(547 days)
The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (%HbA1c) levels in fresh fingerstick capillary blood or venous whole blood samples. This system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes.
The SD A1cCare Spoit Type Test Kit is part of the SD A1cCare System. It includes the test panel that receives the blood sample and is used with the SD A1cCare Analyzer for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh fingerstick capillary or venous whole blood samples. The system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control in persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes.
The SD HbA1c Control Set (Level 1, Level 2) and SD HbA1c Control Level M are intended for use as quality control materials for the SD A1cCare System.
The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh capillary or venous whole blood samples. It is intended for professional use.
The SD HbA1c Control Set is intended for use as quality control materials for the SD A1cCare System.
The SD A1cCare System include the analyzer, analyzer check strip, DC power adapter, immunoassay test panels, lot-specific calibration code chips, and control set.
Here's a breakdown of the acceptance criteria and study information for the SD A1cCare System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that "All testing met acceptance criteria," but it does not provide a table with specific numerical acceptance criteria alongside the reported device performance for each test. Instead, it lists the types of tests conducted.
To provide a tabular format, I will extract the types of tests mentioned under "Functional and Safety Testing" and indicate that the results met unstated acceptance criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| NGSP certification | Met acceptance criteria |
| Accuracy method comparison | Met acceptance criteria |
| Linearity | Met acceptance criteria |
| Precision | Met acceptance criteria |
| Comparison of Spoit Type test kit performance | Met acceptance criteria |
| Hematocrit range | Met acceptance criteria |
| Interferences | Met acceptance criteria |
| Hemoglobin variants | Met acceptance criteria |
| Total hemoglobin | Met acceptance criteria |
| Altitude | Met acceptance criteria |
| Testing time | Met acceptance criteria |
| Operating temperature range | Met acceptance criteria |
| Optimal sample and mixture volume | Met acceptance criteria |
| Anticoagulants | Met acceptance criteria |
| Sample collection and preparation | Met acceptance criteria |
| Stability of blood samples | Met acceptance criteria |
| Vibration | Met acceptance criteria |
| Temperature and humidity | Met acceptance criteria |
| EMC and electrical safety testing | Met acceptance criteria |
| Shelf-life testing | Met acceptance criteria |
| Software verification and validation | Met acceptance criteria |
2. Sample Sizes Used for the Test Set and Data Provenance
The document mentions "a user study clinical evaluation was conducted comparing home user results against a reference method." However, it does not specify the sample size for this test set nor the specific country of origin for the data. It implies the data is prospective, gathered from the user study.
For other functional and safety tests, no specific sample sizes are provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number or qualifications of experts used to establish ground truth. It states "comparing home user results against a reference method," but the nature of this reference method and the involvement of experts in its establishment or application are not detailed.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. It only mentions a comparison against a "reference method."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The device is an immunoassay system designed for quantitative measurement, not an imaging or diagnostic aid typically assessed via MRMC studies. The "user study clinical evaluation" compared home user results to a reference method, which is different from an MRMC study assessing human reader improvement with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Yes, the studies described are indicative of standalone performance of the device. The "SD A1cCare System" is an automated reflectometry immunoassay system. The bench testing and clinical evaluation would assess the performance of this system (analyzer and test kit) in isolation, measuring its accuracy, precision, linearity, etc., without an explicit human-in-the-loop component influencing the measurement itself. The "user study clinical evaluation" did involve home users, but their role was in operating the device, not in interpreting results in conjunction with an AI algorithm.
7. Type of Ground Truth Used
The ground truth for the clinical evaluation was established by a "reference method". The specific nature of this reference method is not detailed, but for HbA1c assays, it typically refers to a highly accurate laboratory method (e.g., HPLC or mass spectrometry, often NGSP-certified) used to provide the true HbA1c values against which the device's measurements are compared.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. Immunoassays like the SD A1cCare System typically use a different development and validation paradigm than machine learning models that require distinct training and test sets. While the system may have undergone internal calibration and optimization during development, the text does not refer to a "training set" in the context of a machine learning algorithm.
9. How Ground Truth for the Training Set Was Established
As no "training set" in the machine learning sense is mentioned, this information is not available in the provided text. The calibration and performance optimization of an immunoassay system would typically be based on a series of characterized samples and reference methods, but this is not referred to as a "training set."
§ 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).