# K062316: Dimension Vista Ammonia (Amon) Flex Reagent Cartridge

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: Sep 6, 2006 after 28 days
- Product code: JIF (Enzymatic Method, Ammonia)
- Device class: 1
- Regulation: 21 CFR 862.1065
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K863840 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863840: Meth. & Cali. for the Dimension Clini/Chem. System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 1.

## Indications for use
The Dimension VistaTM Ammonia (AMON) Flex® reagent cartridge is an in vitro device intended to measure ammonia levels in plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Source page: https://510kreport.com/device/K062316
Methodology: https://510kreport.com/methodology