# K981498: IS-Toxoplasma Igg Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Aug 21, 1998 after 116 days
- Product code: LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii)
- Device class: 2
- Regulation: 21 CFR 866.3780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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) Incstar Toxoplasma IgG ELISA Kit: named in the summary without a submission number

## Most influential descendants
- K132234: Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg II (2013), 2 descendants of its own
- K161139: LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (2016), 1 descendant of its own
- K181464: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (2018), 0 descendants of its own
- K052499: Diasorin Liaison Toxo Igg and Liaison Toxo Igm Assays (2006), 0 descendants of its own

## Indications for use
The Diamedix Is-Toxoplasma IgG Test Kit is an Enzyme Immunoassay (EIA) for the qualitative and quantitative determination of IgG antibodies in human serum to aid in the assessment of the patient's immunological response to infection with Toxoplasma gondii and in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of primary or reactivated infection with Toxoplasma gondii. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor. This product is not FDA cleared for use in screening blood and plasma donors.

Source page: https://510kreport.com/device/K981498
Methodology: https://510kreport.com/methodology