510(k) · Cleared
ClearedImmunalysis Tapentadol Urine HEIA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lmmunalysis Corporation · DJG Enzyme Immunoassay, Opiates
Cleared on May 9, 2022 as substantially equivalent to K141803 (Immunalysis Corporation, 2015) after a 523-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- May 9, 2022
- Review
- 523 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983159 (1998). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK983159 Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998
- 3 generations backK020769 Single Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002
- 2 generations backK120761 Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000…Lin-Zhi International, Inc. · 2012
- 1 generation backK141803 Immunalysis Tramadol Urine Enzyme ImmunoassayImmunalysis Corporation · 2015
- This deviceK203527 Immunalysis Tapentadol Urine HEIALmmunalysis Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983159 | Drugs of Abuse Urine Calibrators and Controls | Diagnostic Reagents, Inc. | 1998 | — |
| −3 | K020769 | Single Analyte Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International, Inc. | 2002 | — |
| −2 | K120761 | Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators… | Lin-Zhi International, Inc. | 2012 | — |
| −1 | K141803 | Immunalysis Tramadol Urine Enzyme Immunoassay | Immunalysis Corporation | 2015 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K141803 | Immunalysis Tramadol Urine Enzyme ImmunoassaySummary page 4…on Regulation: 21 CFR 862.3650, Opiate Test System Panel: Toxicology (91) Predicate Device: Immunalysis Tramadol Enzyme Immunoassay [K141803] 1 D. DEVICE DESCRIPTION The… | 2015 |
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 24 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
For in vitro diagnostic use. The Inmunalysis Tapentadol Urine HEIATM is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of tapentadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against tapentadol. This in vitro diagnostic device is for prescription use only. The Immunalysis Tapentadol Urine HEIATM…
Read the full statement (161 words)
For in vitro diagnostic use.
The Inmunalysis Tapentadol Urine HEIATM is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of tapentadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against tapentadol. This in vitro diagnostic device is for prescription use only.
The Immunalysis Tapentadol Urine HEIATM 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-Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation using a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203527: Immunalysis Tapentadol Urine HEIA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203527
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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