# K200544: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Oct 1, 2020 after 212 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- 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 5.

## Indications for use
The SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diluted Urine samples. The SmartLyte® Plus Sodium Assay is intended to measure sodium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. 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 SmartLyte® Plus Potassium Assay is intended to measure potassium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. The SmartLyte® Plus Chloride Assay is intended to measure the level of chloride in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The SmartLyte® Plus Calcium Assay is intended to measure ionized calcium levels in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The SmartLyte® Plus Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. 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). For in-vitro diagnostic use only.

Source page: https://510kreport.com/device/K200544
Methodology: https://510kreport.com/methodology