# K180340: Stat Profile Prime Plus Analyzer System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Sep 26, 2018 after 231 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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
- K200349: Stat Profile Prime Plus Analyzer System (2020), 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 Glucose, Creatinine, and Blood Urea Nitrogen, in heparinized arterial and venous whole blood. Glucose (Glu) Measurements are used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell tumor. Creatinine (Creat) Measurements are used in the diagnosis and treatment of certain renal conditions and for monitoring adequacy of dialysis. Blood Urea Nitrogen (BUN) Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

Source page: https://510kreport.com/device/K180340
Methodology: https://510kreport.com/methodology