FREELITE HUMAN KAPPA AND LAMBDA KITS

K040009 · The Binding Site, Ltd. · DFH · Mar 11, 2004 · Immunology

Device Facts

• Record ID: K040009
• Device Name: FREELITE HUMAN KAPPA AND LAMBDA KITS
• Applicant: The Binding Site, Ltd.
• Product Code: DFH · Immunology
• Decision Date: Mar 11, 2004
• 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 (BN™II). 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 disorders such as systemic lupus erythematosus.

Device Story

The FREELITE™ Human Kappa or Lambda Free Kit is an in vitro diagnostic assay for quantifying free light chains in serum and urine. The device utilizes latex-enhanced nephelometric or turbidimetric technology; polystyrene beads are coated with monospecific antibodies. When the sample is added, antigen-antibody reactions form insoluble immune complexes, increasing light scatter. The intensity of scattered light is proportional to the antigen concentration. The assay is performed on automated clinical chemistry analyzers (Dade Behring BN II, Beckman Coulter IMMAGE, or Roche HITACHI series). Healthcare providers use the quantitative results to assist in diagnosing and monitoring plasma cell dyscrasias and related autoimmune conditions. The primary change in this submission is the transition of the latex reagent from a freeze-dried to a liquid format and the addition of an amyloidosis clinical claim.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Latex-enhanced nephelometric/turbidimetric immunoassay. Reagents consist of polystyrene beads coated with monospecific antibodies. Energy source is the light beam of the clinical analyzer. Analyzers used: Dade Behring BN II, Beckman Coulter IMMAGE, Roche HITACHI 911/912/917/Modular P. Liquid reagent format. Quantitative measurement of light scatter.

Indications for Use

Indicated for the quantitation of kappa or lambda free light chains in serum and urine to aid in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinemia, amyloidosis, light chain deposition disease, and 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures.

MAR 1 1 2004

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: k040009

> Trade/Device Names: FREELITE™ Human Kappa Free Kit for use on the Dade Behring Nephelometer "11 II FREELITE™ Human Lambda Free Kit for use on the Dade Behring Nephelometer 11 FREELITE™ Human Kappa Free Kit for use on the Beckman Coulter IMMAGE™ FREELITE™ Human Lambda Free Kit for use on the Beckman Coulter IMMAGE™ FREELITE™ Human Kappa Free Kit for use on the HITACHI 911/912/917/Modular P FREELITE™ Human Lambda Free Kit for use on the HITACHI 911/912/917/Modular P Regulation Number: 21 CFR § 866.5550 Regulation Name: Immunoglobulins (Light Chain Specific) Immunological Test System Regulatory Class: II Product Code: DFH, DEH Dated: December 29, 2004 Received: January 2, 2004

Dear 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, listing 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.

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 recuirements, 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

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Page 2 - Jay H. Geller

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). 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Joseph L. Hackett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices 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):

FREELITE™ Human Kappa Free kit for use on the Dade Behring Device Name: Nephelometer™ II

Indications For Use:

This kit is intended for the quantitation of kappa free light chains in serum and urine on the Dade Behring Nephelometer II (BN™II). 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 disorders such as systemic lupus erythematosus.

e Clan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040009

Prescription Use ____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

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510(k) Number (if known): Ko 4000 9

FREELITE™ Human Lambda Free kit for use on the Dade Behring Device Name: 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 (BN™II). 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 disorders such as systemic lupus erythematosus.

ia chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Ko40009

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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510(k) Number (if known): Ko 40009

FREELITE™ Human Kappa Free kit for use on the Beckman Device Name: Coulter IMMAGE™

Indications For Use:

This kit is intended for the quantitation of kappa free light chains in serum and urine on the Beckman Coulter IMMAGE™. 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 disorders such as systemic lupus erythematosus.

Maria Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040009

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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510(k) Number (if known): Ko 4000 9

FREELITE™ Human Lambda Free kit for use on the Beckman Device Name: Coulter IMMAGE™

Indications For Use:

This kit is intended for the quantitation of lambda free light chains in serum and urine on the Beckman Coulter IMMAGE™. 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 disorders such as systemic lupus erythematosus.

Maria Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040009

Prescription Use 1 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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510(k) Number (if known): Ko40009

FREELITE™ Human Kappa Free kit for use on the Hitachi Device Name: 911/912/917/Modular P

Indications For Use:

This kit is intended for the quantitation of kappa free light chains in serum and urine on the Hitachi 911/912/917/Modular P. 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 disorders such as systemic lupus erythematosus.

Mana Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040009

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

{7}------------------------------------------------

510(k) Number (if known): Ko 40009

FREELITE™ Human Lambda Free kit for use on the Hitachi Device Name: 911/912/917/Modular P

Indications For Use:

This kit is intended for the quantitation of lambda free light chains in serum and urine on the Hitachi 911/912/917/Modular P. 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 disorders such as systemic lupus erythematosus.

Maria Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040009

1 Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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