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

- Pathway: 510(k) (Traditional)
- Applicant: Advin Biotech
- Decided: Jun 17, 2013 after 277 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945610 (1995). 26 ancestors in all.
55 later devices descend from it; 12 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061718: Innovacon Spectrum II Test Card, Innovacon, Inc. (2006) Summary page 4.

## Most influential descendants
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard (2014), 16 descendants of its own
- K182701: Wondfo T-Cup Multi-Drug Urine Test Cup (2018), 13 descendants of its own
- K142800: Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard (2014), 13 descendants of its own
- K181768: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (2018), 12 descendants of its own
- K182123: ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card (2019), 11 descendants of its own

## Indications for use
The Advin Multi-Drug Screen Test is a one-step immunoassay for the qualitative detection of multiple drugs of abuse and/or their metabolites in human urine at the following cutoff levels: Drug Test — Calibrator — Cutoff Level Amphetamine (AMP) — d-Amphetamine — 500 ng/mL Barbiturates (BAR) — Secobarbital — 300 ng/mL Benzodiazepines (BZO) — Oxazepam — 300 ng/mL Buprenorphine (BUP) — Buprenorphine — 10 ng/mL Cocaine (COC) — Benzoylecgnine — 150 ng/mL EDDP — 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine — 300 ng/mL Ecstasy (MDMA) — Methylenedioxymethamphetamine — 500 ng/mL Methamphetamine (MET) — d-Methamphetamine — 500 ng/mL Methadone (MTD) — Methadone — 300 ng/mL Morphine (MOR300) — Morphine — 300 ng/mL Opiates (OPI) — Morphine — 2,000 ng/mL Oxycodone (OXY) — Oxycodone — 100 ng/mL Phencyclidine (PCP) — Phencyclidine — 25 ng/mL Propoxyphene (PPX) — Propoxyphene — 300 ng/mL Tricyclic-antidepressant (TCA) — Nortriptynine — 1,000 ng/mL Marijuana (THC) — 1-nor-A9-THC-9-COOH — 50 ng/mL The Advin Multi-Drug Screen Test consists of three formats: a Cassette, a Dip Card and a Cup, which may be configured in any combination of the drug analytes listed in the above table. Advin Multi-Drug Screen Test is used to obtain a visual, qualitative, preliminary test result for prescription use in point of care sites, laboratory settings and is also intended for workplace and over-the-counter use. The Propoxyphene test strip is not intended for over-the-counter use. The Advin Multi-Drug Screen Test will yield preliminary positive results when prescription drugs TCA, Barbiturates and Benzodiazepine, Methadone, Buprenorphine and Opiates are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for TCA, Barbiturates and Benzodiazepine in urine. The Advin Multi-Drug Screen Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry/Mass (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in the evaluation of a preliminary positive test result.

Source page: https://510kreport.com/device/K122809
Methodology: https://510kreport.com/methodology