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510(k) Data Aggregation
K Number
K992124Device Name
AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI
Manufacturer
AVANTI POLAR LIPIDS, INC.
Date Cleared
1999-09-20
(89 days)
Product Code
GMQ
Regulation Number
866.3820Why did this record match?
Applicant Name (Manufacturer) :
AVANTI POLAR LIPIDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 is for the detection of IgM and IgG anticardiolipin antibodies in serum specimens.
Device Description
The Venereal Disease Research Laboratory slide test is a test for the detection of syphilis. The test employs an antigen containing cardiolipin, phosphatidylcholine (lecithin), and cholesterol dissolved in ethanol. The antigen is suspended in a buffered saline solution, which flocculates when combined with serum containing IgM and IgG anti-cardiolipin antibodies. The IgM and IgG antibodies are produced in response to infection by Treponema pallidum the causitive agent of syphilis. The flocculation forms a three-dimensional lattice structure that can be seen at low magnification (10x oculars and 10x objective) with a light microscope.
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