# K962602: Aca Plus Free Thyroxine (FT4) Method

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Aug 15, 1996 after 44 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
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. The FDA summary names its predicate without a number.
- (no number) Abbott Laboratories IMX® Free T4: named in the summary without a submission number

## Indications for use
The FT4 Method is used in the aca® plus immunoassay system to quantitatively measure free thyroxine (FT4) in human serum and heparinized plasma.

Source page: https://510kreport.com/device/K962602
Methodology: https://510kreport.com/methodology