XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01

K020595 · Xenotope Diagnostics, Inc. · JWZ · Feb 20, 2003 · Microbiology

Device Facts

• Record ID: K020595
• Device Name: XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
• Applicant: Xenotope Diagnostics, Inc.
• Product Code: JWZ · Microbiology
• Decision Date: Feb 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2660
• Device Class: Class 1

Intended Use

The Xenotope Diagnostics' Inc. XenoStrip™-Tv Trichomonas Cassette Test is intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen.

Device Story

XenoStrip-TV is a lateral flow immunoassay cassette test for qualitative detection of Trichomonas vaginalis antigens. Input: vaginal swab specimen. Principle: immunochromatographic assay; antigen-antibody binding produces visible line on test strip. Output: visual qualitative result (positive/negative). Used in clinical laboratory settings by trained personnel. Assists clinicians in diagnosing Trichomonas vaginalis infection in symptomatic patients or those with suspected exposure.

Technological Characteristics

Lateral flow immunoassay cassette; qualitative visual readout; manual test procedure.

Indications for Use

Indicated for qualitative detection of Trichomonas vaginalis antigens in vaginal swabs from patients exhibiting symptoms of vaginosis/vaginitis or suspected exposure to the pathogen.

Regulatory Classification

Identification

A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850 ----

Xenotope Diagnostics, Inc. c/o Robin J. Hellen, M.S. President Hellen Professional Services 9418 Lasaine Avenue Northridge, CA 91325

FEB 2 0 2003

Re: k020595

Trade/Device Name: XenoStrip-TVTM Trichomonas Cassette Test Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism Differentiation and Identification Device Regulatory Class: Class I Product Code: JWZ Dated: January 7, 2003 Received: January 7, 2003

Dear Ms. Hellen:

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 either class II (Special Controls) or class III (PMA), 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 020595

Device Name: XenoStrip™-TV Trichomonas Cassette Test

Indications For Use:

The Xenotope Diagnostics' Inc. XenoStrip™-Tv Trichomonas Cassette Test is intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lueddin Lu, Poole

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K02 0595

For Prescription Use ✓

(Optional Format 3-10-98)