(119 days)
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.
Synthetic VDRL Antigen
I am sorry, but the provided text is a letter from the FDA to Dr. Victoria Pope regarding the 510(k) clearance of the "Synthetic VDRL Antigen" device. It confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory obligations.
The document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
§ 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).