GENZYME OSOM TRICHOMONAS RAPID TEST

K033864 · Genzyme Corp. · JWZ · Apr 2, 2004 · Microbiology

Device Facts

• Record ID: K033864
• Device Name: GENZYME OSOM TRICHOMONAS RAPID TEST
• Applicant: Genzyme Corp.
• Product Code: JWZ · Microbiology
• Decision Date: Apr 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2660
• Device Class: Class 1

Intended Use

The OSOM® Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis (Trichomonas) antigens from vaginal swabs or from the saline solution prepared when making wet mounts 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

OSOM Trichomonas Rapid Test is a lateral flow immunochromatographic dipstick assay for qualitative detection of Trichomonas vaginalis antigens. Input: vaginal swab or saline solution from wet mount preparation. Principle: solubilized Trichomonas proteins migrate along a nitrocellulose membrane; target antigens bind to blue-colored particle-conjugated primary antibodies; complex captured by secondary antibody on membrane. Output: visual blue test line (positive) and red control line. Used in physician offices and clinical labs by healthcare professionals. Provides rapid point-of-care diagnostic information to assist in clinical management of patients presenting with vaginosis/vaginitis symptoms.

Clinical Evidence

Clinical study of 449 patients comparing OSOM test to wet mount microscopy and InPouch™ culture. Vaginal swab sensitivity 83% (76-91% CI), specificity 99% (98-100% CI). Saline wet mount sample sensitivity 75% (67-84% CI), specificity 99% (97-100% CI). Agreement with composite reference standard was 95%.

Technological Characteristics

Lateral-flow immunochromatographic dipstick. Materials: membrane, mouse monoclonal antibodies, blue latex conjugate particles. Qualitative visual readout. Standalone point-of-care device. No external energy source or software required.

Indications for Use

Indicated for qualitative detection of Trichomonas vaginalis antigens in patients with symptoms of vaginosis/vaginitis or suspected exposure to the pathogen. Suitable for use in physicians' offices and clinical laboratories.

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.

Predicate Devices

• Xenotope XenoStrip®-Tv Test (K020226)

Reference Devices

• InPouch™ TV culture

Submission Summary (Full Text)

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K03864

## 510(k) SUMMARY

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for the OSOM® Trichomonas Rapid Test.

- 1. Sponsor/Applicant Name and Address:
Genzyme Corporation One Kendall Square Cambridge, MA 02139

- 2. Sponsor Contact Information:
E.V. Goorchenko Director of Regulatory Affairs Phone: [phone] FAX: [phone] Email: [e-mail]

- 3. Date of Preparation of 510(k) Summary: December 11, 2003
- 4. Device Trade or Proprietary Name:

OSOM Trichomonas Rapid Test

- Device Common/Usual or Classification Name: ട.
Microorganism differentiation and identification device

- 6. Legally Marketed Devices to which Equivalence is Being Claimed: Xenotope XenoStrip®-Tv Test (K 020226)
- 7. Device Description Intended Use

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The OSOM Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaqinal swabs or from the saline solution prepared when making wet mounts from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen. This device is for use in physicians' offices as well as clinical laboratories.

### Principle of The Device

The OSOM Trichomonas Rapid Test uses color immunochromatographic, capillary flow, "dipstick" technology with antibodies coated on a nitrocellulose membrane. The test procedure requires the solubilization of Trichomonas proteins from a vaginal swab by placing it in a Sample Buffer. The OSOM Trichomonas Rapid Test is then placed in the Sample Buffer, and the mixture migrates along the membrane surface. If Trichomonas is present in the sample, it will form a complex with the primary anti-Trichomonas antibody conjugated to colored particles (blue). The complex will then be bound by the second anti-Trichomonas capture antibody. The appearance of a visible blue test line together with the red control line indicates a positive result.

### 8. Comparison of Technological Characteristics of Genzyme OSOM Trichomonas Rapid Test with Legally Marketed Device:

The similarities with, and differences between, the OSOM test and the Xenotope XenoStrip®-Tv device are described in Table 1.

#### 9. Agreement with Wet Mount Microscopy and In-Pouch Trichomonas Culture Device:

The performance of the OSOM Trichomonas Rapid Test was analyzed using a composite reference standard (CRS) calculation (Alonzo, T. & Pepe M., Statistics in Medicine, 18: 2987-3003, 1999), which includes the results from wet mount microscopy and culture (InPouch TV™ , BioMed Diagnostics Inc., San Jose, CA). In this analysis any sample with a positive result from either wet mount or culture was defined as positive. Accordingly, samples that were negative in both wet mount and culture tests were defined as negative. The results of the comparison of the OSOM Trichomonas Rapid Test using a standard vaginal swab sample to the CRS were:

| Sensitivity: 85/102 | = 83% |
|----------------------|-------|
| Specificity: 331/335 | = 99% |
| Agreement: 416/437 | = 95% |

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| | OSOM Trichomonas Rapid<br>Test | Xenotope XenoStrip®-Tv Test |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Intended for the qualitative<br>detection of <i>Trichomonas<br/>vaginalis</i> ("Trichomonas")<br>antigens from vaginal swabs<br>or from the saline solution<br>prepared when making wet<br>mounts from vaginal swabs.<br>This test is intended for use in<br>patients with symptoms of<br>vaginosis/vaginitis or<br>suspected exposure to the<br><i>Trichomonas</i> pathogen. | Intended for the qualitative<br>detection of <i>Trichomonas<br/>vaginalis</i> ("Trichomonas")<br>antigens from vaginal swabs.<br>This test is intended for use in<br>patients with symptoms of<br>vaginosis/vaginitis or suspected<br>exposure to the <i>Trichomonas</i><br>pathogen. |
| Assay Format | Lateral flow immunoassay | Lateral flow immunoassay |
| Specimen | - vaginal swabs<br>- saline solution prepared for<br>wet mount microscopy | - vaginal swabs |
| Antibodies (labeled<br>and capture) | Mouse monoclonal antibodies | Mouse monoclonal antibodies |
| Conjugate | Latex | Colloidal gold |
| Objective Test Line | Blue line | Red line |
| Internal Control | Yes - red line | Yes - red line |

| | Table 1. Summary of Device Similarities and Differences | | | |
|--|---------------------------------------------------------|--|--|--|
|--|---------------------------------------------------------|--|--|--|

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR - 2 2004

Mr. E. V. Goorchenko Director of Regulatory Affairs Genzyme General Diagnostics 6659 Top Gun Street San Diego, CA 92121

Re: k033864

Trade/Device Name: OSOM® Trichomonas Rapid Test Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism Differentiation and Identification Device Regulatory Class: Class I Product Code: JWZ Dated: March 16, 2004 Received: March 17, 2004

Dear Mr. Goorchenko:

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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## Page 2

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). You may obtain other general information on your responsibilities under the Act 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,

Salazar

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):__K033864

Device Name: __ OSOM® Trichomonas Rapid Test

Indications For Use: The OSOM® Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs and from the saline solution prepared when making wet mounts from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen. This device is intended for use in physicians' offices as well as clinical laboratories.

Prescription Use X (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)

Ludolic. Loob

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K033864