# K181201: Synermed ISE Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Infrared Laboratory Systems, LLC (Dba Synermed)
- Decided: Jul 10, 2018 after 64 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- 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 K952179 (1995). 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)
- K952179: Synermed Ise Reagents, Synermed, Inc. (1995) Summary page 4.

## Indications for use
The Synermed ISE Reagents are used for in-vitro diagnostic use to quantitate levels of Sodium, Potassium and Chloride in serum. This device is for use in clinical laboratories only. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Source page: https://510kreport.com/device/K181201
Methodology: https://510kreport.com/methodology