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.

Device Description

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.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details for the OSOM® Trichomonas Rapid Test:

Acceptance Criteria and Device Performance for OSOM® Trichomonas Rapid Test

The provided document describes the performance of the OSOM® Trichomonas Rapid Test against a composite reference standard (CRS) that includes wet mount microscopy and culture. The acceptance criteria themselves are not explicitly stated as distinct numerical targets required for approval, but rather the observed performance metrics are presented. For the purpose of this response, I will interpret the reported agreement, sensitivity, and specificity as the metrics against which the device's performance was judged.

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Sensitivity	Sufficiently high for diagnosis	83% (85/102)
Specificity	Sufficiently high for diagnosis	99% (331/335)
Agreement	Sufficiently high for diagnosis	95% (416/437)

Note: The document does not specify explicit numerical "acceptance criteria" that were pre-defined. The "acceptance criteria (implied)" column reflects the general expectation for diagnostic assays to demonstrate high sensitivity and specificity for their intended use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): 437 samples (102 positive, 335 negative based on composite reference standard).
Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified. The ground truth was established using an objective composite reference standard (wet mount microscopy and culture), not solely based on expert interpretation. While these diagnostic methods are performed by trained personnel, the document doesn't detail the number of individuals involved or their specific qualifications for this study.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: A composite reference standard (CRS) was used. This means that a sample was classified as positive if it tested positive by either wet mount microscopy or culture. Conversely, a sample was classified as negative only if it tested negative by both wet mount microscopy and culture. This method effectively adjudicates discrepancies by prioritizing positive findings from either established method as indicative of true positivity.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. The study described is a standalone performance evaluation of the OSOM® Trichomonas Rapid Test against a reference standard. There is no mention of human readers or comparing their performance with and without AI assistance.

6. Standalone Performance Study

Standalone Performance Study Done: Yes. The reported performance metrics (sensitivity, specificity, and agreement) are for the OSOM® Trichomonas Rapid Test itself, without human-in-the-loop interaction for interpretation beyond the initial sample preparation and visual reading of the test line.

7. Type of Ground Truth Used

Type of Ground Truth: Composite Reference Standard (CRS). This standard combined the results of:
- Wet mount microscopy
- InPouch TV™ culture (BioMed Diagnostics Inc.)
  A sample was considered positive if either wet mount or culture was positive, and negative if both were negative.

8. Sample Size for the Training Set

Sample Size (Training Set): Not applicable. This device is a rapid immunochromatographic test, not an AI/machine learning algorithm requiring a separate training set. Its performance is based on its inherent biochemical and immunological properties.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary

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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
1. Sponsor Contact Information:
  E.V. Goorchenko Director of Regulatory Affairs Phone: 858/777-2614 FAX: 858/452-3258 Email: Gene.Goorchenko@genzyme.com
1. Date of Preparation of 510(k) Summary: December 11, 2003
1. Device Trade or Proprietary Name:

OSOM Trichomonas Rapid Test

Device Common/Usual or Classification Name: ട.
Microorganism differentiation and identification device
1. Legally Marketed Devices to which Equivalence is Being Claimed: Xenotope XenoStrip®-Tv Test (K 020226)
1. 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

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 RapidTest	Xenotope XenoStrip®-Tv Test
Intended use	Intended for the qualitativedetection of Trichomonasvaginalis ("Trichomonas")antigens from vaginal swabsor from the saline solutionprepared when making wetmounts from vaginal swabs.This test is intended for use inpatients with symptoms ofvaginosis/vaginitis orsuspected exposure to theTrichomonas pathogen.	Intended for the qualitativedetection of Trichomonasvaginalis ("Trichomonas")antigens from vaginal swabs.This test is intended for use inpatients with symptoms ofvaginosis/vaginitis or suspectedexposure to the Trichomonaspathogen.
Assay Format	Lateral flow immunoassay	Lateral flow immunoassay
Specimen	- vaginal swabs- saline solution prepared forwet mount microscopy	- vaginal swabs
Antibodies (labeledand 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) K033864

Regulation Number and Section

§ 866.2660 Microorganism differentiation and identification device.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.