FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II

K031016 · The Binding Site, Ltd. · DEH · Jul 15, 2003 · Immunology

Device Facts

• Record ID: K031016
• Device Name: FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
• Applicant: The Binding Site, Ltd.
• Product Code: DEH · Immunology
• Decision Date: Jul 15, 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 Dade Behring Nephelometer II (BNII). 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 erythemoatosus. This kit is intended for the quantitation of lambda free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemoatosus.

Device Story

FREELITE™ kits are quantitative in vitro diagnostic assays for human kappa and lambda free light chains in serum and urine. The device utilizes nephelometry on the Dade Behring Nephelometer™ II (BNII) analyzer. Input samples are mixed with specific anti-free light chain antibodies in a cuvette; antigen-antibody complexes form, causing light scattering proportional to antigen concentration. The analyzer measures light intensity at an angle to the incident beam. Results are calculated via a calibration curve. The device is used in clinical laboratory settings by trained technicians. Output provides quantitative concentrations of free light chains, which clinicians use to diagnose and monitor plasma cell dyscrasias and related systemic diseases. The assay provides an alternative to immunofixation electrophoresis (IFE) for detecting abnormal light chain concentrations or κ/λ ratios.

Clinical Evidence

Clinical study conducted at Mayo Clinic (N=95 amyloidosis, N=18 LCDD). Samples tested with FREELITE™ nephelometry and predicate IFE. Results showed 83-100% agreement for amyloidosis and 88-100% agreement for LCDD between FREELITE™ and IFE. FREELITE™ detected abnormal concentrations or κ/λ ratios in samples where IFE was positive. Bench testing included precision (%CV 4.85-13.9%), linearity, and analytical specificity (cross-reactivity <0.4%).

Technological Characteristics

Quantitative nephelometric assay. Components: anti-free light chain antibodies (κ or λ), diluents, buffers. Instrumentation: Dade Behring Nephelometer™ II (BNII). Measurement principle: light scattering of antigen-antibody complexes. Measuring range: 5.9–190 mg/L (κ) and 8.1–260 mg/L (λ) at 1:100 dilution. Standalone reagent kit for use on specified analyzer.

Indications for Use

Indicated for the quantitation of κ and λ free light chains to aid in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström’s macroglobulinemia, amyloidosis, light chain deposition disease (LCDD), and connective tissue diseases such as 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.

Submission Summary (Full Text)

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is rendered in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 6 2004

The Binding Site, Ltd. c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Coulevard Santa Monica, CA 90404

Re: k031016

> Trade/Device Name: FREELITE® Human Kappa Free Kit and FREELITE® Human Lambda Free Kit for use on the Dade Behring Nephelometer II

Regulation Number: 21 CFR 866.550

Regulation Name: Immunoglobulin (light chain specific) immunological test system

Regulatory Class: Class II

Product Code: DFH [Kappa]; DEH [Lambda] Dated: June 10, 2003 Received: June 13, 2003

Dear Mr. Geller:

This letter corrects our substantially equivalent letter of July 15, 2003, regarding the omission of the FREELITE® Human Lambda Free Kit from the trade name information above, and of the product code for the FREELITE® Human Kappa Free Kit, i.e., DFH.

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 [{{or 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 (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.

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Page 2 - Mr. Jay H. Geller

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); 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.

This letter will allow you to continue 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Fuen Antman, m.D.

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

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510(k) Number (if known): K031016

Device Name: FREELITE® Human Kappa Free Kit for Use on the Dade Behring Nephelometer II

This kit is intended for the quantitation of Indications for Use: kappa free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). 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 erythemoatosus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | A.PReeves for J. Bautista |
|-----------------------------------------|---------------------------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | |

| Prescription Use | <div>✓</div> |
|----------------------|--------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |

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Page 2 of 2

510(k) Number (if known): K03 /0 / L

FREELITE® Human Lambda Free Kit for Use on the Dade Device Name: Behring Nephelometer II

Indications for Use: This kit is intended for the quantitation of lambda free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemoatosus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>J.P.Reeves for J. Bautista</i> |
|-----------------------------------------|-----------------------------------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K031016 |

| Prescription Use <span style="text-decoration: underline;">V</span><br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use <span style="text-decoration: underline;">_</span> |
|---------------------------------------------------------------------------------------------|----|-------------------------------------------------------------------------|
| | | (Optional Format 1-2-96) |

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