Cleared Traditional

K813538 - PHENYTOIN FLUORESCENT IMMUNOASSAY

K813538 is the FDA 510(k) clearance for PHENYTOIN FLUORESCENT IMMUNOASSAY by American Diagnostic Corp.. It is a Class 2 Toxicology device (product code LES) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K813538 · American Diagnostic Corp. · Toxicology device
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Dec 1981
Decision
10d
Days
Class 2
Risk

K813538 is an FDA 510(k) clearance for the PHENYTOIN FLUORESCENT IMMUNOASSAY. Classified as Fluorescent Immunoassay, Diphenylhydantoin (product code LES), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Walker, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 10 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 American Diagnostic Corp. devices

Submission Details

510(k) Number K813538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1981
Decision Date December 31, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 87d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LES Fluorescent 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 - LES Fluorescent Immunoassay, Diphenylhydantoin

Devices cleared under the same product code (LES) and FDA review panel - the closest regulatory comparables to K813538.
SYVA ADVANCE EMIT PHENYTOIN ASSAY
K844990 · Syva Co. · Jan 1985
STRATUS PHENYTOIN FLUOROMETRIC ENZYME
K831154 · American Dade · May 1983
SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY
K820187 · Syva Co. · Feb 1982
AMES TDA TM PHENYTOIN TEST
K811025 · Miles Laboratories, Inc. · Apr 1981
AMES TDA TM PHENYTOIN TEST
K801736 · Miles Laboratories, Inc. · Aug 1980