# K994140: Nichols Chemiluminescence Thyroglobulin, Model 60-4240

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: May 9, 2000 after 153 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.
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) Kronus OptiQuant Thyroglobulin kit: named in the summary without a submission number

## Most influential descendants
- K021057: Brahms Diagnostica Dynotest TG-Plus (2002), 0 descendants of its own

## Indications for use
The Nichols Institute Diagnostics Chemiluminescence Thyroglobulin is a two-site immunometric assay for the quantitative measurement of thyroglobulin in human serum. The assay is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had prior thyroidectomy (using surgery with or without radioiodine). This assay is also indicated for monitoring thyroglobulin levels in combination with radioiodine whole body scans after either rhTSH administration or thyroid hormone withdrawal for detecting presence of thyroid tissue in patients with well-differentiated thyroid cancer. The assay should only be used on patients who lack thyroglobulin autoantibodies. The presence of autoantibodies against thyroglobulin (TgAb) can interfere with assays for thyroglobulin, hence, the TgAb status of the patient should be determined and reported. Thyroglobulin antibodies can be quantitated with the Nichols Chemiluminescence Thyroglobulin Autoantibodies kit (catalog 60-4185). The concentration of thyroglobulin (Tg) in a given specimen determined with assays from different manufacturers can vary due to difference in assay methods, reagent specificity, and presence of thyroglobulin autoantibodies. The results reported by the laboratory to the physician must include the identity of the Tg assay used. Values obtained with different assay methods cannot be used interchangeably. If in the course of serially monitoring a patient, the assay method used for determining Tg levels is changed, additional sequential testing should be carried out to confirm baseline values,

Source page: https://510kreport.com/device/K994140
Methodology: https://510kreport.com/methodology