# K200403: Stat Profile Prime Plus Analyzer System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Apr 14, 2020 after 55 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K061830 (2006). 3 ancestors in all.
1 later device descends 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)
- K180428: Stat Profile Prime Plus Analyzer System, Nova Biomedical Corporation (2018) Summary page 4.

## Most influential descendants
- K252475: ABL90 FLEX PLUS System (2026), 0 descendants of its own

## Recalls of this device
- Sep 18, 2023 · Class II · Z-0207-2024: Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after c
- Sep 18, 2023 · Class II · Z-0208-2024: Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after c

## Indications for use
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Sodium, Potassium, Chloride, Ionized Calcium, and Ionized Magnesium in heparinized arterial and venous whole blood. Sodium (Na) Sodium 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) Potassium measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels. Chloride (Cl) Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Ionized Calcium (iCa) Ionized 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) Ionized Magnesium (iMg) Ionized magnesium 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/K200403
Methodology: https://510kreport.com/methodology