(636 days)
Afinion™ HbA1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (1c, HbA1c) in venous and capillary human whole blood. The measurement of % HbA1c is recommended as a marker of longterm metabolic control in persons with diabetes mellitus.
Afinion™ 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ test cartridges. Afinion™ 2 system, consisting of Afinion™ test cartridges is for in vitro diagnostic use only.
Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion™ Analyzer to a laboratory information system or another electronic journal system.
Alere Afinion™ AS100 Analyzer System, consisting of Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC), Afinion™ Test Cartridges and Afinion™ Controls is for in vitro diagnostic use only,
The Afinion™ HbA1c is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, % HbA1c) in human whole blood. The measurement of % HbA1c is recommended as a marker of long term metabolic control in persons with diabetes mellitus.
The Afinion™ HbA1c assay is designed to be used with the Afinion™ AS100 Analyzer and the Afinion™ 2 analyzer which are compact multi-assay analyzers for point-of-care testing. Quality control using the Afinion™ HbA1c Control is recommended to confirm that the system is working properly and provides reliable results.
The provided text is a 510(k) premarket notification for a medical device, specifically an in-vitro diagnostic test. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical performance study for an AI/ML-based medical device.
The document discusses analytical performance characteristics but does not present clinical performance data with a test set, ground truth established by experts, or MRMC studies. The core of this submission is about demonstrating equivalence to existing, cleared devices rather than providing novel clinical efficacy data for a new type of device or an AI algorithm.
Therefore, I cannot provide all the requested information for an AI/ML device study. I can extract the analytical performance characteristics that serve as "acceptance criteria" for this IVD and the reported device performance within the scope of this regulatory submission.
Here's an attempt to answer the questions based on the provided document, noting the limitations of the document's content for AI/ML specific criteria:
Device: Afinion™ HbA1c, Afinion™ 2, Alere Afinion™ AS100 Analyzer
The device is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (HbA1c) in human whole blood, used as a marker for long-term metabolic control in persons with diabetes mellitus. This is a chemical assay, not an AI/ML device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here refer to analytical performance specifications, not clinical performance for an AI/ML algorithm. The document presents a comparison of the "Candidate Device" (Modified Afinion™ HbA1c) with predicate devices, highlighting improvements or more detailed specifications for analytical specificity and interference.
| Category | Acceptance Criteria (Implied by Predicate/New Specificity) | Reported Device Performance (Candidate Device - Modified Afinion™ HbA1c) |
|---|---|---|
| Analytical Specificity: Hemoglobin Variants & Derivatives | Predicate: HbAC, HbAD, HbAE, HbF, HbAJ, HbAS, Carbamylated Hb, Pre-glycated Hb do not affect result. | No significant interference (≤ 7%) observed for samples with hemoglobin (Hb) variants and hemoglobin derivatives up to the following concentrations: |
| • HbA2 5.7% | ||
| • HbAC 36% | ||
| • HbAD 42% | ||
| • HbAE 26% | ||
| • HbAS 42% | ||
| • HbF 10.4% | ||
| • Acetylated Hb 4.6 mg/mL | ||
| • Carbamylated Hb 13.8 mg/mL | ||
| • Labile (pre-glycated) Hb 11.4 mg/mL | ||
| Limitations (HbF) | Predicate: No HbF limitation. | The highest HbF concentration where no significant interference (≤ 7%) is observed is 10.4% HbF. Above 10.4% HbF, a negative interference is observed. |
| Limitations (Sample Condition) | Predicate: Do not analyze hemolyzed or coagulated samples. | Coagulated or hemolyzed samples cannot be used with Afinion™ HbA1c. Samples with >14% (2000 mg/dL) hemolysis may return an information code. |
| Interference (Endogenous/Exogenous Substances) | Predicate: No significant interference ( |
§ 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).