(363 days)
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No
The summary describes a qualitative antigen detection test using a cassette format, which is a traditional immunoassay technology and does not mention any AI/ML components or image processing.
No
The device is described as a diagnostic test for detecting Trichomonas antigens, not for treating a condition.
Yes
The device is intended for the "qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs," which is a diagnostic purpose to identify the presence of a pathogen.
No
The device is described as a "Cassette Test" and detects antigens from vaginal swabs, indicating it is a physical diagnostic test kit, not software.
Yes, based on the provided information, the Xenotope Diagnostics' Inc. XenoStrip™-Tv Trichomonas Cassette Test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the test is for the "qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs." This involves testing a sample taken from the human body in vitro (outside the body) to provide information about a person's health status (presence of a pathogen).
- Sample Type: The test uses "vaginal swabs," which are biological samples taken from a patient.
- Purpose: The purpose is to aid in the diagnosis of Trichomonas vaginalis infection in patients with symptoms or suspected exposure.
These characteristics are defining features of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
JWZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
vaginal swabs
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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)