The Optilite IgG3 kit

K142735 · The Binding Site Group , Ltd. · CFN · Dec 21, 2014 · Immunology

Device Facts

• Record ID: K142735
• Device Name: The Optilite IgG3 kit
• Applicant: The Binding Site Group , Ltd.
• Product Code: CFN · Immunology
• Decision Date: Dec 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Optilite IgG3 kit is intended for the quantitative in vitro measurement of human IgG3 in serum, using the Binding Site Optilite analyser. Measurement of this immunoglobulin is an aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result should be used in conjunction with other laboratory and clinical findings.

Device Story

The Optilite IgG3 Kit is an in vitro diagnostic assay designed for use on the Binding Site Optilite analyzer. It measures IgG3 concentrations in human serum samples. The device utilizes immunoturbidimetric technology to quantify IgG3 levels. It is intended for use in clinical laboratory settings by trained laboratory personnel. Results are provided to clinicians to assist in diagnosing conditions related to abnormal protein metabolism and immune system function. The output is a quantitative value used alongside other clinical and laboratory findings to inform patient management and diagnostic decisions.

Clinical Evidence

No clinical trials were performed. Substantial equivalence is supported by analytical bench testing, including precision (total CV 5.8-12.1%), linearity (r=1.000), and method comparison against the predicate using 293 clinical serum samples (Passing-Bablok regression y = 1.04x - 6.04, r = 0.991).

Technological Characteristics

Turbidimetric immunoassay; polyclonal monospecific sheep anti-human IgG3 (F(ab)2) fragment bound to 200 nm polystyrene latex particles. Reagents include preservatives (ProClin, sodium azide, EACA, benzamidine). Operates on Optilite analyzer; automated calculation of concentration via stored calibration curve. Traceable to ERM-DA470k reference material.

Indications for Use

Indicated for quantitative measurement of human IgG3 in serum to aid in diagnosis of abnormal protein metabolism and immune deficiency in pediatric and adult populations. Contraindicated for samples containing rheumatoid factor, paraproteins, high levels of circulating immune complexes, or samples that are highly lipemic or hemolyzed.

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

• The Binding Site Human IgG3 Kit (K050656)

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 21, 2014

THE BINDING SITE GROUP LTD. C/O MS. ANDREA THOMAS, REGULATORY AFFAIRS OFFICER 8 CALTHORPE ROAD, EDGBASTON, BIRMINGHAM, WEST MIDLANDS, B15 1QT UNITED KINGDOM

Re: K142735

Trade/Device Name: Optilite® IgG3 Kit Regulation Number: 21 CFR §866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Systems Regulatory Class: Class II Product Code: CFN Dated: September 15, 2014 Received: September 23, 2014

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

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CFR Part 807); labeling (21 CFR Part 801); 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 Part 801), 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" (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.

Sincerely vours.

# Elizabeth A. Stafford -S

for Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health (OIR) Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) k142735

Device Name Optilite® IgG3 Kit

Indications for Use (Describe)

The Optilite IgG3 Kit is intended for the quantitative in vitro measurement of IgG3 in serum using the Binding Site Optilite analyser. Measurement of this immunoglobulin is an aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result should be used in conjunction with other laboratory and clinical findings.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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