| Sample type | Whole Blood / Pre-Diluted Samples |
|---|---|
| Specimen Volume (uL) | Yellow-Pending 510k clearance |
| Reaction Time (Minutes) | N/A |
| ANALYTE | Variant Mode: HbA1c (sA1c) |
| Calibrators | Pending 510k clearance |
| Assay Sample | Pending 510k clearance |
| Antibody/Antigen type | N/A |
| Detection Technology | High performance liquid chromatography |
| Assay Range low | Pending 510k clearance |
| Aspirated Sample Valume | 3μL (Primary tube), 120μL (Diluted samples) |
| Assay Principle | Ion exchange high performance liquid chromatography |
| Assay Range high | Pending 510k clearance |
| Assay Time (Minutes) | 50 seconds |
| Sample Dimensions | 12-15mm diameter, 75-100mm collection tubes |
| Standardization | Pending 510k clearance |
| Unit of Measure | Pending 510k clearance |