COBAS INTEGRA 400/800 BILIRUBIN TOTAL

K081193 · Roche Diagnostics · CIG · Jan 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K081193
• Device Name: COBAS INTEGRA 400/800 BILIRUBIN TOTAL
• Applicant: Roche Diagnostics
• Product Code: CIG · Clinical Chemistry
• Decision Date: Jan 16, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Indications for Use

The Cobas Integra Analyzer and Cobas Integra Reagent Cassettes are intended for the in vitro quantitative determination of analytes in human serum. The system is intended for use in clinical laboratory settings by trained laboratory personnel.

Device Story

Cobas Integra Bilirubin Total reagent performs quantitative in vitro determination of total bilirubin in human serum. System uses diazo method; reagent reacts with bilirubin in serum sample. Automated analyzer processes sample; measures absorbance changes. Used in clinical laboratory settings by trained technicians. Output provided as concentration value (umol/L or mg/dL). Clinicians use results to assess liver function, hemolytic processes, and metabolic disorders. Benefits include rapid, automated diagnostic information for managing hepatobiliary and hematological conditions.

Clinical Evidence

Bench testing only. Precision and method comparison studies performed against an automated laboratory analyzer to validate performance characteristics following modifications.

Technological Characteristics

In vitro diagnostic reagent system using diazo method. Active ingredients include sulfanilic acid, oxalic acid, HEDTA, myristyltrimethylammonium bromide, dodecyltrimethylammonium bromide, and sodium nitrite. Designed for use on Cobas Integra automated analyzers. Measuring range 17-340 umol/L (0.099-20 mg/dL), with automated 1:3 rerun dilution function for higher concentrations. Lower detection limit 1.7 umol/L.

Indications for Use

Indicated for the quantitative determination of total bilirubin in human serum to aid in the diagnosis and treatment 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

• Cobas Integra Bilirubin Total (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: k0801193

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.) Cobas Integra Analyzer and Cobas Integra Reagent Cassettes, 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 Integra 700 as an analyzer for use with the assay.
b. Removal of plasma as a sample type.
c. Quantification of lipemia and hemolysis interferences by using indices for these interferences.
d. Updated/Modified the lower measuring range to 1.7 umol/L (0.099 mg/dL).
e. Calibrator assignment process designed to be in alignment with the US Doumas reference method.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, analytes and performance characteristics. Studies include precision and method comparison with an automated laboratory analyzer.

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. FMEA
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.