Search Results
Found 1 results
510(k) Data Aggregation
(132 days)
The Bio-Rad VARIANT™ II TURBO HbA1c Kit -2.0 is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). Bio-Rad VARIANT™ II TURBO HbA1c kit is intended for Professional Use Only.
Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
The VARIANT II TURBO Hemoglobin-Testing System uses the principles of high performance liquid chromatography (HPLC). The VARIANT II TURBO HbA1c kit -2.0 is based on chromatographic separation of Hemoglobin A1c on a cation exchange cartridge.
The Bio-Rad VARIANT™ II TURBO HbA1c Kit - 2.0 is substantially equivalent to the predicate device, VARIANT™ II Hemoglobin A1c Program (k)070452. The study demonstrating this equivalence focused on accuracy, precision, linearity, and interfering substances.
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly compares the new device's performance against its predicate and generally acceptable analytical performance for HbA1c testing. Explicit "acceptance criteria" are not given as numerical targets, but rather the performance is compared to the predicate device to establish "substantial equivalence." The reported performance of the new device is considered equivalent or better than the predicate for these metrics.
| Performance Metric | VARIANT II TURBO HbA1c Kit - 2.0 Reported Performance | Predicate Device (VARIANT II Hemoglobin A1c Program) Performance | Acceptance Criteria (Implied: Substantial Equivalence to Predicate) |
|---|---|---|---|
| Accuracy (Method Correlation) | |||
| Range of values tested | 2.6% to 19.0% HbA1c | 2.6% to 19.0% HbA1c (same samples used for comparison) | Performance comparable to predicate device across this range |
| Regression Table | Not explicitly provided, but results used for "correlation" for substantial equivalence. | See above | Not explicitly provided, but considered acceptable if correlation is strong. |
| Precision | |||
| Low Patient (HbA1c) n=240 | Mean: 5.6%, Within run (%CV): 0.78%, Within Device Precision (%CV): 1.15% | Mean: 5.5%, Within run (%CV): 0.9%, Within Device Precision (%CV): 1.60% | Equivalent precision to the predicate device. |
| High Patient (HbA1c) n=240/160 (new/predicate) | Mean: 11.4%, Within run (%CV): 0.39%, Within Device Precision (%CV): 0.91% | Mean: 8.8%, Within run (%CV): 0.6%, Within Device Precision (%CV): 1.38% | Equivalent precision to the predicate device. |
| Linearity | |||
| Linear Range | 3.5 – 19.0 % HbA1c | 3.1 – 18.5 % HbA1c | Comparable or expanded linear range to the predicate device. |
| Interfering Substances | |||
| Bilirubin | No interference up to 20 mg/dL | No interference up to 20 mg/dL | No significant interference up to tested levels. |
| Lipids (Triglycerides) | No interference up to 6000 mg/dL | No interference up to 6000 mg/dL | No significant interference up to tested levels. |
| EDTA | No interference up to 11X EDTA | No interference up to 11X EDTA | No significant interference up to tested levels. |
| Hemoglobin F | 25% (new device) | 15% (predicate device) | Acceptable performance for common interferents. Note: The new device has a higher tolerance for HbF. |
| HbS, HbC, HbE, HbD trait samples on %A1c | Demonstrated some differences (>±10%) from boronate affinity method in a subset of samples (e.g., 2/7 for HbAD-trait, 2/11 for HbAS-trait, 1/12 for HbAE-trait, 3/9 for HbAC-trait). | No interference (predicate) | Acceptable performance, with identified limitations for certain hemoglobin variants as disclosed. |
2. Sample size used for the test set and the data provenance:
- Accuracy (Method Correlation): 40 EDTA whole blood patient samples and 12 samples prepared by mixing EDTA whole blood patient samples with Lyphochek® Hemoglobin A1c Linearity Set samples. Total = 52 samples.
- Precision:
- VARIANT II TURBO HbA1c Kit - 2.0: 240 samples for "Low Patient (HbA1c)" and 240 samples for "High Patient (HbA1c)". (These numbers seem to refer to the total number of measurements, not unique patient samples. The text states "low and high EDTA whole blood patient samples", implying at least two unique patient samples were used, each tested multiple times across devices and days.)
- VARIANT II Hemoglobin A1c Program: 240 samples for "Low Patient (HbA1c)" and 160 samples for "High Patient (HbA1c)".
- Data Provenance: Not explicitly stated, but given the manufacturer's location (Bio-Rad Laboratories, California), it is reasonable to infer the data is from the US. The samples were "EDTA whole blood patient samples" and "Lyphochek® Hemoglobin A1c Linearity Set samples." The study is prospective for testing the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement of HbA1c. The "ground truth" for the test set is established by the reference method (the predicate device) or by other analytical methods like boronate affinity for interference studies, not by clinical expert consensus.
4. Adjudication method for the test set:
Not applicable. As an IVD, adjudication by clinical experts is not relevant for technical performance studies. The comparison is against a reference method or predetermined analytical specifications.
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 imaging or AI reader device. There are no "human readers" in the context of this study that would be assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the studies described are standalone performance evaluations of the device (VARIANT II TURBO HbA1c Kit - 2.0) against its predicate and other analytical standards. The device is an automated HPLC system; thus, its performance is inherently "standalone" in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth or reference for comparison were:
- Accuracy: The predicate device, VARIANT II Hemoglobin A1c Program (270-2101NU), considered a legally marketed and established method.
- Precision: Internal replicates and measurements across multiple devices and days.
- Linearity: Presumably, known concentrations of HbA1c (e.g., from linearity sets or spiked samples).
- Interfering Substances: For the interference studies with hemoglobin variants (HbS, HbC, HbE, HbD), a boronate affinity reference method was used as the "ground truth" for comparison.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set." It is a chemical-based analysis system (HPLC).
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1