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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of four stylized human figures, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Sebia, Inc. c/o Ms. Karen Anderson Director of Technical Training and Regulatory 1705 Corporate Drive Suite 400 Norcross, GA 30093

Re: k080916 Trade/Device Name: CAPILLARYS URINE, PN 2012 Regulation Number: 21 CFR 866.5150 Regulation Name: Bence Jones proteins immunological systems Regulatory Class: Class II Product Code: JKM Dated: June 16, 2008 Received: June 19, 2008

Dear Ms. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JIJ -1 2008

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The

{1}------------------------------------------------

Page 2 -

FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Survcillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

In Chan

Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page 1 of 1

CAPILLARYS URINE

510(K) Number: K080916
(Special 510(K): Device modification)

Device name:

## CAPILLARYS URINE, PN 2012

Indications For 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)
✓

OR

Over-The Counter Use

(Optional Format 1-2-96)

Mare M Clan

**Division Sign-Off**

Office of in Viter Tican

K080911e