# K241100: Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard

- Pathway: 510(k) (Traditional)
- Applicant: Co-Innovation Biotech Co., Ltd.
- Decided: May 22, 2024 after 30 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: 7 generations back to K001178 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231904: Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard, Co-Innovation Biotech Co., Ltd. (2024) Summary page 4.

## Indications for use
Rapid Urine Fentanyl (FYL) Test Strip is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Rapid Urine Fentanyl (FYL) Test Dipcard is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method.

Source page: https://510kreport.com/device/K241100
Methodology: https://510kreport.com/methodology