# K242981: Atellica IM Thyroglobulin (Tg)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jun 20, 2025 after 267 days
- Product code: MSW (System, Test, Thyroglobulin)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002905 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241423: Access Thyroglobulin, Beckman Coulter, Inc. (2024) Summary page 6.

## Indications for use
The Atellica IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica IM Analyzer. Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.

Source page: https://510kreport.com/device/K242981
Methodology: https://510kreport.com/methodology