510(k) · Cleared
Recalled · Class II · 2019Cobas 6000 Series System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · CEM Electrode, Ion Specific, Potassium
Cleared on Mar 13, 2006 as substantially equivalent to K953239 (Boehringer Mannheim Corp., 1995) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1995. 18 later devices descend from it. It has been recalled 10 times.
- Decided
- Mar 13, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- CEM
- Recalls
- 10
- Predicates
- 2
Its longest line of descent runs back 1 generation to K953239 (1995). 2 ancestors in all. 18 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995 · Recalled
- This deviceK060373 Cobas 6000 Series SystemRoche Diagnostics · 2006
- Descendant · cites it directly · 9 of its ownK100853 Cobas 8000 Modular Series AnalyzerRoche Diagnostics Corp. · 2010 · Recalled
- Descendant · cites it directly · 3 of its ownK191899 Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro…Roche Diagnostics · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK253491 ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl…Roche Diagnostics · 2026
- Descendant · 2 generations on · 0 of its ownK253490 Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated…Roche Diagnostics · 2026
- Descendant · 2 generations on · 0 of its ownK220134 cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na…Roche Diagnostics · 2022
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K100853Cobas 8000 Modular Series AnalyzerRoche Diagnostics Corp. · 2010 · cites it directly9descendants
- K191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche Diagnostics · 2019 · cites it directly3descendants
- K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…Roche Diagnostics · 2026 · 2 generations on0descendants
- K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche Diagnostics · 2026 · 2 generations on0descendants
- K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT…Roche Diagnostics · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | Boehringer Mannheim Corp. | 1995 | 18 |
| 0 (this device) | K060373 | Cobas 6000 Series System | Roche Diagnostics | 2006 | — |
| +1 | K100853 | Cobas 8000 Modular Series Analyzer | Roche Diagnostics Corp. | 2010 | 11 |
| +1 | K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated… | Roche Diagnostics | 2019 | 3 |
| +2 | K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for… | Roche Diagnostics | 2026 | — |
| +2 | K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics | 2026 | — |
| +2 | K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2… | Roche Diagnostics | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 2 | 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 CEM? 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 CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 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? (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 |
|---|---|---|---|
| * | K953239 | Boehringer Mannheim/Hitachi 917 AnalyzerSummary page 3…stantial equivalence to the predicate devices, the Roche/Hitachi Device MODULAR ANALYTICS System with MODULAR P and ISE Module, cleared in K953239 / A005, and the Roche Elecsys MODULAR El70, cleared in K961481 / A003.… | 1995 |
| * | K961481 | Elecsys 2010 AnalyzerSummary page 2…he e 601 module is analytically identical to the Elecsys El70 MODULAR ANALYTICS immunoassay analyzer, which was cleared in a letter to file K961481 / A003. Hardware changes are only cosmetic (shape, color) or housing related (sample rack interface), and do not i… | 1996 |
What descends from it? (18)
See all 186 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100853 | Cobas 8000 Modular Series Analyzer | 2010 | 9 |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions | 2019 | 3 |
| K163569 | Elecsys CMV IgM | 2017 | 0 |
| K111188 | Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack… | 2012 | 0 |
| K110726 | Roche Acetaminophen Assay | 2011 | 0 |
| K111753 | Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and… | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2019 | Class II | Z-2476-2019 | Device Design | Quality issue with high pressure solenoid valves may cause inaccurate results. |
| Dec 18, 2017 | Class II | Z-1268-2018 | Labeling False and Misleading | Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters. |
| Jul 18, 2017 | Class II | Z-0909-2018 | Device Design | A warning is being added to the cobas 6000 MODULAR Series System - c501 and the cobas 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance. |
| Jun 29, 2017 | Class II | Z-0378-2018 | Software design | Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation. |
| Mar 21, 2017 | Class II | Z-2049-2017 | Component change control | Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and lead to a disturbance of the sample liquid level detection (LLD). When disturbance of the sample liquid level detection (LLD) occurs, the… |
| Jul 15, 2016 | Class II | Z-0096-2017 | 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. |
| May 21, 2014 | Class II | Z-1791-2014 | Labeling design | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms. |
| May 21, 2014 | Class II | Z-1792-2014 | Labeling design | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms. |
| Sep 15, 2008 | Not classified | Z-0542-2009 | Package design/selection | Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours. For further information, please… |
| Dec 4, 2007 | Not classified | Z-0576-2008 | Software design | Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
MAUDE reports naming product code CEM, 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 | 1 | — | 0 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitiative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE), a photometric analysis unit and an immunoassay analysis module. The cobas c501 analyzer is a fully…
Read the full statement (442 words)
The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitiative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE), a photometric analysis unit and an immunoassay analysis module.
The cobas c501 analyzer is a fully automated, discrete clinical chemistry analyzer intended for the in vitro quantitative/ qualitative determination of analytes in body fluids.
The cobas e601 analyzer is a fully automated discrete immunoassay analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
The a-Amylase EPS ver.2 assay is an in vitro test for the quantitative determination of ot-Amylase in serum, plasma and urine on Roche/Hitachi cobas c systems. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis.
The Uric Acid ver.2 assay is an in vitro test for the quantitative determination of uric acid in human serum, plasma and urine on Roche/Hitachi cobas c systems. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
The Tina-quant Complement C3c ver.2 assay is an in vitro test for the quantitative determination of Complement C3c in human serum and plasma on Roche/Hitachi cobas c systems. Measurement of complement C3c aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
The ISE module of the Roche/Hitachi cobas c systems is intended for the quantitative determination of sodium, potassium and chloride in serum, plasma or urine using ion-selective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance.
The Acetaminophen assay is an in vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma on Roche/Hitachi cobas c systems. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.
The Opiates LI assay is an in vitro diagnostic test for the qualitative and semniquantitative detection of morphine and its metabolites in human urine on Roche/Hitachi cobas c systems at cutoff concentrations of 300 and 2000 ng/mL. Semniquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Opiates II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060373 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060373: Cobas 6000 Series System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060373
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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