Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit

K160819 · The Binding Site Group , Ltd. · OPX · Jun 16, 2016 · Immunology

Device Facts

• Record ID: K160819
• Device Name: Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
• Applicant: The Binding Site Group , Ltd.
• Product Code: OPX · Immunology
• Decision Date: Jun 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The Optilite Hevylite IgA Kappa kit is a quantitative in vitro assay intended for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Kappa is used alongside Hevylite IgA Lambda to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients 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. The Optilite Hevylite IgA Lambda kit is a quantitative in vitro assay intended for the measurement of IgA heavy chain and Lambda light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Lambda is used alongside Hevylite IgA Kappa to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients 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

Device consists of ready-to-use polyclonal monospecific sheep anti-human IgA antisera (combined alpha heavy and kappa/lambda light chains) used on the Binding Site Optilite analyzer. Input is patient serum; device performs turbidimetric analysis where specific antiserum reacts with IgA to form insoluble complexes. Light transmission through the suspension is measured by a photodiode; concentration is calculated via an internal calibration curve. Used in clinical laboratories by trained personnel. Output is quantitative IgA Kappa and IgA Lambda levels, used to calculate the IgA Kappa/IgA Lambda ratio. This ratio assists clinicians in monitoring disease status (CR, VGPR, PR, SD, PD) in IgA multiple myeloma patients. Results are used in conjunction with other clinical evaluations (immunofixation, bone marrow, urine assessments).

Clinical Evidence

No prospective clinical trial performed. Clinical validity established via retrospective data modeling. A comparison study of 33 monitoring samples evaluated agreement between Optilite and predicate response categories. Further validation used 449 patient samples from the predicate submission, applying Passing and Bablok regression equations to transform BN II data to Optilite equivalents. Results showed high concordance with the predicate, with linear weighted Kappa values of 0.94–0.96 and unweighted Kappa values of 0.92–0.93, supporting clinical equivalence in monitoring IgA multiple myeloma.

Technological Characteristics

Turbidimetric assay using polyclonal monospecific sheep anti-human IgA antisera. Reagents include sodium azide, EACA, EDTA, and benzamidine preservatives. Measuring range: IgA Kappa 0.18–11.2 g/L; IgA Lambda 0.16–10.4 g/L (standard 1+9 dilution). Traceable to ERM-DA470k. On-board stability: 14 days. Shelf life: 12 months at 2-8°C. Connectivity: Integrated with Binding Site Optilite analyzer.

Indications for Use

Indicated for the quantitative measurement of IgA Kappa and IgA Lambda in serum to calculate the IgA Kappa/IgA Lambda ratio for monitoring patients with previously diagnosed IgA multiple myeloma. For prescription use only.

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

July 26, 2016

The Binding Site Group Ltd. Mr. Jon Lauder Regulatory Affairs Specialist 8 Calthorpe Road Edgbaston Birmingham, West Midlands B15 10T UK

Re: K160819

Trade/Device Name: Optilite Hevylite IgA Kappa Kit, Optilite IgA Lambda Kit Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: Class II Product Code: OPX, OPY Dated: March 23, 2016 Received: March 25, 2016

Dear Mr. Lauder:

This letter corrects our substantially equivalent letter of June 15, 2016.

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

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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); 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 Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerelv.

# Kelly Oliner -S

For

Leonthena Carrington, MBA, MS, MT(ASCP) 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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## Indications for Use

510(k) Number (if known) K160819

Device Name Optilite Hevylite IgA Kappa Kit Optilite Hevylite IgA Lambda Kit

#### Indications for Use (Describe)

The Optilite Hevylite IgA Kappa kit is a quantitative in vitro assay intended for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Kappa is used alongside Hevylite IgA Lambda to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients 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.

The Optilite Hevylite IgA Lambda kit is a quantitative in vitro assay intended for the measurement of IgA heavy chain and Lambda light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Lambda is used alongside Hevylite IgA Kappa to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients 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) |
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| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
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| <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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