# K241869: BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader

- Pathway: 510(k) (Traditional)
- Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
- Decided: Oct 4, 2024 after 99 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: 7 generations back to K001178 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240124: BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader, Vivachek Biotech (Hangzhou) Co., Ltd. (2024) Summary page 5.

## Indications for use
BioSieve™ Fentanyl FIA Home 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 Reader. 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. BioSieve™ Fentanyl FIA Pro 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 Reader. It is for in vitro diagnostic use only. 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 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 is intended for OTC use.

Source page: https://510kreport.com/device/K241869
Methodology: https://510kreport.com/methodology