# K041657: Thermo Electron Angiotensin Converting Enzyme Infinity (Ace) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Electron Corporation
- Decided: Aug 30, 2004 after 73 days
- Product code: KQN (Radioassay, Angiotensin Converting Enzyme)
- Device class: 2
- Regulation: 21 CFR 862.1090
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1. The Thermo Electron InfinityTM ACE Reagent Kit is intended for the quantitative determination of ACE in human serum or plasma. The product is for in vitro diagnostic use only. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen. 2. The Thermo Electron Infinity TM ACE Calibrator is intended for the calibration of ACE assays. The product is for in vitro diagnostic use only. 3. The Thermo Electron ACE Normal and Elevated Controls are intended for monitoring the accuracy and precision of ACE assays. The product is for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K041657
Methodology: https://510kreport.com/methodology