# K020348: Abbott Axsym Anti-Thyroid-Peroxidase, MODELS5F57 Comprising Standards/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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052407: Architect Anti-Tpo Immunoassay, Calibrators & Controls (2006), 1 descendant of its own
- K250250: ADVIA Centaur Anti-Thyroid Peroxidase II (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K020348
Methodology: https://510kreport.com/methodology