(268 days)
The OneDraw™ A1C Test System, which consists of the OneDraw Blood Collection Device and the OneDraw A1C Test, is intended to collect capillary blood from the upper arm of individuals 18 years of age or older onto filter (matrix) paper within the collection device by a healthcare professional. Samples are delivered to the laboratory for the quantitative measurement of HbA1c for monitoring the long-term control of blood sugar (glucose) in people with diabetes. Testing performed on samples collected with this device should not be used to diagnose or screen for diabetes. The OneDraw A1C Test System should not be used with neonates.
The OneDraw™ A1C Test System includes the OneDraw Blood Collection Device and the OneDraw A 1C Test. The OneDraw Blood Collection Device is a single-use, sterile, capillary blood specimen collection device. The OneDraw Blood Collection Device includes a transport sleeve, accessories, and instructions (OneDraw Blood Collection Device Instructions for Use (IFU)) which are needed to collect, package, and mail the sample to the designated certified clinical laboratory for HbA1c testing, using the OneDraw A1C Test.
The OneDraw Blood Collection Device incorporates lancets to make incisions in the skin and a vacuum to draw blood at the surface of the skin through channels to deposit the blood onto collection and stabilization matrices (matrix strips). The matrix strips are contained within a cartridge which is removed from the device after the draw is complete. The cartridge is then inserted into the transport sleeve which encloses and protects the sample during shipping to the clinical laboratory.
Once the transport sleeve containing the sample is received by the clinical laboratory, one of the dry blood sample matrices is removed. The matrix is then eluted in Beckman Hemolyzing Reagent (BHR) in 2 mL tubes or 2.2 mL deepwell plates using an orbital shaker. Next, the sample is diluted in BHR to its final concentration and tested using FDA-cleared Beckman Coulter AU480 Chemistry Analyzer and A 1 c reagents, including calibrators, (K 120199) per the OneDraw A 1 C Test IFU.
The document describes the OneDraw™ A1C Test System, which includes the OneDraw Blood Collection Device and the OneDraw A1C Test. The device is intended to collect capillary blood from the upper arm for quantitative measurement of HbA1c in people with diabetes. The testing is not for diagnosis or screening of diabetes and should not be used with neonates. The following information outlines the acceptance criteria and the studies performed to demonstrate the device meets these criteria.
1. Table of Acceptance Criteria & Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from Study Outcomes) | Reported Device Performance |
|---|---|---|
| Precision (Assay) | Repeatability (within-run and within-day) %CV expected to be low for HbA1c measurements across relevant ranges. | Repeatability (within-run and within-day): |
| Sample 1 (5.10% HbA1c) | - | Within-run SD: 0.073, %CV: 1.44%; Within-day SD: 0.030, %CV: 0.58%; Total SD: 0.119, %CV: 2.33% |
| Sample 2 (6.46% HbA1c) | - | Within-run SD: 0.091, %CV: 1.40%; Within-day SD: 0.033, %CV: 0.51%; Total SD: 0.135, %CV: 2.09% |
| Sample 3 (7.87% HbA1c) | - | Within-run SD: 0.082, %CV: 1.05%; Within-day SD: 0.025, %CV: 0.32%; Total SD: 0.114, %CV: 1.45% |
| Sample 4 (11.44% HbA1c) | - | Within-run SD: 0.119, %CV: 1.04%; Within-day SD: 0.071, %CV: 0.62%; Total SD: 0.161, %CV: 1.40% |
| Precision (Device) | Low %CV for lot-to-lot and operator-to-operator variability to ensure reproducibility. | Lot-to-Lot Analysis: Average CV: 1.6% (range: 0.0% - 3.6%). |
| • 8.5% show significant negative bias and should not be used. | ||
| Limits of Detection | Match the established linearity range. | Claimed measuring range: 4.70%-14.3% HbA1c. |
| Product Stability | OneDraw Blood Collection Device stable for 12 months. Samples stable for 21 days at room temperature, robust to temperature excursions. | Device: 12-month expiry date confirmed. |
| Sample storage and shipping: Stable for up to 21 days at room temperature. Extreme temperature excursions do not cause significant difference in HbA1c measurement. Matrices and transport sleeves withstand stressed shipping/storage conditions. | ||
| Flex Studies | Acceptable performance across variations in blood volume, hematocrit, and comparability of matrix strips and collection methods. | Blood Volume: 52.5 µL and 90 µL volumes were within ±10% relative bias compared to 75 µL samples. |
| Hematocrit: Varying hematocrit levels do not interfere. | ||
| Matrix Strip Comparability: No significant difference in %HbA1c results between the two matrix strips in the same cartridge. | ||
| Collection Method Comparability: HbA1c results from dried whole blood spotted on matrix strips and capillary blood collected with OneDraw device are comparable to standard venipuncture (venous whole blood). |
2. Sample Size for Test Set and Data Provenance
- Precision (Assay - Repeatability): 80 data points were collected. The source of the blood samples is not explicitly mentioned as a specific country of origin, but the testing was performed in the context of an FDA submission, implying a US-based or international study adhering to US regulatory standards. It is a prospective study as samples were specifically analyzed for the purpose of the study.
