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510(k) Data Aggregation

    K Number
    K120977
    Device Name
    DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Date Cleared
    2013-07-03

    (457 days)

    Product Code
    GGN,PLA
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K960749,K941007
    Predicate For
    K202101
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The directCHECK® Whole Blood ACT+ Level 1 (normal) and ACT+ Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT+ assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.

    The directCHECK® Whole Blood ACT-LR Level 1 (normal) and ACT-LR Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT-LR assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.

    Device Description

    The directCHECK® Whole Blood Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation tests. The directCHECK® whole blood control material is prepared from animal plasmas to which fixed animal red blood cells have been added. No human-based materials are contained in directCHECK® Whole Blood Controls. The whole blood control material is lyophilized in glass ampoules, and placed into an individual assembly with liquid diluent. When the glass ampoule is broken (activation of the assembly), the diluent rehydrates the lyophilized material, forming a liquid whole blood control.

    AI/ML Overview

    The acceptance criteria and study proving device performance are described below based on the provided text.

    Acceptance Criteria and Device Performance

    Device: directCHECK® Whole Blood Control for HEMOCHRON® ACT+ assay and directCHECK® Whole Blood Control for HEMOCHRON® ACT-LR assay

    Study Type: Non-clinical precision and stability testing. Clinical studies were not performed.

    Acceptance CriteriaReported Device Performance (directCHECK® ACT-LR assay)Reported Device Performance (directCHECK® ACT+ assay)
    Overall CV for Level 1 ≤ 14%Overall CV for Level 1 is 14%Overall CV for Level 1 is 10%
    Overall CV for Level 2 ≤ 12%1Overall CV for Level 2 is 10%Overall CV for Level 2 is 5%
    Shelf-life Demonstrating 5 months of stability5 months of shelf-life for Level 1 and Level 25 months of shelf-life for Level 1 and Level 2
    Room temperature stability demonstrating 4 weeks4 weeks for Level 1 and Level 24 weeks for Level 1 and Level 2

    Note: The text explicitly states "this satisfies the Level 2 acceptance criteria of CV</2%." However, it then immediately follows with the ACT+ assay where Level 2 performance of 5% satisfies "acceptance criteria for each level at CV ≤12%." This suggests a potential typo in the ACT-LR Level 2 criteria, or different criteria were applied. Given the ACT+ Level 2 satisfaction at ≤12%, and 10% for ACT-LR Level 2, I have assumed the ≤12% applies to both as a reasonable interpretation of the overall statement. If the "<2%" was truly the criterion, the ACT-LR Level 2 (10%) would not have met it.

    Additional Information:

    1. Sample size used for the test set and the data provenance: This information is not explicitly provided in the document. The text mentions "Precision testing was performed according to CLSI Guideline EP5-A2" and "Stability was evaluated following principles in CLSI Guideline EP25-A," which are general guidelines. The specific number of samples or data provenance (e.g., country of origin, retrospective/prospective) is not detailed.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a quality control material for coagulation tests. The "ground truth" for its performance is assessed via objective measurements of its characteristics (e.g., coefficient of variation, stability) against pre-defined analytical acceptance criteria, not through expert consensus on medical images or clinical outcomes.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as expert adjudication is not relevant for determining the performance of a quality control material. Performance is measured analytically.

    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 is a quality control material for in vitro diagnostic coagulation systems, not an AI-assisted diagnostic tool that would involve human readers.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone quality control product; it does not involve an algorithm. Its performance is measured directly.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this quality control material is its intrinsic analytical properties, specifically its precision (measured by coefficient of variation, CV) and stability over time and under various storage conditions. These established analytical targets serve as the ground truth.

    7. The sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set.

    8. How the ground truth for the training set was established: Not applicable.

    Footnotes

    1. The text has a potential discrepancy here. For the ACT-LR assay, it states "this satisfies the Level 2 acceptance criteria of CV</2%." However, Level 2 performance is 10%. For the ACT+ assay, Level 2 performance is 5% which "satisfies the acceptance criteria for each level at CV ≤12%." Given that 10% for ACT-LR Level 2 is "satisfied," it's highly probable the "<2%" was a typo, and the actual acceptance criterion for Level 2 was ≤12%. ↩

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