ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID

K032377 · Roche Diagnostics Corp. · KHS · Aug 21, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032377
• Device Name: ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
• Applicant: Roche Diagnostics Corp.
• Product Code: KHS · Clinical Chemistry
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Indications for Use

The COBAS Integra Bicarbonate liquid (K031879) contains an in vitro diagnostic reagent system for use on the Cobas Integra system for the quantitative determination of bicarbonate concentration in human serum and plasma. The modified device Roche/Hitachi Bicarbonate liquid is an in vitro device for the quantitative determination of bicarbonate in human serum and plasma on Roche clinical analyzer systems.

Device Story

Roche/Hitachi Bicarbonate liquid is a ready-to-use enzymatic assay for quantitative bicarbonate measurement in human serum and plasma. It utilizes phosphoenolpyruvate carboxylase and malate dehydrogenase enzymes. The assay is performed on Roche automated clinical chemistry analyzers in clinical laboratory settings. The principle of operation involves a decrease in absorbance at 415 nm, which is proportional to the bicarbonate concentration in the sample. Healthcare providers use the resulting quantitative values to diagnose and monitor disorders related to body acid-base balance. The device provides automated, high-throughput testing capabilities for clinical diagnostic use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ready-to-use liquid enzymatic reagent system. Enzymes: phosphoenolpyruvate carboxylase and malate dehydrogenase. Detection: colorimetric, absorbance decrease at 415 nm. Form factor: reagent cassette for automated clinical chemistry analyzers. Connectivity: integrated with Roche automated clinical chemistry systems.

Indications for Use

Indicated for the quantitative determination of bicarbonate concentration in human serum and plasma for clinical diagnostic use.

Regulatory Classification

Identification

A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Predicate Devices

• COBAS Integra Bicarbonate liquid (K031879)

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 K032377

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.)
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 applying the reagent to the Roche/Hitachi family of analyzers in accordance with the reagent replacement protocol and changing the name of the assay to Hitachi Integra Bicarbonate liquid.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and measuring range. The COBAS Integra Bicarbonate liquid (K031879) contains an in vitro diagnostic reagent system for use on the Cobas Integra system for the quantitative determination of bicarbonate concentration in human serum and plasma. The modified device Roche/Hitachi Bicarbonate liquid is an in vitro device for the quantitative determination of bicarbonate in human serum and plasma on Roche clinical analyzer systems. The measuring range of the predicate device is 0.46 – 50 mmol/L. The measuring range of the new device is 1.5 – 50 mmol/L.

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.