FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER

K023009 · The Binding Site, Ltd. · DFH · Jan 21, 2003 · Immunology

Device Facts

• Record ID: K023009
• Device Name: FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER
• Applicant: The Binding Site, Ltd.
• Product Code: DFH · Immunology
• Decision Date: Jan 21, 2003
• 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 the Roche Hitachi 911 and Hitachi 912. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myelomas, lymphocytic neoplasms, Waldenstrom's macroglobulinemia and connective tissue diseases, such as systemic lupus erythematosus.

Device Story

The FREELITE Human Kappa Free Kit is an in vitro diagnostic reagent system for use on Roche Hitachi 911/912 clinical chemistry analyzers. It measures kappa free light chains in human serum and urine samples. The device utilizes an immunoturbidimetric assay principle; specific antibodies bind to kappa free light chains, causing agglutination that is measured photometrically by the analyzer. The resulting concentration is used by clinicians to assist in diagnosing and monitoring plasma cell dyscrasias and autoimmune conditions. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analytical performance and technological characteristics consistent with established predicate devices.

Technological Characteristics

Immunoturbidimetric assay kit; designed for use on Roche Hitachi 911/912 automated clinical chemistry analyzers. Measures kappa free light chains via antibody-antigen agglutination. Photometric detection.

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 myelomas, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, and connective tissue diseases (e.g., systemic lupus erythematosus).

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

• Rheumatoid Factor (K023009)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing shapes.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

The Binding Site, Limited c/o Mr. Jay H. Geller 2425 West Olympic Boulevard West Tower, Suite 4000 Santa Monica, California 90404

Re: k023009

> Trade/Device Name: FREELITE Human Kappa Free Kit for Use on the Hitachi 911/912 Analyzer Regulation Number: 21 CFR § 866.5550 Regulation Name: Immunoglobulin (Light Chain Specific) Immunological Test System Regulatory Class: II Product Code: DFH Dated: January 3, 2003 Received: January 8, 2003

JAN 2 1 2003

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. Ilsting 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.

{1}------------------------------------------------

## Page 2

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 requirements as set 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## KD23009

## INDICATIONS FOR USE STATEMENT

FREELITE Human Kappa Free Kit for Use on the Hitachi Device Name: 911/912 Analyzer

This kit is intended for the quantitation of Indications for Use: kappa free light chains in serum and urine on the Roche Hitachi 911 and Hitachi 912. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myelomas, lymphocytic neoplasms, Waldenstrom's macroglobulinemia and connective tissue diseases, such as systemic lupus erythematosus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Al Reeves for J. Bautista

(División Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number ( K 023009
ratory Device 3009 09

Rheumatoid Factor 510(k) 12/5/2002 RF_S_RI.doc