510(k) · Cleared
ClearedAllTest Fentanyl Rapid Test (Urine)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou AllTest Biotech Co., Ltd. · DJG Enzyme Immunoassay, Opiates
Cleared on Jul 31, 2023 as substantially equivalent to K220046 (Shenzhen Superbio Technology Co., Ltd., 2022) after a 49-day review. Its family tree reaches back 6 generations to 2000. 11 later devices descend from it.
- Decided
- Jul 31, 2023
- Review
- 49 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). 11 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 deviceK231698 AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd. · 2023
- Descendant · cites it directly · 9 of its ownK233417 AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK241969 Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel…Qingdao Hightop Biotech Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK242428 Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip…Guangzhou Decheng Biotechnology Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK243064 ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO…Eterbio, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK242802 CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteHangzhou Clongene Biotech Co., Ltd. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K233417AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2023 · cites it directly9descendants
- K241969Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®…Qingdao Hightop Biotech Co., Ltd. · 2024 · 2 generations on1descendant
- K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek®…Guangzhou Decheng Biotechnology Co., Ltd. · 2025 · cites it directly0descendants
- K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl…Eterbio, Inc. · 2024 · 3 generations on0descendants
- K242802CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteHangzhou Clongene Biotech Co., Ltd. · 2024 · 2 generations on0descendants
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) | K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| +1 | K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| +2 | K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®… | Qingdao Hightop Biotech Co., Ltd. | 2024 | — |
| +1 | K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus… | Guangzhou Decheng Biotechnology Co., Ltd. | 2025 | — |
| +3 | K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO… | Eterbio, Inc. | 2024 | — |
| +2 | K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | Hangzhou Clongene Biotech 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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 9 | 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….3650 Toxicology (91) Opiate Test System 5. Predicate Devices: Superbio Fentanyl Urine Detection Kit (K220046) 6. Indications for Use AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of… | 2022 |
What descends from it? (11)
See all 112 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 23 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, K233417 (Hangzhou AllTest Biotech Co., Ltd., 2023) has gone furthest, with 9 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. 2023, 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?
AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231698: AllTest Fentanyl Rapid Test (Urine).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231698
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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