(31 days)
Afinion™ HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% homoglobin Alc, HbAlc) in human venous and capillary whole blood.
This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.
The Afinion™ 2 System consisting of the Afinion™ 2 Analyser and the Afinion™ Test Cartridges is for in vitro diagnostic use only. The Afinion™ 2 Analyzer is a compact multi-of-care testing and is designed to analyze the Afinion™ Test Cartridges.
The Afinion™ HbA1c Dx test system is a CLIA moderate complexity test for diagnosing diabetes and identifying patients who may be at risk for developing diabetes, as a marker of long-term metabolic control in persons with diabetes mellitus.
The Afinion 2 is a multi-assay analyzer for point-of-care testing, designed for use with Afinion assay test cartridges and Afinion controls. It has the same functionality as the Afinion AS100 analyzer performing identical assay processing.
The provided text describes the 510(k) premarket notification for the Afinion™ HbA1c Dx on Afinion™ 2 device. It focuses on demonstrating substantial equivalence to a predicate device (Afinion™ HbA1c Dx on Alere Afinion™ AS100 Analyzer) rather than explicitly outlining a standalone clinical study for new acceptance criteria.
However, the document states: "Verification and validation studies were performed as required by risk analysis and all acceptance criteria were met." It implies that acceptance criteria were established and subsequently met through these studies. The core of the submission is to show that the modified Afinion 2 analyzer performs equivalently to the previous AS100 analyzer when running the same Afinion HbA1c Dx test.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly list specific numerical acceptance criteria (e.g., specific accuracy, precision targets) and their corresponding reported device performance values in a table format. Instead, it broadly states that "all acceptance criteria were met" and that the analytical performance was not adversely affected.
However, by comparing the candidate device (Afinion™ HbA1c Dx with Afinion™ 2 analyzer) to the predicate device, we can infer that the acceptance criterion for the new analyzer is to maintain the same performance characteristics as the predicate. The "reported device performance" is the demonstration that its performance is equivalent.
| Performance Characteristic | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance |
|---|---|---|
| Analytical Performance | Not adversely affected compared to predicate | All acceptance criteria met; analytical performance not adversely affected |
| Assay Sequence Timing | Maintained as in the predicate (AS100) | Software modifications ensured timing is maintained |
| Functionality | Same as the predicate (AS100) | Same functionality as predicate |
| User Interface | Same as the predicate (AS100) | Same user interface as predicate |
| Error Rates | Equivalent to predicate | Risk analysis showed no adverse effect on risk of erroneous results |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "in-house analytical performance verification studies" but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to these as part of "design control activities" to address risk analysis.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The nature of the device (an HbA1c test system) suggests that "ground truth" would likely be based on established reference methods or certified values, rather than expert consensus on images or interpretations.
4. Adjudication Method for the Test Set:
This information is not provided in the document. Given the type of diagnostic test (quantitative determination of glycated hemoglobin), clinical adjudication by experts is unlikely to be the primary method for determining ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC study is typically for evaluating human reader performance, often in image-based diagnostics. This device is an automated in vitro diagnostic test system. Therefore, an MRMC comparative effectiveness study involving human readers is not applicable and was not performed.
6. Standalone (Algorithm Only) Performance:
The entire submission focuses on the performance of the "Afinion™ HbA1c Dx on Afinion™ 2" as a complete system, which is an automated diagnostic test. Therefore, the "standalone" performance is the algorithm's performance integrated into the device, using the specified test cartridges. There is no human-in-the-loop component for the measurement itself. The study details, though not fully disclosed, would pertain to the device operating in this standalone manner.
7. Type of Ground Truth Used:
The document states that the Afinion HbA1c Dx is "traceable to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Reference Method for Measurement of HbA1c" and "certified by NGSP (National Glycohemoglobin Standardization Program)." This indicates that the ground truth for performance evaluation (e.g., accuracy, bias) is established by reference methods and standardization programs rather than expert consensus, pathology, or direct outcomes data.
8. Sample Size for the Training Set:
The document does not provide details on a "training set" or its sample size. This type of device is likely developed and validated using a more traditional analytical validation approach based on measurement science, rather than a machine learning paradigm that typically involves distinct training and test sets. It implies a process of design, calibration, and verification/validation.
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a traditional "training set" in the context of machine learning, this information is not applicable and a method for establishing its ground truth is not provided. The development and calibration of the test would rely on rigorous analytical methods and established reference materials, as indicated by its traceability to IFCC and NGSP certification.
§ 862.1373 Hemoglobin A1c test system.
(a)
Identification. A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA.
(2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following:
(i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable.
(ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method.
(iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent.
(iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.
(3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.