FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER

K062372 · The Binding Site, Ltd. · DFH · Jun 21, 2007 · Immunology

Device Facts

• Record ID: K062372
• Device Name: FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
• Applicant: The Binding Site, Ltd.
• Product Code: DFH · Immunology
• Decision Date: Jun 21, 2007
• 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 Binding Site SpaPlus. 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 in conjunction with other laboratory and clinical findings.

Device Story

In vitro diagnostic assay for quantitative measurement of kappa and lambda free light chains in human serum; utilizes nephelometry on The Binding Site SPAplus™ analyzer. Input: serum sample; reagent containing polyclonal monospecific sheep antibody coated onto polystyrene latex. Principle: antibody-antigen reaction forms insoluble immune complexes; light scattering measured as signal proportional to antigen concentration. Output: quantitative concentration of free light chains. Used in clinical laboratory settings by trained personnel. Results aid clinicians in diagnosing and monitoring monoclonal gammopathies and related systemic diseases. Prozone detection flags potential antigen excess to prevent falsely low values.

Clinical Evidence

No clinical data provided in the document; the submission relies on bench testing and performance validation for the intended use.

Technological Characteristics

Quantitative nephelometric assay. Reagents: polyclonal monospecific sheep antibody coated on polystyrene latex. Detection: light scattering by immune complexes. Instrument: SPAplus™ analyzer. Matrix: serum. Calibration: multi-point curve using provided calibrators. Software: automated kinetic analysis for prozone detection.

Indications for Use

Indicated for the quantitation of kappa and lambda 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 systemic lupus erythematosus in patients requiring clinical laboratory assessment.

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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 1 2007

The Binding Site, Ltd. C/O Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, California 90404

Re: k062372

Trade/Device Name: FREELITE Human Kappa Free Kit for use on the SPAPLUS FREELITE Human Lambda Free Kit for use on the SPAPLUS Regulation Number: 21 CFR 866.5550 Regulation Name: Immunoglobulin (light chain specific) immunological test system Regulatory Class: Class II Product Code: DFH, DEH Dated: August 16, 2006 Received: August 17, 2006

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice

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Page 2 – Jay H. Geller

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as be form inrketing your device as described in your Section 510(k) premarket wifi anow you to begin mating of substantial equivalence of your device to a legally marketed nourteate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, 11 you don't bp the promotion and advertising of your device, 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" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Four may 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,

Polo D. Baker Jr.

Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology 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 : K 062372

Device Name: FREELITE Human Kappa Free kit for use on the SPAPLUS

Indications for Use: This kit is intended for the quantitation of kappa free light chains in serum on The Binding Site SpaPlus. 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 in conjunction with other laboratory and clinical findings.

Prescription Use __ X (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)

Attachment H1

**Division Sign-Off**

Attachment H1

Office of In Vitro Dlagnostic Device Evaluation and Safety

510(k) 2-06672

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## Indications for Use

510(k) Number : K 062372

Device Name: FREELITE Human Lambda Free kit for use on the SPAPLUS

Indications for Use: This kit is intended for the quantitation of lambda free light chains in serum on The Binding Site SpaPlus. 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 in conjunction with other laboratory and clinical findings.

Prescription Use ____X_ (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)

Attachment H1

Division Sign-Off

Office of In Vitro Diagno Device Evaluation an

510(k) K062372

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