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510(k) Data Aggregation
K Number
K160586Device Name
XN-L CHECK
Manufacturer
STRECK
Date Cleared
2016-12-22
(296 days)
Product Code
JPK, PAN
Regulation Number
864.8625Why 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
K160588Device Name
XN CHECK BF
Manufacturer
STRECK
Date Cleared
2016-12-22
(296 days)
Product Code
JPK, PAN
Regulation Number
864.8625Why 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
K160590Device Name
XN CHECK
Manufacturer
STRECK
Date Cleared
2016-12-22
(296 days)
Product Code
JPK, PAN
Regulation Number
864.8625Why 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
K160606Device Name
BC-5D Hematology Control
Manufacturer
R & D SYSTEMS, INC.
Date Cleared
2016-09-01
(183 days)
Product Code
JPK
Regulation Number
864.8625Why 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
K141957Device Name
XN CHECK BF
Manufacturer
Streck
Date Cleared
2014-12-05
(140 days)
Product Code
JPK
Regulation Number
864.8625Why 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
K141964Device Name
XN CHECK
Manufacturer
Streck
Date Cleared
2014-12-05
(140 days)
Product Code
JPK, PAN
Regulation Number
864.8625Why 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
K130962Device 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
864.8625Why 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
K120742Device Name
XN CHECK
Manufacturer
Streck
Date Cleared
2012-10-19
(221 days)
Product Code
JPK
Regulation Number
864.8625Why 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
K120744Device Name
XN CHECK BF
Manufacturer
Streck
Date Cleared
2012-10-19
(221 days)
Product Code
JPK
Regulation Number
864.8625Why 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
K101578Device 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
864.8625Why 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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