# K983553: Anti-TG Igg Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Columbia Bioscience, Inc.
- Decided: Dec 7, 1998 after 59 days
- Product code: JZO (System, Test, Thyroid Autoantibody)
- 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) LIAS TG Kit: named in the summary without a submission number

## Indications for use
The & TG 1gG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection and guantitation of antibodics agains the Thyroglobulin (TG) antigen in serum as an aid in the diagnasis of thyroid autoimmune disease. The test can be performed cither manually or in conjunction with the Mago Plus automated ETA processor.

Source page: https://510kreport.com/device/K983553
Methodology: https://510kreport.com/methodology