# K123379: Abbott Architect Free T4

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Nov 27, 2012 after 26 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 K983417 (1998). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983417: Abbott Architect Free T4, Abbott Laboratories (1998) Summary page 1.

## Most influential descendants
- K173122: Abbott Architect Free T4 (2017), 0 descendants of its own
- K152422: FREND™ Free T4 Test System (2016), 0 descendants of its own

## Indications for use
The ARCHITECT Free T4 (FT4) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free thyroxine (Free T4) in human serum and plasma. The ARCHITECT Free T4 assay is to be used as an aid in the assessment of thyroid status. The ARCHITECT Free T4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit. The ARCHITECT Free T4 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.

Source page: https://510kreport.com/device/K123379
Methodology: https://510kreport.com/methodology