Cleared Traditional

K854014 - ASSERA PLATE IX:AG KIT

K854014 is an FDA 510(k) clearance for ASSERA PLATE IX:AG 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 98-day FDA review.

K854014 · American Bioproducts Co. · Hematology device
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Jan 1986
Decision
98d
Days
Class 2
Risk

K854014 is an FDA 510(k) clearance for the ASSERA PLATE IX:AG 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 January 3, 1986 after a review of 98 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 - K854014

510(k) Number K854014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1985
Decision Date January 03, 1986
Days to Decision 98 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
15d faster than avg
Panel avg: 113d · This submission: 98d
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 K854014.
PROTEIN C CONTROL PLASMA
K861216 · American Bioproducts Co. · May 1986
ASSERACHROM VWF KIT
K860371 · American Bioproducts Co. · Apr 1986
ASSERACHROM IX:AG
K854312 · American Bioproducts Co. · Feb 1986
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
K853461 · American Dade · Aug 1985
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
K853462 · American Dade · Aug 1985
FACTOR IX DEFICIENT PLASMA, B9D -
K843215 · Sigma Chemical Co. · Nov 1984