COBAS 6000 SERIES SYSTEM

K060373 · Roche Diagnostics · CEM · Mar 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060373
• Device Name: COBAS 6000 SERIES SYSTEM
• Applicant: Roche Diagnostics
• Product Code: CEM · Clinical Chemistry
• Decision Date: Mar 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

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 throughout 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 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.

Device Story

The cobas 6000 Series is a modular, fully automated, computerized clinical analyzer system for high-throughput professional laboratory use. It processes serum, plasma, urine, and CSF samples. The system comprises a control unit (PC with Windows XP, GUI), a core unit (sample conveyance, barcode reader, STAT port), and analytical modules: the c 501 (photometric and ISE unit) and the e 601 (electrochemiluminescence immunoassay unit). The core unit manages sample routing to modules. The c 501 performs photometric assays and potentiometric electrolyte measurements. The e 601 performs immunoassay tests. The system automates sample handling, reagent pipetting, incubation, and detection. Results are calculated via calibration curves and reported through the control unit. The system includes internal quality management, error flagging, and automated QC. It benefits patients by providing rapid, accurate diagnostic data for clinical decision-making in professional settings.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design control activities, risk analysis, and verification/validation protocols demonstrating that modifications did not alter fundamental scientific technology.

Technological Characteristics

Modular system with c 501 (photometric/ISE) and e 601 (ECL) modules. Materials include steel probes, plastic reagent bottles with pierceable caps. Sensing: ISE potentiometry, gradient photometer with discrete photodiodes, ECL unit with PMT. Energy: Electrical. Connectivity: RS232C bi-directional host interface. Software: Modified MODULAR ANALYTICS software running on Windows XP. Sterilization: N/A (in vitro diagnostic).

Indications for Use

Indicated for professional use in clinical laboratories for the quantitative and qualitative in vitro determination of various analytes in human serum, plasma, urine, and CSF. Used for the diagnosis and treatment of conditions including pancreatitis, renal and metabolic disorders, immunologic disorders, electrolyte imbalances, and drug overdose (acetaminophen, opiates).

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Predicate Devices

• Roche/Hitachi MODULAR ANALYTICS System with MODULAR P and ISE Module (K953239 / A005)
• Roche Elecsys MODULAR E170 (K961481 / A003)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k060373

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the COBAS 6000 SERIES SYSTEM:

1. The name and 510(k) number of ROCHE DIAGNOSTICS's previously cleared device, Hitachi Modular P and E170 Modular Analytics analyzers, cleared under k953239 and k961481 respectively. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION (S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for the integration and connectivity of the Modular P (c 501 module) and the E170 (e 601 module). The c 501 module is a new family member with software and hardware updates to the Hitachi Family. The e 601 module is essentially the same as the E170, with only cosmetic and sample rack interface to accommodate module integration.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.
5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.
6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA).