Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS

K161854 · The Binding Site Group , Ltd. · PCN · Oct 4, 2016 · Immunology

Device Facts

• Record ID: K161854
• Device Name: Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
• Applicant: The Binding Site Group , Ltd.
• Product Code: PCN · Immunology
• Decision Date: Oct 4, 2016
• 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 SPAPLUS® analyzer for the measurement of IgG Kappa (IgG heavy chain and kappa 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 SPAPLUS® analyzer 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

Hevylite Human IgG Kappa and Lambda kits are quantitative in vitro diagnostic assays for serum measurement of intact IgG kappa and IgG lambda immunoglobulins. Performed on the SPAPLUS analyzer, the device calculates the IgG Kappa/IgG Lambda ratio. Used by laboratory professionals in clinical settings to monitor patients with previously diagnosed IgG multiple myeloma. Results are interpreted alongside other clinical evaluations, immunofixation, bone marrow, and urine assessments to assist in determining disease response. The device provides quantitative data to support clinical decision-making regarding patient monitoring.

Clinical Evidence

Clinical validity established via monitoring study of 63 samples from 21 patients and data modeling of 437 samples from the original BN II submission. Agreement between SPAPLUS and predicate response categories evaluated using Cohen's Kappa. Monitoring study showed weighted kappa 0.94 (95% CI 0.87–1.00). Data modeling study showed weighted kappa 0.92 (95% CI 0.89–0.94). Results demonstrate clinical performance consistency with the predicate device.

Technological Characteristics

Turbidimetric immunoassay; reagents include polyclonal monospecific sheep anti-human IgG antisera, calibrators, controls, and reaction buffer. Preservatives: sodium azide, EACA, EDTA, benzamidine. Instrument: The Binding Site SPAPLUS® analyzer. Traceability: ERM-DA470k/IFCC. Shelf life: 12 months at 2–8°C. Open-vial stability: 2 months. On-board stability: 1 month.

Indications for Use

Indicated for monitoring previously diagnosed IgG multiple myeloma in patients. Used in conjunction with other laboratory tests and clinical evaluations for assessing disease status.

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

October 4, 2016

The Binding Site Group, Ltd. Andrea Thomas Regulatory Affairs Officer 8 Calthorpe Road Edgbaston, Birmingham West Midlands, B15 1QT United Kingdom

Re: K161854

Trade/Device Name: Hevylite® Human IgG Kappa Kit for use on the SPAPLUS® Hevylite® Human IgG Lambda Kit for use on the SPAPLUS® 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: June 30, 2016 Received: July 7, 2016

Dear Ms. Thomas:

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 Parts 801 and 809); medical device 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

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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 regulations (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/Resourcesfor You/Industry/default.htm. 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/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.

Sincerely yours,

# 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) K161854

#### Device Name

Hevylite Human IgG Kappa Kit for use on the SPAPLUS (NK621.S) Hevylite Human IgG Lambda Kit for use on the SPAPLUS (NK622.S)

#### Indications for Use (Describe)

Hevylite Human IgG Kappa is a quantitative in vitro assay performed on the SPAPLUS analyser for the measurement of IgG kappa (IgG heavy chain and kappa 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 SPAPLUS analyser for the measurement of IgG lambda (IgG heavy chain and kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human lgG 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.

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

| <div> <span style="font-size:16px">❌</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px">❍</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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