SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel

K241741 · Guangzhou Wondfo Biotech Co., Ltd. · NGL · Jul 16, 2024 · Clinical Toxicology

Device Facts

• Record ID: K241741
• Device Name: SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: NGL · Clinical Toxicology
• Decision Date: Jul 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The SAFElife™ Fentanyl Urine Home Test (Cassette) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. For Over The Counter (OTC) use. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method. The SAFElife™ Fentanyl (FTY) Urine Test Cassette is a competitive binding, lateral flow immunochromatoqraphic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. It is not intended to distinquish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method. The SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. For Over The Counter (OTC) use. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method. The SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. It is not intended to distinguish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. Chromatography/Mass Spectrometry (GC/ MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine; competitive binding principle. Input: human urine specimen; capillary action drives sample across membrane. If Fentanyl concentration <1 ng/mL, antibody-coated particles bind to immobilized Fentanyl conjugate, forming visible test line. If Fentanyl >1 ng/mL, binding sites saturate, preventing test line formation. Control line confirms proper wicking. Used in home or clinical settings; operated by lay users or professionals. Output: visual qualitative result (positive/negative). Results are preliminary; require confirmation by GC/MS or LC/MS-MS. Assists in identifying potential Fentanyl presence for clinical consideration.

Clinical Evidence

Bench testing only. Precision studies (n=25 days/lot), interference testing, and specificity testing (cross-reactivity with various opioids/metabolites) performed. Method comparison study (n=84 clinical samples) compared to LC/MS. Lay-user study (n=140 per format) confirmed performance across diverse demographics and reading levels.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: Cassette and Dip Card. Storage: 4-30°C. Shelf life: 24 months. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Fentanyl in human urine at 1 ng/mL cutoff. For OTC or professional in vitro diagnostic use. Not intended to distinguish between prescription use and drug abuse. Preliminary results require confirmation via GC/MS or LC/MS-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}

1 of 1

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

510(k) Number: K241741

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.