Cleared Traditional

K870917 - PROTEIN S CONTROL PLASMA

K870917 is the FDA 510(k) clearance for PROTEIN S CONTROL PLASMA by American Bioproducts Co.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K870917 · American Bioproducts Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1987
Decision
48d
Days
Class 2
Risk

K870917 is an FDA 510(k) clearance for the PROTEIN S CONTROL PLASMA. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on April 23, 1987 after a review of 48 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 K870917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1987
Decision Date April 23, 1987
Days to Decision 48 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
65d faster than avg
Panel avg: 113d · This submission: 48d
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 K870917.
STACHROM VIII:C TEST KIT
K874097 · American Bioproducts Co. · Dec 1987
ASSERACHROM PROTEIN S TEST KIT
K872479 · American Bioproducts Co. · Aug 1987
STACHROM PROTEIN C TEST KIT
K871039 · American Bioproducts Co. · May 1987
IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)
K870353 · American Dade · Feb 1987
IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)
K870354 · American Dade · Feb 1987
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA
K864480 · Instrumentation Laboratory CO · Jan 1987