AllTest Fentanyl Rapid Test (Urine)

K231698 · Hangzhou AllTest Biotech Co., Ltd. · DJG · Jul 31, 2023 · Clinical Toxicology

Device Facts

• Record ID: K231698
• Device Name: AllTest Fentanyl Rapid Test (Urine)
• Applicant: Hangzhou AllTest Biotech Co., Ltd.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jul 31, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This in vitro diagnostic device is for prescription use only. 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.

Device Story

AllTest Fentanyl Rapid Test (Urine) is a lateral flow immunochromatographic assay for qualitative detection of fentanyl in human urine. Device consists of a test cassette containing a nitrocellulose membrane strip coated with fentanyl-BSA conjugate and goat anti-rabbit IgG. Principle of operation is competitive binding: fentanyl in sample competes with conjugate for monoclonal antibody binding sites. Absence of fentanyl allows antibody binding to conjugate, producing a visible test line (negative result); presence of fentanyl at or above 1.0 ng/mL inhibits binding, preventing test line formation (positive result). A control line confirms proper flow. Used in clinical settings by healthcare professionals for preliminary screening. Results are visual and qualitative; require confirmatory testing via GC/MS or LC/MS. Benefits include rapid, preliminary identification of fentanyl presence to inform clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (spiked samples, 10-day testing), interference testing (physiological/pathological substances), specificity/cross-reactivity (tested against various opioids and metabolites), and method comparison. Method comparison conducted at three sites using 80 clinical samples compared against LC/MS reference method. No clinical prospective or retrospective studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: test cassette, nitrocellulose membrane, fentanyl-BSA conjugate, goat anti-rabbit IgG polyclonal antibody, monoclonal antibody indicator. Cutoff: 1.0 ng/mL. Storage: 2-30°C. No electronic components or software; standalone manual test.

Indications for Use

Indicated for the qualitative detection of fentanyl in human urine at a 1.0 ng/mL cutoff. For prescription use only. Intended for use as a preliminary screening test; requires confirmation by 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: k231698

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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