510(k) · Cleared
Recalled · Class II · 2016Cobas C 111 Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Cleared on Jul 30, 2007 as substantially equivalent to K063744 (Rochdiag, 2007) after a 90-day review. Its family tree reaches back 4 generations to 1979. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jul 30, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- CIT
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K781921 (1979). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK781921 Bilirubin, Dingle Valve DPDBoehringer Mannheim Corp. · 1979
- 3 generations backK981632 Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH · 1998
- 2 generations backK063543 Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total…Roche Diagnostics Corp. · 2006
- 1 generation backK063744 Cobas Integra C 111Rochdiag · 2007
- This deviceK071211 Cobas C 111 AnalyzerRoche Diagnostics · 2007
- Descendant · cites it directly · 0 of its ownK102647 Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and…Elitechgroup Vital Scientific BV · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K102647Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1…Elitechgroup Vital Scientific BV · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K781921 | Bilirubin, Dingle Valve DPD | Boehringer Mannheim Corp. | 1979 | — |
| −3 | K981632 | Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent | Roche Diagnostics/Boehringer Mannheim GmbH | 1998 | — |
| −2 | K063543 | Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models… | Roche Diagnostics Corp. | 2006 | — |
| −1 | K063744 | Cobas Integra C 111 | Rochdiag | 2007 | — |
| 0 (this device) | K071211 | Cobas C 111 Analyzer | Roche Diagnostics | 2007 | — |
| +1 | K102647 | Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol… | Elitechgroup Vital Scientific BV | 2011 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 CIT? 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 |
|---|---|---|---|
| * | K063744 | Cobas Integra C 111Summary page 2…mission The cobas clII analyzer is a member of the COBAS INTEGRA® family of history analyzers cleared in the Total Bilirubin reagent submission as K063744. The reagents applied to this analyzer are cleared reagents for the COBAS INTEGRA famil… | 2007 |
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 |
|---|---|---|---|
| K102647 | Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1… | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2016 | Class II | Z-0387-2017 | Software design | cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a… |
| Oct 18, 2011 | Not classified | Z-0311-2012 | Software design | Internal investigations have revealed a potential printer malfunction on the Cobas c 111 analyzer, where one or more numbers or characters can be missing on the hard copy result printout, or the printer may skip leaving blanks which may… |
| Nov 17, 2008 | Not classified | Z-1009-2009 | Nonconforming Material/Component | Due to a manufacturing error at the supplier, not all cobas c 111 pinch valve caps are properly glued to the correct position on the pinch valve shaft. Without the glue, the cap can become loose or misaligned. The effect of these faulty… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K102647 (Elitechgroup Vital Scientific BV, 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K063744.
How does its category compare?
All CIT devicesCIT Nadh Oxidation/Nad Reduction, Ast/Sgot: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CIT
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · CIT
Too few CIT 510(k)s in any year since 2007 to give a median.
Recalls per year · CIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIT
10in 2025
MAUDE reports naming product code CIT, 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 | 23 |
| 2008 | 2 | — | 3 | 17 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 1 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Roche cobas e 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests for professional settings and small laboratories, specialized testing and CLIA-licensed doctor's offices. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. In vitro test for the quantitative determination of…
Read the full statement (339 words)
The Roche cobas e 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests for professional settings and small laboratories, specialized testing and CLIA-licensed doctor's offices. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
In vitro test for the quantitative determination of AST in human serum and plasma on the cobas cl II system. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
In vitro test for the quantitative immunological determination of human C-reactive protein in human serum and plasma on the cobas clI II system. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
In vitro test for the quantitative determination of glucose concentration in human serum and plasma on the cobas el 11I system. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia.
The chloride electrode for the cobas clI II system is intended for the quantitative determination of chloride in diluted serum, plasma, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The potassium electrode for the cobas clI II system is intended for the quantitative determination of potassium in diluted serum, plasma; and urine. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
The sodium electrode for the cobas clI II system is intended for the quantitative determination of sodium in diluted serum, plasma, and urine. Measurements of sodium are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretie hormone secretion, or other diseases involving electrolyte imbalance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071211: Cobas C 111 Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071211
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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