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510(k) Data Aggregation
(17 days)
The D-10TM Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c Program is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System. For In Vitro Diagnostic Use.
The Bio-Rad D-10™ Dual Program system is intended for the percent determination of hemoglobins A1c, A2 and F, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The Bio-Rad D-10™ Dual Program is intended for Professional Use Only. For in vitro diagnostic use.
Measurement of the percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus, and measurement of the percent HbA2 and HbF are effective in screening of ß—thalassemias (i.e., hereditary hemolytic anemias characterized by decreased synthesis of one or more types of abnormal hemoglobin polypeptide chains). Detection of hemoglobin variants such as hemoglobins S, C, D and E by HPLC is effective in presumptive identification of these variants.
The Bio-Rad Hemoglobin Testing System is a fully automated analyzer consisting of a single module that rovides an integrated method for sample preparation, and determination of specific hemoglobins in whole blood. The Bio-Rad Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g. A2, F and A1c in whole blood). The separation is based on the principles of high performance liquid chromatography. The system can accommodate 1 to 10 samples per run using a single rack currently.
The new feature in this submission is the optional D-10 Rack Loader which will be available for use with the D-10 Hemoglobin Testing System. The D-10 Rack Loader accommodates 5 racks and automatically transports each rack into and out of the D-10 System. The D-10 Rack Loader offers continuous loading, allowing the operator to insert or remove racks during a run.
The Bio-Rad D-10 Hemoglobin Testing System with the D-10 Rack Loader demonstrates substantial equivalence to its predicate devices (D-10 Hemoglobin A1c Program and D-10 Dual Program without the Rack Loader) through method correlation and precision studies.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the demonstration of substantial equivalence to the predicate devices. The study aims to show that the new device, with the rack loader, performs as similarly as possible to the predicate devices. The reported device performance is presented as correlation and precision data against these predicate devices.
D-10 Hemoglobin A1c Program (3-minute run):
| Metric | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (New Device vs. Predicate) |
|---|---|---|
| Accuracy | High Correlation to Predicate (r² close to 1, slope close to 1, intercept close to 0) | r² = 0.9950, Slope = 0.9415, Intercept = 0.2714 |
| Precision | Similar %CVs to Predicate | See detailed table below |
D-10 Dual Program (6.5-minute run) - HbA1c:
| Metric | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (New Device vs. Predicate) |
|---|---|---|
| Accuracy | High Correlation to Predicate (r² close to 1, slope close to 1, intercept close to 0) | r² = 0.9956, Slope = 0.9827, Intercept = 0.1208 |
| Precision | Similar %CVs to Predicate | See detailed table below |
D-10 Dual Program (6.5-minute run) - HbA2:
| Metric | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (New Device vs. Predicate) |
|---|---|---|
| Accuracy | High Correlation to Predicate (r² close to 1, slope close to 1, intercept close to 0) | r² = 0.9975, Slope = 0.9902, Intercept = 0.2476 |
| Precision | Similar %CVs to Predicate | See detailed table below |
D-10 Dual Program (6.5-minute run) - HbF:
| Metric | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (New Device vs. Predicate) |
|---|---|---|
| Accuracy | High Correlation to Predicate (r² close to 1, slope close to 1, intercept close to 0) | r² = 0.9956, Slope = 1.0188, Intercept = -0.3863 |
| Precision | Similar %CVs to Predicate | See detailed table below |
Detailed Precision Tables (New Device with Rack Loader vs. Predicate without Rack Loader):
D-10 HbA1c Program (3 minute):
| New Device (with Rack Loader) | Predicate (without Rack Loader) | |
|---|---|---|
| Normal Sample | ||
| n= | 400 | 80 |
| Mean (%HbA1c) | 5.6 | 5.9 |
| Within run (%CV) | 0.6 | 0.8 |
| Total Precision (%CV) | 1.5 | 1.8 |
| Diabetic Sample | ||
| n= | 400 | 80 |
| Mean (%HbA1c) | 11.0 | 13.1 |
| Within run (%CV) | 0.6 | 0.3 |
| Total Precision (%CV) | 1.4 | 0.9 |
D-10 Dual Program (6.5 minutes) HbA1c:
| New Device (with Rack Loader) | Predicate (without Rack Loader) | |
|---|---|---|
| Normal Sample | ||
| n= | 400 | 80 |
| Mean (%HbA1c) | 5.5 | 5.9 |
| Within run (%CV) | 0.7 | 0.8 |
| Total Precision (%CV) | 1.5 | 1.8 |
| Diabetic Sample | ||
| n= | 400 | 80 |
| Mean (%HbA1c) | 10.6 | 13.1 |
| Within run (%CV) | 0.4 | 0.3 |
| Total Precision (%CV) | 1.2 | 0.9 |
D-10 Dual Program (6.5 minutes) HbA2:
| New Device (with Rack Loader) | Predicate (without Rack Loader) | |
|---|---|---|
| Low Sample | ||
| n= | 400 | 80 |
| Mean (%HbA2) | 2.9 | 2.2 |
| Within run (%CV) | 1.8 | 4.5 |
| Total Precision (%CV) | 3.6 | 5.3 |
| High Sample | ||
| n= | 400 | 80 |
| Mean (%HbA2) | 4.9 | 5.4 |
| Within run (%CV) | 1.2 | 1.7 |
| Total Precision (%CV) | 3.6 | 3.1 |
D-10 Dual Program (6.5 minutes) HbF:
| New Device (with Rack Loader) | Predicate (without Rack Loader) | |
|---|---|---|
| Low Sample | ||
| n= | 400 | 80 |
| Mean (%HbF) | 1.4 | 2.1 |
| Within run (%CV) | 2.1 | 1.7 |
| Total Precision (%CV) | 2.9 | 3.3 |
| High Sample | ||
| n= | 400 | 80 |
| Mean (%HbF) | 6.6 | 8.7 |
| Within run (%CV) | 0.8 | 1.4 |
| Total Precision (%CV) | 1.8 | 2.0 |
2. Sample sizes used for the test set and the data provenance:
-
Accuracy (Method Correlation) Test Sets:
- D-10 HbA1c Program: 40 EDTA whole blood samples.
