# K220046: Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Superbio Technology Co., Ltd.
- Decided: Dec 13, 2022 after 342 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- 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: 5 generations back to K001178 (2000). 6 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180427: ARK Fentanyl Assay, Ark Diagnostics, Inc. (2018) Summary page 4.
- K973547: Triage Statmeter, Biosite Incorporated (1998) Summary page 4.

## Most influential descendants
- K231698: AllTest Fentanyl Rapid Test (Urine) (2023), 11 descendants of its own
- K233417: AllTest Fentanyl Urine Test Cassette (2023), 9 descendants of its own
- K240124: BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (2024), 2 descendants of its own
- K241969: Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel (2024), 1 descendant of its own
- K231904: Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (2024), 1 descendant of its own

## Indications for use
The Superbio Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Superbio Immunofluorescence Analyzer EASY-11. This in vitro diagnostic device is for prescription use only. The test provides only preliminary test results. 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 Superbio Immunofluorescence Analyzer EASY-11 is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to perform in vitro diagnostic tests on clinical specimens. This analyzer can be used in a laboratory or in a point-of-care setting.

Source page: https://510kreport.com/device/K220046
Methodology: https://510kreport.com/methodology