# K972190: Thyroglobulin Assay System

- Pathway: 510(k) (Traditional)
- Applicant: American Laboratory Products Co., Ltd.
- Decided: Jul 14, 1997 after 56 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K982468: Immulite 2000 Thyroglobulin Model L2KTY (1999), 0 descendants of its own
- K982466: Immulite Thyroglobulin Model Lkty (1999), 0 descendants of its own

## Indications for use
The Thyroglobulin ELISA Assay is intended for the quantitative determination of thyroglobulin (TG) in human serum or plasma in patients who do not have TG antibodies; to aid in confirming the diagnosis of thyroid diseases, such as Graves’ Disease; and to monitor for the absence of thyroglobulin in thyroidectomized patients,

Source page: https://510kreport.com/device/K972190
Methodology: https://510kreport.com/methodology