# K241969: Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Hightop Biotech Co., Ltd.
- Decided: Aug 14, 2024 after 40 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.
1 later device descends from it; 1 cites it directly.
0 of 11 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.

## Most influential descendants
- K243064: ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test (2024), 0 descendants of its own

## Indications for use
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl and norfentanyl, the major metabolite of fentanyl in human urine at the cut-off concentrations listed below: Analyte Cut-off Level Fentanyl (FYL) 1ng/mL Norfentanyl (NFYL) 5ng/mL The test is available in a single test of FYL or NFYL or a Double panel of FYL and NFYL. It is intended for OTC use. The test provides only a preliminary test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl and norfentanyl, the major metabolite of fentanyl in human urine at the cut-off concentrations listed below: Analyte Calibrator Cut-off level Fentanyl (FYL) Fentanyl 1ng/mL Norfentanyl (NFYL) Norfentanyl 5ng/mL The test is available in a single test of FYL or NFYL or a Double panel of FYL and NFYL. The test panel provides only a preliminary test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The test panel is not intended to distinguish between prescription use or abuse of fentanyl. Clinical consideration and professional judgment should be applied to the test result, particularly in evaluating a preliminary positive result.

Source page: https://510kreport.com/device/K241969
Methodology: https://510kreport.com/methodology