# K222955: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

- Pathway: 510(k) (Traditional)
- Applicant: Xenta Biomedical Science Co., Ltd.
- Decided: Feb 6, 2023 after 132 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: 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 4.

## Indications for use
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: Test Calibrator Cut-off level Marijuana (THC) Delta-9-THC-COOH 50 ng/mL Cocaine (COC) Benzoylecgonine 300 ng/mL Methylenedioxymethamphetamine (MDMA) 3,4-Methylenedioxymethamphetamine 500 ng/mL Methamphetamine (MET) D-Methamphetamine 1000 ng/mL Morphine 300 (MOP) Morphine 300 ng/mL The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use. The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Source page: https://510kreport.com/device/K222955
Methodology: https://510kreport.com/methodology