COBAS INTEGRA CHLORIDE ELCTRODE GEN.2

K060108 · Roche Diagnostics Corp. · CGZ · Feb 16, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060108
• Device Name: COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
• Applicant: Roche Diagnostics Corp.
• Product Code: CGZ · Clinical Chemistry
• Decision Date: Feb 16, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1170
• Device Class: Class 2

Indications for Use

The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode.

Device Story

The COBAS INTEGRA Chloride Electrode Gen. 2 is an ion-selective electrode (ISE) module component used for quantitative chloride measurement in serum, plasma, and urine. It processes undiluted (ISE Direct) or automatically diluted (ISE Indirect/Urine) specimens. The device operates within the COBAS INTEGRA system, utilized in clinical laboratory settings by trained technicians. It measures potential differences across the electrode to determine ion concentration. Results are provided to clinicians to assist in diagnosing and managing electrolyte and metabolic disorders. The Gen. 2 electrode offers improved stability and performance characteristics compared to the predicate, specifically optimized for environments processing high volumes of plasma samples.

Clinical Evidence

Bench testing only; validation protocols addressed hazards identified in FMEA risk analysis; no clinical data provided.

Technological Characteristics

Ion-selective electrode; electro-chemical membrane; modification to substance mediating chloride ion binding to membrane; fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for quantitative determination of chloride in serum, plasma, and urine to aid in the diagnosis and treatment of electrolyte and metabolic disorders. Recommended for use when a significant portion of samples are plasma.

Regulatory Classification

Identification

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Predicate Devices

• Chloride Electrode (K963627)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k060108

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 INTEGRA CHLORIDE ELCTRODE GEN.2:

1. The name and 510(k) number of ROCHE DIAGNOSTICS CORP.'s previously cleared device, COBAS INTEGRA Chloride Electrode, cleared under k963627. (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 Electro-Chemical properties of the electrode membrane change to the substance mediating the binding of chloride ions to be more closely linked to the membrane and package insert revisions.

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)