(498 days)
The URight Hemoglobin A1c System is intended to quantitatively measure the percent of hemoglobin A1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.
The URight Hemoglobin A1c Control Solution is intended for use as quality control material for the URight Hemoglobin A1c System.
The FORA A1c System is intended to quantitatively measure the percent of hemoglobin A1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.
The FORA A1c Control Solution is intended for use as quality control material for the FORA A1c System.
The hemoglobin A1c system is comprised of a fully automated desktop electric spectrophotometer that measures HbA1c in capillary or venous whole blood samples collected in EDTA (K2 and K3) or sodium heparin using a dedicated cartridge, which is pre-filled with the reagent; latex (reagent 1), antibody and sample dilute solution (reagent 2). The hemoglobin A1c system shines a light through the test material and measures the quantity of hemoglobin A1c in the total hemoglobin (HbA1c %) based on the lot-specific reagent parameters and changes in light absorbency caused by antigen-antibody reactions.
Two levels of hemoglobin A1c control are provided for routine quality checks - level 1 in the normal HbA1c range and level 2 in the elevated HbA1c range. The HbA1c controls are lyophilized hemolysates prepared from packed human erythrocytes.
The provided document is a 510(k) Summary for the URight Hemoglobin A1c System and FORA A1c System. It describes the device, its intended use, and performance characteristics in comparison to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the performance characteristics. Instead, it presents the results of various validation studies (linearity, precision, accuracy, interference, matrix comparison) which demonstrate the device's performance against a reference method (Tosoh G8 analyzer) or established expectations for diagnostic devices of this type.
Interpretation for Acceptance Criteria and Performance:
For this type of device, "acceptance criteria" are typically implied requirements for analytical performance that are considered acceptable for clinical use and demonstrate substantial equivalence to a predicate device. These criteria often relate to quantitative measures like R-squared values for correlation, percent recovery for linearity, and Coefficients of Variation (CV%) for precision.
Given the context, I will infer the acceptance criteria based on generally accepted standards for HbA1c assays and what is presented as demonstrating acceptable performance for regulatory approval.
| Performance Characteristic | Inferred Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|---|
| Linearity | R² ≥ 0.98 or similar high correlation; Recovery within a tight range (e.g., 90-110%) | R² = 0.9913; Recovery = 95-104% |
| Precision (Within-run %CV) | Should be low, typically |
§ 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).