(143 days)
The CAPILLARYS Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 FLEX-PIERCING instrument. The CAPILLARYS Hb A1c kit is designed for laboratory use. Measurement of the hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The CAPILLARYS Hb A1c kit is designed for Professional Use Only. For In Vitro Diagnostic Use.
The Hb A1c CAPILLARY Calibrators are designed for the calibration and migration control of human glycated hemoglobin A1c quantification with SEBIA CAPILLARYS Hb A1c electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb A1c CAPILLARY Calibrators are designed for Professional Use Only. For In Vitro Diagnostic Use.
The Hb A1c CAPILLARY Controls are designed for the quality control of human glycated hemoglobin A1c quantification with CAPILLARYS Hb A1c electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb A1c CAPILLARY Controls are designed for Professional Use Only. For In Vitro Diagnostic Use.
The CAPILLARYS Hb A1c kit, controls and calibrators are used with the CAPILLARYS 2 FLEX-PIERCING system. The CAPILLARYS 2 FLEX-PIERCING instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation also occurs according to the electrolyte pH and electroosmotic flow. The CAPILLARYS 2 FLEX-PIERCING instrument has silica capillaries functioning in parallel allowing 8 simultaneous analyses for HbA1c quantification from whole blood sample. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the absorbance wave length specific to hemoglobins. Before each run, the capillaries are washed with a wash solution and prepared for the next analysis with buffer.
This document describes the CAPILLARYS Hb A1c kit, Hb A1c CAPILLARY Calibrators, and Hb A1c CAPILLARY Controls for use with the CAPILLARYS 2 FLEX-PIERCING instrument, designed for the separation and quantification of HbA1c in human whole blood.
The information provided focuses on demonstrating substantial equivalence to a predicate device (TOSOH G8 Automated Glycohemoglobin Analyzer HLC-723G8) for HbA1c measurement.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list "acceptance criteria" in a quantitative format for the CAPILLARYS Hb A1c system's performance. Instead, it describes a "comparison" or "concordance" study against a predicate device to establish substantial equivalence.
The document highlights the following performance aspects through comparison:
| Feature/Performance Aspect | Predicate Device (TOSOH G8 Automated Glycohemoglobin Analyzer HLC-723G8) | New Device (SEBIA CAPILLARYS Hb A1c with CAPILLARYS 2 FLEX-PIERCING) |
|---|---|---|
| Intended Use | For In Vitro Diagnostic Use for the measurement of hemoglobin A1c (HbA1c) in whole blood specimens. Used in clinical management of diabetes to assess long-term efficacy of diabetic control. | Designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human whole blood, by capillary electrophoresis. Measurement effective in monitoring long-term glycemic control in individuals with diabetes mellitus. Designed for Professional Use Only. In Vitro Diagnostic Use. |
| Separation System | Ion-exchange high performance liquid chromatography (HPLC) | Free solution capillary electrophoresis (FSCE) |
| Instrument | TOSOH G8 instrument | SEBIA CAPILLARYS 2 FLEX-PIERCING instrument, PN 1227 |
| Absorbance Wavelength | 415 and 510 nm | 415 nm |
| Analysis Throughput | 37 analyses / hour | 40 analyses / hour |
| Sample Type | Whole blood in capped tube | Whole blood in capped tube |
| Hemolysis | Performed automatically by the system | Performed automatically by the instrument |
| Introduction of Samples | Continuous loading | Continuous loading using sample racks |
| Collection Tubes | Tubes with EDTA anticoagulant | Tubes with EDTA anticoagulant |
| Standardization | NGSP, IFCC | NGSP, IFCC |
The text explicitly states: "The SEBIA CAPILLARYS Hb A1c procedure, performed with the CAPILLARYS 2 FLEX-PIERCING system were found to be substantially equivalent in function, use, safety, effectiveness and the performance to predicate devices described above." This statement implies that the device meets the functional and performance criteria demonstrated by the predicate device. However, specific quantitative acceptance criteria (e.g., precision, accuracy ranges) and their corresponding reported values for the new device are not detailed in the provided excerpt. The comparison table focuses on defining similarities to establish equivalence rather than listing specific performance metrics against pre-defined acceptance limits.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "performance and comparative studies" were conducted. However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As this is an in vitro diagnostic device for quantitative measurement, the "ground truth" would typically refer to reference method results or highly accurate measurements, rather than expert consensus on image interpretation. The document indicates standardization against NGSP and IFCC, which are recognized programs for HbA1c measurement, implying traceability to established reference methods, but details on how ground truth was established for this specific study's test set are absent.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple experts review cases and resolve discrepancies. For a quantitative in vitro diagnostic device, the ground truth is established through analytical methods, not typically by expert adjudication of diagnoses.
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
This information is not applicable. The device is an in vitro diagnostic instrument for HbA1c quantification. It is not an AI-assisted diagnostic tool for human readers/clinicians, and thus, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone in vitro diagnostic instrument. The performance studies mentioned refer to the analytical performance of the instrument system (CAPILLARYS Hb A1c procedure with the CAPILLARYS 2 FLEX-PIERCING instrument) in measuring HbA1c. Therefore, the entire system operates in a standalone capacity for measurement. The document states that the performance studies were performed using SEBIA's commercially available materials and standard procedures, and compared against a predicate device, which inherently implies standalone performance evaluation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this type of quantitative diagnostic device for HbA1c is typically established by reference methods traceable to internationally recognized standardization programs (NGSP and IFCC). The document explicitly states: "CAPILLARYS Hb A1c test is standardized according to NGSP and IFCC requirements/guidelines." This means that the accuracy of the device's measurements would be compared against results obtained by these highly accurate, standardized reference methods.
8. The Sample Size for the Training Set
This information is not provided. As this is a laboratory diagnostic assay, there isn't typically a "training set" in the machine learning sense. The assay is developed and validated, and its performance characterized through studies. If there were method development activities, the number of samples used for optimization is not specified.
9. How the Ground Truth for the Training Set was Established
This information is not provided and not directly applicable in the context of a traditional training set for an algorithmic device. For the development and validation of an in vitro diagnostic assay like this, the "ground truth" for calibrators and controls (which are used to ensure accurate measurements) is established through precise analytical methods, typically traceable to reference standards from NGSP and IFCC, as mentioned in the document for the device's standardization.
§ 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).