# K983417: Abbott Architect Free T4

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 20, 1998 after 52 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) AxSYM Free T₄ assay: named in the summary without a submission number

## Most influential descendants
- K123379: Abbott Architect Free T4 (2012), 2 descendants of its own
- K173122: Abbott Architect Free T4 (2017), 0 descendants of its own
- K152422: FREND™ Free T4 Test System (2016), 0 descendants of its own

## Recalls of this device
- Dec 15, 2003 · Not classified · Z-0353-04: The calibrator lots may yield Free T4 values that are depressed.
- May 30, 2003 · Not classified · Z-1132-03: The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.

## 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.

Source page: https://510kreport.com/device/K983417
Methodology: https://510kreport.com/methodology