# K982466: Immulite Thyroglobulin Model Lkty

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Mar 12, 1999 after 240 days
- Product code: MSW (System, Test, Thyroglobulin)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972190 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972190: Thyroglobulin Assay System, American Laboratory Products Co., Ltd. (1997) Summary page 1.

## Recalls of this device
- Jan 2, 2018 · Class II · Z-1684-2018: Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur 

## Indications for use
IMMULITE Thyroglobulin is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Analyzer and designed for the quantitative measurement of thyroglobulin in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in monitoring patients who have undergone thyroidectomy.

Source page: https://510kreport.com/device/K982466
Methodology: https://510kreport.com/methodology