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The EasyRA clinical analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na (sodium), K (potassium), Cl (chloride), Li (lithium) and Glucose (Trinder method) in human serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.

Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.

Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and 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.

Lithium measurements are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

The EasyRA clinical analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na (sodium), K (potassium), Cl (chloride), Li (lithium) and Glucose (Trinder method) in human serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.

Here's an analysis of the provided text in relation to acceptance criteria and study details.

Analysis of the Provided Document:

The provided document is a 510(k) clearance letter from the FDA for a device called the "EasyRa Clinical Chemistry Analyzer." This type of document declares "substantial equivalence" to a predicate device, meaning it is deemed as safe and effective as a device already on the market. It does not contain the detailed acceptance criteria or study results that would typically be found in a study report or a more comprehensive FDA submission summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the given FDA 510(k) clearance letter.

This document confirms the device's regulatory clearance based on substantial equivalence, but it does not delve into the specifics of the underlying studies that demonstrated this equivalence in the way you've requested.

Information I can extract from the document:

• Device Name: EasyRa Clinical Chemistry Analyzer
• Indicated Measurements: Na (sodium), K (potassium), Cl (chloride), Li (lithium), and Glucose (Trinder method) in human serum samples.
• Regulatory Class: Class II
• Product Codes: CGA, JGS, CEM, CGZ, JIH, JJE, JIT, JJY
• Ground Truth Type (Implied for Glucose during validation): The "Trinder method" is explicitly mentioned for Glucose, which suggests a standard chemical reference method. For other analytes, it implies established laboratory reference methods for comparison.
• Study Type (Implied): Substantial Equivalence study against a legally marketed predicate device.

To answer your questions fully, you would need access to the actual 510(k) submission summary or the underlying study reports submitted by Medica Corporation to the FDA, which are not included in this clearance letter.

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