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510(k) Data Aggregation

    K Number
    K242294
    Device Name
    DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
    Manufacturer
    DiaSys Diagnostic Systems GmbH
    Date Cleared
    2025-05-09

    (280 days)

    Product Code
    PTF
    Regulation Number
    866.3215
    Why did this record match?
    Product Code :

    PTF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DiaSys Procalcitonin FS assay is a particle enhanced immunoturbidimetric test intended for the quantitative in vitro determination of procalcitonin (PCT) in human serum and lithium heparin plasma on automated Abbott ARCHITECT c8000 analyzer. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock. The TruCal Procalcitonin Calibrator Set is intended for in vitro use for calibration of the DiaSys Procalcitonin FS assay. TruLab Procalcitonin Bi-Level Controls are an assayed quality control material for monitoring the performance of quantitative in vitro determination of Procalcitonin (PCT) for the DiaSys Procalcitonin FS assay. For in vitro diagnostic use only.
    Device Description
    The DiaSys Procalcitonin FS assay is a particle enhanced turbidimetric immunoassay (PETIA) test for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and lithium heparin plasma on automated photometric systems. The test utilizes anti-human PCT polyclonal antibodies (goat) covalently bound to polystyrene particles. PCT in the sample binds to the anti-PCT antibodies on the particles and causes agglutination. The degree of the turbidity caused by agglutination is optically measured at 660 nm by the automated photometric system and is proportional to the amount of PCT in the sample. DiaSys Procalcitonin FS Reagent specifies settings for an automated photometric analyzer, the Abbott ARCHITECT c8000. The DiaSys TruCal Procalcitonin Calibrator Set is provided in 6 levels, traceable to a commercial assay for use in the calibration of the DiaSys Procalcitonin FS assay. The DiaSys TruLab Procalcitonin Bi-Level Controls, Levels 1 (low) and 2 (high) are intended for use as quality control for the DiaSys Procalcitonin FS assay. DiaSys PCT Calibrators and Bi-Level Controls are ready-to-use, stable, aqueous solutions containing recombinant human full-length PCT and biological additives from bovine origin.
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    K Number
    K222996
    Device Name
    Access PCT
    Manufacturer
    Beckman Coulter, Inc
    Date Cleared
    2023-04-26

    (210 days)

    Product Code
    PTF
    Regulation Number
    866.3215
    Why did this record match?
    Product Code :

    PTF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.
    Device Description
    The Access PCT assay is a paramaqnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock. A description of the reagent pack is provided below. - R1a: Dynabeads* paramagnetic particles coated with mouse anti-. human Procalcitonin monoclonal antibody in a TRIS buffer with surfactant, protein (bovine), ≤ 0.1% sodium azide, and 0.1% ProClin**300 - R1b: 0.10 N Sodium Hydroxide ● - R1c: MOPS Buffer with surfactant and protein (bovine, murine), ≤ ● 0.1 % sodium azide, and 0.1% ProClin 300 - R1d: Rat anti-Procalcitonin recombinant alkaline phosphatase . coniugate in a MOPS buffer with surfactant and protein (bovine, murine, recombinant). ≤ 0.1% sodium azide, and 0.1% ProClin 300
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    K Number
    K192271
    Device Name
    Access PCT, Access PCT Calibrators
    Manufacturer
    Beckman Coulter, Inc.
    Date Cleared
    2019-11-26

    (96 days)

    Product Code
    PTF
    Regulation Number
    866.3215
    Why did this record match?
    Product Code :

    PTF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission to severe sepsis and septic shock. The Access PCT Calibrators are intended to calibrate the Access PCT assay for the quantitative determination of procalcitonin levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems.
    Device Description
    The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission for progressive to severe sepsis and septic shock. A description of the reagent pack is provided below. - R1a: Dynabeads* paramagnetic particles coated with mouse anti-human ● Procalcitonin monoclonal antibody in a TRIS buffer with surfactant, protein (bovine), ≤ 0.1% sodium azide, and 0.1% ProClin**300 - R1b: 0.10 N Sodium Hvdroxide ● - R1c: MOPS Buffer with surfactant and protein (bovine, murine). ≤ 0.1% . sodium azide, and 0.1% ProClin 300 - R1d: Rat anti-Procalcitonin recombinant alkaline phosphatase conjugate in a ● MOPS buffer with surfactant and protein (bovine, murine, recombinant), ≤ 0.1% sodium azide, and 0.1% ProClin 300
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    K Number
    K162297
    Device Name
    Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
    Manufacturer
    Diazyme Laboratories
    Date Cleared
    2017-04-18

    (245 days)

    Product Code
    PTF
    Regulation Number
    866.3215
    Why did this record match?
    Product Code :

    PTF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diazyme PCT Assay is a latex particle enhanced immunoturbidimetric method for the quantitative determination of PCT in human serum, EDTA or lithium heparin plasma. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock. For in vitro diagnostic use only. The Diazyme PCT Calibrator Set is intended for use in the Diazyme PCT Assay. For in vitro diagnostic use only. The Diazyme PCT Control Set is intended for use as quality control for the Diazyme PCT Assay. For in vitro diagnostic use only.
    Device Description
    Diazyme PCT Assay is a latex particle enhanced immunoturbidimetric method for the quantitative determination of PCT in human serum, EDTA or lithium heparin plasma.
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