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510(k) Data Aggregation

    K Number
    K160586
    Device Name
    XN-L CHECK
    Manufacturer
    STRECK
    Date Cleared
    2016-12-22

    (296 days)

    Product Code
    JPK, PAN
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    JPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XN-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assayed parameters include: RBC (10^6/uL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (10^3/uL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (10^3/uL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), IG (%), NEUT# (10^3/uL), LYMPH# (10^3/μL), MONO# (10^3/μL), EO# (10^3/μL), BASO# (10^3/μL), IG# (10^3/μL), RET# (10^6/uL), RET%, IRF%, RET-He (pg).
    Device Description
    XN-L CHECK™ is an in-vitro diagnostic, three level (Levels 1, 2, and 3) hematology product that contains the following stabilized red blood cell component(s), stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vias with screw caps with a 3 ml fill. The vials will be pacum formed clamshell container with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.
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    K Number
    K160588
    Device Name
    XN CHECK BF
    Manufacturer
    STRECK
    Date Cleared
    2016-12-22

    (296 days)

    Product Code
    JPK, PAN
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    JPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XN CHECK BF is used for control and calibration of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: WBC-BF (10^3/μL), RBC-BF (10^6/μL), MN# (10^3/μL), PMN# (10^3/μL), MN%, PMN%, TC-BF# (10^3/uL)
    Device Description
    XN CHECK™ BF is an in-vitro diagnostic, two level, control. It contains the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium in polypropylene plastic vials with screw caps with a 3 mL fill. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use (IFU) / assay sheet. Product storage conditions are 2 - 8° C.
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    K Number
    K160590
    Device Name
    XN CHECK
    Manufacturer
    STRECK
    Date Cleared
    2016-12-22

    (296 days)

    Product Code
    JPK, PAN
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    JPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: RBC(106/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F*(103/μL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/uL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103/pL), LYMPH#(103/pL), MONO# (103/pL), BASO#(103/pL), IG#(103/ μL), IPF(%)*, IPF#* (103/pL), RET#(106/μL), RET%, IRF%, RET-HE(pg), NRBC#* (100 WBC) *Not Available on the XN-L.
    Device Description
    XN CHECK™ is a three level hematology control the following: stabilized red blood cell component(s), stabilized white blood cell component(s) stabilized platelet component(s), and stablic on onnonent(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps with a 3 mL fill. The vials will be pacum formed clamshell container with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.
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    K Number
    K160606
    Device Name
    BC-5D Hematology Control
    Manufacturer
    R & D SYSTEMS, INC.
    Date Cleared
    2016-09-01

    (183 days)

    Product Code
    JPK
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    JPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BC-5D is an assayed whole blood control designed for Mindray BC-5390 (Mindray 5000 series) Auto Hematology Analyzer for the following parameters: WBC, Neu#, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD. PLT. and MPV.
    Device Description
    The BC-5D Hematology Control consists of three levels of controls (Low, Normal, and High). It is recommended to perform quality control check using these controls established by the laboratory procedures and/or local/national regulations. BC-5D Hematology Control is an in vitro diagnostic reagent composed of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid with preservatives. This control is contains stabilized materials that provide a means of monitoring the performance of hematology blood cell counters. It is sampled in the same manner as a patient specimen.
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    K Number
    K141957
    Device Name
    XN CHECK BF
    Manufacturer
    Streck
    Date Cleared
    2014-12-05

    (140 days)

    Product Code
    JPK
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    JPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. It is not. however, intended for actual calibration of these analyzers. Assayed parameters include: WBC-BF (10^3/μl), RBC-BF (10^6/ μl), ΜΝ# (10^3/μl), ΜΝ% (%), ΡΜΝ% (%), ΡΜΝ% (%), ΤC-ΒΓ# (10°3/μl)
    Device Description
    XN CHECK™ BF is an in-vitro diagnostic product the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with a 3 m fill. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use / assay sheet. The product storage conditions are at 2 - 8° C.
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    K Number
    K141964
    Device Name
    XN CHECK
    Manufacturer
    Streck
    Date Cleared
    2014-12-05

    (140 days)

    Product Code
    JPK, PAN
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    JPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-21) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: RBC(10^6/uL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(10^3/uL), PLT-F(10^3/uL), RDW-SD(fL), RDW-CV(%), MBC(10^3/uL), NEUT(%), LYMPH (%), MONO(%), EQ(%), BASO(%), IG(%), NEUTH(10^3/uL), LYMPH#(10^3/uL), MONO# (10^3/uL), EO#(10^3/uL), BASO#(10^3/uL), IG#(10^3/μL), IPF(%), IPF# (10^3/μL), RET%, IRF%, RET-HE(pg), NRBC#(10^3/uL), NRBC% (/100 WBC)
    Device Description
    XN CHECK™ is an in-vitro diagnostic product that onlowing: stabilized red blood cell component(s), stablized white blood cell component(s), stablized platelet component(s), and stabilized nuclement(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps with a 3 ml fill. The vials will be packaged in (4) welled vacuum formed clamshell ontainer with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.
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    K Number
    K130962
    Device Name
    R&D 5D RETIC HEMATOLOGY CONTROL
    Manufacturer
    R & D SYSTEMS, INC.
    Date Cleared
    2013-07-24

    (107 days)

    Product Code
    JPK, DEV
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    JPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    R&D 5D Retic Control is a tri-level, assayed Hematology control designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers. For in vitro Diagnostic Use Only.
    Device Description
    The R&D 5D Retic Hematology Control is an in vitro diagnostic reagent composed of human in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring reticulocyte counting methods. It is sampled in the same manner as a patient specimen.
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    K Number
    K120742
    Device Name
    XN CHECK
    Manufacturer
    Streck
    Date Cleared
    2012-10-19

    (221 days)

    Product Code
    JPK
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    JPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(102/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/pL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103)µL), LYMPH#(103/pL), MONO# (10°/µL), EO#(10°/µL), BASO#(103/pL), IG#(103/pL), RET#(10°/μL), RET%, IRF%, RET-HE(pg), NRBC#(10°/μL), NRBC% (/100 WBC)
    Device Description
    XN CHECK™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps containing 3 ml. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use / assay sheet. The product must be stored at 2 - 8° C.
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    K Number
    K120744
    Device Name
    XN CHECK BF
    Manufacturer
    Streck
    Date Cleared
    2012-10-19

    (221 days)

    Product Code
    JPK
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    JPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: WBC-BF (103/μl), RBC-BF (10°/μl), MN# (103/μl), PMN# (103/μl), MN% (%), PMN% (%), TC-BF# (103/ul)
    Device Description
    XN CHECK™ BF is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps containing 3 ml. The vials will be packaged in (4) welled vacuum formed clamshell container with the product information sheet / assay sheet. The product must be stored at 2 - 8° C.
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    K Number
    K101578
    Device Name
    R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
    Manufacturer
    R & D SYSTEMS, INC.
    Date Cleared
    2011-04-28

    (325 days)

    Product Code
    JPK, DEV
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    JPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The R&D Body Fluid-I Control is an assayed hematology control intended to monitor the reliability of hematology instruments that quantitatively measure red and white blood cell counts in cerebrospinal fluids, serous fluids, and synovial fluids. For in vitro Diagnostic Use Only
    Device Description
    The R&D Body Fluid-I is an assayed, in vitro, whole blood control composed of human and bovine cells in a plasma-like fluid with preservatives. Three levels are available and each level of control is packaged in a tube containing 3 mL of the control material. It is sampled in the same manner as a patient specimen.
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