510(k) · Cleared
ClearedRoche Cobas Integra Serum Barbiturates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DIS Enzyme Immunoassay, Barbiturate
Cleared on Jun 22, 1999 as substantially equivalent to K982551 (Roche Diagnostic Systems, Inc., 1998) after a 57-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Jun 22, 1999
- Review
- 57 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883730 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK883730 TDX Benzodiazepines SerumAbbott Laboratories · 1988
- 1 generation backK982551 Roche C0BAS Integra Serum Barbiturates Reagent Cassette, Abuscreeb…Roche Diagnostic Systems, Inc. · 1998
- This deviceK991440 Roche Cobas Integra Serum BarbituratesRoche Diagnostics Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883730 | TDX Benzodiazepines Serum | Abbott Laboratories | 1988 | — |
| −1 | K982551 | Roche C0BAS Integra Serum Barbiturates Reagent Cassette, Abuscreeb Online… | Roche Diagnostic Systems, Inc. | 1998 | — |
| 0 (this device) | K991440 | Roche Cobas Integra Serum Barbiturates | Roche Diagnostics Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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 DIS? 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 |
|---|---|---|---|
| * | K982551 | Roche C0BAS Integra Serum Barbiturates Reagent Cassette, Abuscreeb Online Serum…Summary page 1…asma, serum and urine Classification name: Enzyme Immunoassay, Barbiturates test system We claim substantial equivalence to the Roche COBAS INTEGRA Serum Barbiturates (K982551). Continued on next page 26 510(k) Summary, Continued 4) Device description The COBAS INTEGRA Serum Barbitura… | 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 11 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIS
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIS
1in 2018
MAUDE reports naming product code DIS, 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 | 3 | 331 | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 29 | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 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 | — |
What is it indicated for?
The cassette COBAS Integra Serum Barbiturates contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum, heparinized plasma or urine. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose.
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/K991440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991440: Roche Cobas Integra Serum Barbiturates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991440
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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