Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K231469
    Device Name
    PAXgene® Blood DNA Tube
    Manufacturer
    PreAnalytiX GmbH
    Date Cleared
    2023-06-21

    (30 days)

    Product Code
    PJE
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    PJE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PAXgene® Blood DNA Tube is intended to collect, anticoagulate, stabilize, transport, and store a venous whole blood sample for preparation of human DNA for use with molecular diagnostic test methods that require DNA. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.
    Device Description
    The PAXgene® Blood DNA Tube is a sterile, single use, plastic, evacuated blood collection tube with a BD Hemogard™ closure assembly (comprised of Hemogard™ stopper and shield components) and a measured quantity of K2EDTA additive quantity dispensed into each tube is designed to match the nominal blood draw volume of 2.5 mL. The tube is made of polyethylene terephthalate (PET) plastic which functions to maintain vacuum within the tube, allowing for accurate and consistent blood draw for the shelf life of the tube. A predetermined vacuum is drawn inside the tube that is sealed with a BD Hemogard™ closure which consists of a rubber stopper plus BD Hemogard™ shield. The PAXgene® Blood DNA Tube is available as a 13 x 75 mm tube with a 2.5 mL nominal blood draw. The referenced first dimension represents the diameter of the tube, and the second dimension represents the length of the tube.
    Ask a Question
    K Number
    K142821
    Device Name
    PAXgene Blood DNA Tube
    Manufacturer
    PREANALYTIX GMBH
    Date Cleared
    2015-09-09

    (344 days)

    Product Code
    PJE
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    PJE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PAXgene Blood DNA Tube is intended to collect, anticoagulate, stabilize, transport, and store a venous whole blood sample for preparation of human DNA for use with molecular diagnostic test methods that require DNA. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.
    Device Description
    The PAXgene® Blood DNA Tube is a sterile, single use, plastic, evacuated blood collection tube with a BD Hemogard™ closure assembly and a measured quantity of K2EDTA additive. The additive quantity dispensed into each tube is designed to match the nominal blood draw volume of 2.5 mL. The tube is made of polyethylene terephthalate (PET) plastic which functions to maintain vacuum within the tube, allowing for accurate and consistent blood draw for the duration of the shelf life of the tube. A predetermined vacuum is drawn inside the tube that is sealed with a BD Hemogard™ closure which consists of a rubber stopper plus BD Hemogard™ shield. The tube is intended to be placed inside a tube holder or an adaptor that contains a needle designed to pierce the tube closure and allow blood to flow into the tube. Once the vein has been penetrated (using either a standard blood collection needle or a blood collection set), the tube is pushed into the holder, and the blood enters the tube. Once a tube has drawn the appropriate amount of blood, it is disengaged from the holder and inverted the recommended number of times (8–10) to mix the additive with the blood. The DNA in whole blood collected in the PAXgene® Blood DNA Tube has been shown to be suitable for molecular diagnostic testing for 14 days at room temperature (18–25°C), 28 days refrigerated (2–8°C), 3 days at 35°C, up to 52 weeks frozen (–20°C), or when subjected to up to three freeze-thaw cycles. The PAXgene® Blood DNA Tube is robust with respect to mishandling including reduced inversions and partial blood draw. The product shelf life is one year from the date of manufacture including limited storage temperature excursions which simulate shipping conditions from –20°C to 45°C. The PAXgene® Blood DNA Tube is available as a 13 x 75 mm tube with a 2.5 mL nominal blood draw. The referenced first dimension represents the diameter of the tube and the second dimension represents the length of the tube.
    Ask a Question
    K Number
    K042927
    Device Name
    VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
    Manufacturer
    GREINER BIO-ONE VACUETTE NORTH AMERICA
    Date Cleared
    2005-04-15

    (175 days)

