510(k) · Cleared
ClearedSuperbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Superbio Technology Co., Ltd. · DJG Enzyme Immunoassay, Opiates
Cleared on Dec 13, 2022 as substantially equivalent to K180427 (Ark Diagnostics, Inc., 2018) and 1 other predicate after a 342-day review. Its family tree reaches back 5 generations to 2000. 17 later devices descend from it.
- Decided
- Dec 13, 2022
- Review
- 342 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001178 (2000). 6 ancestors in all, the oldest K973547 (1998). 17 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 4 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 3 generations backK150606 Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug…Siemens Healthcare Diagnostics, Inc. · 2015
- 2 generations backK161216 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2017
- 1 generation backK180427 ARK Fentanyl AssayArk Diagnostics, Inc. · 2018
- This deviceK220046 Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence…Shenzhen Superbio Technology Co., Ltd. · 2022
- Descendant · cites it directly · 11 of its ownK231698 AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd. · 2023
- Descendant · 2 generations on · 9 of its ownK233417 AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK240124 BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd. · 2024
- Descendant · 3 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 · 1 of its ownK231904 Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardCo-Innovation Biotech Co., Ltd. · 2024
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K231698AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd. · 2023 · cites it directly11descendants
- K233417AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2023 · 2 generations on9descendants
- K240124BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd. · 2024 · cites it directly2descendants
- K241969Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®…Qingdao Hightop Biotech Co., Ltd. · 2024 · 3 generations on1descendant
- K231904Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardCo-Innovation Biotech Co., Ltd. · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −4 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −3 | K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| −2 | K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl… | Immunalysis Corporation | 2017 | — |
| −1 | K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018 | — |
| 0 (this device) | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer… | Shenzhen Superbio Technology Co., Ltd. | 2022 | — |
| +1 | K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| +2 | K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| +1 | K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 | — |
| +3 | K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®… | Qingdao Hightop Biotech Co., Ltd. | 2024 | — |
| +1 | K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | Co-Innovation 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 | 2 | 0 |
| 2024 | 13 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K180427 | ARK Fentanyl AssaySummary page 4…21 CFR § 862.2560 Clinical Chemistry Fluorometer for clinical use 5. Predicate Devices: The ARK™ Fentanyl Assay K180427; TRIAGE STATMETER K973547 6. Indications for Use The Superbio Fentanyl Urine Detection Kit is a fluorescence immunoassay i… | 2018 |
| * | K973547 | Triage StatmeterSummary page 4…linical Chemistry Fluorometer for clinical use 5. Predicate Devices: The ARK™ Fentanyl Assay K180427; TRIAGE STATMETER K973547 6. Indications for Use The Superbio Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for the qualitativ… | 1998 |
What descends from it? (17)
See all 173 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 22 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K231698 (Hangzhou AllTest Biotech Co., Ltd., 2023) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K180427.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The Superbio Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Superbio Immunofluorescence Analyzer EASY-11. 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…
Read the full statement (122 words)
The Superbio Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Superbio Immunofluorescence Analyzer EASY-11. 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.
The Superbio Immunofluorescence Analyzer EASY-11 is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to perform in vitro diagnostic tests on clinical specimens. This analyzer 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/K220046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220046: Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220046
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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