# K982468: Immulite 2000 Thyroglobulin Model L2KTY

- 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: 3 (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
- Dec 7, 2022 · Class II · Z-0949-2023: Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users
- Dec 7, 2022 · Class II · Z-0950-2023: Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users
- Jan 2, 2018 · Class II · Z-1685-2018: 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 2000 Thyroglobulin is a two-site chemiluminescent immunometric assay for use with the IMMULITE 2000 Analyzer and designed for the quantitative measurement of thyrogiobulin 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/K982468
Methodology: https://510kreport.com/methodology