    Product Code
    PJE
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    PJE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® EDTA K3 Tubes are used for testing plasma in molecular diagnostics. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.
    Device Description
    VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. VACUETTE® EDTA K3 Tubes are used for testing whole blood in molecular diagnostics.
    Ask a Question
    K Number
    K031359
    Device Name
    S-MONOVETTE EDTA K2-GEL
    Manufacturer
    SARSTEDT, INC.
    Date Cleared
    2003-09-12

    (135 days)

    Product Code
    PJE
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    PJE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The S-Monovette® EDTA K2-Gel provides a means for collection, processing and transportation of a plasma specimen in a closed system. Following collection of the blood, the S-Monovette® EDTA K2-Gel is to be centrifuged such that the gel creates a barrier between the plasma and cellular components. The plasma specimen can then be removed for testing or the specimen can be transported for testing at another location without the plasma mixing with the cellular components. The plasma specimen produced by the S-Monovette® EDTA K2-Gel can be used for Nucleic Acid Testing (NAT) by methods such as PCR - Polymerase Chain Reaction or for other procedures where the laboratory has determined that a plasma specimen is appropriate.
    Device Description
    Not Found
    Ask a Question
    K Number
    K014104
    Device Name
    VACUETTE EDTA K2 TUBES
    Manufacturer
    GREINER VACUETTE NORTH AMERICA, INC.
    Date Cleared
    2002-02-01

    (50 days)

    Product Code
    PJE
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    PJE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VACUETTE® EDTA K2 tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume. The VACUETTE® EDTA K2 tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
    Device Description
    The VACUETTE® EDTA K2 Tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
    Ask a Question
    K Number
    K012043
    Device Name
    VACUETTE EDTA K2 GEL TUBES
    Manufacturer
    GREINER VACUETTE NORTH AMERICA, INC.
    Date Cleared
    2001-09-24

    (87 days)

    Product Code
    PJE
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    PJE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume, and a gel barrier material. The VACUETTE® EDTA K2 Gel tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
    Device Description
    The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume, and a gel barrier material. The VACUETTE® EDTA K2 Gel Tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
    Ask a Question
    K Number
    K010328
    Device Name
    MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
    Manufacturer
    IZON BUSINESS PRODUCTS, INC.
    Date Cleared
    2001-04-09

    (66 days)

    Product Code
    PJE
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    PJE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A blood collection kit for D.N.A. is a device intended for medical purposes to collection tubes. A blood collection kit for D.N.A. is a device may include blood collection tubes, vials, systems, or vacuum sample tubes.
    Device Description
    A blood collection kit for D.N.A. is a device intended for medical purposes to collection tubes. A blood collection kit for D.N.A. is a device may include blood collection tubes, vials, systems, or vacuum sample tubes.
    Ask a Question
    K Number
    K972075
    Device Name
    VACUTAINER BRAND PPT PLASMA PREPARATION TUBE
    Manufacturer
    BECTON DICKINSON VACUTAINER SYSTEMS
    Date Cleared
    1998-02-24

    (266 days)

    Product Code
    PJE
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    PJE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VACUTAINER® Brand PPT™ Plasma Preparation Tube with HDTA anticoagulant and a gel barrier material are evacuated blood collection which provide a means of collecting, processing and transporting blood in a closed plastic tube. When the Tube is .. used together with VACUPAINER® Brand needles and holders, it is a closed system for the collection of venous blood with the same indications identified here. Blood collected in a tube containing HDTA anticoagulant and gel barrier material can be primarily used to provide undiluted plasma for use in molecular diagnostic test methods; including but not limited to Polymerase Chain Reaction (PCR) and branched-DNA (bDNA). The specimen may also be used for other testing that requires an undiluted plasma sample as determined by the laboratory.
    Device Description
    The VACUTAINER® Brand PPT™-Plasma Preparation Tube (blood collection The VACOTAINER® Brand Property is an evacuated plastic tube containing EDTA Antiocagana, processing and transporting blood in a blood obliobiler Rabe for Selleum NER® Brand PPT™ consists of a Closed plastic tube. The VAOS v. ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (dipotassium or tripotassium) and a polymeric gel barrier material.
    Ask a Question

    Page 1 of 1