(119 days)
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No
The summary describes a synthetic antigen for a laboratory test, with no mention of AI or ML technologies.
No.
The device is described as an antigen intended for laboratory tests to detect antibodies related to syphilis, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that the device is for "detection of IgM and IgG nontreponemal antibodies in the serum or cerebrospinal fluid of persons with syphilis," which is a diagnostic purpose.
No
The device description explicitly states "Synthetic VDRL Antigen," which is a chemical reagent, not software. The summary provides no information suggesting a software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "detection of IgM and IgG nontreponemal antibodies in the serum or cerebrospinal fluid". This involves testing biological samples (serum and CSF) in vitro (outside the body).
- Device Description: The device is described as "Synthetic VDRL Antigen", which is a reagent used in a laboratory test.
- VDRL Slide Tests: The intended use specifies its use in "VDRL slide tests", which are standard laboratory procedures for diagnosing syphilis.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
Synthetic Venereal Disease Research Laboratory (VDRL) antigen is intended for use in the qualitative and quantitative VDRL slide tests for the detection of IgM and IgG nontreponemal antibodies in the serum or cerebrospinal fluid of persons with syphilis.
Product codes
GMQ
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
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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
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Key Metrics
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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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§ 866.3820
Treponema pallidum nontreponemal test reagents.(a)
Identification. Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
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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 human figure with three wavy lines representing the body and head. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the figure. The logo is simple and uses a black and white color scheme.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 3 2000
Victoria Pope, Ph.I). Chief, Syphilis Diagnostic Activity Centers for Disease Control 1600 Clifton Road, N.E. Atlanta, Georgia 30333
Re: K993633 Trade Name: Synthetic VDRL Antigen Regulatory Class: II Product Code: GMQ Dated: January 14, 2000 Received: January 24, 2000
Dear Dr. Pope:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Mcdical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Tave For regulations.
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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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. 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 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,
Steven Sutman
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
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Public Health Service
Centers for Disease Control and Prevention (CDC) Allanta (GA 30333
Indication for Use.
510(k) Number: K993633 Device Name: Synthetic VDRL Antigen
Synthetic Venereal Disease Research Laboratory (VDRL) antigen is intended for use in the qualitative and quantitative VDRL slide tests for the detection of IgM and IgG nontreponemal antibodies in the serum or cerebrospinal fluid of persons with syphilis.
Woody Dubois
(Division Sign-Off) Division of Chical Laboratory Devices 510(k) Number 199363
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)