Search Results

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.

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.

Ask a specific question about this device

Afinion™ HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) 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™ HbA1c Dx is a fully automated boronate affinity assay for the determination of the percentage of hemoglobin A1c in human whole blood. The Afinion™ HbA1c Dx is a modification of the existing device, Alere Afinion™ HbA1c for use with the Alere Afinion™ AS100 Analyzer, with the addition of a diagnostic intended use.

The test begins with a blood sample collected with the integrated sampling device before the test cartridge is placed in the cartridge chamber of the Alere Afinion™ AS100 Analyzer. The sample is then automatically diluted and mixed with a solution that releases hemoglobin from the erythrocytes. After the hemoglobin is precipitated, the sample mixture is transferred to a blue boronic acid conjugate which binds to the cis-diols of glycated hemoglobin. This reaction mixture is soaked through a filter membrane and all precipitated hemoglobin, conjugate-bound and unbound (i.e. glycated and non-glycated hemoglobin) remains on the membrane. Excess conjugate is removed with a washing reagent. The analyzer measures the reflectance of the precipitate on the membrane as blue (glycated hemoglobin) and red (total hemoglobin) color intensities. The analyzer calculates a ratio proportional to the percentage of HbA1c in the sample and displays as the % HbA1c (NGSP).

The medical device is the Afinion™ HbA1c Dx, a fully automated boronate affinity assay for the determination of the percentage of hemoglobin A1c in human whole blood. It is an in vitro diagnostic test for the quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human venous and capillary whole blood. Its intended use is as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. It is also used as a marker of long-term metabolic control in persons with diabetes mellitus.

1. Table of Acceptance Criteria and Reported Device Performance

All reported TE values are ≤ 6.0%. |
| Precision/Reproducibility | Not explicitly stated as a single numerical acceptance criteria in terms of SD or CV, but assessed through detailed studies. | Internal (Venous Whole Blood): Total %CV ranged from 1.32% to 1.74% across HbA1c levels and analyzers.
External (Venous Whole Blood): Total %CV ranged from 1.22% to 1.78% across HbA1c levels.
Fingerstick Samples (Combined Studies): Total %CV ranged from 1.30% to 2.03% across HbA1c levels. |
| Linearity/Reportable Range | No specific numerical acceptance criterion stated, but implicitly expected to cover the medical decision range. | Reportable range: 4.00-15.00 % HbA1c (DCCT/NGSP). Previously established in K050574. |
| Endogenous Interference | Significant interference defined as exceeding a 7% change in %HbA1c value from control. | No significant interference observed for tested substances (Bilirubin, Glucose, Intralipid, Rheumatoid factor, Total protein) at specified concentrations. |
| Hemolysis Interference | Significant interference defined as exceeding a 7% change in %HbA1c value from control. | No significant interference observed up to 24% hemolysis. Information codes related to hemolysis may occur above 14% hemolysis. |
| Drug Interference | Significant interference defined as exceeding a 7% change in %HbA1c value from control. | No significant interference observed for 20 tested drugs at specified concentrations. |
| Cross-reactivity with Hemoglobin Derivatives | Significant interference defined as exceeding a 7% change in %HbA1c value from control. | No significant interference observed for Acetylated hemoglobin, Carbamylated hemoglobin, Labile HbA1c, and Glycated albumin at specified concentrations. |
| Hemoglobin Variants Interference | Significant interference defined as exceeding a 7% change in %HbA1c value from reference method. | No significant interference for HbA2, HbS, HbC, HbE, HbD. Significant negative interference with HbF (highest concentration with no significant interference at 10.4% HbF). Device includes a prominent boxed warning for HbF. |

2. Sample Sizes Used for the Test Set and Data Provenance

• Accuracy/Method Comparison Study (Test Set):
  • Sample Size: 120 subjects.
  • Data Provenance: Samples from each study subject were tested with both fingerstick samples and fresh venous EDTA samples. Divided across three study sites. Retrospective or prospective is not explicitly stated, but the collection of fresh venous and fingerstick samples suggests it was prospective. The country of origin of the data is not specified.
• Precision (Internal, Venous Whole Blood): 4 levels of HbA1c patient samples. Each level tested with 2 replicates, twice a day for 20 days with 3 lots on 3 analyzers. (240 measurements per analyzer, 720 combined).
• Precision (External, Venous Whole Blood): 4 levels of HbA1c patient samples. 4 replicates analyzed twice a day for 10 days with 3 lots at each of 3 sites, using 3 analyzers.
• Precision (Fingerstick Samples):
  • Study A (Accuracy study - within-run): 172 subjects (fingerstick samples in duplicate).
  • Study C (Between-instrument and between-operator): 15-16 subjects per HbA1c level (total of 4 levels) across 3 sites. Each subject gave 6 fingerstick samples. Total of 90-96 fingerstick measurements per level.
• Between-Instrument Precision: 4 venous whole blood samples measured in 6 replicates on each of 14 analyzers with 1 test cartridge lot (total of 84 replicates per sample).
• Lot-to-Lot Variation: 18 EDTA venous whole blood samples spanning the reportable range. Each sample analyzed in 1 replicate with each of 3 test cartridge lots on the same analyzer.
• Endogenous/Hemolysis/Drug Interference, Hemoglobin Derivatives Cross-reactivity: Whole blood sample pools. Specific number of samples not given, but tested with 10 replicates for each condition/substance.
• Hemoglobin Variants Interference: 234 fresh EDTA whole blood samples containing 6 common hemoglobin variants. Also, 100 samples for HbA0, HbA1a, HbA1b components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• For the Method Comparison study, the ground truth was established by an NGSP secondary reference laboratory method (Tosoh Glycohemoglobin test on the G8 HPLC analyzer). This method itself serves as the "expert" or gold standard. The document does not specify the number or qualifications of human experts involved in operating or verifying this reference method.

4. Adjudication Method for the Test Set

• The document implies that the reference method (Tosoh G8 HPLC) was considered the definitive ground truth for the method comparison study. There is no mention of a human adjudication method (like 2+1 or 3+1 consensus) for the test set results against the reference method. The comparison was statistical, using Deming and Passing-Bablok regressions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This device is an automated in vitro diagnostic test (HbA1c assay). It does not appear to involve "human readers" in the sense of image interpretation or other judgmental tasks where AI assistance might improve their performance. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

• Yes, the performance studies described are for the "algorithm only" (device only) performance. The Afinion™ HbA1c Dx is a fully automated system for determining HbA1c. The performance metrics (precision, accuracy, interference, etc.) reflect the standalone operation of the device.

7. The Type of Ground Truth Used

• The ground truth used for the method comparison and hemoglobin variant interference studies was a reference method, specifically an NGSP secondary reference laboratory method (Tosoh Glycohemoglobin test on the G8 HPLC analyzer). For interference studies, the ground truth was derived from non-spiked control samples or reference samples without the interfering substance.

8. The Sample Size for the Training Set

• The document describes performance characteristics for the Afinion™ HbA1c Dx. It does not provide information on a separate "training set" for an algorithm, as this typically applies to machine learning models. Instead, the device is a chemical assay with established analytical principles. Therefore, a distinct "training set" size in the context of an AI/ML algorithm is not applicable as presented in this document. The "training" or development would refer more to the optimization and validation of the analytical method itself.

9. How the Ground Truth for the Training Set Was Established

• As a chemical assay rather than an AI/ML algorithm, the concept of a "training set" with established ground truth is not applicable in the same way. The device's analytical method (boronate affinity assay) is based on scientific principles and validated through extensive performance testing as detailed in the document, against established reference methods.

Ask a specific question about this device