HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS

K082823 · The Binding Site Group , Ltd. · CFN · Mar 1, 2010 · Immunology

Device Facts

• Record ID: K082823
• Device Name: HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
• Applicant: The Binding Site Group , Ltd.
• Product Code: CFN · Immunology
• Decision Date: Mar 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

This kit is intended for the in vitro quantification of IgA Kappa (combined α heavy and κ light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed IgA multiple myeloma, in conjunction with other clinical and laboratory findings. This kit is intended for the in vitro quantification of IgA Lambda (combined α heavy and λ light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed IgA multiple myeloma, in conjunction with other clinical and laboratory findings.

Device Story

Hevylite™ Human IgA Kappa and IgA Lambda Kits are in vitro diagnostic reagents for use on Siemens BN™ II systems. The device uses polyclonal monospecific sheep anti-IgA antisera to detect combined α heavy and κ/λ light chains in human serum. Principle of operation is nephelometry: sample is mixed with antibody in a cuvette; antigen-antibody reaction forms insoluble immune complexes; light scatter is measured at an angle to incident light. Light scatter intensity is proportional to antigen concentration, determined via a calibration curve. Used in clinical laboratories by trained personnel. Output is a quantitative concentration (g/L) of IgA Kappa or IgA Lambda. Results assist clinicians in assessing patients with previously diagnosed IgA multiple myeloma by providing specific heavy/light chain quantification, complementing other clinical and laboratory findings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Quantitative nephelometric assay. Reagents: polyclonal monospecific sheep anti-IgA antisera (combined α heavy/κ or λ light chain), calibrators, controls. Preservative: 0.099% sodium azide. Instrument: Siemens Behring Nephelometer™ II (BN™ II). Connectivity: System-integrated. Calibration: Traceable to CRM470 International Reference Material. Measuring range: IgAK (0.35–11.2 g/L), IgAL (0.33–10.4 g/L).

Indications for Use

Indicated for in vitro quantification of IgA Kappa or IgA Lambda concentrations in human serum for patients with previously diagnosed IgA multiple myeloma. Prescription use only. Not established for diagnosis, monitoring, or prognosis of IgA myeloma.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

The Binding Site Group Ltd. c/o Mr. Jay H. Geller Authorized U.S. Representative 12100 Wilshire Boulevard, Suite 500 Los Angeles, CA 90025-7121

MAR 0 1 2010

Re: k082823

Trade/Device Name: Hevylite™ Human IgA Kappa Kit for use on the Siemens BN™ II Hevylite™ Human IgA Lambda Kit for use on the Siemens BNTM II Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E Immunological Test System Regulatory Class: Class II Product Code: CFN. OPX. OPY Dated: January 18, 2010 Received: January 27, 2010

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. Drue, 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 class II (Special Controls), 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

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Page 2 – Mr. Jay H. Geller

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); 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (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/ReportalProblem/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/cdrh/industry/support/index.html.

Sincerely vours,

ia m chen

Maria M. Chan, Ph.D. 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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## Indications for Use

510(k) Number (if known): K082823

Device Name: Hevylite™ Human IgA Kappa Kit for use on Siemens BN™II Systems

Indications for Use: This kit is intended for the in vitro quantification of IgA Kappa (combined a heavy and k light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed IgA multiple myeloma, in conjunction with other clinical and laboratory findings.

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD).

Deena Philip

Division Sign-Off

Office of In Vitro Diaanostic Device Evaluation and Safety

510(k) 082823

Page 1 of 1

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## Indications for Use

510(k) Number (if known): K082823

Device Name: Hevylite™ Human IgA Lambda Kit for use on Siemens BN™II Systems

Indications for Use: This kit is intended for the in vitro quantification of IgA Lambda (combined a heavy and À light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed IgA multiple myeloma, in conjunction with other clinical and laboratory findings.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD).

Page 1 of 1

Reena Philip

Division Sign-Off

510(k) 082823

Office of In Vitro Diagnostic Device Evaluation and Safety