# K971792: Immulite Free T4 (2-Step)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jul 25, 1997 after 71 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K822882 (1982). 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)
- K822882: Coat-a-Count Free Thyroxine Kit/Componen, Diagnostic Products Corp. (1982) Summary page 3.

## Indications for use
DPC's IMMULITE® Free T4 is intended for use with the IMMULITE® Automated Analyzer. It is a solid-phase, 2-step chemiluminescent enzyme immunoassay designed for the quantitative measurement of non-protein-bound thyroxine (free T4) levels in serum. It is intended strictly for in vitro use as an aid in the clinical assessment of thyroid status related to abnormality in thyroid function or simply a variation (physiological or pathological) in the carrier proteins, chief of which is thyroxine-binding globulin (TBG). This assay is useful in assessment of thyroid status due to TBG elevations typical of pregnancy, oral contraceptive use and estrogen therapy. Additionally, this test system is for use as an aid in detecting alterations in the TBG level which mask the effects of abnormal thyroid function in hypothyroid and hyperthyroid patients.

Source page: https://510kreport.com/device/K971792
Methodology: https://510kreport.com/methodology