FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT

K070900 · The Binding Site, Ltd. · DFH · Nov 30, 2007 · Immunology

Device Facts

• Record ID: K070900
• Device Name: FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
• Applicant: The Binding Site, Ltd.
• Product Code: DFH · Immunology
• Decision Date: Nov 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

The FREELITE™ Human Kappa Free kit is intended for the quantitation of Kappa free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. Measurement 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. The FREELITE™ Human Lambda Free kit is intended for the quantitation of Lambda free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. Measurement of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom’s mac疗globulinemia, 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 kit for quantitative measurement of human Kappa and Lambda free light chains in serum; utilizes polyclonal monospecific antibodies coated onto polystyrene latex particles. Operates via turbidimetric assay on Roche COBAS INTEGRA 400/400plus analyzers. Sample mixed with antibody reagent in cuvette; antigen-antibody reaction forms insoluble immune complexes; light scatter measured as decrease in intensity of incident beam. Amount of immune complex proportional to antigen concentration; results derived from calibration curve. Used in clinical laboratory settings by trained personnel. Output aids clinicians in diagnosis and monitoring of plasma cell dyscrasias and related conditions. Benefits include rapid, automated quantification of free light chains to support clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance validation of the assay on the specified analyzer platform.

Technological Characteristics

Polystyrene latex-enhanced turbidimetric immunoassay. Reagents: polyclonal monospecific antibodies, latex particles, buffer, PEG solution. Instrumentation: Roche COBAS INTEGRA 400/400plus. Measurement: light scatter (turbidimetry). Storage: 2-8°C. Connectivity: automated analyzer integration. Sterilization: N/A (reagents).

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 connective tissue diseases (e.g., 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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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 3 0 2007

The Binding Site, Ltd. c/o Mr. Jay H. Geller East Tower, Suite 600 2425 West Olympic Blvd. Santa Monica, CA 90404

Re: k070900

Trade/Device Name: FREELITE™ Human Lambda Free Kit for use on Roche COBAS® INTEGRA 400/400 plus FREELITE™ Human Kappa Free Kit for use on Roche COBAS® INTEGRA 400/400 plus Regulation Number: 21 CFR 866.5550 Regulation Name: Immunoglobulin (light chain specific) immunological test system Regulatory Class: Class II Product Code: DFH, DEH Dated: November 29, 2007 Received: November 30, 2007

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

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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 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 information about the application of labeling requirements to your device, or questions on 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance 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,

Edert. Rockee

Robert L. Becker, Jr., M.D., Ph.D. 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): K070 900

Device Name: FREELITE® Human Kappa Free Kit for use on the Roche COBAS® INTEGRA 400/400 plus Analyzer

Indications for Use: For the quantitation of kappa free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. 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.

Maria Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K070900

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)

Attachment K

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## Indications for Use

510(k) Number (if known): K070900

Device Name: FREELITE® Human Lambda Free Kit for use on the Roche COBAS® INTEGRA 400/400 plus Analyzer

Indications for Use: For the quantitation of lambda free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. 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.

Marie Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

5100k: Ko 70906

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)

Attachment K 2