# K241741: 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

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Jul 16, 2024 after 29 days
- Product code: NGL (Test, Opiates, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001178 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233417: AllTest Fentanyl Urine Test Cassette, Hangzhou AllTest Biotech Co., Ltd. (2023) Summary page 5.

## 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 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 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 method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.

Source page: https://510kreport.com/device/K241741
Methodology: https://510kreport.com/methodology