(85 days)
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), Alere Afinion™ Test Cartridges and Alere Afinion™ Controls is for in vitro diagnostic use only.
Alere 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 longterm metabolic control in persons with diabetes mellitus.
Alere Afinion™HbA1c Controls have been designed for use with the Alere Afmion™AS100 Analyzer System. Quality control using the Alere Afinion™HbA1c Control should be done to confirm that the Alere Afinion™AS100 Analyzer System is working properly and provides reliable result.
The Alere Afinion™ ACR assay is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine using the Alere Afinion™ AS100 Analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.
The Alere Afinion™ ACR Control kit contains liquid preparations of albumin and creatinine in citrate buffer. The controls should be used to confirm that the Alere Afinion™AS100 Analyzer System is working properly and provides reliable results.
The Afinion™ Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio) are used in the diagnosis and treatment of disorders involving excess or low cholesterol in the blood and lipid and lipoprotein metabolism disorders. Afinion™ Lipid Panel Control has been designed for use with the Afinion™ AS100 Analyzer and Afinion™ Lipid Panel. Afinion™ Lipid Panel Control is intended for use as assayed control material for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.
For use in clinical laboratories and point of care laboratory settings. For prescription use only.
The Alere Afinion HbA1c test cartridge contains all of the reagents necessary for the determination of % HbA1c. The sample material is collected from a fingerstick or a sample tube with the integrated sampling device before the test cartridge is placed in the cartridge chamber of the Alere Afinion AS100 Analyzer. The blood sample is then automatically diluted and mixed with a solution that releases hemoglobin from the erythrocytes. The hemoglobin precipitates. This 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. Any excess of conjugate is removed with a washing reagent. The analyzer evaluates the precipitate on the membrane. By measuring the reflectance, the blue (glycated hemoglobin) and the red (total hemoglobin) color intensities are evaluated, the ratio between them of which is proportional to the percentage of HbA1c in the sample. The % HbA1c is displayed on the Alere Afinion™ AS100 Analyzer.
The analyzer uses different chemical and mechanical assay methods combined with advanced, computerized processing and measuring technology to perform a variety of diagnostic assays.
A test cartridge with patient sample or control is placed in the cartridge chamber of the analyzer. By manually closing the lid, the test cartridge is transported into the analysis compartment of the analyzer. There is no further user intervention or activity required to perform the assay. Test and lot specific information are obtained from the test cartridge barcode label, which then initiates the processing of the test. The sample and reagents are automatically transferred between the wells of the test cartridge.
A monochrome solid-state camera monitors the entire process. When the assay is completed, lightemitting diodes (LEDs) illuminate the final reaction area, which can be either a colored membrane or a reaction well. The camera detects the reflected or transmitted light, which is converted to a test result and displayed on the touch screen. When the user accepts the result, the lid covering the cartridge chamber opens automatically and the used test cartridge can be removed and discarded. The analyzer is then ready for the next run.
The current sampling device integrated in the test cartridge is made of plastic with a glass capillary tube glued into the sampling device. The new, modified plastic sampling device will be manufactured in one piece of plastic of the same base material (polystyrene) as the plastic part of the current sampling device.
The provided text describes a 510(k) premarket notification for a modification to the Alere Afinion HbA1c and Alere Afinion AS100 Analyzer. The modification specifically concerns the sampling device capillary, changing it from glass to plastic. The document outlines the study (design control activities) performed to demonstrate that the modified device meets acceptance criteria.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "acceptance criteria were set to maintain the efficiency and safety of the assay in the hands of waived users" and that the verification/validation program included studies of "precision, accuracy, robustness and potential interference of plastic additive as well as external waived user studies." However, the specific quantitative acceptance criteria and the detailed reported device performance against these criteria are not provided in the publicly available summary. The document only offers a general statement: "all verification and validation activities were performed and the results demonstrated that the predetermined acceptance criteria were met."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "in-house studies" and "external waived user studies."
- Sample Size for Test Set: The specific number of samples (e.g., number of patient samples, number of replicates) used in these studies is not explicitly stated in the provided text.
- Data Provenance: The document implies the studies were conducted by Alere Technologies AS. The location of "in-house" studies is likely Norway (where Alere Technologies AS is based). "External waived user studies" suggests data collected from various waived user sites, but no specific countries or locations are mentioned. It is retrospective in the sense that the data proving the device meets acceptance criteria has already been collected and is being used to support the premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. Given that the device measures glycated hemoglobin, the ground truth would likely be established using a reference method in a clinical laboratory.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study, which typically involves human readers and assesses the impact of AI assistance, is not applicable to this device. This device is an in-vitro diagnostic assay and analyzer, not an AI-assisted diagnostic tool for human interpretation.
6. Standalone Performance Study
Yes, a standalone study (algorithm/device only performance) was conducted. The "in-house studies of precision, accuracy, robustness and potential interference of plastic additive" and "external waived user studies" would assess the Alere Afinion AS100 Analyzer's performance with the modified sampling device independently. The entire premise of this 510(k) is to demonstrate the modified device's performance when used alone.
7. Type of Ground Truth Used
The ground truth for the HbA1c measurement would be established by a reference method for glycated hemoglobin in human whole blood, typically performed by a laboratory instrument following established clinical laboratory standards. The document doesn't explicitly state the specific reference method used, but it's implied by the nature of the device (in-vitro diagnostic for quantitative determination of % HbA1c).
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an AI/machine learning model. This is an IVD device, and the verification and validation studies are typically used to confirm the performance characteristics rather than to train an algorithm.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of AI/machine learning for this IVD device, this question is not applicable. The "ground truth" for evaluating the device's accuracy would be established by comparing its results to a recognized reference method.
§ 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).