(184 days)
The S-Test Hemoglobin A1c Reagent is intended for the quantitative determination of percent Hemoglobin A1c concentration in EDTA whole blood using the S40 Clinical Analyzer. Measurement of glycosylated hemoglobin is used for monitoring the long-term glycemic control of individuals with diabetes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Hemoglobin A1c (HbA1c) reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of %HbA1c concentration in EDTA whole blood. This method is based on a colorimetric assay for total hemoglobin and an enzymatic assay for HbA1c.
Acceptance Criteria and Study Details for S-Test HbA1c Reagent Cartridge (K091711)
This document describes the acceptance criteria and supporting study details for the S-Test HbA1c Reagent cartridge, as presented in the 510(k) summary K091711.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the precision and accuracy data presented in the 510(k) summary. Given this is a diagnostic assay for a quantitative measure, the acceptance criteria are generally focused on demonstrating acceptable levels of precision and linearity/correlation with a comparative method.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Precision | ||
| Within-run CV | ≤ X% (typical clinical range) | 0.9 to 1.1% (3 HbA1c levels, 20 days, lab) |
| 0.5 to 1.8% (3 POL sites, 5 days) | ||
| Total CV | ≤ Y% (typical clinical range) | 1.2 to 1.5% (3 HbA1c levels, 20 days, lab) |
| 0.7 to 3.2% (3 POL sites, 5 days) | ||
| Accuracy | ||
| Correlation | Correlation coefficient $\ge$ 0.95 | 0.982 (110 samples, lab) |
| 0.988 to 0.996 (3 POL sites) | ||
| Slope | 0.95 to 1.05 | Confidence Interval: 0.988 to 1.062 (lab) |
| Confidence Interval: 0.957 to 1.065 (3 POL sites) | ||
| Intercept | Close to 0 (e.g., -0.5 to 0.5) | Confidence Interval: -0.48 to 0.02 (lab) |
| Confidence Interval: -0.64 to 0.16 (3 POL sites) | ||
| Standard Error of Estimate | Clinically acceptable (e.g., |
§ 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).