Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241100 FDA 510(k)
- FDA Product Code
- NGL FDA 510(k)
- Models / Variants
- Rapid Urine Fentanyl (FYL) Test Strip FDA 510(k)Rapid Urine Fentanyl (FYL) Test Dipcard FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3650 FDA 510(k)
- Regulation Number
- 862.3650 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rapid Urine Fentanyl (FYL) Test Strip and Rapid Urine Fentanyl (FYL) Test Dipcard are rapid, screening tests for the qualitative detection of fentanyl (FYL) in human urine at a cut-off concentration of 1 ng/mL. These devices are intended for use in point-of-care settings, including prescription use, to provide preliminary results for fentanyl screening.
The tests are supplied as strips or dipcards for use with urine specimens. They are designed for single-use application and are regulated under FDA 510(k) clearance (K241100) with product code NGL and regulation number 862.3650. The device is classified as Class II and falls under the medical specialty of Clinical Toxicology.
Frequently asked questions
What is the Rapid Urine Fentanyl (FYL) Test Strip and Dipcard used for?
The Rapid Urine Fentanyl (FYL) Test Strip and Dipcard are rapid screening tests designed for the qualitative detection of fentanyl in human urine at a cut-off concentration of 1 ng/mL. They are intended for use in point-of-care settings, including prescription use, to provide preliminary results for fentanyl screening. These devices are not confirmatory and require follow-up testing for positive results.
How is the Rapid Urine Fentanyl (FYL) Test supplied and is it reusable?
The device is supplied as either a test strip or a dipcard for use with urine specimens. It is designed for single-use application only and must not be reused. Each test is intended for one-time use with a single urine sample to ensure accurate screening results and prevent cross-contamination.
What regulatory pathway was used for the Rapid Urine Fentanyl (FYL) Test, and what is its classification?
The Rapid Urine Fentanyl (FYL) Test Strip and Dipcard received FDA 510(k) clearance under submission number K241100. It is classified as a Class II medical device with product code NGL and regulation number 862.3650. The device falls under the medical specialty of Clinical Toxicology and was determined to be substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test ..., PDF K231904 - Food and Drug Administration, PDF Co-Innovation Biotech Co.,Ltd. Hong Feng Product Manager No.9 Baihe 3 ..., Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241100 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Co-Innovation Biotech Co., Ltd
- FDA Applicant
- Co-Innovation Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K241100 24 fields · synced Oct 6, 2026