(137 days)
Afinion™ AS100 Analyzer System, consisting of the Afinion™ AS100 Analyzer Afinion™ Test Cartridges and Afinion™ Controls is for in-vitro diagnostic use only. Afinion™ AS100 Analyzer is a compact multi-assay analyzer for point-of -care testing, designed to analyze the Afinion™ Test Cartridges. The Afinion™ Analyzer System is easy to use, rapid and gives reliable and accurate results.
Afinion™ HbA Ic is an in-vitro test for quantitative determination of glycated hemoglobin in human blood. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.
Afinion™ HbA1c Controls have been designed for use with the Afinion™ AS100 Analyzer System. Quality control using the Afinion™ HbA 1c Control should be done to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.
Instrument read, single usc in-vitro test for quantitative determination of glycated hemoglobin in human whole blood.
Afinion™ AS100 Analyzer utilizes a digital camera and Light Emitting Diodes to perform two kinds of measurements; reflection mcasurement (amount of light rcflected from a membrane) and transmission measurement (amount of light propagating through a liquid). The analyzer is self-calibrated and no calibration by user is needed.
This looks like a 510(k) summary for a medical device called Afinion™ HbA1c, Afinion™ HbA1c Control, and Afinion™ AS100 Analyzer. I will extract the requested information based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally inferred from the "acceptable agreement" statements and specific thresholds mentioned for CV, linearity, and interference.
| Study Type | Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Method Comparison (Internal) | Acceptable agreement (implied by predicate equivalence) | Bias: -0.3 % HbA1c; 95% Limit of Agreement: -1.0 to 0.4 % HbA1c (vs. Bayer DCA 2000®) |
| Method Comparison (External) | Acceptable agreement (implied by predicate equivalence) | Slope: 0.91; y-intercept: 0.2 % HbA1c; r²: 0.96 (vs. Bayer DCA 2000®) |
| Method Comparison (vs. ERL Ref Method) | Excellent agreement (implied by predicate equivalence) | Bias: 0.0 % HbA1c; 95% Limit of Agreement: -0.3 to 0.3 % HbA1c (vs. Primus CLC385) |
| Capillary vs. Venous Blood | Excellent agreement | Bias: 0.0 %; 95% Limit of Agreement: -3.5 to 3.6 %; Slope: 0.99; y-intercept: 0.1 % HbA1c; r²: 0.99 |
| Precision (Internal) | Within-run CV |
§ 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).