# K182123: ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

- Pathway: 510(k) (Traditional)
- Applicant: Advin Biotech, Inc.
- Decided: Mar 29, 2019 after 235 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.
11 later devices descend from it; 3 cite it directly.
0 of 39 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 5.

## Most influential descendants
- K201630: AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests (2021), 8 descendants of its own
- K232659: Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup (2023), 6 descendants of its own
- K240686: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (2024), 3 descendants of its own
- K253567: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (2025), 0 descendants of its own
- K250803: Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup (2025), 0 descendants of its own

## 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 Barbiturates Secobarbital/Pentobarbital 300 Benzodiazepines 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 50 Methadone d/l-Methadone 300 Opiates Morphine 300 Opiates Morphine 2,000 Oxycodone Oxycodone 100 Phencyclidine Phencyclidine 25 Propoxyphene Propoxyphene 300 Tricyclic Antidepressants 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. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive positive result if the donor doesn’t admit use or anytime required by testing procedures. 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/K182123
Methodology: https://510kreport.com/methodology