510(k) · Cleared
Recalled · Class II · 2020Cobas 8000 Modular Series Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DCF Albumin, Antigen, Antiserum, Control
Cleared on Sep 9, 2010 as substantially equivalent to K060373 (Roche Diagnostics, 2006) after a 167-day review. Its family tree reaches back 2 generations to 1995. 9 later devices descend from it. It has been recalled 11 times.
- Decided
- Sep 9, 2010
- Review
- 167 days
- Class
- Class II
- Product code
- DCF
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953239 (1995). 3 ancestors in all. 9 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995 · Recalled
- 1 generation backK060373 Cobas 6000 Series SystemRoche Diagnostics · 2006 · Recalled
- This deviceK100853 Cobas 8000 Modular Series AnalyzerRoche Diagnostics Corp. · 2010
- Descendant · cites it directly · 0 of its ownK132462 S Test Reagent Cartridge Bun and S Test Reagent Cartridge CreHitachi Chemical Diagnostics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK130685 Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and AmyHitachi Chemical Diagnostics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK120945 Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi…Hitachi Chemical Diagnostics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK131051 Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb)Hitachi Chemical Diagnostics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK131217 S Test Reagent Cartridge Total BilirubinHitachi Chemical Diagnostics, Inc. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K132462S Test Reagent Cartridge Bun and S Test Reagent Cartridge CreHitachi Chemical Diagnostics, Inc. · 2013 · cites it directly0descendants
- K130685Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and AmyHitachi Chemical Diagnostics, Inc. · 2013 · cites it directly0descendants
- K120945Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test…Hitachi Chemical Diagnostics, Inc. · 2013 · cites it directly0descendants
- K131051Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb)Hitachi Chemical Diagnostics, Inc. · 2013 · cites it directly0descendants
- K131217S Test Reagent Cartridge Total BilirubinHitachi Chemical Diagnostics, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | Boehringer Mannheim Corp. | 1995 | 18 |
| −1 | K060373 | Cobas 6000 Series System | Roche Diagnostics | 2006 | 10 |
| 0 (this device) | K100853 | Cobas 8000 Modular Series Analyzer | Roche Diagnostics Corp. | 2010 | — |
| +1 | K132462 | S Test Reagent Cartridge Bun and S Test Reagent Cartridge Cre | Hitachi Chemical Diagnostics, Inc. | 2013 | — |
| +1 | K130685 | Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and Amy | Hitachi Chemical Diagnostics, Inc. | 2013 | — |
| +1 | K120945 | Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical… | Hitachi Chemical Diagnostics, Inc. | 2013 | — |
| +1 | K131051 | Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb) | Hitachi Chemical Diagnostics, Inc. | 2013 | — |
| +1 | K131217 | S Test Reagent Cartridge Total Bilirubin | Hitachi Chemical Diagnostics, Inc. | 2013 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 7 | 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 DCF? 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 |
|---|---|---|---|
| * | K060373 | Cobas 6000 Series SystemSummary page 1…Product Code: CZP Predicate We claim substantial equivalence to the Roche cobas 6000 Analyzer Series Device Predicate device cleared in K060373. Device The cobas 800%Modular Analyzer Series is a fully automated system for Description clinical chemi… | 2006 |
What descends from it? (9)
9 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132462 | S Test Reagent Cartridge Bun and S Test Reagent Cartridge Cre | 2013 | 0 |
| K130685 | Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and Amy | 2013 | 0 |
| K120945 | Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test… | 2013 | 0 |
| K131051 | Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb) | 2013 | 0 |
| K131217 | S Test Reagent Cartridge Total Bilirubin | 2013 | 0 |
| K130870 | Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (CA) | 2013 | 0 |
| K130141 | S Test Reagent Cartridge Alp (Alkaline Phosphatase) | 2013 | 0 |
| K113809 | Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP) | 2012 | 0 |
| K120369 | Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu) | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 8, 2020 | Class II | Z-0754-2021 | Software design | Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may… |
| Jul 18, 2019 | Class II | Z-2477-2019 | Device Design | Quality issue with high pressure solenoid valves |
| Mar 15, 2019 | Class II | Z-1249-2019 | Device Design | The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment. |
| Apr 3, 2018 | Class II | Z-2136-2018 | Process design | The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function. |
| Jul 28, 2017 | Class II | Z-0675-2018 | Device Design | A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results. |
| Jul 18, 2017 | Class II | Z-0910-2018 | Device Design | A warning is being added to the cobas 6000 analyzer and the cobas 8000 modular analyzer series Operators Manual 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-0097-2017 | 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. |
| Mar 13, 2014 | Class II | Z-1449-2014 | Software Manufacturing/Software Deployment | The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c pack MULTI or empty… |
| Apr 4, 2013 | Class II | Z-1368-2013 | Software design | When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following conditions are met… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K132462 (Hitachi Chemical Diagnostics, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K060373.
How does its category compare?
All DCF devicesDCF Albumin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DCF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DCF
167in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DCF
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCF
12in 2025
MAUDE reports naming product code DCF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 167 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 1 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. It is intended for use in conjunction with certain materials to measure a variety of analytes…
Read the full statement (225 words)
The cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. It is intended for use in conjunction with certain materials to measure a variety of analytes that may bbe adaptable to the below analyzers depending on the reagents used.
The cobas c701 analyzer is a fully automated, discrete clinical chemistry analyzer intended for the in vitro quantitative! qualitative determination of analytes in body fluids.
The cobas c502 analyzer is a fully automated discrete clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
The cobas 8000 ISE module is a fully automated ion- specific analyzer intended for the in vitro potentiometric determination of chloride, potassium and sodium in serum and plasma using ion-selective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance.
IGA-2 is an in vitro test for the quantitative determination of IgA in human serum and plasma on Roche/Hitachi cobas c systems. IgA measurements aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100853: Cobas 8000 Modular Series Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100853
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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