510(k) · Cleared
ClearedRoche Abuscreen Online for Opiates 1000 Test Kit-2000 NG/ML Cutoff Olympus AU800 Instrument Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Cleared on Jun 1, 1995 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jun 1, 1995
- Review
- 70 days
- Class
- Class II
- Product code
- DOE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK951319 Roche Abuscreen Online for Opiates 1000 Test Kit-2000 NG/ML Cutoff…Roche Diagnostic Systems, Inc. · 1995
- Descendant · cites it directly · 3 of its ownK974840 Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates…Roche Diagnostic Systems, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK013482 Abuscreen Online Opiates 300 / 2000Roche Diagnostics Corp. · 2001
- Descendant · 2 generations on · 0 of its ownK992890 Roche Cobas Integra Opiates 300/2000Roche Diagnostics Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK990399 Ontrak Testcup M2K, Model Cat. 11 1849 8Roche Diagnostics Corp. · 1999
Most influential descendants
Showing 4 of 4 · See all- K974840Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack…Roche Diagnostic Systems, Inc. · 1998 · cites it directly3descendants
- K013482Abuscreen Online Opiates 300 / 2000Roche Diagnostics Corp. · 2001 · 2 generations on0descendants
- K992890Roche Cobas Integra Opiates 300/2000Roche Diagnostics Corp. · 1999 · 2 generations on0descendants
- K990399Ontrak Testcup M2K, Model Cat. 11 1849 8Roche Diagnostics Corp. · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951319 | Roche Abuscreen Online for Opiates 1000 Test Kit-2000 NG/ML Cutoff Olympus… | Roche Diagnostic Systems, Inc. | 1995 | — |
| +1 | K974840 | Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration… | Roche Diagnostic Systems, Inc. | 1998 | — |
| +2 | K013482 | Abuscreen Online Opiates 300 / 2000 | Roche Diagnostics Corp. | 2001 | — |
| +2 | K992890 | Roche Cobas Integra Opiates 300/2000 | Roche Diagnostics Corp. | 1999 | — |
| +2 | K990399 | Ontrak Testcup M2K, Model Cat. 11 1849 8 | Roche Diagnostics Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DOE? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K974840 | Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack… | 1998 | 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?
- Of its descendants, K974840 (Roche Diagnostic Systems, Inc., 1998) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DOE devicesDOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DOE
FDA has decided no DOE device since 2007.
Median 510(k) review, days · DOE
Too few DOE 510(k)s in any year since 2007 to give a median.
Recalls per year · DOE
No recall names DOE since 2007.
Adverse event reports per year · DOE
No MAUDE report names DOE since 2007.
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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 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 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K951319 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951319: Roche Abuscreen Online for Opiates 1000 Test Kit-2000 NG/ML Cutoff Olympus AU800 Instrument Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951319
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026