(65 days)
The Precision A1c Home HbA1c Sample Collection Kit is intended to be a home-use or office-use device for the collection of a capillary blood sample on a blood sample collection card for in vitro diagnostic laboratory evaluation of the amount of HbA1c (glycosylated hemoglobin). This collection device will be used to monitor long-term blood glucose control in patients with diabetes mellitus.
The Precision Alc sample collection device will be marketed over-the-counter. This kit is not indicated for the diagnosis of diabetes mellitus.
The Precision A1c Home HbA1c Sample Collection Kit contains the materials necessary to collect a capillary blood sample from a finger-stick to a piece of filter paper and mail it to a clinical laboratory for the determination of percent hemoglobin A1c (also known as glycohemoglobin or glycosylated hemoglobin).
The Precision A1c sample collection kit contains a lancet, patient information sheet, instruction sheet, alcohol pad, gauze pad, bandage, pre-paid mailing envelope, and a blood sample collection card (inside a zip-locked foil pouch containing a desiccant).
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Device Performance for Precision A1c™ Home HbA1c Sample Collection Kit (K983253)
The key performance criteria for the Precision A1c™ Home HbA1c Sample Collection Kit are based on the correlation and agreement of HbA1c results obtained from samples collected with the kit compared to whole blood samples. The study assessed the performance of the device when used by both trained operators and lay users.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria values (e.g., "correlation coefficient must be > 0.95"). However, the language of the conclusion, stating "Results indicate excellent correlation... and equivalent results," strongly implies that the observed performance values were considered acceptable. Based on the data presented and the concluding remarks, the implied acceptance criteria would generally be a correlation coefficient close to 1.000, a slope close to 1.000, and a y-intercept close to 0.0, along with low bias and Sy.x values.
| Metric | Implied Acceptance Goal (Based on "excellent correlation" and "equivalent") | Trained Operator vs. Whole Blood | Lay User vs. Whole Blood | Trained Operator vs. Lay User |
|---|---|---|---|---|
| Correlation Coefficient | Close to 1.000 | 0.993 | 0.989 | 0.996 |
| Slope | Close to 1.000 | 1.019 | 1.016 | 0.999 |
| y-Intercept | Close to 0.0 | -0.02 | -0.05 | -0.04 |
| Sy.x | Low (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).