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

K242540 · Hangzhou AllTest Biotech Co., Ltd. · NFT · Sep 27, 2024 · Clinical Toxicology

Device Facts

• Record ID: K242540
• Device Name: AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel
• Applicant: Hangzhou AllTest Biotech Co., Ltd.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Sep 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

AllTest Multi-Drug Urine Test Panel 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 cutoffs]. AllTest Multi-Drug Urine Test Panel can be a single drug test panel 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 for qualitative detection of drugs of abuse in human urine; competitive binding principle. Urine sample absorbed via capillary action; mixes with drug-specific monoclonal antibody conjugate; flows across pre-coated membrane. Negative result: colored test line appears (drug level below cutoff). Positive result: no colored test line (drug level at/above cutoff). Control line confirms proper procedure. Used in OTC or clinical settings; operated by lay users or healthcare providers. Provides preliminary screening results; requires confirmatory testing via GC/MS or LC/MS. Assists in identifying potential drug presence for clinical consideration.

Clinical Evidence

Bench testing only. Precision/reproducibility studies performed over 25 days with three lots. Analytical specificity/interference evaluated against various metabolites and common compounds. Method comparison study conducted with 80 clinical samples per drug compared to LC-MS/MS. Lay-person study (n=140) conducted at three sites; participants demonstrated high agreement across various drug concentrations relative to cutoffs.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding. Materials include chromatographic absorbent device, drug monoclonal antibody (mouse) conjugate, and drug-protein conjugate. Ready-to-use panel format; sealed with desiccant in aluminum pouch. No electronic components or software. Stability: 2-30°C for 24 months.

Indications for Use

Indicated for 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 and prescription use. Not for distinguishing between prescription use and abuse. Preliminary results only; requires GC/MS or LC/MS confirmation.

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: K242540

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.