AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup

K250727 · Hangzhou AllTest Biotech Co., Ltd. · NFT · Apr 4, 2025 · Clinical Toxicology

Device Facts

• Record ID: K250727
• Device Name: AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
• Applicant: Hangzhou AllTest Biotech Co., Ltd.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Apr 4, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of: [Table of cutoffs]. AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine; cup format. Device uses competitive binding principle: drug in urine competes with drug-protein conjugate for limited antibody binding sites. Absence of colored test line indicates preliminary positive result; presence of line indicates negative result. Control line confirms proper test performance. Used in OTC settings by lay users. Results are preliminary; requires professional clinical judgment and confirmatory testing (GC/MS or LC/MS) for definitive identification. Benefits include rapid, point-of-care screening for multiple substances.

Clinical Evidence

Bench testing only. Precision/reproducibility studies performed over 25 days using three lots. Analytical specificity and interference evaluated against various compounds. Method comparison study conducted with 80 clinical samples per drug compared to LC-MS/MS. Lay-person study conducted with 280 participants across three sites using samples at various concentrations relative to cutoff; results showed high agreement with expected values.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Materials include chromatographic absorbent membrane, drug-protein conjugates, and monoclonal antibody conjugates. Form factor is a test cup. No electronic components; standalone device. Stable at 2-30°C for 24 months.

Indications for Use

Indicated for OTC use for the qualitative, simultaneous detection of various drugs of abuse and their metabolites in human urine. Intended for use by lay persons to obtain preliminary results. Not intended to distinguish between prescription use and abuse. Requires confirmatory testing via GC/MS or LC/MS.

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 SUMMARY

510(k) Number: K250727

This 510(k) was reviewed under the OHT7/OHT8 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.