# K261409: BioTeke® Multi-Drug Urine Test Cup

- Pathway: 510(k) (Traditional)
- Applicant: Bioteke Corporation (Wuxi) Co., Ltd.
- Decided: Sep 10, 2026 after 133 days
- Product code: NFT (Test, Amphetamine, Over The Counter)
- 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: 10 generations back to K001178 (2000). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241428: AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup, Hangzhou AllTest Biotech Co., Ltd. (2024) Summary page 6.

## Indications for use
BioTeke® Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay. It is a rapid drug test for the qualitative and simultaneous detection of drugs and drug metabolites in human urine. It is for in vitro diagnostic use only. Prescription Use Only. Drug test cut-off concentrations are listed below: Test Calibrator Cut-off (ng/mL) Amphetamine (AMP) Amphetamine 500 Phenobarbital (BAR) Phenobarbital 300 Buprenorphine (BUP) Buprenorphine 10 Oxazepam (BZO) Oxazepam 300 Cocaine (COC) Benzoylecgonine 150 Fentanyl (FTY) Fentanyl 1 Methylenedioxymethamphetamine (MDMA) Methylenedioxymethamphetamine 500 Methamphetamine (MET) Methamphetamine 500 Morphine (MOP/OPI) Morphine 300 Methadone (MTD) Methadone 300 Oxycodone (OXY) Oxycodone 100 Phencyclidine (PCP) Phencyclidine 25 Marijuana (THC) 11-nor-Δ9-THC-9-COOH 50 Nortriptyline (TCA) Nortriptyline 1000 BioTeke® Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. The test provides only preliminary test results. A more specific method must be used in order to obtain a confirmed result. GC/MS or LC/MS is the preferred method.

Source page: https://510kreport.com/device/K261409
Methodology: https://510kreport.com/methodology