# K991720: Kronus Optiquant Thyroglobulin Kit

- Pathway: 510(k) (Traditional)
- Applicant: Unchanged
- Decided: Aug 9, 1999 after 81 days
- Product code: MSW (System, Test, Thyroglobulin)
- Device class: 2
- Regulation: 21 CFR 866.6010
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The KRONUS OPTIQUANT THYROGLOBULIN KIT is intended for the quantitative determination of thyroglobulin (Tg) in human serum as an aid in the detection of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioiodine), and who lack serum thyrogliobulin antibodies.

Source page: https://510kreport.com/device/K991720
Methodology: https://510kreport.com/methodology