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510(k) Data Aggregation

    K Number
    K053571
    Device Name
    MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    Manufacturer
    INTERLAB S.R.L.
    Date Cleared
    2006-06-30

    (190 days)

    Product Code
    JBD
    Regulation Number
    864.7440
    Why did this record match?
    Product Code :

    JBD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microgel Alkaline Hemoglobin Electrophoresis test kit is intended for qualitative and semiquantitative determination of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using agarose gel. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglish hemoglobin electrophoresis is necessary. The electrophoretic test is performed at allialine pH and provides a valuable screening method for hemoglobin patterns. Densitometry of the pattern allows the relative quantification of hemogram patism belief allows the pattern allows the relative automated Microod instrument automated Microgel instrument. The Microgel Acid Hemoglobin Electrophoresis kit is a qualitative test for the identification of both normal and abnomal or variant hemoglobins, and to confirm the identify of clinication of hemoglobins such as A. E. Gand O. Th hemoglobins such as A, F, S and C. The Acid Hemoglobin test kit employs agarose gel at acidic pH and is for in vitro diagnes and of The Rold Hemoglouin test Kit Employs agarose gel at acidid Microgel instrument Microgel instrument.
    Device Description
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    K Number
    K032862
    Device Name
    INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    Manufacturer
    INTERLAB S.R.L.
    Date Cleared
    2004-02-03

    (144 days)

    Product Code
    JBD
    Regulation Number
    864.7440
    Why did this record match?
    Product Code :

    JBD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Interlab Alkaline Hemoglobin Electrophoresis test system is intended for the separation of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using cellulose acetate supported on Mylar®. The test is a screening method for in vitro diagnostic use on the Microtech 672 PC and the Microtech 648 ISO fully automated analyzers. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglobin electrophoresis is necessary.
    Device Description
    The InterLab Hemoglobin devices test kits for the electrophoretic separation of hemoglobin in whole blood and are intended for In-Vitro diagnostic use only. The InterLab Alkaline Hemoglobin Electrophoresis Test Devices provide semi-quantitative identification of hemoglobin bands visualized by staining of the fractions. The principle of hemoglobin electrophoresis is based upon the visualization of specific hemoglobin bands following separation by electrophoresis. Dilutions of a patient's specimen are placed on separate tracks (fingers) on a cellulose acetate slide six fingers shaped, and the major hemoglobin groups are separated by electrophoresis. The migration rate depends on the temperature, pH, ionic force of the solution and proportions of the reactants. After electrophoresis, the slide is processed to remove excess soluble materials through a washing step. Fractionated hemoglobins are stained. The excess of stain is removed by a destaining step.
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    K Number
    K992199
    Device Name
    ACID HEMOGLOBIN KIT
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    1999-09-21

    (83 days)

    Product Code
    JBD
    Regulation Number
    864.7440
    Why did this record match?
    Product Code :

    JBD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acid Hemoglobin system is intended as a qualitative screening method for the presence of abnormal hemoglobins such as HbS, HbC or HbF using agar electrophoresis. The system will provide two kits for use on the REP, REP 3 and the SPIFE electrophoresis analyzers.
    Device Description
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    K Number
    K991362
    Device Name
    HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
    Manufacturer
    MORAX
    Date Cleared
    1999-06-21

    (68 days)

    Product Code
    JBD, GIQ, GKA, KQI, MLL
    Regulation Number
    864.7440
    Why did this record match?
    Product Code :

    JBD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sebia's HYDRAGEL HEMOGLOBIN(E) and HYDRAGEL ACID(E) HEMOGLOBIN(E) lines of devices are intended as an aid in the detection and identification of human hemoglobin abnormalities, namely hemoglobinopathies (structural hemoglobin abnormalities) and thalassemias (regulation abnormalities). The uses are indicated as follows: The HYDRAGEL HEMOGLOBIN(E) and HYDRAGEL MINI HEMOGLOBIN(E) Kits are designed for use in conjunction with a manual electrophoretic apparatus. The HYDRAGEL 7/15 HEMOGLOBIN(E) Kits are designed for use with the semi-automated HYDRASYS electrophoretic apparatus. All these kits utilize alkaline agarose gels for electrophoretic separation of human hemoglobins. The electrophoregrams are interpreted visually for pattern abnormalities. Densitometry can serve as an aid in the interpretation by providing relative concentrations of individual fractions. The kits are intended for the normal hemoglobins (A and A2) and the major hemoglobin variants S or D and C or E. They are indicated for screening for clinically important abnormal hemoglobins. Electrophoresis on acidic gel, e.g., HYDRAGEL ACID(E) HEMOGLOBIN(E), should follow to confirm the identification of hemoglobin variants, in particular, to differentiate hemoglobins S from D and E from C. The HYDRAGEL ACID(E) HEMOGLOBIN(E) and HYDRAGEL MINI ACID(E) HEMOGLOBIN(E) Kits are designed for use in conjunction with a manual electrophoretic apparatus. The HYDRAGEL 7/15 ACID(E) HEMOGLOBIN(E) Kits are designed for use with the semi-automated HYDRASYS electrophoretic apparatus. All these kits utilize acid buffered agarose gels for electrophoretic separation of human hemoglobins. The electrophoregrams serve for qualitative, visual interpretation of the patterns. The kits are indicated for confirming the identity of clinically important abnormal hemoglobins that have been previously detected on alkaline buffered HYDRAGEL HEMOGLOBIN(E) gels. Primarily, they serve for differentiation of hemoglobins S from D and E from C.
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    K Number
    K982426
    Device Name
    SPIFE ALKALINE HEMOGLOBIN
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    1998-12-17

    (157 days)

    Product Code
    JBD
    Regulation Number
    864.7440
    Why did this record match?
    Product Code :

    JBD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPIFE Alkaline Hemoglobin system is intended for the qualitative and semi-quantitative determination of abnormal hemoglobins using agarose electrophoresis on the SPIFE Analyzer. The system is used as a screening method for in vitro diagnostic use.
    Device Description
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