# K112933: Access Thyroglobulin Anitbody

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 27, 2011 after 85 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: 2 generations back to K012208 (2001). 2 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K062516: Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators), Beckman Coulter, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- Sep 5, 2024 · Class II · Z-0265-2025: IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
- Apr 30, 2019 · Class II · Z-2242-2020: The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830

## Indications for use
The Access Thyroglobulin Antibody 11 assay is a paramagnetic chemiluminescent immunoassay for the 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/K112933
Methodology: https://510kreport.com/methodology