# K062516: Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators)

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 5, 2006 after 38 days
- Product code: JNL (Immunochemical, Thyroglobulin Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012208 (2001). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012208: Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay Systems, Models 33890, 33895, Beckman Coulter, Inc. (2001) Summary page 1.

## Most influential descendants
- K112933: Access Thyroglobulin Anitbody (2011), 3 descendants of its own
- K213517: Access Thyroglobulin Antibody II (2023), 1 descendant of its own
- K250816: ADVIA Centaur Anti-Thyroglobulin II (aTgII) (2025), 0 descendants of its own
- K240996: Access Thyroglobulin Antibody II (2024), 0 descendants of its own

## Recalls of this device
- Jan 26, 2011 · Not classified · Z-1818-2011: The recall was initiated after Beckman Coulter confirmed customer reports of reagent pack to pack variability for the Access Thyroglobulin Antibody II (TgAb) reagent lot numbers identified in the reca
- Jun 29, 2010 · Not classified · Z-2355-2010: The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits.

## Indications for use
The Access Thyroglobulin Antibody II Assay provides in vitro quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.

Source page: https://510kreport.com/device/K062516
Methodology: https://510kreport.com/methodology