Cleared Traditional

K821743 - EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY

K821743 is the FDA 510(k) clearance for EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code LFG) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K821743 · Syva Co. · Toxicology device
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Jul 1982
Decision
18d
Days
Class 2
Risk

K821743 is an FDA 510(k) clearance for the EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY. Classified as Radioimmunoassay, Tricyclic Antidepressant Drugs (product code LFG), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3910 - 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 Syva Co. devices

Submission Details

510(k) Number K821743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1982
Decision Date July 02, 1982
Days to Decision 18 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
69d faster than avg
Panel avg: 87d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3910
Definition Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine.
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.