# K200349: Stat Profile Prime Plus Analyzer System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Mar 13, 2020 after 30 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: 3 generations back to K061830 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180340: Stat Profile Prime Plus Analyzer System, Nova Biomedical Corporation (2018) Summary page 4.
- K110648: Nova Stat Profile Phox Ultra Analyzer System, Nova Biomedical Corporation (2011) Summary page 7.

## 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 Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood. Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis Creatinine measurement is used in the diagnosis and treatment of certain renal conditions and for monitoring adequacy of dialysis. Blood Urea Nitrogen measurement is used in the diagnosis and treatment of certain renal and metabolic diseases

Source page: https://510kreport.com/device/K200349
Methodology: https://510kreport.com/methodology