(59 days)
The SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent Kit, in conjunction with SYNCHRON HbA1c Calibrators and SYNCHRON HbA1c Hemolyzing Reagent, is intended for the quantitative determination of Hemoglobin A1c concentrations in whole blood on SYNCHRON Clinical Systems.
The SYNCHRON Hemoglobin A1c (HbA1c) Reagent kit contains two reagents, Hb and A1c for determining the Hemoglobin A1c concentrations in whole blood on SYNCHRON Clinical Systems.
Here's an analysis of the provided text regarding the Beckman SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent, structured according to your requirements:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Note: This document describes an in vitro diagnostic (IVD) reagent, not an AI/ML powered device. Therefore, many of the requested fields (like those pertaining to AI model performance, expert ground truth, MRMC studies, or training sets) are not applicable. I will indicate "N/A" where appropriate and provide relevant information based on the type of device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for slope, intercept, r-value, or imprecision directly. Instead, it presents the results of equivalence studies against a predicate device and a reference method. The "acceptance" is implied by the FDA's substantial equivalence determination, meaning the performance of the new device is comparable to legally marketed devices.
However, we can infer the performance metrics from the results provided:
| Performance Metric | Acceptance Criteria (Implied by equivalence) | Reported Device Performance (SYNCHRON HbA1c Reagent) |
|---|---|---|
| Method Comparison (vs. Predicate): | ||
| Slope | Close to 1.0 | 0.9906 |
| Intercept | Close to 0.0% | -0.19% |
| Correlation Coefficient (r) | High (typically > 0.95 for good correlation) | 0.9698 |
| Method Comparison (vs. HPLC): | ||
| Slope | Close to 1.0 | 0.9937 |
| Intercept | Close to 0.0% | -0.25% |
| Correlation Coefficient (r) | High (typically > 0.95 for good correlation) | 0.9678 |
| Within-Run Imprecision: | Low %CV for each level | Level 1: 4.5% CV (Mean 6.05% HbA1c) |
| Level 2: 3.0% CV (Mean 8.75% HbA1c) | ||
| Level 3: 2.9% CV (Mean 10.73% HbA1c) | ||
| Total Imprecision: | Low %CV for each level | Level 1: 7.2% CV (Mean 6.05% HbA1c) |
| Level 2: 6.0% CV (Mean 8.75% HbA1c) | ||
| Level 3: 6.9% CV (Mean 10.73% HbA1c) | ||
| Stability | Adequate shelf-life and in-use stability | Results not numerically provided in summary |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the method comparison studies beyond implying "data" was used. The imprecision study specifies a sample size (N) of 80 for each level tested for both within-run and total imprecision.
Data Provenance: Not specified, but implied to be clinical samples or controls used in laboratory settings for method comparison and imprecision studies. Country of origin not mentioned. The studies appear retrospective in the sense that they are conducted on samples/controls to compare against established methods, not necessarily prospectively collected for this trial alone.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is an IVD reagent. "Ground truth" for this type of device is established by the results of accepted reference methods or predicate devices, as well as the intrinsic chemical properties and stability of the reagent itself. No human experts are establishing "ground truth" in the way they would for image interpretation or diagnosis.
4. Adjudication Method for the Test Set
N/A. As an IVD reagent, adjudication methods for expert consensus are not applicable. The comparison is quantitative against established methods.
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
N/A. This is an IVD reagent, not an AI/ML powered device. No human readers or AI assistance are involved in the direct output of the device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in spirit. The performance data (method comparison, imprecision, stability) represent the intrinsic performance of the SYNCHRON HbA1c Reagent system (reagent + SYNCHRON analyzer) operating in a "standalone" fashion to generate a quantitative result. There is no human interpretation or intervention in deriving the numerical output. The human operator's role is in running the test and interpreting the final quantitative value within a clinical context.
7. The Type of Ground Truth Used
For the method comparison studies, the "ground truth" was established by:
- The predicate device: Tina-quant® Hemoglobin A1c Assay on a SYNCHRON CX4CE System.
- A reference method: Biorad Diamat™ HPLC Hemoglobin A1c Method.
For imprecision studies, the "ground truth" is the true concentration of the assayed control material, against which the variability of repeated measurements is assessed.
8. The Sample Size for the Training Set
N/A. This is an IVD reagent. There is no "training set" in the context of machine learning or AI models. The development and optimization of the reagent formulation and assay parameters would involve internal R&D studies, but these are not referred to as "training sets" in this context.
9. How the Ground Truth for the Training Set was Established
N/A. See point 8.
§ 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).