510(k) · Cleared
ClearedCedia Buprenorphine Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · DJG Enzyme Immunoassay, Opiates
Cleared on Jun 23, 2004 as substantially equivalent to K001178 (Microgenics Corp., 2000) after a 135-day review. Its family tree reaches back 1 generation to 2000. 52 later devices descend from it.
- Decided
- Jun 23, 2004
- Review
- 135 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001178 (2000). 52 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- This deviceK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- Descendant · cites it directly · 25 of its ownK150606 Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug…Siemens Healthcare Diagnostics, Inc. · 2015
- Descendant · 2 generations on · 23 of its ownK161216 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2017
- Descendant · 3 generations on · 19 of its ownK180427 ARK Fentanyl AssayArk Diagnostics, Inc. · 2018
- Descendant · cites it directly · 18 of its ownK042988 Rapid One Step Buprenorphine Test CardTianjin New Bay Bioresearch Co., Ltd. · 2005
- Descendant · 4 generations on · 17 of its ownK220046 Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence…Shenzhen Superbio Technology Co., Ltd. · 2022
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K150606Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level…Siemens Healthcare Diagnostics, Inc. · 2015 · cites it directly25descendants
- K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine…Immunalysis Corporation · 2017 · 2 generations on23descendants
- K180427ARK Fentanyl AssayArk Diagnostics, Inc. · 2018 · 3 generations on19descendants
- K042988Rapid One Step Buprenorphine Test CardTianjin New Bay Bioresearch Co., Ltd. · 2005 · cites it directly18descendants
- K220046Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11Shenzhen Superbio Technology Co., Ltd. · 2022 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| 0 (this device) | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| +1 | 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 | — |
| +3 | K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018 | — |
| +1 | K042988 | Rapid One Step Buprenorphine Test Card | Tianjin New Bay Bioresearch Co., Ltd. | 2005 | — |
| +4 | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer… | Shenzhen Superbio Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 15 | 0 |
| 2025 | 7 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K001178 | Cedia Dau 6-Acetylmorphine AssaySummary page 1…Predicate Devices: The CEDIA® Buprenorphine Assay is substantially equivalent to other CEDIA test systems cleared by FDA, e.g., the CEDIA DAU 6-Acetylmorphine Assay (K001 178), and GC/MS for its stated intended use. Device Description: The CEDIA® Buprenorphine Assay uses recombinant DN… | 2000 |
| * | — | GC/MS Named without a submission number |
What descends from it? (52)
See all 526 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level… | 2015 | 25 |
| K042988 | Rapid One Step Buprenorphine Test Card | 2005 | 18 |
| K081008 | Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron… | 2008 | 2 |
| K042990 | For Sure One Step Buprenorphine Test Strip | 2005 | 1 |
| K163101 | CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative… | 2017 | 0 |
| K141406 | Immunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine… | 2014 | 0 |
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?
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 CEDIA® Buprenorphine assay is a homogenous enzyme immunoassay for qualitative or semi-quantitative determination of the presence of buprenorphine in human urine at cutoff concentration of 5 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine. The CEDIA® Buprenorphine calibrators are used to calibrate the CEDIA® Buprenorphine Assay in human urine. The CEDIA® Buprenorphine controls are used…
Read the full statement (128 words)
The CEDIA® Buprenorphine assay is a homogenous enzyme immunoassay for qualitative or semi-quantitative determination of the presence of buprenorphine in human urine at cutoff concentration of 5 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.
The CEDIA® Buprenorphine calibrators are used to calibrate the CEDIA® Buprenorphine Assay in human urine.
The CEDIA® Buprenorphine controls are used to qualify the CEDIA® Buprenorphine Assay in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GCIMS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test resuIt articularly when preliminary results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040316 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040316: Cedia Buprenorphine Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040316
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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