510(k) · Cleared
ClearedModification to Abuscreen Online for Methadone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · DJR Enzyme Immunoassay, Methadone
Cleared on Dec 11, 1998 as substantially equivalent to K930928 (Roche Diagnostic Systems, Inc., 1993) after a 51-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Dec 11, 1998
- Review
- 51 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930928 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK930928 Roche Abuscreen Online for MethadoneRoche Diagnostic Systems, Inc. · 1993
- This deviceK983703 Modification to Abuscreen Online for MethadoneRoche Diagnostic Systems, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK021505 Online Dat II Methadone IIRoche Diagnostics Corp. · 2002
- Descendant · 2 generations on · 0 of its ownK253491 ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl…Roche Diagnostics · 2026
- Descendant · 2 generations on · 0 of its ownK253490 Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated…Roche Diagnostics · 2026
- Descendant · 2 generations on · 0 of its ownK220134 cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na…Roche Diagnostics · 2022
Most influential descendants
Showing 4 of 4 · See all- K021505Online Dat II Methadone IIRoche Diagnostics Corp. · 2002 · cites it directly3descendants
- K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…Roche Diagnostics · 2026 · 2 generations on0descendants
- K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche Diagnostics · 2026 · 2 generations on0descendants
- K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT…Roche Diagnostics · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930928 | Roche Abuscreen Online for Methadone | Roche Diagnostic Systems, Inc. | 1993 | — |
| 0 (this device) | K983703 | Modification to Abuscreen Online for Methadone | Roche Diagnostic Systems, Inc. | 1998 | — |
| +1 | K021505 | Online Dat II Methadone II | Roche Diagnostics Corp. | 2002 | — |
| +2 | K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for… | Roche Diagnostics | 2026 | — |
| +2 | K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2002 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K930928 | Roche Abuscreen Online for MethadoneSummary page 2…ms equivalence. Table 2 Product Name Predicate Product Name 510(k) Number and Date Predicate Cleared Abuscreen ONLINE for Methadone Abuscreen ONLINE for Methadone K930928 /24/93 Ruoche Diagnostic Systems. Inc. Abuscreen ONLINE® Methadone somerville, New Jersey 08876 Special 510¢k) U… | 1993 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021505 | Online Dat II Methadone II | 2002 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K021505 (Roche Diagnostics Corp., 2002) has gone furthest, with 3 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?
Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of methadone use or abuse.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983703: Modification to Abuscreen Online for Methadone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983703
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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