AllTest Fentanyl Urine Test Cassette

K233417 · Hangzhou AllTest Biotech Co., Ltd. · NGL · Oct 26, 2023 · Clinical Toxicology

Device Facts

• Record ID: K233417
• Device Name: AllTest Fentanyl Urine Test Cassette
• Applicant: Hangzhou AllTest Biotech Co., Ltd.
• Product Code: NGL · Clinical Toxicology
• Decision Date: Oct 26, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

AllTest Fentanyl Urine Test Cassette is is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

Device Story

The AllTest Fentanyl Urine Test Cassette is a lateral flow immunochromatographic assay for the qualitative detection of fentanyl in human urine. The device utilizes competitive binding with monoclonal antibodies as indicator markers. The test cassette contains a nitrocellulose membrane coated with fentanyl-BSA conjugate in the test area and goat anti-rabbit IgG in the control area. In the presence of fentanyl at or above the 1 ng/mL cutoff, the drug competes with the conjugate for antibody binding, inhibiting the test line (positive result). In the absence of fentanyl or at concentrations below the cutoff, the conjugate binds the antibody, producing a visible test line (negative result). The device is intended for over-the-counter (OTC) use by lay users. Users interpret the presence or absence of colored lines on the cassette to determine preliminary results. The device provides a rapid screening tool; positive results require confirmation by a more specific chemical method such as GC/MS or LC/MS.

Clinical Evidence

No clinical studies were performed. Evidence consists of a lay-user study (n=140) conducted at three sites with participants aged 21 to >50. Samples were spiked with fentanyl at concentrations ranging from -100% to +75% of the 1 ng/mL cutoff. Results showed high accuracy (95-100% correct) across all concentrations. Analytical performance and comparison studies were leveraged from the predicate device (K231698).

Technological Characteristics

Lateral flow immunochromatographic assay. Nitrocellulose membrane coated with fentanyl-BSA conjugate and goat anti-rabbit IgG. Competitive binding principle using monoclonal antibodies. Form factor: test cassette. Storage: 4-30°C. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Fentanyl in human urine at 1 ng/mL cutoff. Intended for over-the-counter (OTC) use. Provides preliminary results; requires confirmatory testing via GC/MS or LC/MS.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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: k233417

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.

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