(207 days)
The Avie™ Total Hb Test System is for the quantitative measurement of total hemoglobin in whole blood (capillary or venous EDTA,K2). The test system is designed for point-of-care use in primary care settings. The test system is for professional in vitro diagnostic use only.
The Avie™ Total Hb Test System is a point of care (POC) IVD system that utilizes general chemistry reactions to quantify total hemoglobin in fresh capillary blood and venous blood. The test system includes a small instrument (Reader) and disposable reagent strips- the strips are packaged in a reusable canister with desiccant, similar to the packaging of routine urine test strips. The concentration of total hemoglobin is calculated photometrically and is based on the optical intensity of the reaction within the quantitative area of the test strip. The calibration of the Avie™ Total Hb Test is traceable to the same high-order reference method as the HemoCue (hemiglobincyanide [HiCN].
Here's an analysis of the acceptance criteria and study details for the Avie™ Total Hb Test System based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for each performance metric (e.g., "Slope must be between 0.98 and 1.02"). Instead, it reports the results of the performed studies, implying that these results were considered acceptable for demonstrating substantial equivalence to the predicate device.
However, we can infer performance goals based on the reported values and the comparison to the HiCN method (a high-order reference method). The reported "r" values (correlation coefficients) close to 1.0 indicate a strong correlation, and slopes near 1.0 with y-intercepts near 0 indicate good agreement with the reference method. Precision %CV values in the low single digits ($
§ 864.5620 Automated hemoglobin system.
(a)
Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.(b)
Classification. Class II (performance standards).