510(k) · Cleared
ClearedImmunalysis Tramadol Urine Enzyme Immunoassay
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 Feb 12, 2015 as substantially equivalent to K120761 (Lin-Zhi International, Inc., 2012) after a 224-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Feb 12, 2015
- Review
- 224 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983159 (1998). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK983159 Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998
- 2 generations backK020769 Single Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002
- 1 generation backK120761 Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000…Lin-Zhi International, Inc. · 2012
- This deviceK141803 Immunalysis Tramadol Urine Enzyme ImmunoassayImmunalysis Corporation · 2015
- Descendant · cites it directly · 0 of its ownK203527 Immunalysis Tapentadol Urine HEIALmmunalysis Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K203527Immunalysis Tapentadol Urine HEIALmmunalysis Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983159 | Drugs of Abuse Urine Calibrators and Controls | Diagnostic Reagents, Inc. | 1998 | — |
| −2 | K020769 | Single Analyte Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International, Inc. | 2002 | — |
| −1 | K120761 | Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators… | Lin-Zhi International, Inc. | 2012 | — |
| 0 (this device) | K141803 | Immunalysis Tramadol Urine Enzyme Immunoassay | Immunalysis Corporation | 2015 | — |
| +1 | K203527 | Immunalysis Tapentadol Urine HEIA | Lmmunalysis Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K120761 | Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate…Summary page 4…LZI Opiate 2000 Enzyme Calibrators 2. Predicate Company: Lin-Zhi International Inc. 3. Predicate K Number: K120761 Immunalysis Corporation Page 1 of 11 E. Device Descr… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203527 | Immunalysis Tapentadol Urine HEIA | 2022 | 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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K203527 (Lmmunalysis Corporation, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Tramadol Urine Enzyme Immunoassay: The Immunalysis Tramadol Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Tramadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against Tramadol. This in-vitro diagnostic device is for prescription use only. The semi-quantitative…
Read the full statement (246 words)
Immunalysis Tramadol Urine Enzyme Immunoassay:
The Immunalysis Tramadol Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Tramadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against Tramadol. 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 test is not intended to differentiate between drugs of abuse and prescription use of Tramadol. There are no uniformly recognized drug levels for Tramadol in urine.
The Immunalysis Tramadol 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 Tramadol Urine Controls:
The Immunalysis Tramadol Urine Controls are used as control materials in the Immunalysis Tramadol Urine Enzyme Immunoassay.
Immunalysis Tramadol Urine Calibrators:
The Immunalysis Tramadol Urine Calibrators are used as calibrators in the Immunalysis Tramadol Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Tramadol in urine on automated clinical chemistry analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141803: Immunalysis Tramadol Urine Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141803
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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