510(k) · Cleared
ClearedBioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivachek Biotech (Hangzhou) Co., Ltd. · NGL Test, Opiates, Over The Counter
Cleared on Oct 4, 2024 as substantially equivalent to K240124 (Vivachek Biotech (Hangzhou) Co., Ltd., 2024) after a 99-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Oct 4, 2024
- Review
- 99 days
- Class
- Class II
- Product code
- NGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001178 (2000). 8 ancestors in all, the oldest K973547 (1998). No later device cites it as a predicate yet.
- Root · 7 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 6 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 5 generations backK150606 Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug…Siemens Healthcare Diagnostics, Inc. · 2015
- 4 generations backK161216 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2017
- 3 generations backK180427 ARK Fentanyl AssayArk Diagnostics, Inc. · 2018
- 2 generations backK220046 Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence…Shenzhen Superbio Technology Co., Ltd. · 2022
- 1 generation backK240124 BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd. · 2024
- This deviceK241869 BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro…Vivachek Biotech (Hangzhou) Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −6 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −5 | K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| −4 | K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl… | Immunalysis Corporation | 2017 | — |
| −3 | K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018 | — |
| −2 | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer… | Shenzhen Superbio Technology Co., Ltd. | 2022 | — |
| −1 | K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 | — |
| 0 (this device) | K241869 | BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit… | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NGL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NGL device
- #1 K233417 AllTest Fentanyl Urine Test Cassettescore 32.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderSummary page 5…21 CFR § 862.2560 Clinical Chemistry Fluorometer for clinical use 5. Predicate Devices: K240124 BioSieve™ Fentanyl FIA Test Kit BioSieve™ Toxismart FIA Reader 6. Intended U… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K240124.
How does its category compare?
All NGL devicesNGL Test, Opiates, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NGL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGL
39in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGL
No recall names NGL since 2007.
Adverse event reports per year · NGL
1in 2024
MAUDE reports naming product code NGL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 13 | 40 | 0 | 1 |
| 2025 | 4 | 39 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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™…
Read the full statement (207 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241869: BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241869
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026