CAPILLARYS URINE

K080916 · Sebia · JKM · Jul 1, 2008 · Immunology

Device Facts

• Record ID: K080916
• Device Name: CAPILLARYS URINE
• Applicant: Sebia
• Product Code: JKM · Immunology
• Decision Date: Jul 1, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5150
• Device Class: Class 2

Intended Use

The CAPILLARYS URINE kit is designed for the preparation of urine samples before separation of human urine proteins in alkaline buffer (pH 9.9) with the CAPILLARYS system. The CAPILLARYS performs automatically all sequences to obtain a urinary protein profile for qualitative analysis. The proteins, separated in silica capillaries, are directly detected at an absorbance of 200 nm. The electrophoretograms can be interpreted visually to detect for any pattern abnormalities (monoclonal components, particularly Bence Jones proteins and other urinary proteins). The test results should be used in conjunction with clinical and laboratory findings.

Device Story

The Sebia Capillarys Urine system is an automated capillary electrophoresis instrument used for the analysis of urine samples. The device processes urine to identify protein profiles. The system utilizes capillary electrophoresis technology to separate proteins based on their charge-to-mass ratio. The modified device (software v5.50) automates the sample processing workflow, replacing manual application of 200μl samples to uncolored segments with automated application of 100μl samples to green dilution segments. The system requires a normalization step using Normal Control Serum (diluted 80 times in buffer) prior to analysis sequences. The device is operated by laboratory personnel in a clinical setting. Output consists of electrophoretic patterns used by clinicians to assist in the diagnosis of protein-related disorders. The automation and procedural changes are intended to improve workflow efficiency while maintaining the fundamental scientific technology of the previously cleared predicate.

Clinical Evidence

No clinical data provided; device relies on bench testing and performance validation of the CAPILLARYS system for urine protein separation.

Technological Characteristics

Uses capillary electrophoresis in silica capillaries; alkaline buffer (pH 9.9); optical detection at 200 nm; automated sample preparation and separation sequences; system-based analysis.

Indications for Use

Indicated for the qualitative analysis of human urine proteins to detect pattern abnormalities, including monoclonal components and Bence Jones proteins, in conjunction with clinical and laboratory findings.

Regulatory Classification

Identification

A Bence-Jones proteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of polypeptide chains (subunits) of unequal size (light chains and heavy chains) bound together by several disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody-producing cell) with excess production of light chains of one specific kind (monoclonal light chains). These free homogeneous light chains not associated with an immunoglobulin molecule can be found in urine and plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination that they are monoclonal aid in the diagnosis of multiple myeloma (malignant proliferation of plasma cells), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins by spleen and bone marrow cells), leukemia (cancer of the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).

Submission Summary (Full Text)

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Special 510(k): Device Modification OIVD Review Memorandum

To: The File
Re: k080916

This 510(k) submission contains information/data on modifications made to the SUBMITTER’S own Class II device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER’S previously cleared device.

SEBIA CAPILLARYS URINE, PN 2012, software release 5.40 (k070486)

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).

There are no changes in Intended Use of Indications for Use (Section).

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.

The modifications were:

a) Upgrade of software to the 5.50 release to allow for an automated, as opposed to a manual, method for processing urine samples.

b) Change from 200μl of samples manually applied to uncolored dilution segments to 100μl of samples automatically applied to green dilution segments for analysis.

c) Additional step of normalizing capillaries with the Normal Control Serum, SEBIA, PN 4785, prior to starting a new analysis sequence. The Normal Control Serum is now diluted 80, as opposed to 40 times, in working dialysis buffer.

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

Similarities:

| Feature | Modified Device |
| --- | --- |
| Intended Use | No Change |
| Fundamental Scientific Technology | No Change |
| Design Assay Detection | No Change |
| Performance | No Change |

Differences:

a) Upgrade software from 5.40 to 5.50
b) Automated, as opposed to a manual, method for processing urine samples.
c) Change from 200 μL of samples manually applied to uncolored dilution segments to 100 μL of samples automatically applied to green dilution segments for analysis.

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d) Additional step of normalizing capillaries with the Normal Control Serum (SEBIA, PN 4785), prior to starting a new analysis sequence.
e) The Normal Control Serum is diluted 80, as opposed to 40 times, in working dialysis buffer.

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.

Sebia used failure mode and effect analysis (FMEA) (page 6-7).

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.

These are listed as part of the failure mode and effect analysis (FMEA) (pages 6-7).

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 (Page 220).
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 (Page 221).

6. A Truthful and Accurate Statement, a 510(k) Statement and the Indications for Use Enclosure.

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 device.