Cleared Traditional

K811290 - ARACHIDONIC ACID

K811290 is an FDA 510(k) clearance for ARACHIDONIC ACID, manufactured by Bio/Data Corp.. The device is a Class 2 Chemistry device with product code JBX cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K811290 · Bio/Data Corp. · Chemistry device
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Jul 1981
Decision
77d
Days
Class 2
Risk

K811290 is an FDA 510(k) clearance for the ARACHIDONIC ACID. Classified as Aggregrometer, Platelet (product code JBX), Class II - Special Controls.

Submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1981 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.6675 - the FDA in vitro diagnostics and chemistry 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.

FDA 510(k) Submission Details - K811290

510(k) Number K811290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1981
Decision Date July 27, 1981
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 89d · This submission: 77d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JBX Aggregrometer, Platelet

All 11
Devices cleared under the same product code (JBX) and FDA review panel - the closest regulatory comparables to K811290.
RISTOCETIN PLATELET AGGREGA-REAGENT TEST
K832929 · Sigma Chemical Co. · Sep 1983
PLATELET AGGREGOMETER
K830749 · Chrono-Log Corp. · May 1983
PLATELET AGGREGATION PROFILER #PAP-4
K821005 · Bio/Data Corp. · Jun 1982
BUFFER, COLLAGEN REAGENT AND DILUENT
K781710 · Diagnostica, Inc. · Oct 1978
AGGREGOMETER, DUAL CHANNEL PLATELET
K760159 · Chrono-Log Corp. · Jul 1976
K811290 · ARACHIDONIC ACID
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