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

K241428 · Hangzhou AllTest Biotech Co., Ltd. · NFT · Jun 17, 2024 · Clinical Toxicology

Device Facts

• Record ID: K241428
• Device Name: AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup
• Applicant: Hangzhou AllTest Biotech Co., Ltd.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Jun 17, 2024
• 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, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of: [Table of 14 drugs and cut-offs]. AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination 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 cup for qualitative detection of drugs of abuse in human urine; competitive binding principle; drug-specific monoclonal antibody conjugates compete with drug in urine for binding sites on pre-coated membrane; colored line in Test Region (T) indicates negative result (drug below cutoff); absence of line indicates preliminary positive result (drug at or above cutoff); Control Region (C) line confirms proper test performance; intended for OTC use; results are preliminary and require confirmation by GC/MS or LC/MS; clinical judgment required for interpretation.

Clinical Evidence

Bench testing only. Precision/reproducibility studies conducted over 25 days with three lots. Analytical specificity/interference evaluated against numerous compounds. Method comparison study performed with 80 clinical samples per drug compared to LC-MS/MS. Lay person study with 140 participants across three sites confirmed ease of use and performance across various concentrations.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding; cup format; desiccant-sealed in aluminum pouch; ready-to-use; no assembly required; stable at 2-30°C for 24 months.

Indications for Use

Indicated for the qualitative, simultaneous detection of drugs of abuse (Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl) in human urine. Intended for OTC use. Not intended to distinguish between prescription use and abuse. Preliminary results require confirmation 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)

{0}

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

510(k) Number: K241428

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.