# K102283: Zeus Scientific, Inc.  Treponema Pallidum Igg Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Feb 10, 2011 after 182 days
- Product code: LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum)
- Device class: 2
- Regulation: 21 CFR 866.3830
- 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) Phoenix Bio-Tech Trep-Chek: named in the summary without a submission number

## Indications for use
The ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T.palidum in human serum. The test may be used in conjunction with non treponemnal testing and clinical findings to provide serological evidence of infection with T.pallidumn. This test isfor in vitro diagnostic use only. This test is not intended for screening blood or plasma donors.

Source page: https://510kreport.com/device/K102283
Methodology: https://510kreport.com/methodology