- Precision (Device - Lot-to-Lot Analysis): 23 participants. The study involved multiple collection sites, suggesting prospective data collection.
- Precision (Device - Operator-to-Operator): 25 participants. The study involved multiple collection sites, suggesting prospective data collection.
- Method Comparison: 107 participants. Blood collections were conducted at two different clinical sites. This implies prospective collection for the study.
- Linearity, Interference, Limits of Detection, Product Stability, Flex Studies: The sample sizes (e.g., number of replicates, levels tested, specific blood specimens) were described within each section (e.g., "at least 20 days, two runs per day" for assay precision, "two (2) HbA1c levels... six (6) blood volumes per level... 6 matrix strips per volume" for blood volume flex study). Data provenance is prospective testing conducted for the device's validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- The document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for this in vitro diagnostic device.
- Instead, the ground truth for HbA1c measurements is established by comparison to a "standard venipuncture (tested using Beckman's NGSP-certified method on the Beckman Coulter AU480 Analyzer)" (for method comparison) and other established laboratory methods and guidelines (e.g., CLSI guidelines). The accuracy of these reference methods is implicitly accepted as the ground truth.
- The qualifications of the personnel operating the reference methods are not explicitly stated but are assumed to be trained laboratory professionals.
4. Adjudication Method for the Test Set
- Adjudication methods (like 2+1, 3+1) are typically used in image-based diagnostic studies where human interpretation of medical images can vary.
- For this in vitro diagnostic device, which provides quantitative measurements, there is no "adjudication" in the sense of reconciling differing expert opinions. The performance is assessed by comparing the device's quantitative results against established reference methods or accepted criteria through statistical analysis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted.
- MRMC studies are relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This device is a blood collection and testing system for HbA1c, not an AI diagnostic imaging tool or a system designed to assist human readers in interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, the performance studies described are essentially standalone performance evaluations of the OneDraw™ A1C Test System.
- The device functions as a blood collection and testing system, and its output (HbA1c levels) is directly measured and compared to reference methods. There is no "human-in-the-loop" interpretative step by a medical professional whose diagnostic accuracy is being augmented or tested. The healthcare professional collects the sample, but the analysis is done by the device system and associated laboratory methods.
7. Type of Ground Truth Used
- The ground truth used is primarily based on reference laboratory results obtained from "standard venipuncture (tested using Beckman's NGSP-certified method on the Beckman Coulter AU480 Analyzer)" for HbA1c measurement.
- Other ground truth validations include established ranges for linearity, known concentrations for interference testing, and performance against recognized CLSI guidelines for precision, stability, and limits. This is essentially measurement against accepted reference methods and established statistical criteria.
8. Sample Size for the Training Set
- The document does not describe explicit "training sets" in the context of machine learning or AI models.
- This device is an in vitro diagnostic system for quantitative measurement, not a machine learning algorithm that requires a training set in the typical sense.
- The "development" or "internal validation" data—distinct from the performance data presented for regulatory submission—is not detailed in this summary.
9. How the Ground Truth for the Training Set Was Established
- As concluded in point 8, the document does not describe a "training set" for a machine learning model for which ground truth would need to be established. Therefore, this question is not applicable based on the provided information.
§ 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).