Cleared Traditional

K861417 - ASSERA-PLATE VWF KIT

K861417 is the FDA 510(k) clearance for ASSERA-PLATE VWF KIT by American Bioproducts Co.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K861417 · American Bioproducts Co. · Hematology device
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Jun 1986
Decision
71d
Days
Class 2
Risk

K861417 is an FDA 510(k) clearance for the ASSERA-PLATE VWF KIT. 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 June 25, 1986 after a review of 71 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 K861417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1986
Decision Date June 25, 1986
Days to Decision 71 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
42d faster than avg
Panel avg: 113d · This submission: 71d
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 K861417.
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA
K864480 · Instrumentation Laboratory CO · Jan 1987
COAGULATION INTRINSIC DEFICIENT PLASMAS
K864481 · Instrumentation Laboratory CO · Jan 1987
COAGULATION EXTRINSIC DEFICIENT PLASMAS
K864497 · Instrumentation Laboratory CO · Jan 1987
ASSERA-PLATE PROTEIN C KIT
K861475 · American Bioproducts Co. · Jun 1986
STACLOT PROTEIN C TEST KIT
K861079 · American Bioproducts Co. · Jun 1986
PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765
K861048 · Sigma Chemical Co. · May 1986