Cleared Traditional

K902952 - IL PHENYTOIN ASSAY SYSTEM

K902952 is the FDA 510(k) clearance for IL PHENYTOIN ASSAY SYSTEM by Instrumentation Laboratory CO. It is a Class 2 Toxicology device (product code DIP) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K902952 · Instrumentation Laboratory CO · Toxicology device
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Aug 1990
Decision
48d
Days
Class 2
Risk

K902952 is an FDA 510(k) clearance for the IL PHENYTOIN ASSAY SYSTEM. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on August 22, 1990 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3350 - the FDA toxicology 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K902952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1990
Decision Date August 22, 1990
Days to Decision 48 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 87d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIP Enzyme Immunoassay, Diphenylhydantoin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
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 Toxicology devices follow this clearance model.

Regulatory Peers - DIP Enzyme Immunoassay, Diphenylhydantoin

All 33
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K902952.
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS
K913429 · Syva Co. · Aug 1991
DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD
K911056 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1991
CEDIA PHENYTOIN ASSAY
K905689 · Microgenics Corp. · Jan 1991
VISION PHENYTOIN
K896074 · Abbott Laboratories · Nov 1989
EMIT CONVENIENCE PACK: PHENYTOIN ASSAY
K874856 · Syva Co. · Jan 1988
PHENYTOIN FPIA REAGENT SET
K870953 · Sigma Diagnostics, Inc. · Mar 1987