# K953943: Axsym CMV Igg Antibody Assay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 20, 1996 after 396 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- Recalls of this device: 2 (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) Vidas CMV IgG Assay: named in the summary without a submission number

## Recalls of this device
- Jan 19, 2009 · Not classified · Z-1047-2009: Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
- Apr 23, 2007 · Not classified · Z-1033-200: 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 CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomegalovirus in serum and plasma (EDTA, heparin or sodium citrate) as an indication of past or current infection with cytomegalovirus. This product is not FDA cleared for use in testing blood or plasma donors.

Source page: https://510kreport.com/device/K953943
Methodology: https://510kreport.com/methodology