Cleared Traditional

K854312 - ASSERACHROM IX:AG

K854312 is the FDA 510(k) clearance for ASSERACHROM IX:AG by American Bioproducts Co.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K854312 · American Bioproducts Co. · Hematology device
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Feb 1986
Decision
99d
Days
Class 2
Risk

K854312 is an FDA 510(k) clearance for the ASSERACHROM IX:AG. 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 February 4, 1986 after a review of 99 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

Submission Details

510(k) Number K854312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date February 04, 1986
Days to Decision 99 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
14d faster than avg
Panel avg: 113d · This submission: 99d
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 K854312.
VWF-IX:AG CONTROL PLASMA
K861217 · American Bioproducts Co. · May 1986
PROTEIN C CONTROL PLASMA
K861216 · American Bioproducts Co. · May 1986
ASSERACHROM VWF KIT
K860371 · American Bioproducts Co. · Apr 1986
ASSERA PLATE IX:AG KIT
K854014 · American Bioproducts Co. · Jan 1986
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
K853461 · American Dade · Aug 1985
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
K853462 · American Dade · Aug 1985