(113 days)
The Hemoglobin A1c- reagent, when used in coniunction with UniCel® DxC 600/800 SYNCHRON® Systems, UniCel® DxC SYNCHRON® Systems HbA1c-Calibrators and SYNCHRON® and AU® Systems Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood.
Measurement of hemoglobin A1c measures long-term alvcemic control in patients with diabetes mellitus.
The UniCel DxC SYNCHRON Systems Hemoglobin A1c- (HbA1c-) Reagent is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. The UniCel DxC Systems utilize two unique cartridges, Hband A1c-, to determine hemoglobin A1c concentration as a ratio of total hemoqlobin.
Hb- reagent is used to measure total hemoglobin concentration by a colorimetric method. The system automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 8.6 parts reagent. The system monitors the change in absorbance at 410 nanometers. This change in absorbance is directly proportional to the concentration of total hemoglobin in the sample and is used by the system to calculate and express total hemoglobin concentration.
A1c- reagent is used to measure the hemoglobin A1c concentration by a turbidimetric immunoinhibition method. In the reaction, hemoglobin A1c antibodies combine with hemoglobin A1c from the sample to form soluble antigen-antibody complexes. Polyhaptens from the reagent then bind with the excess antibodies and the resulting agglutinated complex is measured turbidimetrically. The system automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 28 parts reagent. The system monitors the change in absorbance at 340 nanometers. This change in absorbance is inversely proportional to the concentration of hemoglobin A1c in the sample and is used by the systems to calculate and express hemoglobin A1c concentration as a ratio of total hemoglobin.
This 510(k) premarket notification describes the UniCel DxC SYNCHRON Systems Hemoglobin A1c- (HbA1c-) Reagent, which is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. The submission compares the modified device to a predicate device and presents performance study results to demonstrate substantial equivalence.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Area of Study | Test Protocols | Acceptance Criteria | Reported Device Performance (Pass/Fail) |
|---|---|---|---|
| Method Comparison | CLSI EP9A | Slope 1.0 ± 0.05, Intercept |
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).