# K220972: Access Thyroglobulin

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 15, 2023 after 529 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: 1 generation back to K002905 (2000). 1 ancestor in all.
3 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)
- K002905: Access Thyroglobulin Reagents on the Access Analyzer, Beckman Coulter, Inc. (2000) Summary page 5.

## Most influential descendants
- K241423: Access Thyroglobulin (2024), 1 descendant of its own
- K242981: Atellica IM Thyroglobulin (Tg) (2025), 0 descendants of its own
- K240927: Access Thyroglobulin (2024), 0 descendants of its own

## Indications for use
Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.

Source page: https://510kreport.com/device/K220972
Methodology: https://510kreport.com/methodology