# K130275: Quikscreen Multi (Mdma and Opi) Otc Drug Cup Test

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin New Bay Bioresearch Co., Ltd.
- Decided: Sep 26, 2013 after 234 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: 1 generation back to K121166 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121166: Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel, Guangzhou Wondfo Biotech Co., Ltd. (2012) Summary page 2.

## Indications for use
The QuikScreen T M Multi (MDMA and OPI) Drug Cup Test consists of competitive binding, lateral flow immunochromatographic assays and provides a simple and rapid analytical screening procedure to simultaneously detect the drugs of abuse MDMA at or above the cutoff level of 500 nglml and OPI at or above the cutoff level of 300 nglml in human urine. The device is intended for prescription use and Over-The-Counter settings. Test Calibrator Cutof Opiate Morphine 300 nglml MOMA (+/-)-3,4Mcthylene- 500 ng/ml dioxymethamphetamine The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GCIMS or LC/MS is the preferred confirmatory method. Clinical and professional judgment should be exercised with any drug of abuse test result, particularly when preliminary results are used. The assay does not distinguish whether OPI or MDMA is being taken therapeutically or abused.

Source page: https://510kreport.com/device/K130275
Methodology: https://510kreport.com/methodology