(199 days)
BD Vacutainer® Barricor™ Lithium HeparinN Plasma Blood Collection Tubes (BD Barricor™ Tubes) are used to collect, separate, process, transport and store venous blood samples for use in chemistry determinations, therapeutic drug monitoring (TDM), and zinc testing in plasma for in vitro diagnostic use. It is used in settings where a venous blood sample is collected by a trained healthcare worker.
The BD Vacutainer® Barricor™ Lithium HeparinN Plasma Blood Collection Tubes (BD Barricor™ Tubes) are sterile (interior), single-use, evacuated blood collection tubes for collecting, separating, processing, transporting, and storing lithium heparin plasma in a closed tube. These products are comprised of a plastic tube containing a mechanical separator (in place of gel), a low-zinc stopper and a plastic BD Hemogard™ color-coded Lime Green safety-engineered shield. The interior of the BD Barricor™ Tube is spray coated with a lithium heparin anticoagulant. Tube stopper and mechanical separator are lubricated with silicone based surfactant to facilitate product assembly. The BD Barricor™ Tubes contain less than 50 μg/L of zinc to enable zinc testing. These tubes are available in 13x75mm and 13x100mm configurations with various nominal draw volumes ranging from 3.0mL to 5.5mL. The BD Barricor™ Blood Collection Tube is designed to be compatible with current phlebotomy and clinical laboratory practice. It employs a novel separation technology, a mechanical separator, which remains stable in its initial position, to enable the blood to be filled via current methods and subsequently creates a stable, robust barrier during processing. The mechanical separator is comprised of two materials of different densities - an elastomer and a higher density base material. In its resting position, the diameter of the mechanical separator is greater than that of the tube. The resulting friction from this interface allows the separator to maintain its position and orientation prior to blood collection and permits filling of the tube. Under centrifugation, the force applied on the separator will correctly orient the separator and allows it to move within the tube. While immersed in the collected sample, the differential buoyancy of the two materials will stretch the separator enabling the passage of cellular content and appropriate positioning of the separator between the cell column and plasma sample. When centrifugation stops, the mechanical separator returns to its original shape to form a barrier between the plasma sample (at the top), which is subsequently available for analysis, and the sedimented cells below.
The provided text describes the performance of the BD Vacutainer® Barricor™ Lithium Heparin Plasma Blood Collection Tube and compares it to predicate devices (BD PST™ Plasma Separator Tube and BD Serum Tubes) for substantial equivalence.
Here's an analysis of the acceptance criteria and the studies, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Equivalence | The BD Barricor™ Tube results, when compared to the predicate device (BD PST™ for chemistry, BD Serum for TDM), should demonstrate clinical equivalence. This was assessed using Deming Regression, with acceptance based on: |
- Slope and intercept of the fitted line with 95% confidence intervals.
- Standard error of the estimate.
- Biases with individual 100(1-2α)% confidence intervals (or 2 one-sided 95% limits) calculated from the regression line at medical decision points.
When the mean bias and the 95% limit of the comparison were both within the Clinical Acceptance Limit (CAL), results were considered clinically equivalent. If the 95% limit exceeded the CAL, data were reviewed for clinical acceptability. | Chemistry analytes (vs. BD PST™): Demonstrated clinically equivalent or clinically acceptable performance for representative analytes in routine and special chemistry.
Therapeutic drugs (vs. BD Serum Tubes): Demonstrated clinically equivalent or clinically acceptable performance for therapeutic drugs on both instrument platforms. |
| Variability (Repeatability, Lot-to-Lot, Tube-to-Tube) | For each routine and special chemistry analyte, the ratio of the total variability [Standard deviation (SD)] for BD Barricor™ to the total variability (SD) for BD PST™ did not exceed 2.0 with 95% confidence.
For each therapeutic drug, the ratio of the total variability [standard deviation (SD)] for BD Barricor™ to the total variability (SD) for BD Serum did not exceed 2.0 with 95% confidence. | The acceptance criteria were met for each routine and special chemistry analyte and each therapeutic drug tested on two instrument platforms. The variability in the BD Barricor™ Tubes was considered acceptable. |
| Within-Tube Stability | For the within-tube comparison at each time point vs. 0 hr, equivalence was demonstrated when the mean bias and the 95% limits were within the established Clinical Acceptance Limit (CAL). If the mean bias of the evaluation was within the CAL but the 95% limit exceeded the CAL, this constituted clinical non-equivalence requiring further interpretation and assessment to determine if the difference was clinically acceptable or not. If the mean bias of the comparison exceeded the CAL, this constituted clinical non-equivalence and was considered clinically unacceptable, unless a rationale was provided. | Routine & Special Chemistry: Stability demonstrated for up to 24hrs at room temperature and up to 7 days refrigerated storage for all analytes except Folate, Glucose, and CO2.
