FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)

K240351 · Assure Tech., LLC · NGL · Mar 6, 2024 · Clinical Toxicology

Device Facts

• Record ID: K240351
• Device Name: FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
• Applicant: Assure Tech., LLC
• Product Code: NGL · Clinical Toxicology
• Decision Date: Mar 6, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The FaStep 111 Fentanyl Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only. The tests provide 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. The FaStep™ Rapid Fentanyl Urine Test (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Device Story

Rapid visual immunoassay for qualitative detection of Fentanyl in human urine; utilizes competitive binding lateral flow immunochromatography. Device consists of test cassette and dropper. User applies urine specimen to cassette; capillary action moves sample across membrane. Fentanyl below 1 ng/mL fails to saturate antibody-coated particles, allowing binding to immobilized conjugate, forming visible test line. Fentanyl above 1 ng/mL saturates antibodies, preventing test line formation. Control line confirms proper wicking. Intended for OTC use by lay persons; results interpreted visually by user. Provides preliminary screening; requires professional clinical judgment and confirmatory testing (GC/MS or LC/MS) for positive results. Benefits include rapid, point-of-care identification of potential Fentanyl presence.

Clinical Evidence

Bench testing only. Precision studies (n=60 per concentration) across 10 days showed consistent results at cut-off levels. Method comparison against LC/MS using 82 clinical samples demonstrated performance. Lay-user study (n=140) confirmed ease of use and accuracy across diverse demographics. Interference and specificity testing confirmed no cross-reactivity with common opioids or physiological substances.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factor: test cassette. Storage: 4-30°C. No electronic components, software, or energy source. Materials include antibody-coated particles and immobilized fentanyl conjugate on membrane.

Indications for Use

Indicated for qualitative, presumptive detection of Fentanyl in human urine at 1.0 ng/mL cut-off. For OTC use. Preliminary results only; requires confirmation 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: K240351

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.