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510(k) Data Aggregation
(8 days)
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). 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 is effective in long-term monitoring 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 thalassemia variants such as hemoglobins S, C, D and E by HPLC is effective in presumptive identification of these variants. The Bio-Rad D-10TM Dual Program is intended for Professional Use Only. For in vitro diagnostics use.
The Bio-Rad D-10™ Dual Program is a new device system that utilizes the principles of high performance liquid chromatography (HPLC), by which chromatographic separation of performance nquild chromatography (THLC), of willen exchange cartridge. The Bio-Rad D-10™ nemogrooms is a new program system that combines the determination of percent hemoglobin A = 1 = d for diabetes monitoring with percent hemoglobins A2 and F used for evaluation of (3 = thalassemia. The D-10™ Dual Program system consists of two different reagent programs with two intended uses. The D-10TM Dual Program reagent kit has a short program (3 minutes) for the determination of hemoglobin Are in which the components exactly the same as the D-10™ Hemoglobin Atc Program (K031043) reagents. The second program includes an extended program (6.5 minutes) that can be used for the determination of HbA2, HbF as well as HbA1c The components are exactly the same as the D-10™ Hemoglobin A12 Program (K031043) system and reagents with an additional HbA2/F/A1e Calibrator/Diluent Set and floppy diskette for the new program parameters.
Here's a breakdown of the acceptance criteria and study information for the Bio-Rad D-10™ Dual Program, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the Bio-Rad D-10™ Dual Program are not explicitly stated as distinct pass/fail thresholds in the document. Instead, the study aims to demonstrate substantial equivalence to existing predicate devices (VARIANT™ II Hemoglobin A1c Program and VARIANT™ II β-thalassemia Short Program). The performance of the D-10™ Dual Program is compared against these predicates across several metrics.
Table of Acceptance Criteria (Inferred by comparison to predicate) and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied: Comparable to Predicate) | Bio-Rad D-10™ Dual Program Reported Performance (6.5 Minutes) |
|---|---|---|
| HbA1c Accuracy | r² ≥ ~0.98, Slope ~1, Intercept ~0 | r² = 0.9843, Slope = 0.9906, Intercept = 0.4310 |
| HbA2 Accuracy | r² ≥ ~0.98, Slope ~1, Intercept ~0 | r² = 0.9832, Slope = 1.0898, Intercept = -0.2407 |
| HbF Accuracy | r² ≥ ~0.99, Slope ~1, Intercept ~0 | r² = 0.9959, Slope = 0.9497, Intercept = -0.1785 |
| HbA1c Precision (Normal Sample) | Total Precision (%CV) comparable to predicate (~2.1%) | Total Precision (%CV) = 1.8% |
| HbA1c Precision (Diabetic Sample) | Total Precision (%CV) comparable to predicate (~1.7%) | Total Precision (%CV) = 0.9% |
| HbA2 Precision (Low Sample) | Total Precision (%CV) comparable to predicate (~2.0%) | Total Precision (%CV) = 5.3% |
| HbA2 Precision (High Sample) | Total Precision (%CV) comparable to predicate (~2.1%) | Total Precision (%CV) = 3.1% |
| HbF Precision (Low Sample) | Total Precision (%CV) comparable to predicate (~3.9%) | Total Precision (%CV) = 3.3% |
| HbF Precision (High Sample) | Total Precision (%CV) comparable to predicate (~1.4%) | Total Precision (%CV) = 2.0% |
| HbA1c Linearity | % Recovery for theoretical vs. observed HbA1c comparable to predicate (e.g., 97-100%) | % Recovery for HbA1c is "essentially the same" (example: 97.7-100%) |
| HbA2 Linearity | % Recovery for theoretical vs. observed HbA2 comparable to predicate (e.g., 91-100%) | % Recovery for HbA2 is "essentially the same" (example: 91.2-100%) |
| HbF Linearity | % Recovery for theoretical vs. observed HbF comparable to predicate (e.g., 89-110%) | % Recovery for HbF is "essentially the same" (example: 100-112.5%) |
| Interference (Labile Hb on HbA1c) | No significant interference up to predicate levels (4.8%) | No significant interference up to 3.5% |
| Interference (Labile Hb on HbF) | No significant interference up to predicate levels (Not Applicable) | No significant interference up to 2.6% |
| Interference (Bilirubin) | No interference up to 20 mg/dL | No interference up to 20 mg/dL |
| Interference (Lipids) | No interference up to ~4600-6000 mg/dL | No interference up to 5680 mg/dL |
| Interference (EDTA) | No interference up to 11x EDTA | No interference up to 11x EDTA |
Study Details for Demonstrating Equivalence:
The study described is a series of laboratory performance evaluations comparing the Bio-Rad D-10™ Dual Program (6.5 minute extended program) to its predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- HbA1c Accuracy: 40 EDTA whole blood samples.
