Cleared Traditional

K821408 - PHENOBARBITAL FLUORESCENT IMMUNO

K821408 is the FDA 510(k) clearance for PHENOBARBITAL FLUORESCENT IMMUNO by American Diagnostic Corp.. It is a Class 2 Toxicology device (product code LET) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K821408 · American Diagnostic Corp. · Toxicology device
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May 1982
Decision
13d
Days
Class 2
Risk

K821408 is an FDA 510(k) clearance for the PHENOBARBITAL FLUORESCENT IMMUNO. Classified as Fluorescent Immunoassay, Phenobarbital (product code LET), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on May 24, 1982 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3660 - 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 K821408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1982
Decision Date May 24, 1982
Days to Decision 13 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 87d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LET Fluorescent Immunoassay, Phenobarbital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3660
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 - LET Fluorescent Immunoassay, Phenobarbital

Devices cleared under the same product code (LET) and FDA review panel - the closest regulatory comparables to K821408.
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AMES TDA PHENOBARBITAL TEST
K802255 · Miles Laboratories, Inc. · Sep 1980