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510(k) Data Aggregation

    K Number
    K131975
    Device Name
    ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
    Manufacturer
    ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
    Date Cleared
    2013-10-02

    (96 days)

    Product Code
    CFJ, JIY, JMO
    Regulation Number
    862.1440
    Why did this record match?
    Product Code :

    CFJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Alera Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE Total Iron Reagent is intended for the quantitative determination of iron in serum using the ACE Alera Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE LDH-L Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the ACE Alera Clinical Chemistry System. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
    Device Description
    In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct TIBC Color Reagent, an acidic buffer containing an iron-binding dye and ferric chloride, is added to the serum sample. The low pH of Direct TIBC Color Reagent releases iron from transferrin. The iron then forms a colored complex with the dye. The colored complex at the end of the first step represents both the serum iron and excess iron already present in Direct TIBC Color Reagent. Direct TIBC Buffer, a neutral buffer, is then added, shifting the pH and resulting in a large increase in the affinity of transferrin for iron. The serum transferrin rapidly binds the iron by abstracting it from the dye-iron complex. The observed decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the serum sample. The absorbance is measured at 647 nm. In the ACE Total Iron Reagent assay, transferrin-bound iron in serum is released at an acidic pH and reduced from ferric to ferrous ions. These ions react with ferrozine to form a violet colored complex, which is measured bichromatically at 554 nm/692 nm. The intensity of color produced is directly proportional to the serum iron concentration. In the ACE LDH-L Reagent assay, lactate dehydrogenase catalyzes the conversion of L-lactate to pyruvate. Nicotinamide adenine dinucleotide (NAD+) acts as an acceptor for the hydrogen ions released from the L-lactate and is converted to reduced nicotinamide adenine dinucleotide (NADH). NADH absorbs strongly at 340 nm whereas NAD+ does not. Therefore, the rate of conversion of NAD+ to NADH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NAD+ to NADH is directly proportional to the lactate dehydrogenase activity in the sample.
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    K Number
    K091544
    Device Name
    S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
    Manufacturer
    ALFA WASSERMANN, INC.
    Date Cleared
    2009-09-09

    (105 days)

    Product Code
    CFJ
    Regulation Number
    862.1440
    Why did this record match?
    Product Code :

    CFJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
    Device Description
    The S-Test Lactate Dehydrogenase (LD) reagent cartridge, used with the S40 Clinical Analyzer, is intended for the quantitative in vitro diagnostic determination of LD activity in serum based on a photometric test measuring the rate of conversion of NADH from NAD in an enzyme assay. It is composed of a bi-reagent cartridge, and is intended for use in clinical laboratories or physician office laboratories.
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    K Number
    K051108
    Device Name
    PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
    Manufacturer
    ABAXIS, INC.
    Date Cleared
    2005-07-08

    (67 days)

    Product Code
    CFJ
    Regulation Number
    862.1440
    Why did this record match?
    Product Code :

    CFJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Piccolo Lactate Dehydrogenase Test System (presently contained on the Piccolo Basic Metabolic Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate dehydrogenase activity in heparinized plasma or serum in a clinical laboratory setting or point-of-care location. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis and cirrhosis; cardiac diseases such as myocardial infarction; malignant diseases; and tissue alterations of the heart, kidney, liver, and muscle.
    Device Description
    The Piccolo Basic Metabolic Panel Plus Reagent Disc (which contains the Piccolo Lactate Dehydrogenase Test System) is designed for heparinized plasma and serum, only. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted samples mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.
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    K Number
    K974859
    Device Name
    LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    1998-01-22

    (24 days)

    Product Code
    CFJ
    Regulation Number
    862.1440
    Why did this record match?
    Product Code :

    CFJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of Lactate Dehydrogenase in serum. For IN VITRO diagnostic use. Elevated levels of lactate dehydrogenase are clinically significant and can be found in disease states which result in cell damage. Myocardial infarcts, liver disease, megaloblastic anemias, renal disease, progressive muscular dystrophy and some malignancies all produce elevated lactate dehydrogenase values in serum (1).
    Device Description
    Lactate Dehydrogenase-SL Assay
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    K Number
    K973589
    Device Name
    LIQUID LDH-L REAGENT SET
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    1997-10-08

    (16 days)

    Product Code
    CFJ
    Regulation Number
    862.1440
    Why did this record match?
    Product Code :

    CFJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of Lactate dehydrogenase in serum or leomonogram in the for in vitro diagnostic use only. The determination of Lactate dehydrogenase in serum is most commonly performed for the diagnosis and treatment of myocardial infarctions. LD elevations are also observed in liver disease, pernicious anemia, some cases of renal disease, and in cases of skeletal muscle trauma.
    Device Description
    Liquid LDH-L Reagent Set
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    K Number
    K970684
    Device Name
    LACTATE DEHYDROGENASE (LD)
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    1997-05-07

    (72 days)

    Product Code
    CFJ
    Regulation Number
    862.1440
    Why did this record match?
    Product Code :

    CFJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K971398
    Device Name
    LD-L REAGENT
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    1997-05-02

    (17 days)

    Product Code
    CFJ
    Regulation Number
    862.1440
    Why did this record match?
    Product Code :

    CFJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964912
    Device Name
    LACTATE DEHYDROGENASE
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-01-09

    (31 days)

    Product Code
    CFJ
    Regulation Number
    862.1440
    Why did this record match?
    Product Code :

    CFJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961431
    Device Name
    LACTATE DEHYDROGENASE REAGENT SET
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    1996-06-03

    (49 days)

    Product Code
    CFJ
    Regulation Number
    862.1440
    Why did this record match?
    Product Code :

    CFJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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