(135 days)
The diagnosis of disorders associated with abnormal carbohydrate metabolisms depends in part on the measurement of glucose. The most significant of these diseases is diabetes mellitus, which is characterized by abnormally high concentrations of glucose in physiological fluids. Increased glucose concentration also occurs during hyperactivity of endocrine glands such as the theroid and the adrenal. Hypoglycemia is a condition characterized by low glucose levels that can result from a variety of conditions such as insulin overdose, liver diseases, and hypopituitarism. Glucose determinations, therefore, are useful for detection and management of diabetes mellitus, and for investigation of hypoglycemic conditions.
The Sigma Diagnostics Glucose Reagent is formulated to use this methodology on the SYNCHRON CX®3 System.
The provided text describes a glucose reagent (Sigma Diagnostics Glucose Reagent), not a device in the AI/ML sense that would have specific acceptance criteria for diagnostic performance metrics like sensitivity, specificity, or AUC. This is a chemical reagent used in a laboratory setting on an existing automated system (SYNCHRON CX®3 System).
Therefore, many of the requested points are not applicable. However, I can interpret the "acceptance criteria" and "study" in the context of demonstrating substantial equivalence for a medical device (reagent) as outlined in a 510(k) submission.
Here's an attempt to answer based on the provided information, noting where sections are not applicable to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Correlation to Predicate Device | |
| Serum Samples: R > 0.95 (implied) | R = 0.997 |
| Urine Samples: R > 0.95 (implied) | R = 0.976 |
| CSF Samples: R > 0.95 (implied) | R = 0.981 |
| Regression Slope (Predicate vs. Device) | |
| Serum Samples: Slope ≈ 1 (implied) | y = 1.01x - 1.73 |
| Urine Samples: Slope ≈ 1 (implied) | y = 0.97x - 2.68 |
| CSF Samples: Slope ≈ 1 (implied) | y = 1.02x - 2.95 |
| Precision (%CV) | |
| Serum Samples: %CV 0.95, %CV |
§ 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.