510(k) · Cleared
ClearedAbuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack, Abuscreen Online Opiates Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Apr 24, 1998 as substantially equivalent to K951319 (Roche Diagnostic Systems, Inc., 1995) and 2 other predicates after a 121-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Apr 24, 1998
- Review
- 121 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K935550 (1994). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK935550 Abuscreen Online Negative Cal/Control Cal Pack and Mil Calibration…Roche Diagnostic Systems, Inc. · 1994
- This deviceK974840 Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates…Roche Diagnostic Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK013482 Abuscreen Online Opiates 300 / 2000Roche Diagnostics Corp. · 2001
- Descendant · cites it directly · 0 of its ownK992890 Roche Cobas Integra Opiates 300/2000Roche Diagnostics Corp. · 1999
- Descendant · cites it directly · 0 of its ownK990399 Ontrak Testcup M2K, Model Cat. 11 1849 8Roche Diagnostics Corp. · 1999
Most influential descendants
Showing 3 of 3 · See all- K013482Abuscreen Online Opiates 300 / 2000Roche Diagnostics Corp. · 2001 · cites it directly0descendants
- K992890Roche Cobas Integra Opiates 300/2000Roche Diagnostics Corp. · 1999 · cites it directly0descendants
- K990399Ontrak Testcup M2K, Model Cat. 11 1849 8Roche Diagnostics Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935550 | Abuscreen Online Negative Cal/Control Cal Pack and Mil Calibration Pack | Roche Diagnostic Systems, Inc. | 1994 | — |
| 0 (this device) | K974840 | Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration… | Roche Diagnostic Systems, Inc. | 1998 | — |
| +1 | K013482 | Abuscreen Online Opiates 300 / 2000 | Roche Diagnostics Corp. | 2001 | — |
| +1 | K992890 | Roche Cobas Integra Opiates 300/2000 | Roche Diagnostics Corp. | 1999 | — |
| +1 | K990399 | Ontrak Testcup M2K, Model Cat. 11 1849 8 | Roche Diagnostics Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K951319 | Roche Abuscreen Online for Opiates 1000 Test Kit-2000 NG/ML Cutoff Olympus AU800…Summary page 2…claimns equivalence. Table 2 Product Name Predicate Product Name K number |Date of substantial equivalence Abuscreen OnlLine |l for Opiates Abuscreen OnLine for Opiates K951319 |8/2/95 300/2000 Reagent Abuscreen OnLine Opiates Calibration |Abuscreen ONLINE MiL Cal Pack K935550 |1/3/94 Pack Abuscreen OnlLi… | 1995 |
| * | K935550 | Abuscreen Online Negative Cal/Control Cal Pack and Mil Calibration PackSummary page 2…alence Abuscreen OnlLine |l for Opiates Abuscreen OnLine for Opiates K951319 |8/2/95 300/2000 Reagent Abuscreen OnLine Opiates Calibration |Abuscreen ONLINE MiL Cal Pack K935550 |1/3/94 Pack Abuscreen OnlLine Opiates Control Abuscreen OnLine Controls KS9622B0 |8/16/96 Pack idiooa 04/20/98… | 1994 |
| * | K962280 | Abuscreen Online Positive Control / 1.5X Calibrator | 1996 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K013482 (Roche Diagnostics Corp., 2001) has gone furthest, with 0 descendants of its own.
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?
The Abuscreen OnLine II for Opiates 300/2000 Reagent is an in vitro diagnostic test for the qualitative (at 300 and 2000 ng/mL cutoff) and semi-quantitative (at 2000 ng/mL cutoff) detection of morphine and its metabolites in human urine.
The Abuscreen ONLINE Opiates Calibration Pack is an in vitro diagnostic device designed for the calibration of the Roche reagent assays for opiates.
The Roche Abuscreen ONLINE Opiates Control Pack is an assayed quality control sample for use with the Roche assays for opiates.
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/K974840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974840: Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack, Abuscreen Online Opiates Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974840
Report an extraction error
Are you the manufacturer?
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