# K210933: YSI 2900C Biochemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Ysi, Inc.
- Decided: Sep 30, 2024 after 1,281 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 K913806 (1991). 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)
- K913806: Ysi Model 2300 Stat Plus, Ysis, Inc. (1991) Summary page 4.

## Indications for use
The YSI 2900C Biochemistry Analyzer is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of venous whole blood samples, fingerstick capillary whole blood samples, serum and plasma in the laboratory. For in vitro diagnostic use. Glucose measurements from the YSI 2900C Biochemistry Analyzer are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell tumors. The YSI 2900C Biochemistry Analyzer is not intended for use in the screening or quantitative analysis on neonates. The YSI 2900C Biochemistry Analyzer is not intended for point of care (POC) use. This test is for prescription use only.

Source page: https://510kreport.com/device/K210933
Methodology: https://510kreport.com/methodology