Cleared Traditional

A-GENT PHERYTOIN (K832419) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832419 · Abbott Laboratories · Toxicology device
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Sep 1983
Decision
41d
Days
Class 2
Risk

K832419 is an FDA 510(k) clearance for the A-GENT PHERYTOIN. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 1, 1983 after a review of 41 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 Abbott Laboratories devices

Submission Details

510(k) Number K832419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1983
Decision Date September 01, 1983
Days to Decision 41 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
46d faster than avg
Panel avg: 87d · This submission: 41d
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 29
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K832419.
PHENYTOIN ACA ANALYTICAL TEST PACK
K843209 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1984
EMIT QST PHENYTOIN ASSAY
K834406 · Syva Co. · Feb 1984
CHEMKIT PHENYTOIN DIAG. KIT
K833806 · Abbott Laboratories · Jan 1984
EMIT AED PHENYTOIN ASSAY
K832033 · Syva Co. · Aug 1983
ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE
K780218 · Syva Co. · Mar 1978
EMIT ANTIEPILEPTIC DRUG ASSAYS
K772179 · Syva Co. · Dec 1977