Rheumatoid Factor (RF) Kit for use on SPAPLUS

K160070 · The Binding Site Group , Ltd. · DHR · Dec 7, 2016 · Immunology

Device Facts

• Record ID: K160070
• Device Name: Rheumatoid Factor (RF) Kit for use on SPAPLUS
• Applicant: The Binding Site Group , Ltd.
• Product Code: DHR · Immunology
• Decision Date: Dec 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The Rheumatoid Factor (RF) Kit for use on SPAPLUS® is intended for the quantitative in vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS® analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.

Device Story

The Rheumatoid Factor (RF) Kit is an in vitro diagnostic reagent system designed for use on the Binding Site SPAPLUS analyzer. It measures rheumatoid factor levels in human serum samples. The device operates via an automated immunoassay process on the SPAPLUS platform. It is intended for use in clinical laboratory settings by trained laboratory personnel. The quantitative output provides clinicians with data to assist in the diagnosis of rheumatoid arthritis, serving as an adjunct to other clinical and laboratory findings.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing and performance validation of the assay on the SPAPLUS analyzer.

Technological Characteristics

Quantitative immunoturbidimetric assay. Reagents include latex particles adsorbed with human IgG, glycine buffer, and sodium azide. Operates on the SPAPLUS® turbidimetric analyzer using optical lens system and photodiode detection. Measuring range 10–1040 IU/mL. Traceable to WHO NIBSC 64/2. Software performs automated calculation of concentrations based on stored calibration curves.

Indications for Use

Indicated for the quantitative in vitro measurement of rheumatoid factors in human serum to aid in the diagnosis of rheumatoid arthritis. For prescription use only.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

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

December 7, 2016

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

Re: K160070

Trade/Device Name: Rheumatoid Factor (RF) Kit For Use On SPAPLUS® Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: II Product Code: DHR Dated: November 30, 2016 Received: December 5, 2016

Dear Mr. Lauder:

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 (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/ResourcesforYou/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,

## Leonthena R. Carrington -S

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) K160070

Device Name

Rheumatoid Factor (RF) Kit for use on SPAPLUS

Indications for Use (Describe)

The Rheumatoid Factor (RF) Kit for use on SPAPLUS is intended for the quantitative in vitro measurement of theumatoid factors in serum using the Binding Site SPAPLUS analyser. Measurement of theumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.

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

| <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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