# K050594: Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine, Methamphetamine & Phencyclidine

- Pathway: 510(k) (Traditional)
- Applicant: Nano-Ditech Co.
- Decided: May 15, 2005 after 68 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961249 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003557: Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device (Urine), ACON Laboratories, Inc. (2001) Summary page 1.
- K040274: Acon Opi One Step Opiate Test Strip and Acon Opi One Step Opiate Test Device, ACON Laboratories, Inc. (2004) Summary page 1.
- K010841: Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test Device, ACON Laboratories, Inc. (2001) Summary page 1.
- K011672: Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test Device, ACON Laboratories, Inc. (2001) Summary page 2.
- K011730: Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device, ACON Laboratories, Inc. (2001) Summary page 2.

## Indications for use
The Nano-CheckTM DAT 5 Multi Drug Screening Test for Marijuana, Opiates, Cocaine, Methamphetamine and Phencyclidine is a rapid, self-controlled immunoassay for the qualitative detection of Cannabinoids (THC), Opiates (OPI), Benzoylecgonine (COC), Methamphetamine (mAMP) and Phencyclidine (PCP) compounds and their metabolites in human urine. The detection limits (cut-off concentrations) of this test are as follows: Cannabinoids at 50 ng/ml, Opiates at 2000 ng/ml, Cocaine at 300 ng/ml, Methamphetamine at 1000 ng/ml and Phencyclidine at 25 ng/ml. This assay is intended for Professional and Laboratory In-Vitro Use Only.

Source page: https://510kreport.com/device/K050594
Methodology: https://510kreport.com/methodology