510(k) · Cleared
ClearedBioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivachek Biotech (Hangzhou) Co., Ltd. · DJG Enzyme Immunoassay, Opiates
Cleared on Jun 14, 2024 as substantially equivalent to K220046 (Shenzhen Superbio Technology Co., Ltd., 2022) after a 150-day review. Its family tree reaches back 6 generations to 2000. 2 later devices descend from it.
- Decided
- Jun 14, 2024
- Review
- 150 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001178 (2000). 7 ancestors in all, the oldest K973547 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 5 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 4 generations backK150606 Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug…Siemens Healthcare Diagnostics, Inc. · 2015
- 3 generations backK161216 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2017
- 2 generations backK180427 ARK Fentanyl AssayArk Diagnostics, Inc. · 2018
- 1 generation backK220046 Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence…Shenzhen Superbio Technology Co., Ltd. · 2022
- This deviceK240124 BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK251972 Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit -…Healgen Scientific,, LLC · 2025
- Descendant · cites it directly · 0 of its ownK241869 BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro…Vivachek Biotech (Hangzhou) Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See all- K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…Healgen Scientific,, LLC · 2025 · cites it directly0descendants
- K241869BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™…Vivachek Biotech (Hangzhou) Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −5 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −4 | K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| −3 | K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl… | Immunalysis Corporation | 2017 | — |
| −2 | K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018 | — |
| −1 | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer… | Shenzhen Superbio Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 | — |
| +1 | K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit -… | Healgen Scientific,, LLC | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 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 |
|---|---|---|---|
| * | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11Summary page 4…560 Clinical Chemistry Fluorometer for clinical use 5. Predicate Devices: Superbio Fentanyl Urine Detection Kit, K220046; Superbio Immunofluorescence Analyzer EASY-11, K220046 6. Indications for Use BioSieve™ Fentanyl FIA Test Kit is a fluores… | 2022 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K251972 (Healgen Scientific,, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K220046.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
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…
Read the full statement (151 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240124 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240124: BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240124
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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