Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the JgA Kappa / IgA I levylite I luman IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple mycloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunotixation. bone marrow and urine assessments.

Hevylite Human IgA Lambda is a quantiative in vitro assy performed on the Siemens IN II nepheloment of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in scrum. Mcasurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Lamburratio. The Hevylite Human IgA Kappa / 12A Lambda ratio can be used when monitoring previously diagnosed lgA multiple mycloma 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

This document is a 510(k) clearance letter from the FDA for two in-vitro diagnostic devices: the Hevylite™ Human IgA Kappa Kit and the Hevylite™ Human IgA Lambda Kit, both for use on Siemens BN™ II Systems. The letter states that the devices are substantially equivalent to legally marketed predicate devices.

The "Indications for Use" section on page 3 describes the purpose of these devices:

Hevylite Human IgA Kappa is a quantitative in vitro assay for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum.
Hevylite Human IgA Lambda is a quantitative in vitro assay for the measurement of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum.

Both kits are used to calculate the IgA Kappa/IgA Lambda ratio or IgA Lambda/IgA Kappa ratio, respectively, for monitoring previously diagnosed IgA multiple myeloma, in conjunction with other laboratory tests and clinical evaluations. They are not to be used alone for the assignment of complete response, which requires other tests like immunofixation, bone marrow, and urine assessments.

While the document details the intended use and regulatory clearance, it does not contain the specific acceptance criteria for performance, nor does it describe a study proving the device meets acceptance criteria with the requested details (sample sizes, ground truth establishment, expert qualifications, etc.). This document confirms the device's clearance based on substantial equivalence, but it does not present the underlying performance study data.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them because that information is not provided in the supplied text. The document is an FDA clearance letter, not a detailed study report.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Scrvice

Food and Drug Administration 10903 New Humashite Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18, 2014

THE BINDING SITE GROUP, LTD. Č/O MR. PAUL KĖNNY HEAD OF REGULATORY AFFAIRS 8 CALTHORPE RD, EDGBASTON BIRMINGHAM, WEST MIDLANDS, B15 IQT UNITED KINGDOM

Re: K140105

Trade/Device Name: Hevylite™ Human IgA Kappa Kit for use on Siemens BN™ II Systems and Hevylite™ Human IgA Lambda Kit for use on Siemens BNTM II Systems Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E Immunological Test System Regulatory Class: II Product Code: OPX, OPY Dated: January 13, 2014 Received: January 15, 2014

Dear Mr. Kenny:

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. Iisting 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 Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Paul Kenny

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours.

Maria M. Chan -S

Maria M. Chan, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

Indications for Use

510(k) Number (if known)

Device Name

Hevylite Human IgA Kappa Kit for use on Siemens BNII and Hevylite Human IgA Lambda Kit for use on Sicmens BNII

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (1/14)

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).