ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2

K033009 · Roche Diagnostics Corp. · CIX · Oct 16, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033009
• Device Name: ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
• Applicant: Roche Diagnostics Corp.
• Product Code: CIX · Clinical Chemistry
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1035
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The cassette COBAS Integra Albumin Gen.2 (ALB2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the albumin concentration in human serum and plasma.

Device Story

In vitro diagnostic assay modification; transition from mono-reagent to dual-reagent format; buffer change from succinate to citrate; assay pH adjustment from 4.1 to 4.3. Device intended for clinical laboratory use to measure specific analytes. Modification verified via design control activities, risk analysis, and performance testing to ensure fundamental scientific technology remains unchanged from previously cleared predicate.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analytical performance characteristics and comparison of the modified reagent system to the predicate device.

Technological Characteristics

In vitro diagnostic assay; dual-reagent format; citrate buffer; assay pH 4.3. Replaces previous mono-reagent, succinate buffer, pH 4.1 configuration.

Indications for Use

Indicated for quantitative determination of albumin in human serum and plasma to aid in diagnosis and treatment of liver or kidney diseases. Applicable to adults, newborns, and children.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K033009

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 changing from a mono-reagent to a dual-reagent format, changing fro a succinate to a citrate buffer, and a change in assay pH from 4.1 to 4.3.

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