# K183549: GEM Premier ChemSTAT

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Feb 16, 2019 after 58 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: 9 generations back to K801848 (1980). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133407: Gem Premier 4000, Instrumentation Laboratory CO (2014) Summary page 4.

## Most influential descendants
- K223090: GEM Premier ChemSTAT (2023), 0 descendants of its own

## Indications for use
The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Sodium (Na+), Potassium (K+), Ionized Calcium (Ca++) and Chloride (Cl-) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient’s electrolyte balance. Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes: • Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance. • Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. • Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. • Chloride (Cl-) 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/K183549
Methodology: https://510kreport.com/methodology