(160 days)
The Glucose test, as part of the epoc Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial or venous whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.
Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, and idiopathic hypoglycemia, and of pancreatic islet cell tumors.
The EPOC glucose test is being added as an additional sensor to the existing single use test card that is used with the EPOC Blood Analysis System. This test card is inserted into the EPOC Reader and all analytical steps are performed automatically. Patient and user information may be entered into the mobile computing device (EPOC Host) during the automated analysis cycle.
The EPOC Blood Analysis System is an in vitro analytical system comprising a network of one or more EPOC Readers designed to be used at the point of care (POC). The readers accept an EPOC single use test card containing a group of sensors that perform diagnostic testing on whole blood. The blood test results are transmitted wirelessly to an EPOC Host, which displays and stores the test results.
Here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: EPOC Glucose Test (part of the EPOC Blood Analysis System)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the EPOC Glucose Test are not explicitly stated as quantitative targets in the document. Instead, the studies demonstrate the device's performance characteristics (precision, linearity, hematocrit effect, and analytical specificity) and then conclude equivalence to the predicate device. The performance data itself acts as the evidence to satisfy implicit acceptance criteria generally expected for such a device (i.e., that it performs reliably and comparably to a legally marketed device).
Therefore, the table below summarizes the reported performance characteristics from the provided studies. The acceptance criteria are inferred as demonstrating comparable or acceptable performance for each metric.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Aqueous Precision (CV%) | Low variability (e.g., comparable to industry standards) | L1: 2.30% CV |
| L3: 2.30% CV | ||
| Blood Precision (CV%) - Glucose 20 | ≤ 4.8% CV (based on predicate/industry standards) | 5.4% CV (Total) at 20 mg/dL (Note: One lot met 4.8% CV) |
| Blood Precision (CV%) - Glucose 120 | ≤ 4% CV (based on predicate/industry standards) | 2.4% CV (Total) at 120 mg/dL |
| Blood Precision (CV%) - Glucose 200 | ≤ 4% CV (based on predicate/industry standards) | 3.9% CV (Total) at 200 mg/dL |
| Blood Precision (CV%) - Glucose 300 | ≤ 6% CV (based on predicate/industry standards) | 4.2% CV (Total) at 300 mg/dL |
| Blood Precision (CV%) - Glucose 500 | ≤ 6% CV (based on predicate/industry standards) | 3.2% CV (Total) at 500 mg/dL |
| Linearity (Slope) | Close to 1.0 | 0.9996 |
| Linearity (Intercept) | Close to 0.0 | 0.64 |
| R-squared (Method Comparison) | High correlation (e.g., > 0.95 or 0.98) | R2: 0.999 (overall vs. predicate) |
| Hematocrit Effect (Bias) | Minimal bias across different Hct levels | Varied from -18.9 mg/dL to +20.0 mg/dL, with most biases being smaller than these extremes across different glucose and Hct levels. (Specific criteria for acceptable bias are not explicitly stated, but the values are presented as acceptable by the manufacturer.) |
| Analytical Specificity (Interference Bias) | Interferent bias |
§ 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.