CLEARVIEW IM

K981946 · Unipath , Ltd. · KTN · Dec 10, 1998 · Immunology

Device Facts

• Record ID: K981946
• Device Name: CLEARVIEW IM
• Applicant: Unipath , Ltd.
• Product Code: KTN · Immunology
• Decision Date: Dec 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5640
• Device Class: Class 2

Indications for Use

Clearview IM is an immunoassay for the qualitative detection of Infectious Mononucleosis lgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis.

Device Story

Clearview IM is an immunoassay for qualitative detection of Infectious Mononucleosis IgM heterophile antibodies. Device utilizes human serum or plasma specimens as input. Principle of operation involves immunochemical detection of heterophile antibodies associated with infectious mononucleosis. Intended for use as an aid in clinical diagnosis. Operated by laboratory professionals in clinical settings. Output provides qualitative result to assist healthcare providers in confirming infectious mononucleosis diagnosis, facilitating appropriate patient management.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) regulatory review process.

Technological Characteristics

In vitro diagnostic immunoassay for qualitative detection of IgM heterophile antibodies. Form factor is a test device for serum or plasma specimens. No specific materials, software, or connectivity described.

Indications for Use

Indicated for the qualitative detection of Infectious Mononucleosis IgM heterophile antibodies in human serum or plasma specimens to aid in the diagnosis of infectious mononucleosis.

Regulatory Classification

Identification

An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.

Submission Summary (Full Text)

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## DEC 1 0 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Louise Roberts Requlatory Affairs Manager Unipath Limited Bedford, MK44 3UP UNITED KINGDOM

Re: K981946 Clearview™ IM Trade Name: Requlatory Class: II Product Code: KTN Dated: June 1, 1998 Received: June 3, 1998

Dear Ms. Roberts:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral controls provisions of the Act include requirements for annual reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K981946

Clearview re IM Device Name:

Indications For Use:

Clearview IM is an immunoassay for the qualitative detection of Infectious Mononucleosis lgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis.

Tita E. Mafere
Division Sign-Off

Division of Clinical 510(k) Numb

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Countor Use_

(Optional Format 1-2-96)

O