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510(k) Data Aggregation

    K Number
    K101502
    Device Name
    BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774
    Manufacturer
    BECTON DICKINSON & CO.
    Date Cleared
    2010-06-29

    (28 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BD Vacutainer® Rapid Serum Tube Blood Collection Tube with Hemogard™ Closure (BD RST HG) is a single use tube used to collect, separate, transport and process venous blood specimens to obtain serum for chemistry determinations for in vitro diagnostic use. It is used in settings where a venous blood sample is collected by a trained healthcare worker.

    Clot time has not been established for patients on heparin therapy, direct thrombin inhibitor therapy or with Factor I deficiency. As a result, the use of BD RST HG in these patients is not recommended.

    Device Description

    BD Vacutainer® Tubes are sterile, single-use, evacuated plastic blood collection tubes with rubber stoppers that provide a means of collecting, transporting, separating, and processing blood in a closed tube. The BD Vacutainer® Rapid Serum Tube Blood Collection Tube with Hemogard™ Closure (BD RST HG) clots blood specimens much faster than other additives (5 minutes), and therefore is desirable when a fast turnaround-time is necessary.

    AI/ML Overview

    The provided document is a 510(k) Summary for a medical device called the "BD Vacutainer® Rapid Serum Tube Blood Collection Tube with Hemogard™ Closure (BD RST HG)". This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining explicit acceptance criteria and presenting a detailed study report. Therefore, some of the requested information (like specific numerical acceptance criteria or detailed study methodologies) is not explicitly stated.

    However, I can extract the available information to address your points as much as possible.

    Acceptance Criteria and Reported Device Performance

    The core "acceptance criteria" appear to be the demonstration of "substantial equivalence" to the predicate device, the BD Vacutainer® SST™ Plus Blood Collection tube (BD SST™), across several performance aspects.

    Acceptance Criteria (Implied)Reported Device Performance
    Clot blood specimens within 5 minutes.Met: "Clotting of blood within 5 minutes was demonstrated in the BD RST HG."
    Substantially equivalent performance to predicate BD SST™ for collection, separation, transport, and processing of venous blood specimens for chemistry determinations.Met: "The test results demonstrated that the evaluation device's performance was substantially equivalent to the legally marketed predicate device for tested analytes." (This is a general statement; specific metrics are not provided in this summary).
    Substantially equivalent performance to predicate BD SST™ for selected serology analytes (anti-CMV IgG, anti-CMV-IgM, CRP).Met: "BD RST HG tube demonstrates substantially equivalent performance to the predicate BD SST™ tube for the following selected serology analytes: anti-CMV IgG anti-CMV-IgM, and CRP." (Specific equivalence metrics/P-values are not provided).
    Substantially equivalent performance to predicate BD SST™ for selected immunology analytes (C3, C4, IgG IgM, Rf).Met: "BD RST HG tube demonstrates substantially equivalent performance to the predicate BD SST™ tube for the following selected immunology analytes: C3, C4, IgG IgM, and Rf." (Specific equivalence metrics/P-values are not provided).
    Substantially equivalent performance to predicate BD SST™ for 24-hour stability for evaluated analytes.Met (with exceptions): "BD RST HG tube demonstrates substantially equivalent performance to the predicate BD SST™ tube for 24 hr stability for analytes evaluated except LDL (16 hours), Progesterone (8 hours), and Triglycerides (15 hours)." (This indicates equivalence for most, but not all, analytes for 24 hours, with specific shorter stability times noted for LDL, Progesterone, and Triglycerides. The document doesn't provide specific criteria for "substantially equivalent" in this context).

    Additional Requested Information:

    Since this is a 510(k) Summary, much of the granular detail about the study methodology (like sample sizes, expert qualifications, etc.) is not present. This document provides a high-level overview to satisfy the regulatory requirements for substantial equivalence.

    1. Sample size used for the test set and the data provenance:

      • Sample Size: Not specified in the provided document. The document states "Clinical testing was performed on blood collected in both the evaluation and predicate tubes for a battery of routine and special chemistry analytes, and selected serology and immunology analytes." This implies a set of human blood samples were used, but the quantity is not given.
      • Data Provenance: Not specified. There is no information about the country of origin of the data, nor whether it was retrospective or prospective. Given it's "clinical testing," it was likely prospective collection for the purpose of the study.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • This question is largely irrelevant for this type of device. Blood collection tubes are evaluated based on their ability to preserve analytes and facilitate accurate lab test results, not on expert interpretation of images or clinical reports. The "ground truth" here would be the actual concentration of analytes in the blood as measured by standardized laboratory methods, usually comparing samples from the test device to samples from the predicate device (or sometimes a gold standard collection method, though not explicitly stated here). There is no mention of human "experts" establishing a ground truth in the sense of a diagnostic interpretation.

    3. Adjudication method for the test set:

      • Not applicable/Not specified. As explained above, this isn't a device that relies on human interpretation or adjudication in the typical sense (e.g., for image reading). The "adjudication" is done by laboratory equipment measuring analyte concentrations.

    4. 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 device is a blood collection tube, not an AI-powered diagnostic or imaging system that would involve human readers or AI assistance.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Not applicable. This device does not involve an algorithm. Its performance is chemical, mechanical, and biological; it's about the physical collection and preservation of blood.

    6. The type of ground truth used:

      • The "ground truth" in this context is the accurate measurement of analyte concentrations in blood serum, typically achieved through standard laboratory assays (e.g., spectrophotometry, immunoassays) using clinically validated instruments. The performance of the BD RST HG is compared to the predicate device (BD SST™) to demonstrate that it yields comparable and accurate results for these measurements.

    7. The sample size for the training set:

      • Not applicable. This document describes a clinical validation study for a physical medical device (blood collection tube), not a machine learning or AI algorithm that requires a "training set."

    8. How the ground truth for the training set was established:

      • Not applicable, as there is no "training set" for this type of device.
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