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510(k) Data Aggregation
(113 days)
The Hemoglobin A1c- reagent, when used in coniunction with UniCel® DxC 600/800 SYNCHRON® Systems, UniCel® DxC SYNCHRON® Systems HbA1c-Calibrators and SYNCHRON® and AU® Systems Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood.
Measurement of hemoglobin A1c measures long-term alvcemic control in patients with diabetes mellitus.
The UniCel DxC SYNCHRON Systems Hemoglobin A1c- (HbA1c-) Reagent is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. The UniCel DxC Systems utilize two unique cartridges, Hband A1c-, to determine hemoglobin A1c concentration as a ratio of total hemoqlobin.
Hb- reagent is used to measure total hemoglobin concentration by a colorimetric method. The system automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 8.6 parts reagent. The system monitors the change in absorbance at 410 nanometers. This change in absorbance is directly proportional to the concentration of total hemoglobin in the sample and is used by the system to calculate and express total hemoglobin concentration.
A1c- reagent is used to measure the hemoglobin A1c concentration by a turbidimetric immunoinhibition method. In the reaction, hemoglobin A1c antibodies combine with hemoglobin A1c from the sample to form soluble antigen-antibody complexes. Polyhaptens from the reagent then bind with the excess antibodies and the resulting agglutinated complex is measured turbidimetrically. The system automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 28 parts reagent. The system monitors the change in absorbance at 340 nanometers. This change in absorbance is inversely proportional to the concentration of hemoglobin A1c in the sample and is used by the systems to calculate and express hemoglobin A1c concentration as a ratio of total hemoglobin.
This 510(k) premarket notification describes the UniCel DxC SYNCHRON Systems Hemoglobin A1c- (HbA1c-) Reagent, which is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. The submission compares the modified device to a predicate device and presents performance study results to demonstrate substantial equivalence.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Area of Study | Test Protocols | Acceptance Criteria | Reported Device Performance (Pass/Fail) |
|---|---|---|---|
| Method Comparison | CLSI EP9A | Slope 1.0 ± 0.05, Intercept < ± 0.50, R ≥ 0.97 | Pass |
| Analytic Sensitivity | CLSI EP17A | Total Hemoglobin (Hb-): LoD ≤ 6 g/dL (3.72 mmol/L) Hemoglobin A1c (A1c-): LoD ≤ 0.3 g/dL (0.19 mmol/L) | Pass |
| Linearity | CLSI EP6A | Recovery mean: - within ±6% bias for Hb- - within ±6% bias %HbA1c- - within ±6% bias A1c- ≥0.4 g/dL - within ±15% bias for A1c- < 0.4 g/dL | Pass |
| Precision | CLSI EP5A2 | Within-run: - < 0.4 g/dL A1c-: HbA1c %CV ≤ 5.0 %CV - ≥ 0.4 g/dL A1c-: HbA1c %CV ≤4.0%CV Total: - ≥ 0.4 g/dL A1c-: HbA1c %CV ≤7.5%CV - < 0.4 g/dL A1c-: HbA1c %CV ≤4.0 %CV | Pass |
| Reference Interval | CLSI C28-A3 | 90% of samples fall within reference range (4 - 6 %HbA1c NGSP) | Pass |
| Interferences | CLSI EP7-A2 | No Significant Interference (within ± 6% mathematical) | Pass |
| Specificity | CLSI EP7-A2 | Recovery within ±10% mathematical | Pass |
| Anticoagulants | Development procedures | Slope 1.0 ± 0.05, Intercept < ± 0.75, r ≥ 0.97 | Pass |
| Stability | Development procedures | Recovery of test samples is within ± 6% | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., Method Comparison, Linearity, Precision). It references CLSI (Clinical and Laboratory Standards Institute) protocols, which typically outline recommended sample sizes. However, the exact numbers used in this specific study are not provided.
The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be part of the development and verification process for a commercial medical device, likely conducted internally or with contracted labs. The document does not specify if the data is retrospective or prospective, but given the context of design verification and validation, it is highly likely to be prospective data generated during the development process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device and study. The UniCel DxC SYNCHRON Systems Hemoglobin A1c- (HbA1c-) Reagent is an in-vitro diagnostic device that quantitatively measures a biomarker (HbA1c) in whole blood. The "ground truth" for such devices is established through analytical methods and reference standards, not through expert consensus or interpretation of images/cases.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is an analytical device, and ground truth is not established through expert adjudication of cases.
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
Not applicable. This is an in-vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device's analytical system as a standalone unit, which is the primary focus of all the listed performance studies. The studies assess the accuracy, precision, linearity, sensitivity, etc., of the reagent and instrument system in determining HbA1c concentration. Therefore, all the listed studies can be considered "standalone" in the sense that they evaluate the device's technical performance without human intervention in the HbA1c measurement process itself beyond standard laboratory procedures.
7. The Type of Ground Truth Used
The ground truth for this device is based on analytical reference methods and established standards. For example:
- Method Comparison: Likely compares the new device's results against a previously validated or reference method (the predicate device in this case, or IFCC reference method for calibrator traceability).
- Analytic Sensitivity, Linearity, Precision: Ground truth is derived from known concentrations of analytes, reference materials, and statistical methods to assess the device's ability to accurately and consistently measure those concentrations.
- Calibrator Traceability: Explicitly states "maintaining traceability to IFCC reference method." This indicates that the ground truth for calibration is linked to internationally recognized reference standards for HbA1c.
8. The Sample Size for the Training Set
The document submitted is a 510(k) summary for a reagent, not a machine learning or AI model. Therefore, there is no "training set" in the context of data used to train an algorithm. The development of the reagent and its associated instrument parameters would involve extensive testing and optimization, but this is a different concept than a machine learning training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for an AI algorithm in this context. The "ground truth" for the development and optimization of the reagent and system (analogous to how a training set might inform an algorithm) would be established through established chemical and biochemical principles, analytical testing, and comparison to reference measurement procedures and materials, as described in point 7.
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