# K260613: AMI™ Plasma Cartridge, AMI™

- Pathway: 510(k) (Traditional)
- Applicant: Sequitur Health Corp.
- Decided: Sep 1, 2026 after 188 days
- Product code: JID (Photometric 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 K811919 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820723: Kodak Ektachem Clinical Chem. NH3, Eastman Kodak Company (1982) Summary page 5.
- K811919: Kodak Ektachem 400 Analyzer, Eastman Kodak Company (1981) Summary page 5.

## Indications for use
The AMI™ Plasma Cartridge is a photometric in vitro test for the quantitative determination of ammonia in human plasma on the AMI™ analyzer. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome. The AMI™ is an analyzer for in vitro diagnostic use in clinical laboratories, utilizing photometric technology for analyte detection.

Source page: https://510kreport.com/device/K260613
Methodology: https://510kreport.com/methodology