Search Results

Autoanalyzer Pictus 400 is designed for Clinical Laboratory Use, with direct determination of Na, K, Cl in serum, and Glucose in serum, and to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.

Sodium measurements are used for monitoring electrolyte imbalances. Potassium measurements are used for diagnosis in diseases with high and low Potassium levels. Chloride measurements are primarily use to detect and treatment of metabolic disorders. 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.

Not Found

This document is a 510(k) premarket notification from the FDA, indicating clearance for the Diatron PICTUS 400 device. While it lists the "Indications for Use" for various analytes (Na, K, Cl, Glucose), it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request for that specific information based on the provided text. The document's purpose is to state FDA's determination of substantial equivalence, not to detail the technical validation studies.

Ask a specific question about this device