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510(k) Data Aggregation
(16 days)
The Bio-Rad VARIANTnbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high performance liquid chromatography (HPLC).
The Bio-Rad VARIANTnbs Sickle Cell Program is intended for Professional Use Only. For In Vitro Diagnostic Use.
The Bio-Rad VARIANTnbs Sickle Cell Program is for use only with the Bio-Rad VARIANTnbs Newborn Screening System.
The VARIANTnbs Newborn Screening System is a High Performance Liquid Chromatography (HPLC) System consisting of an auto sampler for microwell plates (VARIANTnbs Neonatal Auto Sampler) and a chromatography station (VARIANTnbs Chromatography Station). The VARIANTnbs Sickle Cell Program consists of an analytical cartridge containing cation exchange resin and two (2) buffers for establishing a gradient. The Genetic Data Management (GDM) software is designed to operate the VARIANTnbs Newborn Screening System for the purposes of qualitatively screening for the presence of normal hemoglobins F and A and abnormal hemoglobins S, D, C and E in eluates of discs punched from neonatal heel stick blood collected on filter paper or of one aspirated directly from microwell plates with the filter paper disc still present, collected in a sample loop and then injected into the flow path of the chromatography module. The hemoglobins are bound on the analytical cartridge in the presence of Elution Buffer 1. The ionic strength is subsequently raised by adding increasing amounts of Elution Buffer 2. The program is designed to have the hemoglobins of interest elute from the cartridge with retention times that fall within pre-determined windows characteristic of known hemoglobins. Eluted hemoglobins are detected with a dual-wavelength filter photometer which monitors hemoglobin absorbance at 415 mm and corrects for any gradient induced absorbance changes at 690 nm. Processed data is output in a printed report that contains 1) sample identification, 2) date and time of analysis, 3) a peak table containing observed peak name(s), retention time(s), peak height(s), peak area(s), and relative area percent(s), 4) total chromatogram area, 5) chromatogram and 6) any error message(s). Also reported is an optional "pattern assignment" based upon "pattern rules" derived from literature.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (New Device) |
|---|---|---|
| Correlation | Not explicitly defined, but implied by substantial equivalence to K924813. | High agreement with predicate device: 590/591 (FA), 52/52 (FAE), 37/38 (FAD), 247/247 (FAS), 90/90 (FAC), 3/3 (FSC), 2/2 (FC), 1/1 (FE), 1/1 (F). |
| Precision (Retention Time, within-run) | Peak retention time precision <1% for all hemoglobin peaks. | QC Control 1: Peak F (0.3-0.5 CV%), Peak A (0.3-0.4 CV%), Peak E (0.3-0.4 CV%), Peak S (0.2-0.3 CV%). QC Control 2: Peak F (0.3-0.5 CV%), Peak A (0.3-0.4 CV%), Peak D (0.2-0.3 CV%), Peak C (0.1-0.3 CV%). All within <1%. |
| Precision (Retention Time, within-device) | Not explicitly reported for predicate device, implied by substantial equivalence. | QC Control 1: Peak F (0.3-0.6 CV%), Peak A (0.4-0.6 CV%), Peak E (0.4-0.6 CV%), Peak S (0.5-0.6 CV%). QC Control 2: Peak F (0.3-0.7 CV%), Peak A (0.4-0.6 CV%), Peak D (0.4-0.5 CV%), Peak C (0.2-0.3 CV%). All within <1%. |
| Variant Peak Area Limit of Detection | 1% of total area when total chromatogram area is 1.0 million microvolt·second. | 1% of total area when total chromatogram area is 1.5 million microvolt·second for E, D, S, and C. |
2. Sample Size and Data Provenance for Test Set
- Sample Size:
- Correlation Study: 1035 samples (591 FA, 52 FAE, 38 FAD, 247 FAS, 90 FAC, 3 FSC, 2 FC, 1 FE, 1 F) were used for method correlation between the new device and the predicate device.
- Precision Study: For within-run and within-device precision, 4 replicates of two retention time positional QC controls were run per day, across 20 days, on each of 3 separate systems, for a total of 160 runs per system (160 x 3 = 480 total measurements for each QC control in each peak category presented).
- Variant Peak Area Limit of Detection: 102 sample measurements.
- Data Provenance: Not explicitly stated, but given the context of a 510(k) submission for a device to be marketed in the US, it is an in-house study for regulatory purposes. The data is likely retrospective for the comparative correlation study as it compares against an existing predicate device using samples processed by both.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The correlation study relies on the predicate device's results as a reference, implying the predicate itself is the "truth" or was previously validated.
4. Adjudication Method (Test Set)
- The document does not describe a specific adjudication method. For the correlation study, the comparison is directly between the new device's identification and the predicate device's identification, noting "Agree" or "Disagree." Discrepancies (e.g., 1 FAS for FA, 1 FADC for FAD) are noted, but an adjudication process for these discrepancies is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study focuses on validating the performance of an automated analytical instrument (HPLC system), not on human reader performance with or without AI assistance.
6. Standalone Performance Study
- Yes, a standalone performance study was conducted. The precision and variant peak area limit of detection studies specifically evaluate the performance of the new device (Bio-Rad VARIANT™nbs Sickle Cell Program) in isolation, establishing its intrinsic analytical capabilities. The correlation study also demonstrates the device's performance in identifying different hemoglobin types compared to a predicate method. Therefore, the presented data reflects the algorithm's (or device's) standalone performance.
7. Type of Ground Truth Used
- The ground truth for the correlation study is based on the results obtained from the predicate device (Bio-Rad VARIANT™ Sickle Cell Short Program, K924813).
- For the precision and variant peak area limit of detection studies, the ground truth is established by defined QC controls and samples used to determine analytical limits. Given the nature of a diagnostic device measuring specific biomarkers, the "ground truth" for individual samples would typically be derived from established reference methods or known concentrations/compositions of hemoglobin variants.
8. Sample Size for Training Set
- The document does not provide information regarding a specific "training set" or its sample size. This type of device (HPLC system) is not typically "trained" in the machine learning sense with a distinct training and test set as described for AI algorithms classifying images, for example. Its operational parameters and "pattern rules" are likely derived from scientific literature and established chemical and physical principles rather than statistical training on a large dataset in the way an AI model would be.
9. How Ground Truth for Training Set Was Established
- As noted above, the document does not describe a training set in the context of machine learning. The "pattern assignment" feature, which uses "pattern rules derived from literature," implies that the underlying logic for identifying hemoglobin peaks is based on established scientific knowledge and empirical data from previous research, rather than a separate training dataset with adjudicated ground truth in the current study.
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