# K954575: Axsym Toxo Igg Antibody Assay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 16, 1996 after 319 days
- Product code: LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii)
- Device class: 2
- Regulation: 21 CFR 866.3780
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) bioMerieux VIDAS Toxo IgG assay: named in the summary without a submission number

## Most influential descendants
- K080869: Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QC (2008), 1 descendant of its own
- K242022: Access Toxo IgG (2025), 0 descendants of its own

## Recalls of this device
- Apr 23, 2007 · Not classified · Z-1024-2007: Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instru

## Indications for use
The AxSYM Toxo IgG Antibody assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of IgG antibodies to Toxoplasma gondii in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the determination of immune status. This product is not FDA cleared for use in testing blood or plasma donors.

Source page: https://510kreport.com/device/K954575
Methodology: https://510kreport.com/methodology