COBAS INTEGRA C 111

K063744 · Rochdiag · CIG · Jan 17, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063744
• Device Name: COBAS INTEGRA C 111
• Applicant: Rochdiag
• Product Code: CIG · Clinical Chemistry
• Decision Date: Jan 17, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Indications for Use

In vitro test for the quantitative determination of total bilirubin in human serum and plasma on the cobas c 111 system. Measurements of the levels of bilirubin and organic compound formed during normal and abnormal destruction of red cells, is used in the diagnosis of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block.

Device Story

Total Bilirubin Special is an in vitro diagnostic reagent used on the cobas c 111 analyzer. The system accepts human serum or plasma samples. The analyzer uses photometric analysis to measure bilirubin levels via a diazo-based chemical reaction. The cobas c 111 is a benchtop, random-access analyzer operated by professional laboratory staff in clinical environments. The device transforms optical absorbance data into quantitative concentration results through automated calculation against a calibration curve. Healthcare providers use these results to diagnose liver, hemolytic, hematological, and metabolic conditions. The device benefits patients by providing rapid, automated clinical chemistry testing to support timely medical decision-making.

Clinical Evidence

Bench testing only; design control activities and risk analysis performed to verify/validate modifications against predetermined acceptance criteria.

Technological Characteristics

Photometric chemistry analyzer; uses diazo reagent chemistry. Reagents: Sodium acetate buffer, sulfamic acid, hydrochloric acid, diazonium ion. Sensing: Absorbance photometry (tungsten/halogen lamp, 20W). Form factor: Benchtop. Connectivity: RS232C host interface. Software: Embedded Linux/vxWorks. Sterilization: N/A (reagent).

Indications for Use

Indicated for the quantitative determination of total bilirubin in human serum and plasma to aid in the diagnosis of liver, hemolytic, hematological, and metabolic disorders (e.g., hepatitis, gall bladder block).

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Predicate Devices

• K951595

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K063744

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.) k951595
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:

A. Removal of the fluorescence photometer.
B. Change in reagent container.
C. Lowered the overall throughput, sample and reagent capacity.
D. ISE module now integrated rather than separate.

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