THE HELENA V8 IMMUNODISPLACEMENT KIT by HELENA LABORATORIES UK LTD

The Helena V8 Immunodisplacement Kit is designed for the detection and the characterization of monoclonal proteins (immunoglobulin's IgG, IgA, IgM, kappa (bound) and lambda (bound) light chains), in human serum with the Helena V8 Capillary Electrophoresis System. It is used in conjunction with the Helena V8 Serum Protein SPE Kit designed for serum protein separation into 6 major fractions in alkaline buffer. The electrophoretograms of separated proteins mixed with individual specific antisera are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins. The test results are to be used in conjunction with clinical findings and other laboratory tests.

For In Vitro Diagnostic Use Only.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the "V8 Immunodisplacement Kit" and does not contain the detailed study information required to fully answer the request. This document primarily focuses on the regulatory aspects of the device's clearance based on substantial equivalence to a predicate device.

Therefore, I cannot provide all the requested information. However, I can extract what is available and note what is missing.

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided document. The document states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not detail specific acceptance criteria or performance metrics from a study.

2. Sample size used for the test set and the data provenance

This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided document.

4. Adjudication method for the test set

This information is not available in the provided document.

5. 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

This information is not available in the provided document. The device described (V8 Immunodisplacement Kit) is for in vitro diagnostic use involving capillary electrophoresis and visual evaluation of electrophoretograms. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting imaging or similar data.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not available in the provided document. As mentioned, this device appears to be an in vitro diagnostic kit with visual evaluation by a human.

7. The type of ground truth used

This information is not available in the provided document. For this type of device (detection and characterization of monoclonal proteins), ground truth would likely involve established laboratory methods or clinical diagnoses.

8. The sample size for the training set

This information is not available in the provided document. As this is not an AI/machine learning device, the concept of a "training set" in that context may not apply.

9. How the ground truth for the training set was established

This information is not available in the provided document.

Summary of available information from the document:

Device Name: V8 Immunodisplacement Kit
Intended Use: Detection and characterization of monoclonal proteins (IgG, IgA, IgM, kappa (bound), and lambda (bound) light chains) in human serum with the Helena V8 Capillary Electrophoresis System. It is used in conjunction with the Helena V8 Serum Protein SPE Kit.
Evaluation Method: Electrophoretograms of separated proteins mixed with individual specific antisera are evaluated visually to detect the presence of specific reactions with suspect monoclonal proteins.
Context of Use: Test results are to be used in conjunction with clinical findings and other laboratory tests.
Regulatory Status: 510(k) clearance based on substantial equivalence to legally marketed predicate devices.
Classification: Class II, Product Codes: CFF (Immunoglobulins A, G, M, D, and E immunological test systems).
Prescription Use: Yes.

To obtain the detailed study information regarding acceptance criteria, sample sizes, ground truth establishment, and performance, one would typically need to review the 510(k) submission summary or additional technical documentation provided by Helena Biosciences Europe to the FDA, which is not part of this clearance letter.

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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines or strokes.

10903 New Hampshire Avenue Silver Spring, MD 20993

Helena Biosciences Europe c/o Mr. Mick Henderson Regulatory Affairs Officer Queensway South, Team Valley Trading Estate Gateshead, Tyne and Wear, NE 11 OSD United Kingdom

JUN 2 6 2012

Re: K111369

Trade/Device Name: V8 Immunodisplacement Kit Regulation Number: 21 CFR §866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test systems Regulatory Class: II Product Codes: CFF Dated: June 11, 2012 Received: June 18, 2012

Dear Mr. Henderson:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or cary I vith 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 Cr r ar over, its on a deerse events) (21 CFR 803); and good manufacturing practice

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Page 2 - Mr. Mick Henderson

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as be form arketing your device as described in your Section 510(k) premarket whit anow you to begin mading of substantial equivalence of your device to a legally marketed nontreation. The Drice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Tou may other other gefacturers, 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/cdrh/industry/support/index.html.

Sincerely yours,

Reena Philip

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Maria M. Chan. Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

K111369 510(k) Number (if known):

Device Name: V8 Immunodisplacement Kit

Indications For Use:

For In Vitro Diagnostic Use Only.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

111369 EIOK

Page 1 of

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).