# K971835: Anti-Thyroglobulin (TG) Microplate Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Monobind
- Decided: Jul 3, 1997 after 45 days
- Product code: DDC (Thyroglobulin, Antigen, Antiserum, Control)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Biomerica anti-thyroglobulin ELISA: named in the summary without a submission number

## Indications for use
The quantitative determination of thyroglobulin autoantibodies in human serum or plasma by a microplate enzymeimmunoassay. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto, Graves, and nontoxic goiter.

Source page: https://510kreport.com/device/K971835
Methodology: https://510kreport.com/methodology