# K061879: Sdi CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: Hemodiagnostica, LLC
- Decided: Dec 15, 2006 after 165 days
- Product code: CFR (Hexokinase, 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 K871028 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872302: Model 550 Express Clinical Chemistry Analyzer, Ciba Corning Diagnostics Corp. (1987) Summary page 2.
- K871028: Ciba Corning Model 664/Fast 4 System, Ciba Corning Diagnostics Corp. (1987) Summary page 2.
- K880078: Urea Nitrogen (Bun), Tech-Neal Scientific, Inc. (1988) Summary page 2.
- K880236: Glucose Hexokinase, Tech-Neal Scientific, Inc. (1988) Summary page 2.

## Indications for use
The SDI CA480 Clinical Chemistry System includes a discrete, random access, microprocessor controlled clinical chemistry analyzer and dedicated reagents intended for in vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium and Chloride in serum. Other various chemistry assays are adaptable to the analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. BUN measurements are use in the diagnosis and treatment of certain renal and metabolic diseases. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and are used in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

Source page: https://510kreport.com/device/K061879
Methodology: https://510kreport.com/methodology