(182 days)
The APOLOWAKO HbA1c and APOLOWAKO Glucose are for the quantitative determination on the APOLOWAKO analyzer of hemoglobin A1c (HbA1c) % and glucose in whole blood samples.
HbA1c- Measurement of % HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.
Glucose- Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and pancreatic islet cell carcinoma.
The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. For the HbA Ic test, whole blood, and not plasma, is used. For all other tests, the analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two reagents and a calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results arc shown. The APOLOWAKO HbA1c and APOLOWAKO Glucose include hemoglobin A1c and glucose test reagents. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).
The Wako Diagnostics APOLOWAKO HbA1c and APOLOWAKO Glucose test systems were evaluated for their ability to quantitatively determine hemoglobin A1c (HbA1c) % and glucose in whole blood samples.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device) | APOLOWAKO HbA1c Performance | APOLOWAKO Glucose Performance |
|---|---|---|---|
| Intended Use | Quantitative determination of HbA1c and glucose in whole blood for monitoring diabetes and diagnosing carbohydrate metabolism disorders. | Quantitative determination of HbA1c and glucose in whole blood samples for monitoring long-term glucose control in individuals with diabetes mellitus (HbA1c) and for diagnosis/treatment of carbohydrate metabolism disorders (Glucose). | Quantitative determination of HbA1c and glucose in whole blood samples for monitoring long-term glucose control in individuals with diabetes mellitus (HbA1c) and for diagnosis/treatment of carbohydrate metabolism disorders (Glucose). |
| Reportable Range | HbA1c: 4-15% | ||
| Glucose: 50-500 mg/dL | HbA1c: 3-16.5% | Glucose: 18-350 mg/dL | |
| Precision (Total Imprecision) | HbA1c: |
§ 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.