510(k) · Cleared
ClearedImmunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunalysis Corporation · DJG Enzyme Immunoassay, Opiates
Cleared on Jun 14, 2017 as substantially equivalent to K150606 (Siemens Healthcare Diagnostics, Inc., 2015) after a 411-day review. Its family tree reaches back 3 generations to 2000. 23 later devices descend from it.
- Decided
- Jun 14, 2017
- Review
- 411 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001178 (2000). 23 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 2 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 1 generation backK150606 Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug…Siemens Healthcare Diagnostics, Inc. · 2015
- This deviceK161216 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2017
- Descendant · cites it directly · 19 of its ownK180427 ARK Fentanyl AssayArk Diagnostics, Inc. · 2018
- Descendant · 2 generations on · 17 of its ownK220046 Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence…Shenzhen Superbio Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 11 of its ownK231698 AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd. · 2023
- Descendant · 4 generations on · 9 of its ownK233417 AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2023
- Descendant · 3 generations on · 2 of its ownK240124 BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd. · 2024
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K180427ARK Fentanyl AssayArk Diagnostics, Inc. · 2018 · cites it directly19descendants
- K220046Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11Shenzhen Superbio Technology Co., Ltd. · 2022 · 2 generations on17descendants
- K231698AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd. · 2023 · 3 generations on11descendants
- K233417AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2023 · 4 generations on9descendants
- K240124BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd. · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −2 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −1 | K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| 0 (this device) | K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl… | Immunalysis Corporation | 2017 | — |
| +1 | K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018 | — |
| +2 | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer… | Shenzhen Superbio Technology Co., Ltd. | 2022 | — |
| +3 | K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| +4 | K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| +3 | K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 13 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level…Summary page 4…. Predicate Device: Emit® II Plus Buprenorphine Assay 6. Predicate Company: Siemens Healthcare Diagnostics Inc. 7. Predicate K Number: K150606 Page 1 of 10 D. Device Description The assay consists of antibo… | 2015 |
What descends from it? (23)
See all 232 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 17 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K180427 (Ark Diagnostics, Inc., 2018) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K150606.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 1.0 ng/mL. The assay is intended for use in laboratories for the qualitative analysis of Fentanyl in human urine with automated clinical chemistry analyzers. This assay is calibrated against Fentanyl. This in vitro diagnostic device is for prescription use only. The Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay provides only a preliminary analytical…
Read the full statement (160 words)
The Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 1.0 ng/mL. The assay is intended for use in laboratories for the qualitative analysis of Fentanyl in human urine with automated clinical chemistry analyzers. This assay is calibrated against Fentanyl. This in vitro diagnostic device is for prescription use only.
The Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Immunalysis Fentanyl Urine Calibrators:
The Immunalysis Fentanyl Urine Calibrators are used as calibrators in the Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay for the qualitative determination of Fentanyl in urine on automated clinical chemistry analyzers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161216: Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161216
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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