# K260355: Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup

- Pathway: 510(k) (Traditional)
- Applicant: WEBEST Biotech,, LLC
- Decided: Mar 9, 2026 after 34 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)
- K244043: AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup, Hangzhou AllTest Biotech Co., Ltd. (2025) Summary page 6.

## Indications for use
The WEBEST Multi-Drug Urine Cup is a rapid lateral flow immunoassays for the qualitative detection of O-Amphetamine, Butalbital, Buprenorphine, Oxazepam, Benzoylecgonine, 2-ethylidene-l,5-dimethyl-3,3-diphenylpyrrolidine, Fentanyl, Methylenedioxymethamphetamine, O-Methamphetamine, Methadone, 6-Monoacetylmorphine, Norfentanyl, Morphine, Oxycodone, Phencyclidine, O-Propoxyphene, Nortriptyline, 11-nor-69-THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Test Calibrator Cut-off (ng/ml) AMP O-Amphetamine 1000 or 500 BAR Butalbital 300 BUP Buprenorphine 10 BZO Oxazepam 300 COC Benzoylecgonine 300 or 150 EDDP 2-ethylidene- l ,5-dimethyl-3,3-diphenylpyrrolidine 300 FYL Fentanyl 1 MOMA Methylenedioxymethamphetamine 500 MET O-Methamphetamine 1000 or 500 MTD Methadone 300 6-MAM 6-Monoacetylmorphine 10 NFYL Norfentanyl 5 MOP/OPI Morphine 2000 or 300 OXY Oxycodone 100 PCP Phencyclidine 25 PPX O-Propoxyphene 300 TCA Nortriptyline 1000 THC 11-nor-69-THC-COOH 50 TML Tramadol 100 The single or multi-test cup can consist of up to nineteen (19) of the above listed analytes in any combination with or without on-board adulteration/ specimen validity tests (SVT). The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. The Webest Home Multi-Drug Urine Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below: CODE SUBSTANCE CUT-OFF (ng/ml) AMP O-Amphetamine 1000 or 500 BAR Butalbital 300 BUP Buprenorphine 10 BZO Oxazepam 300 COC Benzoylecgonine 300 orl 50 EDDP 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300 FYL Fentanyl MOMA Methylenedioxymethamphetamine 500 MET D-Methamphetamine 1000 or 500 MTD Methadone 300 6-MAM 6-Monoacetylmorphine 10 NFYL Norfentanyl 5 MOP/OPI Morphine 2000 or300 OXY Oxycodone 100 PCP Phencyclidine 25 PPX D-Propoxyphene 300 TCA Nortriptyline 1000 THC 11-nor-~9-THC-COOH 50 TML Tramadol 100 This is not a screening device to monitor prescription medication. The single or multi-test cup can include any combination of the analytes listed above, with and without on-board adulteration tests. However, only one cut-off concentration can be included per analyte per device. This device provides only a preliminary test result. A more specific alternate method shall be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method.

Source page: https://510kreport.com/device/K260355
Methodology: https://510kreport.com/methodology