# K993319: Vidas Toxo Igg II (TXG) Assay Model 30 210

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: May 22, 2000 after 231 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; 3 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) Abbott IMx Toxo IgG 2.0 Antibody Assay: named in the summary without a submission number

## Most influential descendants
- K080008: Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control Set (2009), 1 descendant of its own
- K210596: ARCHITECT Toxo IgG (2022), 0 descendants of its own
- K120572: Bioplex 2200 Torc Igg (2012), 0 descendants of its own
- K073501: Roche Elecsys Toxo Igg Test System, Roche Elecsys Precicontrol Toxo Igg (2008), 0 descendants of its own

## Indications for use
The VIDAS® TOXO IgG II (TXG) assay is intended for use with a VIDAS® (Vitek ImmunoDiagnostic Assay System) instrument as a quantitative automated enzyme-linked fluorescent immunoassay (ELFA) for the measurement of Toxoplasma gondii-specific IgG in human serum or plasma (EDTA, heparin). It is intended for use as an aid in determination of immune status. It is not intended for use in testing (screening) blood or plasma donors.

Source page: https://510kreport.com/device/K993319
Methodology: https://510kreport.com/methodology