(112 days)
Not Found
No
The device description details a color immunochromatographic test using antibodies and capillary flow, which is a traditional biochemical assay and does not involve AI/ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is intended for qualitative detection of Trichomonas antigens, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended for the qualitative detection of Trichomonas vaginalis antigens to aid in the diagnosis of vaginosis/vaginitis or suspected exposure to the pathogen. This directly supports a diagnostic purpose.
No
The device description clearly outlines a physical "dipstick" technology using antibodies coated on a nitrocellulose membrane, which is a hardware component. The test procedure involves placing this physical dipstick into a sample buffer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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 involves testing samples taken from the body but analyzed outside the body.
- Device Description: The description details a laboratory-based test using immunochromatographic technology to detect specific antigens in a sample. This is a typical characteristic of an in vitro diagnostic test.
- Performance Studies: The performance studies describe comparing the device's results to other diagnostic methods (wet mount microscopy and culture) using patient samples. This further confirms its use in a diagnostic context.
Therefore, based on the provided information, the OSOM® Trichomonas Rapid Test fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
JWZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians' offices as well as clinical laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Sensitivity: 85/102 = 83%
Specificity: 331/335 = 99%
Agreement: 416/437 = 95%
Predicate Device(s)
K 020226
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
-
- Sponsor/Applicant Name and Address:
Genzyme Corporation One Kendall Square Cambridge, MA 02139
- Sponsor/Applicant Name and Address:
-
- Sponsor Contact Information:
E.V. Goorchenko Director of Regulatory Affairs Phone: 858/777-2614 FAX: 858/452-3258 Email: Gene.Goorchenko@genzyme.com
- Sponsor Contact Information:
-
- Date of Preparation of 510(k) Summary: December 11, 2003
-
- Device Trade or Proprietary Name:
OSOM Trichomonas Rapid Test
-
Device Common/Usual or Classification Name: ട.
Microorganism differentiation and identification device -
- Legally Marketed Devices to which Equivalence is Being Claimed: Xenotope XenoStrip®-Tv Test (K 020226)
-
- Device Description Intended Use
1
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% |
2
| | OSOM Trichomonas Rapid
Test | Xenotope XenoStrip®-Tv Test |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | 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. | 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. |
| Assay Format | Lateral flow immunoassay | Lateral flow immunoassay |
| Specimen | - vaginal swabs
- saline solution prepared for
wet mount microscopy | - vaginal swabs |
| Antibodies (labeled
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 | ||||
|---|---|---|---|---|
| -- | --------------------------------------------------------- | -- | -- | -- |
3
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).
4
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
5
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