XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03

K020226 · Hellen Professional Services · JWZ · Aug 22, 2002 · Microbiology

Device Facts

• Record ID: K020226
• Device Name: XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03
• Applicant: Hellen Professional Services
• Product Code: JWZ · Microbiology
• Decision Date: Aug 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2660
• Device Class: Class 1

Intended Use

The Xenotope Diagnostics Inc. XenoStrip™-Tv Trichomonas Test is Intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs. Early detection and treatment of trichomonas-related diseases (vaginitis, trichomoniasis) is useful in the prevention and reduction of disease and disease symptomology.

Device Story

XenoStrip™-Tv is an in vitro diagnostic test for qualitative detection of Trichomonas vaginalis antigens. Device utilizes vaginal swab samples; employs immunochromatographic assay technology to detect specific antigens. Intended for use in clinical laboratory settings by trained personnel. Provides rapid visual results to assist clinicians in diagnosing trichomoniasis and managing associated vaginitis. Facilitates early treatment to reduce disease symptomology and transmission.

Technological Characteristics

Immunochromatographic assay (lateral flow) for antigen detection. Class I device (21 CFR 866.2660). Product code: JWZ.

Indications for Use

Indicated for qualitative detection of Trichomonas vaginalis antigens in vaginal swab specimens for patients suspected of having trichomoniasis or related vaginitis.

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)

{0}------------------------------------------------

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 stylized eagle with three lines forming its body and head. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circle's perimeter.

Food and Drug Administration i 2098 Gaither Road Rockville MD 20850

Ms. Robin J. Hellen, M.S. President Hellen Professional Services 9418 Lasaine Avenue Northridge, CA 91325

AUG 2 2 2002

k020226 Re:

> Trade/Device Name: Xenotope Diagnostics Inc. XenoStrip™-Tv Trichomonas Test Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism differentiation and identification device Regulatory Class: Class I Product Code: JWZ Dated: July 25, 2002 Received: July 25, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

## Page 2 -

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 1 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" (21CFR 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 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

{2}------------------------------------------------

Xenotope Diagnostics Inc. XenoStrip-Tv™ Test Kit Premarket Notification

PART I - 510(k) Information

## STATEMENT FOR INDICATIONS FOR USE (11).

| 510(k) Number (if known): | K020226 |
|---------------------------|----------------------------------------------------------|
| Device Name: | Xenotope Diagnostics Inc. XenoStrip™-Tv Trichomonas Test |

Indications for Use:

The Xenotope Diagnostics Inc. XenoStrip™-Tv Trichomonas Test
is Intended for the qualitative detection of *Trichomonas vaginalis*
("Trichomonas") antigens from vaginal swabs. Early detection and
treatment of trichomonas-related diseases (vaginitis,
trichomoniasis) is useful in the prevention and reduction of
disease and disease symptomology.

Concurrence of the CDRH, Office of Device Evaluation (ODE)

| Prescription Use: | OR | Over the Counter Use: |
|-------------------|----|-----------------------|
|-------------------|----|-----------------------|

Ramely. Lively for Freddie M. Poole

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K020226 |
|---------------|---------|
|---------------|---------|

Xemina Diagnostics Inc., 3707" Street, San Franciaoo, CA 94100