# K231137: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

- Pathway: 510(k) (Traditional)
- Applicant: Xenta Biomedical Science Co., Ltd.
- Decided: May 19, 2023 after 28 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: 6 generations back to K945610 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 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 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 Barbiturates (BAR) Secobarbital 300 ng/mL Benzodiazepines (BZO) Oxazepam 300 ng/mL Amphetamine (AMP) D-Amphetamine 1000 ng/mL Methadone (MTD) Methadone 300 ng/mL Oxycodone (OXY) Oxycodone 100 ng/mL Phencyclidine (PCP) Phencyclidine 25 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/K231137
Methodology: https://510kreport.com/methodology