# K954576: Axsym Toxo Igm

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 23, 1996 after 326 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.
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) bioMerieux VIDAS Toxo-M: named in the summary without a submission number

## Recalls of this device
- Apr 23, 2007 · Not classified · Z-1031-2007: 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 IgM assay is a Microparticle Enzyme Immunoassay (MEIA) for the qualitative measurement of IgM antibodies to Toxoplasma gondii in human serum and plasma (EDTA, heparin, or sodium citrate) to aid in the diagnosis of primary infection. The AXSYM Toxo IgM assay is not for use with cord blood or neonatal specimens. This product is not FDA cleared for use in testing blood or plasma donors.

Source page: https://510kreport.com/device/K954576
Methodology: https://510kreport.com/methodology