# K060373: Cobas 6000 Series System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Mar 13, 2006 after 28 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953239 (1995). 2 ancestors in all.
18 later devices descend from it; 6 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953239: Boehringer Mannheim/Hitachi 917 Analyzer, Boehringer Mannheim Corp. (1995) Summary page 3.
- K961481: Elecsys 2010 Analyzer, Boehringer Mannheim Corp. (1996) Summary page 2.

## Most influential descendants
- K100853: Cobas 8000 Modular Series Analyzer (2010), 9 descendants of its own
- K191899: Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions (2019), 3 descendants of its own
- K253491: ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (2026), 0 descendants of its own
- K253490: Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (2026), 0 descendants of its own
- K220134: cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH (2022), 0 descendants of its own

## Recalls of this device
- Jul 18, 2019 · Class II · Z-2476-2019: Quality issue with high pressure solenoid valves may cause inaccurate results.
- Dec 18, 2017 · Class II · Z-1268-2018: 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: 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: 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-0096-2017: 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
- May 21, 2014 · Class II · Z-1791-2014: 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: 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: 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 hour
- Dec 4, 2007 · Not classified · Z-0576-2008: Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported.

## Indications for use
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.

Source page: https://510kreport.com/device/K060373
Methodology: https://510kreport.com/methodology