Cleared Traditional

K912774 - ARACHIDONIC ACID

K912774 is the FDA 510(k) clearance for ARACHIDONIC ACID by Helena Laboratories. It is a Class 2 Hematology device (product code JBX) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K912774 · Helena Laboratories · Hematology device
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Aug 1991
Decision
59d
Days
Class 2
Risk

K912774 is an FDA 510(k) clearance for the ARACHIDONIC ACID. Classified as Aggregrometer, Platelet (product code JBX), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 22, 1991 after a review of 59 days - a notably fast clearance cycle.

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: 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 Helena Laboratories devices

Submission Details

510(k) Number K912774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1991
Decision Date August 22, 1991
Days to Decision 59 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 113d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K912774.
PAT PLATELET AGGREGATION TEST
K881829 · Streck Laboratories, Inc. · Jul 1988
ASSERACHROM B-TG KIT
K862775 · American Bioproducts Co. · Oct 1986
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