(136 days)
The "LIASYS 450 SAT 450" is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. Other various chemistry assays are adaptable to this instrument.
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. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Measurements of potassium are used to monitor electrolyte balance 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 such as cystic fibrosis and diabetic acidosis.
The "LIASYS 450 SAT 450" is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry.
The provided text is a 510(k) clearance letter from the FDA for a clinical analyzer, "LIASYS 450 SAT 450," which measures glucose, sodium, potassium, and chloride. While it states the device is substantially equivalent to legally marketed predicates, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document refers to a "substantial equivalence determination" based on comparison to predicate devices, but it does not detail the performance study, acceptance criteria, or specific results that would be typically found in a clinical or analytical validation study report.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided text. This information would typically be found in the 510(k) submission itself, not the clearance letter.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.