# K240124: BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader

- Pathway: 510(k) (Traditional)
- Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
- Decided: Jun 14, 2024 after 150 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: 6 generations back to K001178 (2000). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220046: Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11, Shenzhen Superbio Technology Co., Ltd. (2022) Summary page 4.

## Most influential descendants
- K251972: Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) (2025), 0 descendants of its own
- K241869: BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader (2024), 0 descendants of its own

## Indications for use
BioSieve™ Fentanyl FIA Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ ToxiSmart FIA Reader. It is for in vitro diagnostic use only. It is intended for prescription use. The tests provide only preliminary results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive. BioSieve™ ToxiSmart FIA Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader can be used in a laboratory or in a point-of-care setting.

Source page: https://510kreport.com/device/K240124
Methodology: https://510kreport.com/methodology