# K991252: Aia-Pack FT3 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: May 11, 1999 after 28 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Nov 30, 2018 · Class II · Z-0673-2019: 

## Indications for use
AIA-PACK FT3 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine in human serum on TOSOH AIA System analyzers. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Source page: https://510kreport.com/device/K991252
Methodology: https://510kreport.com/methodology