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.

Device Description

Not Found

AI/ML Overview

I'm sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them in the format requested. The document is a 510(k) clearance letter from the FDA for a device called "Optilite® IgG3 Kit," outlining its approval and general regulatory compliance. It does not include performance data, study design, sample sizes, expert qualifications, or ground truth establishment.

Specifically, the document contains:

Device Name: Optilite® IgG3 Kit
Intended Use: Quantitative in vitro measurement of IgG3 in serum using the Binding Site Optilite analyser. Aid in the diagnosis of abnormal protein metabolism and resistance to infectious agents.
Regulatory Information: 510(k) number, regulation number, product code, regulatory class.
FDA Clearance Statement: Confirmation of substantial equivalence to a predicate device.
General Controls Information: Reminders about registration, listing, GMP, labeling, etc.

It does not include:

A table of acceptance criteria and reported device performance.
Sample sizes for test or training sets.
Data provenance.
Number of experts or their qualifications for ground truth.
Adjudication methods.
Information on MRMC comparative effectiveness studies.
Information on standalone algorithm performance.
Details on the type of ground truth used or how it was established.

Therefore, I cannot fulfill your request based on the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the department's focus on people and health.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)

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Regulation Number and Section

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).