510(k) · Cleared
ClearedOnline Dat II Methadone II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DJR Enzyme Immunoassay, Methadone
Cleared on Jul 16, 2002 as substantially equivalent to K983703 (Roche Diagnostic Systems, Inc., 1998) after a 68-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- Jul 16, 2002
- Review
- 68 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930928 (1993). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK930928 Roche Abuscreen Online for MethadoneRoche Diagnostic Systems, Inc. · 1993
- 1 generation backK983703 Modification to Abuscreen Online for MethadoneRoche Diagnostic Systems, Inc. · 1998
- This deviceK021505 Online Dat II Methadone IIRoche Diagnostics Corp. · 2002
- Descendant · cites it directly · 0 of its ownK253491 ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl…Roche Diagnostics · 2026
- Descendant · cites it directly · 0 of its ownK253490 Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated…Roche Diagnostics · 2026
- Descendant · cites it directly · 0 of its ownK220134 cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na…Roche Diagnostics · 2022
Most influential descendants
Showing 3 of 3 · See all- K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…Roche Diagnostics · 2026 · cites it directly0descendants
- K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche Diagnostics · 2026 · cites it directly0descendants
- K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT…Roche Diagnostics · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930928 | Roche Abuscreen Online for Methadone | Roche Diagnostic Systems, Inc. | 1993 | — |
| −1 | K983703 | Modification to Abuscreen Online for Methadone | Roche Diagnostic Systems, Inc. | 1998 | — |
| 0 (this device) | K021505 | Online Dat II Methadone II | Roche Diagnostics Corp. | 2002 | — |
| +1 | K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for… | Roche Diagnostics | 2026 | — |
| +1 | K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics | 2026 | — |
| +1 | K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2… | Roche Diagnostics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 2 | 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 DJR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K983703 | Modification to Abuscreen Online for MethadoneSummary page 1…: Enzyme immunoassay, methadone 3) Predicate We claim substantial equivalence to the currently marketed Abuscreen device OnLine Methadone assay (K983703). Continued on next page… | 1998 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas… | 2026 | 0 |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | 2026 | 0 |
| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT… | 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 9 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253491 (Roche Diagnostics, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DJR devicesDJR Enzyme Immunoassay, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJR
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · DJR
59in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJR
1in 2025
MAUDE reports naming product code DJR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 3 | 469 | 1 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 3 | 59 | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
An in vitro diagnostic test for the qualitative and semi-quantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021505 · printed Nov 3, 2026
Cite this page
510(k) Report. “K021505: Online Dat II Methadone II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021505
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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