# KLI: Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

- Device class: 2; regulation: 21 CFR 862.1700; FDA's rule: 510(k) exempt
- FDA decisions: 86
- Recalls: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1997: 4
- 1998: 2
- 1999: 2
- 2000: 2
- 2002: 1
- 2003: 1
- 2009: 1
- 2011: 1
- 2013: 1
- 2016: 1

## Most-cited predicates
- K981377: Ace T4 Reagent T4 Calibrators (1998), cited by 2
- K926475: Access (R) Thyroxine Assay (1993), cited by 1
- K160495: VITROS® Automation Solutions (2016), cited by 1
- K912616: Technicon Immuno 1 TM System Additional Analytes (1991), cited by 1
- K926393: Vidas Thyroxine (T4) Assay (T4) (1993), cited by 1
- K082638: Advia Centaur System with Streamlab Analytical Workcell (2009), cited by 1
- K944703: Thyroxine Enzyme Immunoassay (1994), cited by 1
- K983440: Abbott Architect Total T4 (1998), cited by 1
- K942575: Cedia T4 Mab Assay (1994), cited by 1

Source page: https://510kreport.com/product-code/KLI
Data by year (CSV): https://510kreport.com/product-code/KLI.csv