510(k) · Cleared
Recalled · Class II · 2021Roche Cobas Integra Analyzer, Reagent Cassettes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Sep 8, 1995 after a 155-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 88 later devices descend from it. It has been recalled 7 times.
- Decided
- Sep 8, 1995
- Review
- 155 days
- Class
- Class II
- Product code
- CGX
- Recalls
- 7
- Predicates
- 0
88 later devices descend from it, 32 citing it directly.
- This deviceK951595 Roche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. · 1995
- Descendant · cites it directly · 20 of its ownK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
- Descendant · cites it directly · 17 of its ownK972250 Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 12 of its ownK003400 CRP HS Test SystemRoche Diagnostics Corp. · 2001
- Descendant · cites it directly · 10 of its ownK063543 Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total…Roche Diagnostics Corp. · 2006
- Descendant · 2 generations on · 9 of its ownK980996 Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK…Roche Diagnostic Systems, Inc. · 1998
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K981897Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas…Roche Diagnostic Systems, Inc. · 1998 · cites it directly20descendants
- K972250Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · cites it directly17descendants
- K003400CRP HS Test SystemRoche Diagnostics Corp. · 2001 · 2 generations on12descendants
- K063543Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322…Roche Diagnostics Corp. · 2006 · cites it directly10descendants
- K980996Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)Roche Diagnostic Systems, Inc. · 1998 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951595 | Roche Cobas Integra Analyzer, Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1995 | — |
| +1 | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… | Roche Diagnostic Systems, Inc. | 1998 | — |
| +1 | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1997 | 1 |
| +2 | K003400 | CRP HS Test System | Roche Diagnostics Corp. | 2001 | — |
| +1 | K063543 | Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models… | Roche Diagnostics Corp. | 2006 | — |
| +2 | K980996 | Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) | Roche Diagnostic Systems, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 12 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 12 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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 CGX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CGX device
- #1 K242685 Atellica® CH Creatinine_3 (Crea3)score 12.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (88)
See all 8832 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas… | 1998 | 20 |
| K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | 1997 | 17 |
| K063543 | Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322… | 2006 | 10 |
| K033306 | Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators | 2003 | 2 |
| K031775 | Preciset Dat Plus I Calibrators | 2003 | 2 |
| K012393 | Tina-Quant Transferrin Ver.2 | 2001 | 2 |
| K031902 | Online TDM Carbamazepine | 2003 | 1 |
| K990595 | Integra Reagent Cassette for Apolipoprotein B | 1999 | 1 |
| K964457 | Roche Cobas Ibtegra Reagent Cassettes | 1997 | 1 |
| K963292 | Cobas Integra Reagent Cassettes & Ancillary Reagents | 1996 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2021 | Class II | Z-1675-2021 | Process control | Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer. |
| Jul 15, 2016 | Class II | Z-0100-2017 | Device Design | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Sep 16, 2013 | Class II | Z-0168-2014 | Software Design Change | Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not… |
| Nov 19, 2012 | Class III | Z-0696-2013 | Software design | A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and… |
| Jun 11, 2008 | Not classified | Z-0007-2009 | Labeling Change Control | Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. |
| Jun 11, 2008 | Not classified | Z-0012-2009 | Labeling Change Control | Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. |
| Feb 13, 2003 | Not classified | Z-0667-03 | Other | After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K981897 (Roche Diagnostic Systems, Inc., 1998) has gone furthest, with 20 descendants of its own.
How does its category compare?
All CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGX
25in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGX
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGX
34in 2025
MAUDE reports naming product code CGX, 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 | 4 | 25 | 0 | 15 |
| 2008 | 0 | — | 1 | 27 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 2 | 5 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 1 | — | 2 | 13 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 2 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 2 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K951595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951595: Roche Cobas Integra Analyzer, Reagent Cassettes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951595
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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