HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER

K120056 · The Binding Site Group , Ltd. · DFH · Apr 1, 2013 · Immunology

Device Facts

• Record ID: K120056
• Device Name: HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER
• Applicant: The Binding Site Group , Ltd.
• Product Code: DFH · Immunology
• Decision Date: Apr 1, 2013
• 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 and urine on Binding Site SPApLus. Measurement of free light chains in serum aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. Measurement of free light chains in urine aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis and light chain deposition disease in conjunction with other laboratory and clinical findings.

Device Story

The Freelite Human Kappa Kit is an in vitro diagnostic assay for the quantitative measurement of kappa free light chains in human serum and urine. The device is designed for use on the Binding Site SPApLus analyzer. It utilizes an immunoturbidimetric principle where specific antibodies react with free light chains in the patient sample to form an insoluble complex, resulting in turbidity measured by the analyzer. The output is a quantitative concentration value provided to clinicians to assist in the diagnosis and monitoring of plasma cell dyscrasias and related conditions. The device is intended for professional use in clinical laboratory settings. Results are interpreted by healthcare providers in conjunction with other clinical and laboratory findings to inform patient management and disease monitoring.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by analytical performance data (bench testing) demonstrating the assay's precision, linearity, and correlation with the predicate device on the SPApLus platform.

Technological Characteristics

Quantitative turbidimetric assay. Reagents: Polyclonal monospecific sheep antibody coated on polystyrene latex. Instrument: Binding Site SPA PLUS. Measuring range: 4.0-180 mg/L (standard 1/10 dilution) with extended ranges via automated dilution. Standards/Guidelines: CLSI EP5-A2, EP6-A, EP7-A2, EP17-A, C28-A3c. Connectivity: Integrated with SPA PLUS analyzer.

Indications for Use

Indicated for the quantitation of kappa free light chains in serum and urine to aid in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease, and connective tissue diseases (e.g., SLE).

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

• Freelite® Human Kappa and Lambda Free Kits for use on Hitachi Modular P (k023009)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 1, 2013

The Binding Site Group, Ltd. c/o Jill Constantine, Ph.D. 8 Calthorpe Road, Edgbaston Birmingham, West Midlands, B15 1QT UK

Re: k120056

Trade/Device Name: Freelite® Human Kappa 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 Dated: March 26, 2013 Received: March 28, 2013

Dear Dr. Constantine:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Jill Constantine, Ph.D.

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## Maria M. Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): k120056

Device Name: Freelite Human Kappa Kit for use on the SpaPLUS

Indications For Use:

This kit is intended for the quantitation of kappa free light chains in serum and urine on Binding Site SPApLus. Measurement of free light chains in serum aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. Measurement of free light chains in urine aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis and light chain deposition disease in conjunction with other laboratory and clinical findings.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

## Maria M. Chan -S

Division Sian-Off Office of In Vitro Diagnostics and Radiological Health

510(k) k120056