# K191099: Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

- Pathway: 510(k) (Traditional)
- Applicant: Atlas Medical
- Decided: Oct 3, 2019 after 161 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: 8 generations back to K945610 (1995). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153050: Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard, Co-Innovation Biotech Co., Ltd. (2016) Summary page 6.

## Indications for use
Atlas Multi-Drugs Screening Test Cup and Atlas Multi-Drugs Screening Test Panel are lateral flow chromatographic in vitro diagnostics immunoassays for the qualitative detection of following drugs in urine without the need of instruments: Drug Name Calibrator Cut-off Amphetamine (AMP) D-Amphetamine 1000 Methylenedioxymethamphetamine (MDMA) D,L Methylenedioxymethamphetamine 500 Morphine (MOP) Morphine 300 Morphine (MOP) Morphine 2000 Oxycodone (OXY) Oxycodone 100 Cocaine (COC) Benzoylecgonine 300 Nortriptyline Nortriptyline 1000 Methamphetamine (MET) D-Methamphetamine 1000 Phencyclidine (PCP) Phencyclidine 25 Marijuana (THC) 11-nor-Δ⁹-THC-9 COOH 50 Secobarbital Secobarbital 300 Oxazepam Oxazepam 300 Methadone (MTD) Methadone 300 Propoxyphene (PPX) Propoxyphene 300 Buprenorphine(BUP) Buprenorphine 10 The tests are intended for professional use only. The tests will yield preliminary positive results when the prescription drugs Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline in urine. The multi-drugs screening tests (Cup and Panel formats) show the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.

Source page: https://510kreport.com/device/K191099
Methodology: https://510kreport.com/methodology