(217 days)
The Poly-Chem 90 glucose test system is an in vitro diagnostic procedure intended to measure qlucose quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypodycemia. and idiopathic glycemia, and of the pancreatic isle cell carcinoma.
The Poly-Chem 90 ALP test system is an in vitro diagnostic procedure intended to measure alkaline phosphatase quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. Measurements of alkaline phosphatase are of use in the diagnosis, treatment, and investigation of hepatobiliary disease and in bone disease associated with increased osteoblastic activity. Alkaline phosphatase is also used in the diagnosis of parathyroid and intestinal disease.
The Poly-Chem 90 AST test system is an in vitro diagnostic procedure intended to measure aspartate aminotransferase (AST) quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. AST measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
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This document is an FDA 510(k) clearance letter for an in-vitro diagnostic device, specifically the Poly-Chem 90 Glucose, ALP, and AST tests. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way described in your request (e.g., performance metrics like accuracy, sensitivity, specificity, sample sizes used for testing, expert qualifications, or ground truth establishment for AI/ML devices).
The letter primarily focuses on:
- Substantial Equivalence: Stating that the device is substantially equivalent to legally marketed predicate devices.
- Regulatory Classification: Identifying the device's regulation number (21 CFR §862.1345), name (Glucose test system), regulatory class (Class II), and product codes (CFR, CJE, CIT).
- General Controls: Reminding the applicant of general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling).
- Indications for Use: Detailing what the Poly-Chem 90 Glucose, ALP, and AST tests are intended to measure and in what contexts these measurements are used for diagnosis and treatment.
Therefore, it is not possible to provide the requested information from the given text. This document is a regulatory approval notice, not a clinical study report or a technical performance evaluation. It confirms the device's marketability based on substantial equivalence, but it does not delve into the specific performance studies and acceptance criteria that led to that determination, especially not in the context of AI/ML performance evaluation as your questions imply.
§ 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.