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510(k) Data Aggregation

    K Number
    K033612
    Device Name
    FACTOR II (PROTHROMBIN) G20210A KIT
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2003-12-18

    (31 days)

    Product Code
    NPR
    Regulation Number
    864.7280
    Type
    Traditional
    Panel
    Pathology
    Reference & Predicate Devices
    N/A
    Predicate For
    K070597,K082118,K100943,K132978,K172913
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene, from DNA isolated from human whole peripheral blood. The test is intended to be used on the LightCycler using SW 3.5. The sample preparation must be performed according to the workflow procedure described in the package insert. The Factor II (Prothrombin) G20210A Kit is indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

    Device Description

    The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation, from DNA isolated from human whole peripheral blood.

    AI/ML Overview

    Acceptance Criteria and Device Performance Study for K033612

    This analysis describes the acceptance criteria and the study used to demonstrate that the Factor II (Prothrombin) G20210A Kit meets these criteria, as detailed in the provided 510(k) summary (K033612).

    1. Table of Acceptance Criteria and Reported Device Performance

    FeatureAcceptance Criteria (Implied)Reported Device Performance
    Substantial EquivalenceHigh agreement with a DNA sequencing method.99.5% agreement with a DNA sequencing method.
    PrecisionConsistent and reproducible results.Within-run: Tm1: 0.14 – 0.26 % CV, Tm2: 0.14 – 0.24 % CV, ΔTm: 0.58- 0.90% CV Total: Tm1: 0.19 – 0.33 % CV, Tm2: 0.22 – 0.44 % CV, ΔTm: 1.23- 1.53 % CV Overall median: 0.36%
    Analytical Sensitivity (LDL)Ability to detect low concentrations of allele copies.< 50 allele copies per reaction
    Reagent StabilityStable performance over time and under specified conditions.Store up to stated expiration date at -15 to -25°C. Protect from light. Freeze immediately after use. Kit reagents may be frozen and thawed up to five times.
    InterferencesMinimal interference from common substances in samples.High concentrations of heparin might interfere. No interference from EDTA or citrate anticoagulants.
    Precautions and WarningsIdentification of known limitations or potential false results.One rare mutation (A20218G) will lead to false-positive result after performing the melting curve analysis.

    Note: The 510(k) summary does not explicitly state numerical acceptance criteria for each test; however, the "Performance Characteristics" section implicitly sets the acceptance criteria by reporting the observed performance, which is deemed sufficient for substantial equivalence.

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

    • Sample Size: 572 samples were tested for the substantial equivalence study.
    • Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the samples were collected retrospectively or prospectively.

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

    The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set.

    4. Adjudication Method for the Test Set

    The document does not describe any adjudication method used for the test set. The ground truth was established by a "DNA sequencing method."

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is provided in the document. This type of study is more common for imaging devices where human interpretation is a critical part of the diagnostic process. This device is an in vitro diagnostic test for genetic mutation detection, which typically involves automated or semi-automated analysis rather than human reader interpretation in the context of an MRMC study.

    6. Standalone Performance Study

    Yes, a standalone performance study was done. The "Substantial equivalence" section directly compares the device's performance to a DNA sequencing method (the ground truth), reporting 99.5% agreement. This demonstrates the algorithm's (or kit's) performance without explicit human intervention in the interpretation of the Factor II G20210A Kit results.

    7. Type of Ground Truth Used

    The type of ground truth used for the substantial equivalence study was DNA sequencing method. This is considered a gold standard for genetic mutation detection.

    8. Sample Size for the Training Set

    The document does not specify the sample size for a training set. This is common for IVD kits where the primary validation is often based on the performance of the prepared reagents and assay protocol against a gold standard, rather than training a machine learning algorithm.

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

    As no training set is explicitly mentioned for a machine learning algorithm, there is no information on how its ground truth would have been established. For the overall validation of the kit, the DNA sequencing method served as the established ground truth.

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