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 Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for an in vitro diagnostic device, the Optilite Hevylite IgA Kappa Kit and Optilite Hevylite IgA Lambda Kit. It describes the intended use and regulatory classification, but it does not contain information about:

Acceptance criteria and reported device performance (in the context of a study demonstrating it meets the criteria)
Sample sizes for test sets, data provenance, training sets, or how ground truth was established for training sets
Number/qualifications of experts or adjudication methods for ground truth
MRMC comparative effectiveness studies or standalone algorithm performance

Therefore, I cannot populate the requested table or answer most of the questions based on the provided text.

The document states the Indications for Use of the device, which are:

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.
The Optilite Hevylite IgA Lambda kit is a quantitative in vitro assay intended for the measurement of IgA Lambda (IgA heavy chain and Lambda 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 Kappa/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.

This indicates the device's role in monitoring IgA multiple myeloma patients, but it does not specify performance metrics or the studies used to validate these claims.

Summary of unavailable information from the given text:

Question Item	Information Not Available in Document
1. Acceptance Criteria and Reported Performance Table	No acceptance criteria or performance data are presented in this FDA clearance letter.
2. Test Set Sample Size and Data Provenance	Not mentioned.
3. Number and Qualifications of Experts for Test Set Ground Truth	Not mentioned.
4. Adjudication Method for Test Set	Not mentioned.
5. MRMC Comparative Effectiveness Study	No mention of an MRMC study or effect size for human reader improvement with/without AI assistance (device is an IVD kit).
6. Standalone Algorithm Performance Study	Not mentioned (device is an IVD kit, not an AI algorithm in the traditional sense).
7. Type of Ground Truth Used (for any studies)	Not mentioned.
8. Training Set Sample Size	Not mentioned.
9. How Ground Truth for Training Set Established	Not mentioned.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a cascading manner, with the first profile being the largest and the subsequent ones decreasing in size. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the design.

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

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