Folate: Stable for 24 hours (RT).
Glucose & CO2: Stable for 18hrs (RT).
CRP: Stable for up to 24hrs (RT) and up to 7 days refrigerated storage.
βhCG, Total PSA, CKMB, TnI, TnT: Stable for 24hrs (RT).
Therapeutic Drugs: Stable for up to 48 hours (RT) and up to 7 days refrigerated storage. |
2. Sample Size Used for the Test Set and Data Provenance
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Clinical Equivalence Study (Routine & Special Chemistry):
- Sample Size: Minimum of 86 and up to 104 apparently healthy and diseased subjects were enrolled per study (total of 570 subjects across 6 studies). An additional 68 apparently healthy subjects were enrolled specifically to create abnormally low or high values.
- Data Provenance: Not explicitly stated, but implies multi-site studies ("six (6) studies were conducted at multiple sites" and "BD Franklin Lakes clinical trial site"). Does not specify country of origin.
- Retrospective/Prospective: Prospective (blood collected from subjects into the devices).
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Clinical Equivalence Study (Therapeutic Drug Monitoring):
- Sample Size: A total of 705 adult subjects were enrolled at multiple sites. An additional 25 apparently healthy subjects were enrolled to create contrived specimens.
- Data Provenance: Not explicitly stated, but implies multi-site studies ("evaluated at initial time on two instruments per drug vs. the BD Serum Tubes. A total of 705 adult subjects were enrolled in the study at multiple sites" and "BD Franklin Lakes clinical trial site"). Does not specify country of origin.
- Retrospective/Prospective: Prospective (blood collected from subjects into the devices).
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Variability Study (Study 1 - Chemistry):
- Sample Size: A total of 35 subjects were enrolled (20 for routine/special chemistry, 10 for Testosterone only, 5 for PSA only).
- Data Provenance: Not specified country of origin.
- Retrospective/Prospective: Prospective.
-
Variability Study (Study 2 - Therapeutic Drugs):
- Sample Size: Fifty subjects were enrolled, 41 completed. Contrived specimens prepared from 20 subjects for certain drugs, and 21 subjects for others.
- Data Provenance: Not specified country of origin.
- Retrospective/Prospective: Prospective.
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Within-Tube Stability Studies:
- Study 1 (Routine & Special Chemistry): 92 subjects (minimum 40 subject specimens per analyte).
- Study 2 (Glucose & CO2): Two sets of 40 subjects.
- Study 3 (CRP): Minimum of 40 subjects.
- Study 4 (βhCG & Total PSA): Minimum of 40 subjects.
- Study 5 (CKMB, TnI, TnT): 40 subjects.
- Study 6 (Therapeutic Drugs): Minimum of 40 subjects per therapeutic drug.
- Data Provenance: Not specified country of origin.
- Retrospective/Prospective: Prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe the use of human "experts" to establish a ground truth as would be typical for image-based diagnostic AI. Instead, the "ground truth" (or reference standard) for the device's performance is established by comparing the analytical results from the proposed device to those obtained from legally marketed predicate devices (BD PST™ Tube and BD Serum Tube) using established laboratory instrumentation. The performance is then judged against "Clinical Acceptance Limits (CAL)" which are pre-defined thresholds for acceptable analytical variation. The qualifications of the personnel performing these lab tests are not specified, although it implies trained healthcare workers and laboratory personnel.
4. Adjudication Method for the Test Set
Not applicable in the AI sense. This study involves analytical comparisons of quantitative measurements from blood samples. Performance was judged statistically (Deming Regression and SD ratios) against defined Clinical Acceptance Limits (CALs). If statistical non-equivalence occurred or exceeded limits, "further interpretation and assessment" was performed by presumably scientific/clinical personnel, but this is not an "adjudication" in the sense of resolving discrepancies between human readers or AI.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, this is not an MRMC comparative effectiveness study. This device is a blood collection tube, not an AI-powered diagnostic system that enhances human reader performance. The studies performed are analytical comparisons of blood sample analysis results.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, this is not a standalone AI algorithm study. This device is a medical device (blood collection tube) designed to collect and process blood specimens for in vitro diagnostic use. The "performance" being evaluated is the analytical integrity of the collected sample and its compatibility with standard laboratory assays, not the output of an algorithm.
7. Type of Ground Truth Used
The ground truth or reference standard for these studies is the analytical result obtained from legally marketed predicate devices (BD Vacutainer® Brand PST™ Plasma Separator Tube and BD Serum Tubes) using standard laboratory analytical instruments. The acceptable range of deviation from this reference is defined by pre-established "Clinical Acceptance Limits (CALs)."
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study that involves a training set. The device is a physical blood collection tube.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.