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510(k) Data Aggregation
(205 days)
D-100 HbA1c, D-100 HbA1c Calibrator Pack
The D-100™ HbA1c test is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood using ion-exchange high-performance liquid chromatography (HPLC) on the D-100 Hemoglobin Testing System.
Hemoglobin A1c measurements are used as an aid in diagnosis of diabetes mellitus, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
The D-100TM HbA1c test is intended for Professional Use Only.
Calibrators:
The D-100™ HbA1c Calibrator Pack is for the calibration of the D-100 Hemoglobin Testing System used for the quantitative determination of hemoglobin A1c(HbA1c) in human whole blood.
The Bio-Rad D-100™ HbA1c utilizes principles of ion-exchange high-performance liquid chromatography (HPLC). A high-pressure pumping system delivers a buffer solution to an analytical cartridge and detector. Whole blood samples undergo an automatic hemolysis and dilution process before being introduced into the analytical flow path. Prediluted samples are identified based upon the use of a microvial adapter in the sample rack, and the automatic dilution step is omitted.
A programmed buffer gradient of increasing ionic strength delivers the sample to the analytical cartridge where the hemoglobin species are separated based upon their ionic interactions with the cartridge material and the buffer gradient. The separated hemoglobin species then pass through the flow cell where changes in the absorbance are measured at 415 nm and recorded as a digital chromatogram.
The software performs an analysis of the hemoglobin peaks in the chromatogram, recording information including retention time, peak area, and relative are percent. Any peaks that are identified as the target analyte(s) are calibrated before generating a sample report and chromatogram for each sample. The software includes an optional feature (Advisor) that compares the sample report against a set of rules that are programmed to take user-specified actions.
The D-100™ HbA1c test is designed to be used on the D-100™ Hemoglobin Testing System.
This document describes the D-100™ HbA1c test and D-100™ HbA1c Calibrator Pack, intended for the quantitative determination of hemoglobin A1c (HbA1c) in human whole blood using ion-exchange high-performance liquid chromatography (HPLC) on the D-100™ Hemoglobin Testing System. The test is used as an aid in diagnosing diabetes mellitus, identifying individuals at risk for diabetes, and monitoring long-term blood glucose control in diabetic patients. The calibrators are used for the calibration of the system.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied through the study designs, particularly the "significant interference" threshold for analytical specificity and the performance demonstrated in linearity and precision studies. For the purpose of this summary, the relevant performance metrics are extracted and presented.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (NGSP %CV Total Precision) | Not explicitly stated, but results within reasonable analytical variation for diagnostic assays. |
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