# K123320: Dimension Ammonia Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Feb 15, 2013 after 112 days
- Product code: JIF (Enzymatic Method, Ammonia)
- Device class: 1
- Regulation: 21 CFR 862.1065
- Recalls of this device: 3 (0 Class I)
- 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.

## Recalls of this device
- Jun 29, 2017 · Class II · Z-1649-2018: Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely dep
- Dec 16, 2016 · Class II · Z-1140-2017: Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge lots EB7180, FB7152, BA7194, EA7223, BA7250 do not meet the 60-day calibration interval claim due to rea
- Dec 16, 2016 · Class II · Z-1141-2017: Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lots 16187BE, 16225BB, 16265AB do not meet the 60-day calibration interval claim due to reage

## Indications for use
The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma (heparin or EDTA) on the Dimension® clinical chemistry system. 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/K123320
Methodology: https://510kreport.com/methodology