# K983440: Abbott Architect Total T4

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 25, 1998 after 57 days
- Product code: KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1700
- Recalls of this device: none
- 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 Total T4 assay: named in the summary without a submission number

## Most influential descendants
- K151566: Abbott ARCHITECT Total T4 Calibrators (2015), 0 descendants of its own

## Indications for use
The ARCHITECT™ Total T4 (TT4) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of thyroxine (total T4) in human serum and plasma. The ARCHITECT Total T4 assay is to be used as an aid in the assessment of thyroid status.

Source page: https://510kreport.com/device/K983440
Methodology: https://510kreport.com/methodology