# K983992: Nichols Advantage Thyroglobulin Autoantibodies (Tgab) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Jan 26, 1999 after 78 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Nichols Institute Diagnostics Chemiluminescence Thyroglobulin Autoantibodies assay: named in the summary without a submission number

## Most influential descendants
- K052308: Architect Anti-TG Immunoassay Reagents, Calibrators, Controls and System Assay CD-Rom (2006), 0 descendants of its own

## Indications for use
The Nichols Adventage® Chemiluminescence Thyroglobulin Autoantibodies Immunoassay is designed for use with the Nichols Advantage® Specialty System for the quantitative determination of thyroglobulin autoantibodies (TgAb) in human serum. This assay is intended to aid in the diagnosis and assessment of patients with autoimmune thyroid disease.

Source page: https://510kreport.com/device/K983992
Methodology: https://510kreport.com/methodology