Cleared Traditional

K070009 - AT HOME DRUG TEST MODELS, 9308T AND 9308X (FDA 510(k) Clearance)

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

K070009 · Phamatech, Inc. · Toxicology device
Dec 2007
Decision
338d
Days
Class 2
Risk

K070009 is an FDA 510(k) clearance for the AT HOME DRUG TEST MODELS, 9308T AND 9308X. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K070009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date December 07, 2007
Days to Decision 338 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 146d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K070009.
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K161714 · Immunalysis Corporation · Oct 2016
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
K150791 · Healgen Scientific, LLC · Apr 2015