# K180428: Stat Profile Prime Plus Analyzer System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Aug 15, 2018 after 180 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 K061830 (2006). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110648: Nova Stat Profile Phox Ultra Analyzer System, Nova Biomedical Corporation (2011) Summary page 4.

## Most influential descendants
- K200403: Stat Profile Prime Plus Analyzer System (2020), 1 descendant of its own
- K252475: ABL90 FLEX PLUS System (2026), 0 descendants of its own

## Indications for use
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of sodium, potassium, chloride, ionized calcium, and ionized magnesium in heparinized arterial and venous whole blood. Sodium (Na) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, or diseases involving electrolyte imbalance. Potassium (K) measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels. Chloride (Cl) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Ionized Calcium (iCa) 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). Ionized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

Source page: https://510kreport.com/device/K180428
Methodology: https://510kreport.com/methodology