# K983439: Abbott Architect Free T3

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 20, 1998 after 52 days
- Product code: CDP (Radioimmunoassay, Total Triiodothyronine)
- Device class: 2
- Regulation: 21 CFR 862.1710
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) AxSYM Free T₃ assay: named in the summary without a submission number

## Most influential descendants
- K170160: Abbott ARCHITECT Free T3 (2017), 0 descendants of its own

## Recalls of this device
- Sep 11, 2014 · Class II · Z-0474-2015: 17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of rang

## Indications for use
The ARCHITECT™ Free T₃ (FT₃) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (free T₃) in human serum and plasma. The ARCHITECT Free T₃ assay is to be used as an aid in the assessment of thyroid status.

Source page: https://510kreport.com/device/K983439
Methodology: https://510kreport.com/methodology