SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

K240654 · Safecare Biotech (Hangzhou) Co., Ltd. · NGL · Apr 10, 2024 · Clinical Toxicology

Device Facts

• Record ID: K240654
• Device Name: SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette
• Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
• Product Code: NGL · Clinical Toxicology
• Decision Date: Apr 10, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

SAFECARE Fentanyl Urine Test Cassette is a 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. The test is intended for over-the-counter use and for in vitro diagnostic use only. SAFECARE FYL Urine Test Cassette is a 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.

Device Story

Lateral flow immunochromatographic assay; detects fentanyl in human urine via competitive binding. Input: urine specimen; capillary action moves sample across membrane. Principle: fentanyl in sample competes with immobilized fentanyl conjugate for limited antibody-coated particle binding sites. Output: visual colored line in test region indicates negative result (fentanyl < 1 ng/mL); absence of line indicates positive result (fentanyl ≥ 1 ng/mL). Control line confirms proper wicking. Used in OTC settings; operated by lay users. Provides preliminary results only; requires confirmatory testing (GC/MS or LC/MS) for clinical decision-making. Benefits patient by providing rapid, accessible screening for fentanyl presence.

Clinical Evidence

Bench testing only. Performance validated via precision studies (25 days, multiple lots), interference testing (no interference from common physiological/pathological substances), and specificity/cross-reactivity analysis. Method comparison study (n=80 clinical samples) compared rapid test results against LC/MS. Lay-user study (n=140) demonstrated 95-100% accuracy across various concentrations relative to cutoff. No clinical trials performed.

Technological Characteristics

Lateral flow immunochromatographic cassette. Competitive binding principle. Materials: test cassette, dropper, desiccant. Storage: 4-30°C. No electronic components, energy source, or software. Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for qualitative detection of fentanyl in human urine at 1 ng/mL cutoff. Intended for over-the-counter (OTC) use as a preliminary screening tool. 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)

{0}

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

510(k) Number: K240654

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.

Doc ID 05050.02.00
Downloaded and/or hard copy uncontrolled. Controlled version in CDRH Docs.
1 of 1