# K020349: Abbott Axsym Anti-Thyroglobulin, Models 5F5B Comprising Standard/Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: May 2, 2002 after 87 days
- Product code: JZO (System, Test, Thyroid Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- Recalls of this device: none
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The test is for the quantitative measurement of the IgG class of auto-antibodies to anti-Thyroglobulin (anti-Tg) in human serum or plasma (EDTA or heparin) to aid in the diagnosis of thyroid disease

Source page: https://510kreport.com/device/K020349
Methodology: https://510kreport.com/methodology