Cleared Traditional

EMIT AMITRIPTYLINE ASSAY (K844950) - FDA 510(k) Clearance

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

K844950 · Syva Co. · Toxicology device
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Jun 1985
Decision
190d
Days
Class 2
Risk

K844950 is an FDA 510(k) clearance for the EMIT AMITRIPTYLINE ASSAY. Classified as Radioimmunoassay, Tricyclic Antidepressant Drugs (product code LFG), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on June 28, 1985 after a review of 190 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Syva Co. devices

Submission Details

510(k) Number K844950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1984
Decision Date June 28, 1985
Days to Decision 190 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
103d slower than avg
Panel avg: 87d · This submission: 190d
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.

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 K844950.
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 IMIPRAMINE ASSAY
K844951 · Syva Co. · Jun 1985
EMIT NORTRIPTYLINE ASSAY
K844952 · Syva Co. · Jun 1985