# K121140: Prolyte Electrolyte Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Aug 22, 2012 after 128 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: 3 generations back to K861087 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082462: Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+, Diamond Diagnostics, Inc. (2009) Summary page 1.

## Indications for use
The PROLYTE Electrolyte Analyzer Na/K/Cl/Li is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride and lithium in whole blood, plasma, and serum. Sodium, potassium, and chloride can be measured in urine samples. The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na/K/Cl/Li. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. The PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na/K/Cl/Li. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. The PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na/K/Cl/Li. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The PROLYTE lithium test system is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, or serum on the PROLYTE Electrolyte Analyzer Na/K/Cl/Li. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

Source page: https://510kreport.com/device/K121140
Methodology: https://510kreport.com/methodology