# K993633: Synthetic VDRL Antigen

- Pathway: 510(k) (Traditional)
- Applicant: Centers for Disease Control and Prevention
- Decided: Feb 23, 2000 after 119 days
- Product code: GMQ (Antigens, Nontreponemal, All)
- Device class: 2
- Regulation: 21 CFR 866.3820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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.

Source page: https://510kreport.com/device/K993633
Methodology: https://510kreport.com/methodology