THE HELENA V8 IMMUNODISPLACEMENT KIT

K111369 · Helena Laboratories Uk, Ltd. · CFF · Jun 26, 2012 · Immunology

Device Facts

• Record ID: K111369
• Device Name: THE HELENA V8 IMMUNODISPLACEMENT KIT
• Applicant: Helena Laboratories Uk, Ltd.
• Product Code: CFF · Immunology
• Decision Date: Jun 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

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.

Device Story

The V8 Immunodisplacement Kit is an in vitro diagnostic reagent system used with the Helena V8 Capillary Electrophoresis System. It detects and characterizes monoclonal proteins in human serum. The process involves mixing serum samples with specific antisera (IgG, IgA, IgM, kappa, lambda) following initial serum protein separation into six fractions via the V8 Serum Protein SPE Kit in an alkaline buffer. The resulting electrophoretograms are evaluated visually by laboratory personnel to identify specific antigen-antibody reactions indicative of monoclonal proteins. The output provides qualitative information regarding the presence and type of monoclonal proteins, which clinicians use alongside other diagnostic data to assess patients for monoclonal gammopathies.

Clinical Evidence

No clinical data provided; substantial equivalence is based on performance characteristics and technological similarities to existing immunological test systems.

Technological Characteristics

Immunological test system for capillary electrophoresis. Utilizes specific antisera (IgG, IgA, IgM, kappa, lambda) for immunodisplacement. Designed for use with the Helena V8 Capillary Electrophoresis System. Operates via electrophoretic separation of serum proteins in alkaline buffer followed by visual evaluation of reaction patterns.

Indications for Use

Indicated for the detection and characterization of monoclonal proteins (IgG, IgA, IgM, kappa/lambda light chains) in human serum. For prescription use in clinical laboratory settings.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 [phone]. 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 [phone] or [phone] 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:

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)

(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

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