# K201494: ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

- Pathway: 510(k) (Traditional)
- Applicant: Advin Biotech, Inc.
- Decided: Sep 17, 2020 after 104 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945610 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup, Advin Biotech (2013) Summary page 8.

## Indications for use
The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/lMethylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Analyte Calibrator Cutoff (ng/mL) 6-Acetylmorphine 6-monoacetylmorphine 10 Amphetamine d-Amphetamine 500 Amphetamine d-Amphetamine 1,000 Secobarbital Secobarbital 300 Oxazepam Oxazepam 300 Buprenorphine Buprenorphine 10 EDDP 2-ethylidene-1,5-dimethyl-3-3- diphenylpyrrolidine 300 Cocaine Benzoylecgonine 150 Cocaine Benzoylecgonine 300 Ecstasy d,l-Methylenedioxymethamphetamine 500 Methamphetamine d-Methamphetamine 500 Methamphetamine d-Methamphetamine 1,000 Marijuana 11-nor-Δ⁹-THC-9-COOH 20 Marijuana 11-nor-Δ⁹-THC-9-COOH 50 Methadone d/l-Methadone 300 Opiates Morphine 300 Opiates Morphine 2,000 Oxycodone Oxycodone 100 Phencyclidine Phencyclidine 25 Propoxyphene Propoxyphene 300 Nortriptyline Nortriptyline 1,000 The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the dip card format and in the cup format. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. To obtained a confirmed analytical result, a more specific alternative chemical method should be used. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Source page: https://510kreport.com/device/K201494
Methodology: https://510kreport.com/methodology