Cleared Traditional

K861079 - STACLOT PROTEIN C TEST KIT

K861079 is an FDA 510(k) clearance for STACLOT PROTEIN C TEST 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 90-day FDA review.

K861079 · American Bioproducts Co. · Hematology device
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Jun 1986
Decision
90d
Days
Class 2
Risk

K861079 is an FDA 510(k) clearance for the STACLOT PROTEIN C TEST 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 19, 1986 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Bioproducts Co. devices

FDA 510(k) Submission Details - K861079

510(k) Number K861079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1986
Decision Date June 19, 1986
Days to Decision 90 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
23d faster than avg
Panel avg: 113d · This submission: 90d
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 155
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K861079.
COAGULATION EXTRINSIC DEFICIENT PLASMAS
K864497 · Instrumentation Laboratory CO · Jan 1987
ASSERA-PLATE VWF KIT
K861417 · American Bioproducts Co. · Jun 1986
ASSERA-PLATE PROTEIN C KIT
K861475 · American Bioproducts Co. · Jun 1986
PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765
K861048 · Sigma Chemical Co. · May 1986
HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA
K861049 · Sigma Chemical Co. · May 1986
VWF-IX:AG CONTROL PLASMA
K861217 · American Bioproducts Co. · May 1986