# K070104: Prolyte Electrolyte Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: May 7, 2008 after 483 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: 2 generations back to K861087 (1986). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K823480: IL 943 Flame Photometer, Instrumentation Laboratory CO (1983) Summary page 1.
- K000926: Easyelectrolyte Analyzer and Rapidlyte Analyzer, Medica Corp. (2000) Summary page 1.
- K961458: Avl 9180 Electrolyte Analyzer, Avl Scientific Corp. (1996) Summary page 1.
- K810615: Corning 925 Chloride Meter, Corning Medical & Scientific (1981) Summary page 1.

## Most influential descendants
- K102959: Prolyte Electrolyte Analyzer (2011), 0 descendants of its own

## Indications for use
The proLYTE Electrolyte Analyzer is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, and Chloride found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient. This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with electrolyte imbalance. These locations routinely conform to CLIA regulations, and conduct daily quality control programs.

Source page: https://510kreport.com/device/K070104
Methodology: https://510kreport.com/methodology