1995
ASSERACHROM TOTAL PROTEIN S KIT
K954040 · American Bioproducts Co. · Nov 1995
COAMATIC FACTOR VIII
K943225 · Pharmacia Hepar, Inc. · Nov 1995
SPECTROLYSE ANTIPLASMIN KIT
K941752 · Biopool AB · Sep 1995
K954017 · ASSERACHROM FREE PROTEIN S KIT
Download PDF FDA Summary American Bioproducts …