Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard

K241100 · Co-Innovation Biotech Co., Ltd. · NGL · May 22, 2024 · Clinical Toxicology

Device Facts

• Record ID: K241100
• Device Name: Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
• Applicant: Co-Innovation Biotech Co., Ltd.
• Product Code: NGL · Clinical Toxicology
• Decision Date: May 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

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.

Device Story

Rapid Urine Fentanyl (FYL) Test Strip and Dipcard are lateral flow immunochromatographic assays; utilize competitive binding principle for qualitative detection of fentanyl in human urine. Input: human urine sample; Output: visual qualitative result (presence/absence of fentanyl at 1 ng/mL cut-off). Used in point-of-care or home settings by lay users; no instrumentation required. Provides preliminary screening results; requires confirmatory testing via GC/MS or LC/MS for clinical decision-making. Benefits patient by enabling rapid, accessible preliminary identification of fentanyl exposure.

Clinical Evidence

Lay user study conducted at three sites with 360 participants (ages 18-65). Samples spiked with fentanyl at 0, +/- 25%, +/- 50%, and +100% of the 1 ng/mL cut-off. Results showed high agreement (90-100%) across all concentrations for both Strip and Dipcard formats. Analytical performance data leveraged from predicate K231904.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factors: Test Strip and Test Dipcard. Storage: 4-30°C. No instrumentation required. Standalone device.

Indications for Use

Indicated for the qualitative screening of Fentanyl in human urine at a 1 ng/mL cut-off concentration. Intended for over-the-counter (OTC) use by lay users for preliminary detection. Not for definitive diagnosis; 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)

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

510(k) Number: k241100

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.