510(k) · Cleared
ClearedAbuscreen Online Opiates 300 / 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DJG Enzyme Immunoassay, Opiates
Cleared on Dec 21, 2001 as substantially equivalent to K974840 (Roche Diagnostic Systems, Inc., 1998) after a 63-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Dec 21, 2001
- Review
- 63 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935550 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK935550 Abuscreen Online Negative Cal/Control Cal Pack and Mil Calibration…Roche Diagnostic Systems, Inc. · 1994
- 1 generation backK974840 Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates…Roche Diagnostic Systems, Inc. · 1998
- This deviceK013482 Abuscreen Online Opiates 300 / 2000Roche Diagnostics Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935550 | Abuscreen Online Negative Cal/Control Cal Pack and Mil Calibration Pack | Roche Diagnostic Systems, Inc. | 1994 | — |
| −1 | K974840 | Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration… | Roche Diagnostic Systems, Inc. | 1998 | — |
| 0 (this device) | K013482 | Abuscreen Online Opiates 300 / 2000 | Roche Diagnostics Corp. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K974840 | Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack…Summary page 1…tes Test System Classification name: Enzyme immunoassay, opiates We claim substantial equivalence to the currently marketed Abuscreen OnLine II Opiates 300/2000 assay (K974840). Continued on next page 24 510(k) Summary, Continued 4) Device Description The Abuscreen OnLine Opiates 300/… | 1998 |
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 7 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K974840.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
An in vitro diagnostic test for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 300 and 2000 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013482 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013482: Abuscreen Online Opiates 300 / 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013482
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026