# K152422: FREND™ Free T4 Test System

- Pathway: 510(k) (Traditional)
- Applicant: Nanoentek USA, Inc.
- Decided: Feb 17, 2016 after 175 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: 2 generations back to K983417 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123379: Abbott Architect Free T4, Abbott Laboratories (2012) Summary page 7.

## Indications for use
The FREND™ Free T4 Test System is a rapid indirect competitive immunoassay for the quantitative determination of free thyroxine (FT4) in human serum and lithium heparinized plasma specimens using the FREND™ Free T4 system. Measurements of free thyroxine (FT4) are used in the diagnosis of thyroid disorders. The FREND™ Free T4 Test System is intended for use in clinical laboratories. For in vitro diagnostic use only. The test is not intended for point-of-care facilities.

Source page: https://510kreport.com/device/K152422
Methodology: https://510kreport.com/methodology