510(k) · Cleared
ClearedImmunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine Controls and 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 Jul 1, 2014 as substantially equivalent to K040316 (Microgenics Corp., 2004) after a 34-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jul 1, 2014
- Review
- 34 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001178 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K040316 | Cedia Buprenorphine AssaySummary page 1…CEDIA Buprenorphine Calibrators 2. Predicate Company: Microgenics 3. Pre'dicate K Number: K040316 Immunalysis Corporation Page 1 of 11 D. Device De… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 2 companies; a new generation was cleared every 10.0 years on median.
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K040316.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Immunalysis Buprenorphine Urine Enzyme Immunoassay: The Immunalysis Buprenorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 5ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Buprenorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Buprenorphine. This in-vitro diagnostic device is for prescription use only. The…
Read the full statement (220 words)
Immunalysis Buprenorphine Urine Enzyme Immunoassay:
The Immunalysis Buprenorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 5ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Buprenorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Buprenorphine. This in-vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Buprenorphine Urine Enzyme Immunoassay Kit 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 Spectroscopy (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 Buprenorphine Urine Controls:
The Immunalysis Buprenorphine Urine Controls are used as control materials in the Immunalysis Buprenorphine Urine Enzyme Immunoassay.
Immunalysis Buprenorphine Urine Calibrators:
The Immunalysis Buprenorphine Urine Calibrators are used as calibrators in the Immunalysis Buprenorphine Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Buprenorphine in urine on automated clinical chemistry analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141406: Immunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine Controls and Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141406
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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