The kit is intended for the quantitation of lambda free light chains in serum and urine on Binding Site SPAPLUS. Measurement of free light chains in serum aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis, light chain deposition dissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. Measurement of free light chains in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis and light chain deposition with other laboratory and clinical findings.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, indicating that the device, Freelite® Human Lambda Free Kit, has been deemed substantially equivalent to a legally marketed predicate device. This type of document typically does not contain detailed studies, acceptance criteria, or performance data as it's a notification of substantial equivalence, not a detailed clinical trial report or a comprehensive technical specification.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided text.

Here's what can be inferred or stated based on the document's content:

A table of acceptance criteria and the reported device performance:
- Not provided. The document states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". It does not include specific performance metrics or acceptance criteria for the Freelite® Human Lambda Free Kit itself. Substantial equivalence is often based on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not necessarily by meeting pre-defined quantitative acceptance criteria in this document.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document does not describe any specific test set data or its provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not provided. No information about ground truth establishment or experts is included.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided. There is no mention of an adjudication method as no test set details are given.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable / Not provided. This device is an "Immunoglobulin (light chain specific) immunological test system" intended for the quantitation of free light chains in serum and urine. It is an in vitro diagnostic (IVD) test, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated, but implicitly "yes" as an IVD. As an in vitro diagnostic kit, the device itself performs the "algorithm" (i.e., the chemical and immunological reactions and detection) to quantify free light chains. Its performance is measured directly, often against a reference method or known concentrations, rather than being part of a human-in-the-loop system in the way AI algorithms are evaluated. However, the document does not provide details of such standalone performance studies.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided. The document does not specify how ground truth was established for any studies that may have been submitted for the 510(k). For an IVD, ground truth would typically involve reference methods, confirmed clinical diagnoses, or established standards for protein quantification.
The sample size for the training set:
- Not applicable / Not provided. This is an in vitro diagnostic kit, not a machine learning or AI algorithm that typically uses a "training set" in the computational sense. If any form of 'training' or calibration was done for the assay, the sample size or details are not mentioned.
How the ground truth for the training set was established:
- Not applicable / Not provided. See explanation for #8.

In summary, the provided FDA 510(k) clearance letter acknowledges the submission and declares substantial equivalence. It is a regulatory document and does not contain the detailed technical and clinical study results that would provide answers to most of your specific questions. These details would typically be found in the manufacturer's 510(k) submission itself, which is not publicly available in its entirety without a Freedom of Information Act (FOIA) request.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Public Health Service

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

April 16, 2014

THE BINDING SITE GROUP, LTD C/O MR. PAUL KENNY HEAD OF REGULATORY AFFAIRS 8 CALTHORPE ROAD BIRMINGHAM, WEST MIDLANDS, B15 1QT UNITED KINGDOM

Re: K140396

Trade/Device Name: Freelite® Human Lambda Free Kit for use on the SPAPLUS Regulation Number: 21 CFR 866.5550 Regulation Name: Immunoglobulin (light chain specific) immunological test system Regulatory Class: II Product Code: DEH Dated: February 14, 2014 Received: February 18, 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, 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 11 (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 (2 l 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.

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Page 2-Mr. Paul Kenny

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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. 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

Indications for Use

510(k) Number (if known) K140396

Device Name

Freelite® Human Lambda Free Kit for use on the SPAPLUS

Indications for Use (Describe)

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

2 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)

Elizabeth A. Stafford -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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Regulation Number and Section

§ 866.5550 Immunoglobulin (light chain specific) immunological test system.

(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).