# K983434: Abbott Architect Total 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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 T3 assay: named in the summary without a submission number

## Indications for use
The ARCHITECT™ Total T3 (TT3) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total triiodothyronine (total T3) in human serum and plasma. The ARCHITECT Total T3 assay is to be used as an aid in the assessment of thyroid status.

Source page: https://510kreport.com/device/K983434
Methodology: https://510kreport.com/methodology