Cleared Traditional

K122809 - Advin Multi-Drug Screen Test Cassette, Dip Card and Cup

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

K122809 · Advin Biotech · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K122809

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
Combination Product No
PCCP Authorized No
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.

DKZ Device Classification - Class 2, Special Controls

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 184
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K122809.
GENPRIME DRUGS OF ABUSE READER SYSTEM
K130082 · Genprime, Inc. · Dec 2013
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
K131645 · Alfa Scientific Designs, Inc. · Oct 2013
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K131811 · Ucp Biosciences, Inc. · Jul 2013
POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
K121065 · Polymed Therapeutics, Inc. · May 2013
UCP HOME DRUG SCREENING TEST
K130463 · Ucp Biosciences, Inc. · May 2013
PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
K130811 · Psychemedics Corp. · May 2013