Cleared Traditional

K122809 - Advin Multi-Drug Screen Test Cassette

K122809 is the FDA 510(k) clearance for Advin Multi-Drug Screen Test Cassette by Advin Biotech. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K122809 · Advin Biotech · Toxicology device
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Jun 2013
Decision
277d
Days
Class 2
Risk

K122809 is an FDA 510(k) clearance for the Advin Multi-Drug Screen Test Cassette, Dip Card and Cup. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Advin Biotech (San Diego, US). The FDA issued a Cleared decision on June 17, 2013 after a review of 277 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Advin Biotech devices

Submission Details

510(k) Number K122809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2012
Decision Date June 17, 2013
Days to Decision 277 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
190d slower than avg
Panel avg: 87d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 126
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K122809.
WONDFO MULTI-DRUG URINE TEST CUP, PANEL
K133968 · Guangzhou Wondfo Biotech Co., Ltd. · Feb 2014
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131653 · Lin-Zhi International, Inc. · Feb 2014
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
K131645 · Alfa Scientific Designs, Inc. · Oct 2013
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
K122961 · Guangzhou Wondfo Biotech Co., Ltd. · Dec 2012
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU
K122904 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2012
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST
K121987 · Guangzhou Wondfo Biotech Co., Ltd. · Aug 2012