# K954045: Axsym Rubella Igg Antibody Assay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 24, 1996 after 392 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- 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.
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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K080766: Vidas Rub Igg (2008), 2 descendants of its own
- K243168: Alinity i Rubella IgG (2025), 0 descendants of its own
- K141133: VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II (2015), 0 descendants of its own
- K063143: Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and Calibrators (2006), 0 descendants of its own

## Recalls of this device
- Jun 2, 2008 · Not classified · Z-2175-2008: An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes related to elevated Calibrator A (or Master Calibrator 1) rates too high.
- Apr 23, 2007 · Not classified · Z-1025-2007: 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

Source page: https://510kreport.com/device/K954045
Methodology: https://510kreport.com/methodology