HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT

K132555 · The Binding Site · PCN · Dec 20, 2013 · Immunology

Device Facts

• Record ID: K132555
• Device Name: HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
• Applicant: The Binding Site
• Product Code: PCN · Immunology
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

Hevylite Human IgG Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgG kappa (IgG heavy chain and lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Kappa is used alongside Hevylite Human IgG Lambda to calculate the IgG kappa/IgG lambda ratio. The Hevylite Human IgG kappa/IgG lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments. Hevylite Human IgG Lambda is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgG lambda (IgG heavy chain and lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Lambda is used alongside Hevylite Human IgG Kappa to calculate the IgG kappa/IgG lambda ratio. The Hevylite Human IgG kappa/IgG lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

Device Story

Quantitative in vitro nephelometric assay; measures IgG kappa and IgG lambda concentrations in human serum; utilizes sheep anti-human IgG antibodies specific to junctional epitopes (heavy/light chain contact). Performed on Siemens BN II nephelometer; instrument automatically dilutes calibrator to generate calibration curve; light scatter intensity proportional to antigen concentration. Used by laboratory technicians in clinical settings to calculate IgG kappa/IgG lambda ratio; ratio changes used to monitor treatment response in IgG multiple myeloma patients. Results interpreted alongside SPEP, immunofixation, and bone marrow assessments to determine clinical status (e.g., complete response, progressive disease). Benefits include objective monitoring of monoclonal protein levels to assist clinical decision-making regarding patient response to therapy.

Clinical Evidence

Retrospective study of 127 IgG multiple myeloma patients (428 sequential samples). Compared Hevylite IgG kappa/lambda ratio response classifications against NCCN v1.2011 criteria. Sensitivity 93% (95% CI: 89-95%), specificity 75% (95% CI: 65-83%). Weighted kappa analysis showed 0.75-0.78 agreement with clinical reference methods. Study confirmed utility in monitoring treatment response.

Technological Characteristics

Quantitative nephelometric assay. Reagents: polyclonal monospecific sheep anti-IgG antisera (combined heavy/light chain), calibrator, controls. Preservative: 0.099% sodium azide. Platform: Siemens BN II nephelometer. Connectivity: instrument-based processing. Storage: 2-8°C.

Indications for Use

Indicated for monitoring previously diagnosed IgG multiple myeloma in patients. Used in conjunction with other laboratory tests and clinical evaluations. Not for use as a standalone diagnostic for complete response.

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 Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 20, 2013

THE BINDING SITE GROUP, LTD. C/O MR. PAUL KENNY HEAD OF REGULATORY AFFAIRS 8 CALTHORPE RD, EDGBASTON BIRMINGHAM, WEST MIDLANDS, B15 1QT UNITED KINGDOM

Re: k132555

Trade/Device Name: Hevylite™ Human IgG Kappa Kit for use on Siemens BN™ II Systems and Hevylite™ Human IgG Lambda Kit for use on Siemens BN™ II Systems Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E Immunological Test System Regulatory Class: II Product Code: PCN, PCO Dated: November 12, 2013 Received: November 15, 2013

Dear Mr. Kenny:

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 Part 801); medical device reporting of medical

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Page 2 - Mr. Paul Kenny

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

## Maria M. Chan -S

Maria M. Chan, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on fast page.

Indications for Use

510(k) Number (if known) k132555

## Device Name

Hevylite Human IgG Kappa kit for use on the Siemens BN II and Hevylite Human IgO Lamboda kil for use on the Siemens BN II

## Indications for Use (Describe)

Hevylite Human IgG Kappe is a quantitative in viro assay performed on the Siemens BN II nechelometer for the mesurenent of IgG Kappa (lgG heavy chain and Kappa light chain intert immunoglobulin) in serum. Measurement of Hevylite Human IgG Kappa is used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The Hevylice Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other Isporatory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

Hevylite Human IgG Lambda is a quantiative in viro assey performed on the Siemens BN II nephelometer of IgG Lambda (IgO heavy chain and Lambde light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Lambda is used alongside Hevylite Human IgO Kappa I IgO Lambarratio. The Hevylite Human IgO Kappa / IgG Lambaratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

CENTRE FERRENCE SERVET FOR FDA USE ONLY SEBREAK FOR FDA USE ONLY 1988 WE WAS DECEMBER 200 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

**Maria M. Chan -S**

FORM FDA 3881 (9/13)

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