# K203549: Nova Primary Glucose Analyzer System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Oct 18, 2022 after 683 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: 1 generation back to K891480 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891480: Ysi Model 2300 Stat Glucose and L-Lactate Analyzer, Yellow Springs Instrument Co., Inc. (1989) Summary page 4.

## Indications for use
The Nova Primary Glucose Analyzer System is indicated for in vitro diagnostic use by healthcare professionals in clinical laboratory setting for the quantitative determination of Glucose in lithium heparinized venous whole blood and plasma. The measurement of Glucose is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K203549
Methodology: https://510kreport.com/methodology