(151 days)
The Glucose Hexokinase II in vitro diagnostic procedure is intended to measure glucose in human serum, plasma and urine on the Bayer ADVIA® 1650 System. Such measurement is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.
The Glucose Hexokinase II in vitro diagnostic procedure is intended to measure glucose in human serum, plasma and urine on the Bayer ADVIA® 1650 System. The assay buffer is in dual aliquots, allowing for blanking and subtraction of potential interference effects.
Acceptance Criteria and Device Performance for Glucose Hexokinase II method for Bayer ADVIA® 1650 System (K011963)
This submission (K011963) is a 510(k) for a new version of a Glucose Hexokinase assay, called Glucose Hexokinase II, for the Bayer ADVIA® 1650 System. The submission claims substantial equivalence to the predicate device, also a Glucose Hexokinase assay (K991576). The "acceptance criteria" can be inferred from the reported performance of the predicate device, with the new device demonstrating comparable or improved performance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds in this 510(k) summary. Instead, the sponsor demonstrates that the new device's performance characteristics (Imprecision, Correlation, Interfering Substances, Analytical Range) are comparable to, or improved relative to, those of the predicate device.
| Performance Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Glucose Hexokinase II) |
|---|---|---|
| Imprecision (Total CV%) | ||
| Serum (low) | 2.4% at 77 mg/dL | 2.2% at 75 mg/dL |
| Serum (high) | 3.3% at 279 mg/dL | 2.2% at 279 mg/dL |
| Urine (low) | 3.5% at 42 mg/dL | 4.1% at 46 mg/dL |
| Urine (high) | 3.6% at 285 mg/dL | 3.6% at 267 mg/dL |
| Correlation: Regression Equation (Y=new, X=predicate) | Close to Y=1.00x + 0.00 | |
| Serum | Y=1.02x-1.84 | Y=1.02x-1.84 |
| Urine | Y=0.97x-7.44 | Y=0.97x-7.44 |
| Plasma vs Serum* | Y=1.001x+0.088 | Y=1.001x+0.088 |
| Correlation: R-value | High (e.g., >0.99) | |
| Serum | 0.998 | 0.998 |
| Urine | 0.999 | 0.999 |
| Plasma vs Serum* | 0.9997 | 0.9997 |
| Correlation: Syx (mg/dL) | Low (e.g., |
§ 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.