HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII

K140105 · The Binding Site · OPX · Mar 18, 2014 · Immunology

Device Facts

• Record ID: K140105
• Device Name: HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
• Applicant: The Binding Site
• Product Code: OPX · Immunology
• Decision Date: Mar 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgA kappa (IgA heavy chain and lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the IgA kappa/IgA lambda ratio. The Hevylite Human IgA kappa/IgA lambda ratio can be used when monitoring previously diagnosed IgA 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 IgA Lambda is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgA lambda (IgA heavy chain and lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA kappa/IgA lambda ratio. The Hevylite Human IgA kappa/IgA lambda ratio can be used when monitoring previously diagnosed IgA 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

Hevylite IgA Kappa and Lambda kits are quantitative in vitro nephelometric assays for serum IgA kappa and IgA lambda. The device measures intact immunoglobulin heavy/light chain pairs; calculates IgA kappa/IgA lambda ratio. Used in clinical laboratories on Siemens BN II systems; operated by laboratory technicians. Input: patient serum samples. Principle: polyclonal monospecific sheep anti-IgA antibodies bind junctional epitopes; light scatter measured via nephelometry; scatter intensity proportional to antigen concentration. Output: quantitative IgA concentrations and ratio. Healthcare providers use these results alongside standard clinical assessments (SPEP, immunofixation, bone marrow) to monitor disease progression or treatment response in IgA multiple myeloma patients. Benefits include objective monitoring of monoclonal protein levels to assist in determining clinical response criteria.

Clinical Evidence

Retrospective study of 76 IgA multiple myeloma patients (449 sequential samples). Compared Hevylite IgA kappa/lambda ratio response classification against NCCN v1.2011 guidelines. Sensitivity 89% (95% CI 85-92%), specificity 84% (95% CI 76-90%). Weighted kappa 0.87 (bootstrap). Results demonstrate concordance with standard clinical response criteria.

Technological Characteristics

Quantitative nephelometric assay. Reagents: polyclonal monospecific sheep anti-IgA antisera (anti-IgA kappa or anti-IgA lambda). Preservative: 0.099% sodium azide. Instrument: Siemens BN II. Calibration: single-level calibrator, autodiluted to 5-point curve. Traceability: ERM-DA470k. Sample matrix: serum. Stability: 21 days at 2-8°C.

Indications for Use

Indicated for the quantitative measurement of IgA Kappa and IgA Lambda intact immunoglobulins in serum to calculate the IgA Kappa/Lambda ratio for monitoring patients with previously diagnosed IgA multiple myeloma, in conjunction with other clinical and laboratory evaluations.

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.

Predicate Devices

• Hevylite IgA Kappa and IgA Lambda kit (k082823)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Scrvice

Food and Drug Administration 10903 New Humashite Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18, 2014

THE BINDING SITE GROUP, LTD. Č/O MR. PAUL KĖNNY HEAD OF REGULATORY AFFAIRS 8 CALTHORPE RD, EDGBASTON BIRMINGHAM, WEST MIDLANDS, B15 IQT UNITED KINGDOM

Re: k140105

Trade/Device Name: Hevylite™ Human IgA Kappa Kit for use on Siemens BN™ II Systems and Hevylite™ Human IgA Lambda Kit for use on Siemens BNTM 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: OPX, OPY Dated: January 13, 2014 Received: January 15, 2014

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. Iisting 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 (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 (OS) 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: January 31, 2017 See PRA Statement on last page.

## Indications for Use

### 510(k) Number (if known)

#### Device Name

Hevylite Human IgA Kappa Kit for use on Siemens BNII and Hevylite Human IgA Lambda Kit for use on Sicmens BNII

#### Indications for Use (Describe)

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

Hevylite Human IgA Lambda is a quantiative in vitro assy performed on the Siemens IN II nepheloment of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in scrum. Mcasurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Lamburratio. The Hevylite Human IgA Kappa / 12A Lambda ratio can be used when monitoring previously diagnosed lgA multiple mycloma 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (1/14)