Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit

K150658 · The Binding Site Group , Ltd. · DFH · Aug 26, 2015 · Immunology

Device Facts

• Record ID: K150658
• Device Name: Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit
• Applicant: The Binding Site Group , Ltd.
• Product Code: DFH · Immunology
• Decision Date: Aug 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

The Optilite Freelite Kappa Free Kit is intended for the quantitative in vitro measurement of kappa free light chains in serum using the Binding Site Optilite turbidimetric analyser. Measurement of free light chains 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. The Optilite Freelite Lambda Free Kit is intended for the quantitative in vitro measurement of kappa free light chains in serum using the Binding Site Optilite turbidimetric analyser. Measurement of free light chains 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.

Device Story

Optilite Freelite Kappa and Lambda Free Kits are in vitro diagnostic reagents for use on the Binding Site Optilite turbidimetric analyser. The system measures free light chains in serum samples via turbidimetric immunoassay. The analyser automates sample processing and optical measurement; results are provided to clinicians to assist in diagnosing and monitoring plasma cell dyscrasias and related connective tissue disorders. The device is intended for professional use in clinical laboratory settings. Output data supports clinical decision-making regarding disease status and treatment efficacy.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by analytical performance and bench testing on the Optilite turbidimetric analyser.

Technological Characteristics

Turbidimetric immunoassay reagents for use on the Optilite turbidimetric analyser. Measures kappa and lambda free light chains in serum. System utilizes automated optical turbidimetry. Connectivity and software are integrated into the Optilite analyser platform.

Indications for Use

Indicated for quantitative measurement of kappa and lambda free light chains in serum to aid in 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 adult patients.

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 Free kit for use on Roche Cobas Integra® 400/400plus (K070900)
• Freelite® Human Lambda Free kit for use on Roche Cobas Integra® 400/400plus (K070900)

Submission Summary (Full Text)

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

August 26, 2015

THE BINDING SITE GROUP LTD MS. ANDREA THOMAS REGULATORY AFFAIRS OFFICER 8 CALTHORPE ROAD, EDGBASTON BIRMINGHAM B15 1QT, UNITED KINGDOM

Re: K150658

Trade/Device Name: Optilite® Freelite® Kappa Free Kit Optilite® Freelite® Lambda Free Kit Regulation Number: 21 CFR§866.5550 Regulation Name: Immunoglobulin (light chain specific) immunological test system Regulatory Class: II Product Code: DFH, DEH Dated: July 23, 2015 Received: July 27, 2015

Dear Ms. Thomas:

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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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as set forth in the quality systems (OS) 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 regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Leonthena R. Carrington -S

Leonthena R. Carrington, MS, MBA, MT(ASCP) 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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# Indications for Use

510(k) Number (if known) K150658

Device Name Optilite Freelite Kappa Free Kit Optilite Freelite Lambda Free Kit

#### Indications for Use (Describe)

The Optilite Freelite Kappa Free Kit is intended for the quantitative in vitro measurement of kappa free light chains in serum using the Binding Site Optilite turbidimetric analyser. Measurement of free light chains 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.

The Optilite Freelite Lambda Free Kit is intended for the quantitative in vitro measurement of kappa free light chains in serum using the Binding Site Optilite turbidimetric analyser. Measurement of free light chains 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 systematosus (SLE) in conjunction with other laboratory and clinical findings.

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

| | Prescription Use (Part 21 CFR 801 Subpart D) |
|--|----------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |

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