Cleared Traditional

K070009 - AT HOME DRUG TEST MODELS, 9308T AND 9308X

K070009 is an FDA 510(k) clearance for AT HOME DRUG TEST MODELS, manufactured by Phamatech, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K070009 · Phamatech, Inc. · Toxicology device
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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.

View all Phamatech, Inc. devices

FDA 510(k) Submission Details - K070009

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
251d slower than avg
Panel avg: 87d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIS Device Classification - Class 2, Special Controls

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

All 90
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K070009.
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
K140215 · Co-Innovation Biotech Co., Ltd. · Jun 2014
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K092268 · Randox Laboratories, Ltd. · May 2011
UCP DRUG SCREENING TEST CUPS
K110515 · Ucp Biosciences, Inc. · Apr 2011
VITROS CHEMISTRY PRODUCTS BARB REAGENT
K062165 · Ortho-Clinical Diagnostics · Jan 2007
ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
K050024 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2005
ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
K050593 · ACON Laboratories, Inc. · May 2005