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Sigma Diagnostics INFINITY™ HbA1c assay is an in vitro assay for the quantitative determination of hemoglobin A1c (HbA1c) in whole blood for use on automated analyzers.
Sigma Diagnostics INFINITY™ HbA1c is a device to measure the percent hemoglobin A1c in anticoagulated whole blood. Hemoglobin A1c is indicated for the monitoring of long-term glucose control in individuals with diabetes mellitus.
The INFINITY HbA1c assay is a microparticle enhanced turbidimetric immunoassay.
The INFINITY™ HbA1c assay is an in vitro assay for the quantitative determination of hemoglobin A1c (HbA1c) in whole blood for use on automated analyzers.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state formal "acceptance criteria" in terms of predefined performance thresholds (e.g., "correlation coefficient must be ≥ 0.95"). Instead, the substantial equivalence is demonstrated through correlation and regression analysis against two predicate devices. The implicit acceptance criterion is that the correlation coefficients and regression equations should indicate a strong linear relationship and equivalence in measurements.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Correlation Coefficient) | Reported Device Performance (Regression Equation) | Comparator Device |
|---|---|---|---|---|
| Correlation to Roche Diagnostics HbA1c II (on Hitachi 717) | Strong linear correlation expected | 0.976 | y = 0.9513x + 0.4184 | Roche Diagnostics HbA1c II (Cobas Mira) |
| 0.990 | y = 0.9639x + 0.5574 | Roche Diagnostics HbA1c II (Hitachi 911) | ||
| 0.985 | y = 0.8988x + 0.9656 | Roche Diagnostics HbA1c II (Hitachi 717) | ||
| Correlation to Bio-Rad VARIANT™ II HbA1c | Strong linear correlation expected | 0.981 | y = 1.047x - 0.5462 | Bio-Rad VARIANT™ II HbA1c (Cobas Mira) |
| 0.981 | y = 1.046x - 0.2878 | Bio-Rad VARIANT™ II HbA1c (Hitachi 911) | ||
| 0.988 | y = 0.9877x + 0.0711 | Bio-Rad VARIANT™ II HbA1c (Hitachi 717) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 45 patient samples were used for each comparison study.
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission from Sigma Diagnostics Inc. (a US company) to the FDA, it is highly probable that the samples were collected in the United States. The data is retrospective, as patient samples were tested using established methods (predicate devices) and the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in vitro diagnostic (IVD) assay that quantitatively measures a biomarker (HbA1c). The "ground truth" for each sample is assumed to be the measurement obtained by the predicate devices, which are also IVD assays. There is no mention of human expert interpretation of results to establish ground truth for individual samples.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth is established by the measurements from the predicate devices. There is no human interpretation or adjudication involved for the individual sample results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human interpretation is a key component of the diagnostic process. The INFINITY™ HbA1c assay is an IVD for quantitative measurement, not an imaging device requiring human reader interpretation. No effect size for human readers with or without AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are standalone performance studies of the INFINITY™ HbA1c assay. The device directly produces a quantitative result (%HbA1c) without human interpretation steps in the measurement process. Its performance is compared directly against results from predicate devices.
7. The Type of Ground Truth Used
The "ground truth" for the test set was established by the measurements obtained from the predicate devices: the Roche Diagnostics HbA1c II and the Bio-Rad VARIANT™ II Hemoglobin A1c. These are established in vitro diagnostic assays.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" for the INFINITY™ HbA1c assay. As this is a turbidimetric immunoassay, its development likely involves calibration and optimization rather than a machine learning training phase in the conventional sense. The 45 patient samples per comparison would be considered the validation/test set for demonstrating substantial equivalence.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a distinct "training set" with ground truth in the context of machine learning is not described or likely relevant for this type of immunoassay. The development and calibration of the assay would typically rely on reference methods and calibrators, which are not detailed in this summary.
§ 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).