510(k) · Cleared
ClearedImmunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
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 May 20, 2015 as substantially equivalent to K011150 (Microgenics Corp., 2001) and 1 other predicate after a 161-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- May 20, 2015
- Review
- 161 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983159 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK983159 Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998
- 1 generation backK051088 Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2005 · Recalled
- This deviceK143502 Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates…Immunalysis Corporation · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983159 | Drugs of Abuse Urine Calibrators and Controls | Diagnostic Reagents, Inc. | 1998 | — |
| −1 | K051088 | Multiple Analyte Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International, Inc. | 2005 | 3 |
| 0 (this device) | K143502 | Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine… | Immunalysis Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K011150 | Dridau Opiate AssaySummary page 6…2. Predicate Company: Microgenics Lin-Zhi International, Inc. 3. Predicate K Number: K011150 K051088 E. Device Description 1. The assay consists of antibody/substrate r… | 2001 |
| * | K051088 | Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsSummary page 6…nics Lin-Zhi International, Inc. 3. Predicate K Number: K011150 K051088 E. Device Description 1. The assay consists of antibody/substrate reagent and enzyme conjugate reagent. Th… | 2005 |
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 17 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K011150.
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 Opiates Urine Enzyme Immunoassay The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300 ng/mL and 2000 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic device is for prescription use only. The…
Read the full statement (386 words)
Immunalysis Opiates Urine Enzyme Immunoassay
The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300 ng/mL and 2000 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. 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 Opiates 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 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 Opiates Urine Calibrators 300
The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143502: Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143502
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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