Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup

K260355 · WEBEST Biotech,, LLC · NFT · Mar 9, 2026 · Clinical Toxicology

Device Facts

• Record ID: K260355
• Device Name: Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
• Applicant: WEBEST Biotech,, LLC
• Product Code: NFT · Clinical Toxicology
• Decision Date: Mar 9, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The WEBEST Multi-Drug Urine Cup is a rapid lateral flow immunoassays for the qualitative detection of D-Amphetamine, Butalbital, Buprenorphine, Oxazepam, Benzoylecgonine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Fentanyl, Methylenedioxymethamphetamine, D-Methamphetamine, Methadone, 6-Monoacetylmorphine, Norfentanyl, Morphine, Oxycodone, Phencyclidine, D-Propoxyphene, Nortriptyline, 11-nor-Δ9-THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: [Table omitted]. 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: [Table omitted]. 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 onboard 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.

Device Story

Lateral flow immunochromatographic assay; detects drugs of abuse in human urine; competitive binding principle; antigen-antibody reaction. Device format: multi-test cup; ready-to-use; includes desiccant. User: lay person (home use) or professional. Operation: urine sample absorbed into test strip via capillary action; mixes with drug monoclonal antibody conjugate; flows across pre-coated membrane. Negative result: colored test line appears (drug below detection level). Preliminary positive result: no colored test line (drug at/above detection level). Control line confirms proper performance. Output: visual qualitative result. Clinical decision-making: preliminary screen only; requires confirmation via GC-MS or LC-MS. Benefit: rapid, point-of-care drug screening.

Clinical Evidence

Bench testing only. Precision/reproducibility studies (25 days, 3 lots, 3 operators) confirmed performance at cutoff concentrations. Analytical specificity/interference testing evaluated cross-reactivity with numerous compounds. Method comparison study (80 clinical samples per drug) compared device results to LC-MS/MS. Lay person study (280 participants) evaluated usability and performance across various concentrations; all participants found instructions easy to follow (Flesch-Kincaid Grade Level 7).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding; mouse monoclonal antibody conjugates; pre-coated membrane. Cup format; sealed with desiccant. Stability: 36 months at 4-30°C. No electronic components or software.

Indications for Use

Indicated for qualitative detection of drugs of abuse (AMP, BAR, BUP, BZO, COC, EDDP, FYL, MDMA, MET, MTD, 6-MAM, NFYL, MOP/OPI, OXY, PCP, PPX, TCA, THC, TML) in human urine. For OTC and professional use. Not for monitoring prescription medication.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION MEMORANDUM

510(k) Number: k260355

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.