510(k) · Cleared
ClearedRoche Cobas Integra 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 Nov 23, 1999 as substantially equivalent to K974840 (Roche Diagnostic Systems, Inc., 1998) after an 88-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Nov 23, 1999
- Review
- 88 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 deviceK992890 Roche Cobas Integra Opiates 300/2000Roche Diagnostics Corp. · 1999
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) | K992890 | Roche Cobas Integra Opiates 300/2000 | Roche Diagnostics Corp. | 1999 | — |
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…piates test system Classification name: Enzymatic Inmunoassay, Opiate We claim substantial equivalence to the currently marketed Roche Abuscreen OnLine II for Opiates (K974840). Continued on next page 510(k) Summary, Continued 4) Device description The cassette COBAS INTEGRA Opiates co… | 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 5 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?
The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine.
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/K992890 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992890: Roche Cobas Integra 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/K992890
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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