COBAS 8000 MODULAR SERIES ANALYZER

K100853 · Roche Diagnostics Corp. · DCF · Sep 9, 2010 · Immunology

Device Facts

• Record ID: K100853
• Device Name: COBAS 8000 MODULAR SERIES ANALYZER
• Applicant: Roche Diagnostics Corp.
• Product Code: DCF · Immunology
• Decision Date: Sep 9, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Intended Use

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.

Device Story

The cobas 8000 Modular Analyzer is a clinical chemistry system comprising control units, core units, data management software, and modular components (c 502, c 701, and indirect ISE modules). It processes human clinical samples to measure analytes (Na, K, Cl, IgA-2). The system integrates new modules with existing Roche cobas 6000 technology; modifications include new module connectivity, sample rack interfaces, and reagent applications. Operated by laboratory personnel in clinical settings, the system automates sample analysis to provide quantitative results for diagnostic decision-making. The device maintains the fundamental scientific technology of the predicate cobas 6000 series.

Clinical Evidence

Bench testing only. The submission relies on design control activities, risk analysis, and verification/validation of the modified modules and reagent applications to demonstrate performance equivalence to the predicate.

Technological Characteristics

Modular clinical chemistry analyzer; includes photometric and ISE units. Connectivity via core/control units and sample rack interfaces. Software-controlled data management. Reagent applications for Na, K, Cl, and IgA-2. Fundamental technology consistent with cobas 6000 series.

Indications for Use

Indicated for use as an automated clinical chemistry analyzer for the measurement of analytes including Na, K, Cl, and IgA-2 in human clinical samples.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Predicate Devices

• Roche cobas 6000 Analyzer Series (K060373)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k100853

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

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)

Roche Diagnostics cobas 6000 analyzer series (k060373) (which includes the cobas 6000 control and core units, data management software, the c501 module which is comprised of photometric and ISE units, and the e601 electrochemistry immunoassay module), Indirect ISE (Na, K, and Cl) reagents

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 (labeling changes are permitted as long as they do not affect the intended use).

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:

- New analyzer series, cobas 8000 Modular Analyzer (which includes the cobas 8000 control and core units, data management software, indirect ISE module, a new c 502 module, and a new c 701 module) and associated reagents
- Integration and connectivity of the new c 502, new c 701, and indirect ISE modules (with only cosmetic and sample rack interface to accommodate module integration).
- Indirect ISE (Na, K, and Cl) reagent application on the modified device
- IgA-2 reagent application on the modified device

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance 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.