# K905532: Ciba Corning Acs T4 Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Jan 15, 1991 after 36 days
- Product code: CDX (Radioimmunoassay, 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K082638: Advia Centaur System with Streamlab Analytical Workcell (2009), 4 descendants of its own
- K093318: Accelerator Aps (2010), 3 descendants of its own
- K213486: GLP systems Track (2022), 1 descendant of its own
- K230937: Alinity i Total ß-hCG Reagent Kit, GLP systems Track (2023), 0 descendants of its own
- K121012: Flexlab 3.6, Accelerator A3600 (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K905532
Methodology: https://510kreport.com/methodology