(28 days)
The EasyLyte analyzers are used for the in-vitro diagnostic testing of Sodium (Na+), Potassium (K+), chloride (C1-), and Lithium (Li) in clinical laboratories by trained technicians.
Sodium test: The sodium (Na+) assay is intended to measure sodium in serum, plasma, whole blood and urine. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Potassium test: The potassium (K+) assay is intended to measure potassium in serum, plasma, whole blood and urine. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride test: The chloride (Cl-) assay is intended to measure the level of chloride in plasma, serum, whole blood, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Lithium test: The lithium (Li+) assay is intended to measure lithium (from the drug lithium carbonate) in serum, plasma and whole blood. Measurements of lithium 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).
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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The text is a 510(k) clearance letter from the FDA for a medical device (EasyLyte Na/K/Cl/Li Analyzer), which confirms the device's substantial equivalence to a predicate device. It specifies the indications for use but does not include the detailed study design, acceptance criteria, or performance data that would be found in a study report.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, training sets, or data provenance.
- Information on experts used for ground truth (number, qualifications).
- Adjudication methods.
- Details about MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used (beyond implying clinical measurements).
- How ground truth for training or test sets was established.
Therefore, I cannot provide the requested information based on the text provided.
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.