FREELITE HUMAN LAMBDA FREE KIT

K140396 · The Binding Site Group , Ltd. · DEH · Apr 16, 2014 · Immunology

Device Facts

• Record ID: K140396
• Device Name: FREELITE HUMAN LAMBDA FREE KIT
• Applicant: The Binding Site Group , Ltd.
• Product Code: DEH · Immunology
• Decision Date: Apr 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

The kit is intended for the quantitation of lambda 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, Waldenstrom's macroglobulinaemia, AL amyloidosis, light chain deposition dissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. Measurement of free light chains in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis and light chain deposition with other laboratory and clinical findings.

Device Story

The Freelite® Human Lambda Free Kit is an in vitro diagnostic assay for the quantitative measurement of lambda free light chains in serum and urine. The device utilizes turbidimetry; samples are mixed with polyclonal monospecific sheep antibodies in a reaction cuvette. The formation of insoluble immune complexes increases light scatter, which is measured by the SPA_PLUS analyzer. The analyzer compares the light scatter against a calibration curve to determine antigen concentration. The device is intended for use in clinical laboratory settings by trained personnel. The output provides quantitative results that assist clinicians in diagnosing and monitoring plasma cell dyscrasias and related conditions. By measuring free light chains, the device aids in the clinical assessment of disease progression or response to therapy.

Clinical Evidence

No clinical trials were performed. Substantial equivalence was established through analytical performance testing. Method comparison was conducted using 168 urine samples (129 clinical, 39 normal) comparing the SPA_PLUS platform to the predicate IMMAGE analyzer. Regression analysis (n=124 within range) yielded y = 1.03x + 0.14 (R=0.99). Analytical studies included precision (CLSI EP05-A2), linearity (CLSI EP06-A), and limit of detection (CLSI EP17-A). Interference testing showed minimal impact from hemoglobin, bilirubin, ascorbic acid, and albumin.

Technological Characteristics

Turbidimetric immunoassay using polyclonal monospecific sheep antibodies coated onto polystyrene latex. Energy source: SPA_PLUS analyzer light source. Dimensions/form factor: Reagent kit for automated analyzer. Connectivity: Standalone instrument integration. Software: Embedded firmware on SPA_PLUS analyzer. Sterilization: Not applicable (reagents). Standards: CLSI EP05-A2, EP06-A, EP17-A, C28-A3.

Indications for Use

Indicated for the quantitation of lambda 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) in conjunction with other clinical findings.

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 Lambda Free Kit for use on Beckman Coulter IMMAGE™ (k003671)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Public Health Service

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

April 16, 2014

THE BINDING SITE GROUP, LTD C/O MR. PAUL KENNY HEAD OF REGULATORY AFFAIRS 8 CALTHORPE ROAD BIRMINGHAM, WEST MIDLANDS, B15 1QT UNITED KINGDOM

Re: K140396

Trade/Device Name: 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: II Product Code: DEH Dated: February 14, 2014 Received: February 18, 2014

Dear Mr. Kenny:

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 11 (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 (2 l CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical 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.

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Page 2-Mr. Paul Kenny

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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. 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

Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) k140396

#### Device Name

Freelite® Human Lambda Free Kit for use on the SPAPLUS

## Indications for Use (Describe)

The kit is intended for the quantitation of lambda 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, Waldenstrom's macroglobulinaemia, AL amyloidosis, light chain deposition dissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. Measurement of free light chains in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis and light chain deposition with other laboratory and clinical findings.

# Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

# FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Elizabeth A. Stafford -S

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