# K100853: Cobas 8000 Modular Series Analyzer

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 9, 2010 after 167 days
- Product code: DCF (Albumin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5040
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953239 (1995). 3 ancestors in all.
9 later devices descend from it; 9 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060373: Cobas 6000 Series System, Roche Diagnostics (2006) Summary page 1.

## Most influential descendants
- K132462: S Test Reagent Cartridge Bun and S Test Reagent Cartridge Cre (2013), 0 descendants of its own
- K130685: Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and Amy (2013), 0 descendants of its own
- K120945: Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test Reagent Cartridge Ast (2013), 0 descendants of its own
- K131051: Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb) (2013), 0 descendants of its own
- K131217: S Test Reagent Cartridge Total Bilirubin (2013), 0 descendants of its own

## Recalls of this device
- Dec 8, 2020 · Class II · Z-0754-2021: 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 s
- Jul 18, 2019 · Class II · Z-2477-2019: Quality issue with high pressure solenoid valves
- Mar 15, 2019 · Class II · Z-1249-2019: 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
- Apr 3, 2018 · Class II · Z-2136-2018: 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 fun
- Jul 28, 2017 · Class II · Z-0675-2018: 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: 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: 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: 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 
- Jul 15, 2016 · Class II · Z-0097-2017: 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 clarif
- Mar 13, 2014 · Class II · Z-1449-2014: 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 test
- Apr 4, 2013 · Class II · Z-1368-2013: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K100853
Methodology: https://510kreport.com/methodology