- HbA2 Accuracy: 40 EDTA whole blood samples.
- HbF Accuracy: 40 EDTA whole blood samples.
- HbA1c Precision: 80 measurements for each of two sample types (normal, diabetic) for both the D-10 Dual and VARIANT II HbA1c programs (total 320 measurements). Samples were EDTA whole blood patient samples.
- HbA2 Precision: 80 measurements for each of two sample types (low, high) for both the D-10 Dual and VARIANT II β-thalassemia Short programs (total 320 measurements). Samples were EDTA whole blood patient samples.
- HbF Precision: 80 measurements for each of two sample types (low, high) for both the D-10 Dual and VARIANT II β-thalassemia Short programs (total 320 measurements). Samples were EDTA whole blood patient samples.
- Linearity (HbA1c, HbA2, HbF): Eight EDTA-based blood standards (n=2 for each standard) were used for comparison. The document also mentions a "first linearity study" using seven standards (n=2 for each).
- Specificity and Interference: Varies by substance.
- Carbamylated hemoglobin: Specimens spiked with sodium cyanate.
- Labile hemoglobin: Samples spiked with glucose.
- Bilirubin, Lipids, EDTA: Patient pools or individual blood samples obtained as EDTA-anticoagulated blood, with concentrated interfering substances added.
Data Provenance: The document does not explicitly state the country of origin. It indicates that samples were "human whole blood samples" or "human anticoagulated whole blood (EDTA)," and "patient bloods." The context of a 510(k) submission to the FDA for a device manufactured by Bio-Rad Laboratories (Hercules, California) suggests the studies would likely be conducted in the United States or under similar regulatory standards. The studies appear to be retrospective in the sense that they are conducted on collected samples to evaluate the device performance against established methods, rather than following patients prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not an imaging device requiring expert interpretation for ground truth. Ground truth for chemical assays is typically established by reference methods or validated (predicate) assays, or by preparing samples with known concentrations. The predicate devices serve this role.
4. Adjudication Method for the Test Set:
Not applicable for this type of quantitative assay comparison. The comparison is statistical (regression, percentage recovery, CV) against reference methods or predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, this is not an MRMC study. This device is an automated in vitro diagnostic (IVD) device for biochemical analysis, not an imaging device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the performance data presented is for the Bio-Rad D-10™ Dual Program as a standalone device, reporting quantitative values of HbA1c, HbA2, and HbF. The comparison is directly between the new device and the predicate laboratory instruments.
7. The Type of Ground Truth Used:
For accuracy and precision, the "ground truth" for the D-10™ Dual Program is established through method correlation with predicate devices (VARIANT™ II Hemoglobin A1c Program and VARIANT™ II β-thalassemia Short Program). For linearity, "ground truth" refers to the theoretical concentrations of HbA1c, HbA2, and HbF in the prepared standards. For specificity/interference, ground truth involves known concentrations of interfering substances added to samples. The predicates themselves are established and cleared devices, implying their results are considered accurate and reliable. The HbA1c predicate is also traceable to the DCCT reference method and IFCC, and certified by NGSP.
8. The Sample Size for the Training Set:
The document describes performance studies for the new device as compared to predicate devices. It does not explicitly mention a "training set" in the context of machine learning, as this device relies on HPLC principles and established chemical analysis methods, not an AI/ML algorithm that would undergo specific training.
9. How the Ground Truth for the Training Set was Established:
As above, the concept of a "training set" and associated ground truth establishment is not directly applicable in the context of this traditional IVD device and its submission. The studies involve validation against predicate methods and known standards.
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