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510(k) Data Aggregation

    K Number
    DEN160025
    Device Name
    ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
    Manufacturer
    ID-FISH TECHNOLOGY, INC
    Date Cleared
    2017-08-18

    (417 days)

    Product Code
    PYN
    Regulation Number
    866.3367
    Type
    Direct
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    Regulation section:
    21 CFR 866.3367

    this de novo submission is sufficient to classify this device into class II under regulation 21 CFR 866.3367
    controls) |
    | Regulation: | 21 CFR 866.3367

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

    ID-FISH Plasmodium Genus Test Kit (PlasG) and ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit (PlasFV) are intended for in vitro diagnostic use in the clinical laboratory for detection of Plasmodium species in human venous whole blood (EDTA) samples from patients suspected of Plasmodium infection. The test kits are intended to aid in the diagnosis of malaria and to aid in the differential diagnosis of P. falciparum and P. vivax infection. The test kits should be used only on samples from patients with a clinical history, signs and symptoms consistent with malaria, and are not intended as a screen for asymptomatic patients.

    The ID-FISH Plasmodium Genus Test Kit is a qualitative test for detection of malaria parasites in blood smears. Positive results should be supplemented with the Plasmodium species specific test kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit for identification and differentiation of Plasmodium falciparum and Plasmodium vivax. The results of these test kits should be used in conjunction with other diagnostic test results. Clinical performance has not been established for P. ovale, P. malariae, or P. knowlesi.

    Device Description

    The ID-FISH Plasmodium Genus Test Kit (PlasG) and ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit (PlasFV) are fluorescence in situ hybridization (FISH) assays to detect Plasmodium spp. or P. falciparum or P. vivax parasites in thin film blood smears prepared from EDTA venous whole blood samples.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criteria/MetricTarget Performance (Implicit from study results)Reported Device Performance (PlasG)Reported Device Performance (PlasFV - P. falciparum)Reported Device Performance (PlasFV - P. vivax)
    ReproducibilityNegative AgreementHigh agreement (e.g., >95%)99.4% (178/179)99.4% (178/179)N/A (Kit differentiates species)
    Positive Agreement (Low P.f.)100%100% (178/178)99.4% (177/178)N/A
    Positive Agreement (Mod P.f.)100%100% (180/180)100% (180/180)N/A
    Positive Agreement (Low P.v.)100%100% (180/180)N/A100% (180/180)
    Positive Agreement (Mod P.v.)100%100% (180/180)N/A100% (180/180)
    Limit of Detection (LoD)Detection Rate>= 95% at specified concentration143 parasites/uL (P.f.), 126 parasites/uL (P.v.)143 parasites/uL (P.f.), 126 parasites/uL (P.v.)143 parasites/uL (P.f.), 126 parasites/uL (P.v.)
    Analytical Reactivity (Inclusivity)Detection of Plasmodium speciesAll Plasmodium positive samples detectedAll 11 Plasmodium positive samples detectedP. falciparum and P. vivax positive samples correctly identifiedP. falciparum and P. vivax positive samples correctly identified
    Analytical Specificity (Cross-Reactivity)No false positive results0 false positivesNo false positives with 29 pathogens/76 non-malarial blood samplesNo false positives with 29 pathogens/76 non-malarial blood samples (for respective probes)No false positives with 29 pathogens/76 non-malarial blood samples (for respective probes)
    Interfering SubstancesNo false positives/negativesNo impact on resultsNo false positives, expected results for positive samplesNo false positives, expected results for positive samplesNo false positives, expected results for positive samples
    Specimen StabilityStable for 5 years (fixed slides storage)No noticeable reduction in staining intensity, expected resultAll samples produced expected resultsAll samples produced expected resultsAll samples produced expected results
    Clinical Performance (Endemic Regions - All Comers)Sensitivity (Plasmodium spp.)>95% (lower bound 95% CI >90%)95.7% (95% CI 93.0% - 97.4%)N/AN/A
    Specificity (Plasmodium spp.)High specificity, PCR confirmation for "false positives"92.6% (95% CI 89.5% - 94.9%) - improved by PCRN/AN/A
    Sensitivity (P. falciparum)High sensitivityN/A97.4% (95% CI 93.6% - 99.0%)N/A
    Specificity (P. falciparum)High specificity, PCR confirmation for "false positives"N/A96.1% (95% CI 94.1% - 97.4%) - improved by PCRN/A
    Sensitivity (P. vivax)High sensitivityN/AN/A91.2% (95% CI 86.0% - 94.6%)
    Specificity (P. vivax)High specificity, PCR confirmation for "false positives"N/AN/A98.3% (95% CI 96.8% - 99.1%) - improved by PCR
    Clinical Performance (Non-Endemic Regions)Specificity (Plasmodium spp.)High specificity100% (150/150)100% (150/150)100% (150/150)
    Clinical Performance (Low Parasitemia)Sensitivity (Plasmodium spp.
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