510(k) · Cleared
ClearedRoche C0BAS Integra Serum Barbiturates Reagent Cassette, Abuscreeb Online Serum Barbiturates Calibrators, Roche Cobas in
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · DIS Enzyme Immunoassay, Barbiturate
Cleared on Aug 18, 1998 as substantially equivalent to K890690 (Abbott Laboratories, 1989) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- Aug 18, 1998
- Review
- 27 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883730 (1988). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK883730 TDX Benzodiazepines SerumAbbott Laboratories · 1988
- This deviceK982551 Roche C0BAS Integra Serum Barbiturates Reagent Cassette, Abuscreeb…Roche Diagnostic Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK991440 Roche Cobas Integra Serum BarbituratesRoche Diagnostics Corp. · 1999
Most influential descendants
Showing 1 of 1 · See all- K991440Roche Cobas Integra Serum BarbituratesRoche 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 | K883730 | TDX Benzodiazepines Serum | Abbott Laboratories | 1988 | — |
| 0 (this device) | K982551 | Roche C0BAS Integra Serum Barbiturates Reagent Cassette, Abuscreeb Online… | Roche Diagnostic Systems, Inc. | 1998 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (2)
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 |
|---|---|---|---|
| * | K890690 | Adx TM BarbituratesSummary page 2…stems, Inc. claims equivalence. Table 2 Product Name Predicate Product Date Predicate Name Predicate 516(k) Cleared Number COBAS INTEGRA Abbott ADX Barbiturates 8/25/89 K890690 Serum Barbiturates (SBARB) Abuscreen ONLINE Serum Abbott ADX Barbiturates 8/25/89 K890690 Barbiturates Calibrators COBAS INTEGRA… | 1989 |
| * | K883730 | TDX Benzodiazepines SerumSummary page 2…erum Barbiturates (SBARB) Abuscreen ONLINE Serum Abbott ADX Barbiturates 8/25/89 K890690 Barbiturates Calibrators COBAS INTEGRA Serum Abbott TDX Benzodiazepines 11/29/88 K883730 Benzodiazepines (SBENZ) Serum Abuscreen ONLINE Serum Abbott TDX Benzodiazepines 11/29/88 K883730 Benzodiazepines Calibrators Seru… | 1988 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991440 | Roche Cobas Integra Serum Barbiturates | 1999 | 0 |
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 2 ancestors has a recall.
- Of its descendants, K991440 (Roche Diagnostics Corp., 1999) has gone furthest, with 0 descendants of its own.
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 an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose. The Abuscreen ONLINE Serum Barbiturates Calibrators are designed for…
Read the full statement (198 words)
The cassette COBAS INTEGRA Serum Barbiturates contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose.
The Abuscreen ONLINE Serum Barbiturates Calibrators are designed for calibration of the cassette COBAS INTEGRA Serum Barbiturates on the COBAS INTEGRA chemistry systems. The calibrators are used in the determination of values in the measurement of barbiturates in human specimens.
The cassette COBAS INTEGRA Serum Benzodiazepines contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of benzodiazepines and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of benzodiazepine use or overdose.
The Abuscreen ONLINE Serum Benzodiazepines Calibrators are designed for calibration of the cassette COBAS INTEGRA Serum Benzodiazepines on the COBAS INTEGRA chemistry systems. The calibrators are used in the determination of values in the measurement of benzodiazepines in human specimens.
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/K982551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982551: Roche C0BAS Integra Serum Barbiturates Reagent Cassette, Abuscreeb Online Serum Barbiturates Calibrators, Roche Cobas in.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982551
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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