DRYSPOT INFECTIOUS MONONUCLEOSIS KIT

K982634 · Oxoid , Ltd. · KTN · Jan 28, 1999 · Immunology

Device Facts

• Record ID: K982634
• Device Name: DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
• Applicant: Oxoid , Ltd.
• Product Code: KTN · Immunology
• Decision Date: Jan 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5640
• Device Class: Class 2

Indications for Use

Acute infectious mononucleoisis is a self-limiting clinical syndrome that most commonly occurs in teenagers and young adults in developed nations. In developing, IM can occur much earlier in life. This assay is intended for use as an aid in the rapid diagnosis of IM. The Dryspot IM Test is a simple two minute latex agglutination test for the detection of the specific heterophile antibody associated with IM in serum and plasma. The purified specific heterophile antigen from bovine red cell membranes is used to coat latex particles. When a drop of serum or plasma containing the heterophile antibody associated with IM is mixed with a drop of latex, visible agglutination of the latex occurs within 2 minutes. Agglutination will not occur when such an antibody is absent. A final diagnosis of IM, however, should only be made when clinical and haematological findings as well as the results from the Dryspot IM Test have been taken into consideration.

Device Story

The Dryspot Infectious Mononucleosis Kit is a rapid, qualitative latex agglutination test. It utilizes latex particles coated with purified specific heterophile antigen derived from bovine red cell membranes. The test is performed by mixing a patient serum or plasma sample with the reagent on a test card. If heterophile antibodies associated with IM are present, visible agglutination occurs within two minutes. The test is intended for use in clinical laboratory settings to assist healthcare providers in diagnosing IM. Results must be interpreted in conjunction with clinical and haematological findings. The device provides a visual, manual diagnostic aid for the detection of IM-associated antibodies.

Clinical Evidence

No clinical data provided in the document; the submission relies on the performance of the latex agglutination assay for the detection of heterophile antibodies.

Technological Characteristics

Latex agglutination assay; utilizes purified specific heterophile antigen from bovine red cell membranes coated onto latex particles; manual test format; qualitative visual readout.

Indications for Use

Indicated for use as an aid in the rapid diagnosis of infectious mononucleosis (IM) in patients suspected of having the syndrome, including teenagers and young adults.

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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Public Health Service

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JAN 28 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Andy Hollingsworth Regulatory Affairs Manager Oxoid Limited Wade Road Basingstoke Hants RG24 8PW ENGLAND

Re: K982634

Trade Name: DRYSPOT® Infectious Mononucleosis Kit Regulatory Class: II Product Code: KTN Dated: December 21, 1998 Received: December 28, 1998

Dear Mr. Hollingsworth:

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, Drug, and Cosmetic Act (Act). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 diagnostic 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 Putman

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) Submission for Oxoid

## Dryspot Infectious Mononucleosis Kit

510(K) Number: K982634

Dryspot Infectious Mononucleosis Kit Device Name:

## Indications for Use:

Acute infectious mononucleoisis is a self-limiting clinical syndrome that most commonly occurs in teenagers and young adults in developed nations. In developing, IM can occur much earlier in life. This assay is intended for use as an aid in the rapid diagnosis of IM.

The Dryspot IM Test is a simple two minute latex agglutination test for the detection of the specific heterophile antibody associated with IM in serum and plasma. The purified specific heterophile antigen from bovine red cell membranes is used to coat latex particles. When a drop of serum or plasma containing the heterophile antibody associated with IM is mixed with a drop of latex, visible agglutination of the latex occurs within 2 minutes. Agglutination will not occur when such an antibody is absent.

A final diagnosis of IM, however, should only be made when clinical and haematological findings as well as the results from the Dryspot IM Test have been taken into consideration.

Tua E. Maler'

(Division Sign-Off)
Division of Clinical Laboratory Devices K087634
510(k) Number

Prescription Use.....!........................................................................................................................................................

Over-the-Counter-Use .........................................................................................................................................................