# K050590: Enzy-Well Syphilis Igg, Model 91106

- Pathway: 510(k) (Traditional)
- Applicant: Diesse Diagnostica Senese S.P.A.
- Decided: Aug 10, 2006 after 520 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) Trinity Biotech CAPTIA Syphilis-G Elisa Test Kit: named in the summary without a submission number

## Indications for use
1. For in vitro diagnostic use only. 2. ENZY-WELL SYPHILIS IgG is an immunoenzymatic method for the qualitative detection of IgG antibodies to Treponema pallidum in human serum by a manual technique. 3. The test may be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum.

Source page: https://510kreport.com/device/K050590
Methodology: https://510kreport.com/methodology