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    K Number
    K202196
    Device Name
    BioFire RP2.1/RP2.1plus Control Panel M441
    Manufacturer
    Maine Molecular Quality Controls, Inc.
    Date Cleared
    2021-06-24

    (323 days)

    Product Code
    PMN
    Regulation Number
    866.3920
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K173171
    Why did this record match?
    Device Name :

    BioFire RP2.1/RP2.1plus Control Panel M441

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BioFire RP2.1/RP2.1plus Control Panel M441 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BioFire Respiratory Panel 2.1 (RP2.1), BioFire Respiratory Panel 2.1 plus) and BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) assay performed on the BioFire FilmArray systems. BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire RP2.1phus and BioFire RP2.1-EZ assay. This product is not intended to replace manufacturer controls provided with the device.

    Device Description

    BioFire RP2.1/RP2.1plus Control Panel M441, P/N M441, is a quality control panel consisting of 2 ready-to-use, liquid controls, BioFire RP2.1/RP2.1plus Positive (Positive Control) and BioFire RP2.1/RP2.1plus Negative Control). The Positive Control contains noninfectious surrogate control material; a solution of synthetic RNA transcripts in buffer, stabilizers and preservatives. The RNA carries segments of all respiratory pathogens detected by the BioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Respiratory Panel 2.1plus (RP2.1plus), and BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ) assays (Table 1. below) on the BioFire® FilmArray systems, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). BioFire RP2.1/RP2.1plus Negative contains buffer and preservatives with no RNA. Each liquid control of BioFire RP2.1/RP2.1plus Control Panel M441 is processed separately according to BioFire RP2.1, RP2.1plus, and RP2.1-EZ assays manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study detailed in the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Correct detection of Positive Control results100% (86/86 correct positive control results in internal and external studies, excluding 1 invalid result. In external site testing, 26/26 positive controls were correct. In precision testing, all 60 positive controls were correct across 3 lots.)
    Correct detection of Negative Control results100% (85/85 correct negative control results in internal and external studies, excluding 1 invalid result. In external site testing, 25/25 negative controls were correct. In precision testing, all 60 negative controls were correct across 3 lots.)
    Invalid Rate1 out of 172 total tests (0.58%) across internal and external studies. In external site testing, 1 out of 52 tests (1.9%) was invalid. In precision testing, 0 out of 120 tests were invalid.
    Robust and Reproducible performance across multiple control and reagent lotsDemonstrated through precision testing at MMQCI facility over 20 days using 3 pouch lots and 3 operators on two instruments, showing 100% correct results for all positive and negative controls. External study also demonstrated robust performance across 3 pouch lots, multiple instruments, and operators.

    2. Sample Size Used for the Test Set and Data Provenance

    • Total Test Set Sample Size: 172 tests (Internal and External studies combined).
      • Internal Study: 120 tests (Precision testing).
      • External Study: 52 tests.
    • Data Provenance:
      • Internal Study: Performed at MMQCI's facility in Saco, Maine, USA.
      • External Study: Performed at an independent U.S. facility.
    • Retrospective/Prospective: The studies appear to be prospective as they involved testing newly manufactured lots of the control panel on BioFire FilmArray systems under specified conditions.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

    This information is not provided in the document. For quality control materials like the BioFire RP2.1/RP2.1plus Control Panel M441, the "ground truth" is inherent to the composition of the control. The positive control is designed to contain synthetic RNA transcripts for specific pathogens, and the negative control is designed to not contain them. The "correctness" of results is determined by whether the BioFire FilmArray system detects the expected pathogens in the positive control and no pathogens in the negative control. It doesn't rely on human expert interpretation of results, but rather on the objective measurement by the instrument.

    4. Adjudication Method for the Test Set

    This information is not applicable as the "ground truth" for quality control materials is defined by their manufacturing composition and expected reaction, not by expert interpretation requiring adjudication. Results are either "correct" (matching the known composition) or "incorrect," or "invalid" by the instrument.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an assayed quality control material for clinical microbiology assays, not an AI-powered diagnostic device that would assist human readers in interpreting clinical cases. Therefore, the concept of human readers improving with AI assistance is not applicable here.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    This question is not applicable as the device is a physical quality control material, not a software algorithm. The "performance" being evaluated is how reliably the BioFire FilmArray system detects the components of the control panel. The control panel itself does not operate as a standalone algorithm.

    7. The Type of Ground Truth Used

    The ground truth used is the known composition of the control material.

    • Positive Control: Contains synthetic RNA transcripts for all respiratory pathogens detected by the BioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Respiratory Panel 2.1plus (RP2.1plus), and BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ) assays, including SARS-CoV-2.
    • Negative Control: Contains buffer and preservatives with no RNA.

    8. The Sample Size for the Training Set

    This information is not applicable/not provided in the context of this device. This device is a quality control material, not a machine learning model that requires a training set. The manufacturing process and formulation are based on established molecular biology principles, not on training data.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable as there is no "training set" for this quality control material.

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