# K173122: Abbott Architect Free T4

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Oct 27, 2017 after 28 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- Recalls of this device: 1 (0 Class I)
- 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 4.

## Recalls of this device
- Nov 21, 2018 · Class II · Z-0665-2019: Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it ma

## 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. ARCHITECT Free T4 (FT4) assay is to be used as an aid in the assessment of thyroid status.

Source page: https://510kreport.com/device/K173122
Methodology: https://510kreport.com/methodology