510(k) · Cleared
ClearedCobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · KHS Enzymatic, Carbon-Dioxide
Cleared on Jun 5, 1998 as substantially equivalent to K954992 (Roche Diagnostic Systems, Inc., 1996) and 1 other predicate after an 80-day review. Its family tree reaches back 2 generations to 1984. 9 later devices descend from it.
- Decided
- Jun 5, 1998
- Review
- 80 days
- Class
- Class II
- Product code
- KHS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K842280 (1984). 5 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK842280 TDX DigitoxinAbbott Laboratories · 1984
- 1 generation backK972250 Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · Recalled
- This deviceK980996 Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK…Roche Diagnostic Systems, Inc. · 1998
- Descendant · cites it directly · 8 of its ownK031879 Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003
- Descendant · 2 generations on · 2 of its ownK032377 Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp. · 2003
- Descendant · 2 generations on · 1 of its ownK183555 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
- Descendant · 2 generations on · 1 of its ownK060205 General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · Recalled
- Descendant · 3 generations on · 0 of its ownK223090 GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K031879Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003 · cites it directly8descendants
- K032377Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp. · 2003 · 2 generations on2descendants
- K183555GEM Premier ChemSTATInstrumentation Laboratory CO · 2019 · 2 generations on1descendant
- K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · 2 generations on1descendant
- K223090GEM Premier ChemSTATInstrumentation Laboratory CO · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842280 | TDX Digitoxin | Abbott Laboratories | 1984 | — |
| −1 | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1997 | 1 |
| 0 (this device) | K980996 | Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) | Roche Diagnostic Systems, Inc. | 1998 | — |
| +1 | K031879 | Cobas Integra Carbon Dioxide Assay | Roche Diagnostics Corp. | 2003 | — |
| +2 | K032377 | Roche Diagnostics Hitachi Bicarbonate Liquid | Roche Diagnostics Corp. | 2003 | — |
| +2 | K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019 | — |
| +2 | K060205 | General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | 2006 | 2 |
| +3 | K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2023 | — |
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 | 2 | 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? (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 |
|---|---|---|---|
| * | K954992 | Roche Cobas Integra Reagent CassettesSummary page 3…Inc. claims equivalence. Table 2 Product Name Predicate Product Name K number{Date of substantial equivalence COBAS INTEGRA Carbon Dioxide COBAS INTEGRA Carbon Dioxide K954992 | 1/25/96 (CO2-S) (CO2) COBAS INTEGRA Glucose HK Liquid | COBAS INTEGRA Glucose HK Liquid | K972250 | 8/12/97 (GLULF) (GLUCL) I… | 1996 |
| * | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsSummary page 3…uivalence COBAS INTEGRA Carbon Dioxide COBAS INTEGRA Carbon Dioxide K954992 | 1/25/96 (CO2-S) (CO2) COBAS INTEGRA Glucose HK Liquid | COBAS INTEGRA Glucose HK Liquid | K972250 | 8/12/97 (GLULF) (GLUCL) IV. Description of the Device/Statement of Intended Use: The COBAS INTEGRA test applications contain… | 1997 |
| † | K952282 | Roche Ammonia/Ethanol/CO2 Calibrator | 1995 |
| † | K942048 | Roche Ammonia (Various) | 1994 |
| † | K942706 | Roche Calibrator Serum | 1995 |
| † | K972214 | Roche Serum Control Normal (Human), Roche Serum Control Pathological (Human) | 1997 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031879 | Cobas Integra Carbon Dioxide Assay | 2003 | 8 |
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 14 years and passes through 2 companies; a new generation was cleared every 13.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K031879 (Roche Diagnostics Corp., 2003) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K954992.
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 Roche COBAS INTEGRA Carbon Dioxide (CO2-S) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the carbon dioxide concentration in serum and plasma. Determination of carbon dioxide concentration in blood is most commonly performed as an initial test in the evaluation of the body's ability to control blood pH by appropriate removal of metabolism byproducts via the lung and…
Read the full statement (141 words)
The cassette Roche COBAS INTEGRA Carbon Dioxide (CO2-S) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the carbon dioxide concentration in serum and plasma. Determination of carbon dioxide concentration in blood is most commonly performed as an initial test in the evaluation of the body's ability to control blood pH by appropriate removal of metabolism byproducts via the lung and kidneys.
The cassette Roche COBAS INTEGRA Glucose HK Liquid contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma, urine and cerebrospinal fluid (CSF). In addition, an optional glucose “fast application” for serum and plasma is available. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia.
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/K980996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980996: Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980996
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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