510(k) · Cleared
ClearedCobas Integra Carbon Dioxide Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · KHS Enzymatic, Carbon-Dioxide
Cleared on Jul 17, 2003 as substantially equivalent to K980996 (Roche Diagnostic Systems, Inc., 1998) after a 29-day review. Its family tree reaches back 3 generations to 1984. 8 later devices descend from it.
- Decided
- Jul 17, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- KHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K842280 (1984). 6 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK842280 TDX DigitoxinAbbott Laboratories · 1984
- 2 generations backK972250 Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · Recalled
- 1 generation backK980996 Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK…Roche Diagnostic Systems, Inc. · 1998
- This deviceK031879 Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003
- Descendant · cites it directly · 2 of its ownK032377 Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp. · 2003
- Descendant · cites it directly · 1 of its ownK183555 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
- Descendant · cites it directly · 1 of its ownK060205 General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK223090 GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
- Descendant · cites it directly · 0 of its ownK111960 Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical…Elitechgroup · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K032377Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp. · 2003 · cites it directly2descendants
- K183555GEM Premier ChemSTATInstrumentation Laboratory CO · 2019 · cites it directly1descendant
- K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · cites it directly1descendant
- K223090GEM Premier ChemSTATInstrumentation Laboratory CO · 2023 · 2 generations on0descendants
- K111960Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise…Elitechgroup · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K842280 | TDX Digitoxin | Abbott Laboratories | 1984 | — |
| −2 | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1997 | 1 |
| −1 | K980996 | Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) | Roche Diagnostic Systems, Inc. | 1998 | — |
| 0 (this device) | K031879 | Cobas Integra Carbon Dioxide Assay | Roche Diagnostics Corp. | 2003 | — |
| +1 | K032377 | Roche Diagnostics Hitachi Bicarbonate Liquid | Roche Diagnostics Corp. | 2003 | — |
| +1 | K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019 | — |
| +1 | K060205 | General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | 2006 | 2 |
| +2 | K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2023 | — |
| +1 | K111960 | Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems… | Elitechgroup | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 KHS? 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 |
|---|---|---|---|
| * | K980996 | Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)Summary page 1…an serum and plasma. Predicate We claim substantial equivalence to the currently marketed COBAS Integra Device Carbon Dioxide Assay. (K980996). 23… | 1998 |
What descends from it? (8)
4 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K032377 (Roche Diagnostics Corp., 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KHS devicesKHS Enzymatic, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHS
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · KHS
143in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHS
40in 2025
MAUDE reports naming product code KHS, 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 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 14 |
| 2010 | 3 | 143 | 0 | 0 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 2 | — | 1 | 2 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 1 | 35 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 1 | 25 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 1 | 40 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The cassette COBAS Integra Bicarbonate liquid (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the bicarbonate (HCO3-) concentration in human serum and plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031879: Cobas Integra Carbon Dioxide Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031879
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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