Cleared Traditional

K862775 - ASSERACHROM B-TG KIT

K862775 is an FDA 510(k) clearance for ASSERACHROM B-TG KIT, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code JBX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K862775 · American Bioproducts Co. · Hematology device
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Oct 1986
Decision
92d
Days
Class 2
Risk

K862775 is an FDA 510(k) clearance for the ASSERACHROM B-TG KIT. Classified as Aggregrometer, Platelet (product code JBX), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on October 22, 1986 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6675 - 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 - K862775

510(k) Number K862775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1986
Decision Date October 22, 1986
Days to Decision 92 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
21d faster than avg
Panel avg: 113d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBX Device Classification - Class 2, Special Controls

Product Code JBX Aggregrometer, Platelet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6675
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 - JBX Aggregrometer, Platelet

Devices cleared under the same product code (JBX) and FDA review panel - the closest regulatory comparables to K862775.
AGGRO/LINK CONTROL SOFTWARE
K932566 · Chrono-Log Corp. · Nov 1993
ARACHIDONIC ACID
K912774 · Helena Laboratories · Aug 1991
PAT PLATELET AGGREGATION TEST
K881829 · Streck Laboratories, Inc. · Jul 1988
RISTOCETIN PLATELET AGGREGA-REAGENT TEST
K832929 · Sigma Chemical Co. · Sep 1983
PLATELET AGGREGATION PROFILER #PAP-4
K821005 · Bio/Data Corp. · Jun 1982
ARACHIDONIC ACID
K811290 · Bio/Data Corp. · Jul 1981