- D-10 Dual Program (HbA1c): 40 EDTA whole blood samples.
- D-10 Dual Program (HbA2): 39 EDTA whole blood samples.
- D-10 Dual Program (HbF): 39 EDTA whole blood samples.
- Data Provenance: The document does not specify the country of origin of the data. It implies the samples are human anticoagulated whole blood (EDTA) and patient samples (normal and diabetic, low and high concentration for HbA2 and HbF). The study appears to be an internal validation study and implicitly prospective for the "new device" performance, as it compares it concurrently to the "predicate device" performance using the same samples where appropriate for method correlation.
-
Precision Test Sets:
- For the new device (with D-10 Rack Loader), for each analyte (HbA1c, HbA2, HbF) and concentration level (Normal/Diabetic or Low/High), n=400 (two samples run on each of five racks, twice a day over 20 working days, with duplicate aliquots analyzed per run).
- For the predicate device (without D-10 Rack Loader), for each analyte and concentration level, n=80 (two samples run on one rack, twice a day over 20 working days, with duplicate aliquots analyzed per run).
- Data Provenance: Similar to accuracy, the country of origin is not specified. The samples are described as "EDTA whole blood patient samples." The protocol appears to be prospective for establishing precision for both the new and predicate systems under the specific test conditions. The document notes that "precision samples are different, since they were run at different time periods," indicating separate precision studies for the new and predicate configurations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is an in-vitro diagnostic (IVD) test for quantitative measurement of hemoglobin components. The "ground truth" for method correlation and precision studies is typically established by comparing the new device's measurements against a recognized reference method or a legally marketed predicate device (as in this case).
- The document does not mention the use of human experts (e.g., radiologists) to establish ground truth. The ground truth for this type of device is the quantitative value determined by the existing, validated methods (the predicate devices).
4. Adjudication method for the test set:
- Not applicable. This is a quantitative IVD device. "Adjudication" typically refers to resolving discrepancies between human readers or between an algorithm and human readers, often in image-based diagnostics. Here, the comparison is between two analytical methods (new device vs. predicate device).
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 not a diagnostic imaging device involving human readers or AI assistance in interpretation. It is a fully automated analytical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the entire study pertains to the standalone performance of the Bio-Rad D-10 Hemoglobin Testing System with the D-10 Rack Loader. The device itself is an automated analyzer, meaning its performance is "algorithm only" in the sense that the measurement process is automated, without human intervention in the result generation beyond sample loading and instrument operation. The comparison is against the standalone performance of predicate automated analyzers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for evaluating the new device's performance is the measurements obtained from the existing, legally marketed predicate devices (Bio-Rad D-10 Hemoglobin A1c Program and D-10 Dual Program without the D-10 Rack Loader).
- For HbA1c, the predicate device (and by extension the new device) is traceable to the Diabetes Control and Complications Trial (DCCT) reference method and IFCC, and certified by the National Glycohemoglobin Standardization Program (NGSP). This constitutes a high-order reference for HbA1c.
- For HbA2 and HbF, the document states, "The Joint Committee on Traceability in Laboratory Medicine has not identified a higher order reference method or reference material for the quantitation of HbA2 and HbF," implying the predicate device's established performance serves as the practical ground truth for comparison.
8. The sample size for the training set:
- This document describes performance studies (accuracy and precision) for a new version of an existing device (adding a rack loader). It does not explicitly mention a "training set" in the context of machine learning model development. For IVD devices, validation typically involves performance studies on clinical samples, rather than a separate "training" and "test" set as seen in AI/ML. The samples used for method correlation and precision testing serve as the validation data for the device's performance.
9. How the ground truth for the training set was established:
- Not applicable, as a distinct "training set" for an AI/ML model is not described in the context of this IVD device submission. The device's underlying principles (ion-exchange high performance liquid chromatography) are well-established analytical methods, not derived from machine learning. The comparison is made against the established performance of predicate devices.
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