# K992124: Avanti Polar Lipids VDRL Antigen Slide Test Kit with 10 X 0.5 ML Ampules, Avanti Polar Lipids Bulk BDRL Antigen, Avanti

- Pathway: 510(k) (Traditional)
- Applicant: Avanti Polar Lipids, Inc.
- Decided: Sep 20, 1999 after 89 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. The FDA summary names its predicate without a number.
- (no number) VDRL Antigen For Syphilis Serology. Becton Dickinson Microbiology Systems, Becton Dickinson and Company: named in the summary without a submission number
- (no number) Cenogenics ADRL/STS Test. Cenogenics Corporation: named in the summary without a submission number
- (no number) VDRL Antigen. Lee Laboratories, Inc.: named in the summary without a submission number
- (no number) VDRL Antigen. Centers for Disease Control and Prevention: named in the summary without a submission number

## Indications for use
Avanti's VDRL antigen and Buffered Saline are intended for use in the Venereal Disease Research Laboratory (VDRL) slide test for syphilis. The VDRL slide test is a non-treponemal, micro-flocculation test, that provides both qualitative and semi-quantitative results. The test detects the presence of IgM and IgG anticardiolipin antibodies in serum. The IgM and IgG antibodies are produced in response to infection by Treponema pallidum the causitive agent of syphilis.

Source page: https://510kreport.com/device/K992124
Methodology: https://510kreport.com/methodology