FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER

K051915 · The Binding Site, Ltd. · DFH · Sep 6, 2005 · Immunology

Device Facts

• Record ID: K051915
• Device Name: FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER
• Applicant: The Binding Site, Ltd.
• Product Code: DFH · Immunology
• Decision Date: Sep 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

This kit is intended for the quantitation of kappa free light chains in serum on the Bayer Advia® 1650. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.

Device Story

The Freelite™ Human Kappa Free Kit is an in vitro diagnostic reagent system for use on the Bayer ADVIA® 1650 analyzer. It quantifies kappa free light chains in human serum samples. The device utilizes immunoturbidimetric technology to measure light chain concentrations. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output provides quantitative results used by physicians to assist in the diagnosis and monitoring of plasma cell dyscrasias and related connective tissue disorders. By measuring free light chain levels, the device aids in clinical decision-making regarding disease progression and treatment efficacy for conditions like multiple myeloma and amyloidosis.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analytical performance and bench testing demonstrating that the assay performance on the Bayer ADVIA® 1650 is equivalent to the predicate device.

Technological Characteristics

Latex-enhanced nephelometric/turbidimetric assay. Reagents consist of polystyrene beads coated with monospecific antibodies. Dimensions/form factor: kit components (reagent, standard, controls). Connectivity: integrated with Bayer ADVIA 1650 Analyzer. Energy source: optical (light scatter). Sterilization: not applicable. Software: embedded analyzer firmware.

Indications for Use

Indicated for the quantitation of kappa free light chains in serum to aid in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease, and connective tissue diseases (e.g., systemic lupus erythematosus).

Regulatory Classification

Identification

An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Predicate Devices

• The Binding Site (TBS) Freelite BN II kit (k010440)
• TBS Bayer ADVIA Freelite assays (k010441)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the circle is a stylized image of an eagle with its wings spread. The eagle is made up of three curved lines that represent its body, wings, and tail.

SEP - 6 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

The Binding Site, LTD. c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Blvd. Santa Monica, CA 90404

Re: k051915

Trade/Device Name: FREELITE™ Human Kappa Free kit for use on the Bayer ADVIA® 1650 FREELITE™ Human Lambda Free kit for use on the Bayer ADVIA® 1650 Regulation Number: 21 CFR 866.5550 Regulation Name: Immunoglobulin (light chain specific) immunological test system Regulatory Class: Class II Product Code: DFH, DEH Dated: July 11, 2005 Received: July 18, 2005

Dear Mr. Geller:

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.

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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 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 Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Robert D. Beckerf

Robert L. Becker, Jr., M.D., PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use 510(k) Number (if known): KOS 19 15

Device Name: Freelite™ Human Kappa Free Kit for use on the Bayer Advia® 1650

Indications for Use: This kit is intended for the quantitation of kappa free light chains in serum on the Bayer Advia® 1650. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mana M. Chan

Attachment II

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