Cleared Traditional

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 · Toxicology

Aug 2015

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K151348 is an FDA 510(k) clearance for the 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), a Radioimmunoassay, Tricyclic Antidepressant Drugs (Class II — Special Controls, product code LFG), submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on August 18, 2015, 90 days after receiving the submission on May 20, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3910.

Submission Details

510(k) Number	K151348 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 2015
Decision Date	August 18, 2015
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

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