Cleared Traditional

DOXEPIN TRI-CY TEST SET (K821652) - FDA 510(k) Clearance

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

K821652 · Wien Laboratories, Inc. · Chemistry device
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Jun 1982
Decision
11d
Days
Class 2
Risk

K821652 is an FDA 510(k) clearance for the DOXEPIN TRI-CY TEST SET. Classified as Radioimmunoassay, Tricyclic Antidepressant Drugs (product code LFG), Class II - Special Controls.

Submitted by Wien Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1982 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3910 - the FDA in vitro diagnostics and chemistry 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 Wien Laboratories, Inc. devices

Submission Details

510(k) Number K821652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1982
Decision Date June 14, 1982
Days to Decision 11 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 88d · This submission: 11d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LFG Radioimmunoassay, Tricyclic Antidepressant Drugs

All 20
Devices cleared under the same product code (LFG) and FDA review panel - the closest regulatory comparables to K821652.
Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
K151348 · Healgen Scientific, LLC · Aug 2015
EMIT NORTRIPTYLINE ASSAY
K870823 · Syva Co. · Mar 1987
EMIT DESIPRAMINE ASSAY
K861155 · Syva Co. · May 1986
TD TRICYCLIC ANTIDEPRESSANTS
K853113 · Abbott Laboratories · Aug 1985
EMIT AMITRIPTYLINE ASSAY
K844950 · Syva Co. · Jun 1985
EMIT IMIPRAMINE ASSAY
K844951 · Syva Co. · Jun 1985