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510(k) Data Aggregation

    K Number
    K971761
    Device Name
    PERSONALLAB AUTOMATED MICROPLATE ANALYZER
    Manufacturer
    BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
    Date Cleared
    1997-07-22

    (71 days)

    Product Code
    JJE
    Regulation Number
    862.2160
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHEM IMMUNOSYSTEMS (U.S.), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PersonallAB™ Automated Micropiate Analyzer from BloCHEM IMMUNOSYSTEMS (U. S.), INC. of Allentown Pennsylvania is a fully automated microplate analyzer. The analyzer is used for the in vitro diagnostic processing of human and animal specimens with Immunoenzymatic techniques, developed on 96 well microplate formats, such as: - E.I.A. (Enzyme Immuno Assay), and - E.L.I.S.A. (Enzyme Linked Immuno Sorbent Assay). The PersonalLAB™ Automated Microplate Analyzer is intended to duplicate the manual analytical procedures associated to an assay and the assay's reagents, by performing automatically the various steps identified in the assay manufacturer's Instructions For Use. The steps performed are as follows: - Specimen handling and identification, - Specimen pipetting and pre-dilution, - Reagent distribution and pipetting. - Washing of the microplates. - Incubation of the microplates, - Photometric reading of the microplates, - Data analysis -- both quantitative and qualitative, - Data management - displaying, printing and archiving, and - Waste management. The PersonalLAB™ Automated Microplate Analyzer is used for the in vitro diagnostic processing of various specimen types, as define by the assay manufacturer's instructions for use. Examples of specimen types are as follows: - Whole blood, - Serum. - Plasma. - Urine, - Stool. - Spinal fluid, - Saliva, and - Swabs from antigen sites.
    Device Description
    The PersonallAB™ Automated Micropiate Analyzer from BloCHEM IMMUNOSYSTEMS (U. S.), INC. of Allentown Pennsylvania is a fully automated microplate analyzer. The analyzer is used for the in vitro diagnostic processing of human and animal specimens with Immunoenzymatic techniques, developed on 96 well microplate formats, such as: E.I.A. (Enzyme Immuno Assay), and E.L.I.S.A. (Enzyme Linked Immuno Sorbent Assay). The PersonalLAB™ Automated Microplate Analyzer is intended to duplicate the manual analytical procedures associated to an assay and the assay's reagents, by performing automatically the various steps identified in the assay manufacturer's Instructions For Use. The steps performed are as follows: Specimen handling and identification, Specimen pipetting and pre-dilution, Reagent distribution and pipetting. Washing of the microplates. Incubation of the microplates, Photometric reading of the microplates, Data analysis -- both quantitative and qualitative, Data management - displaying, printing and archiving, and Waste management. The PersonalLAB™ Automated Microplate Analyzer is used for the in vitro diagnostic processing of various specimen types, as define by the assay manufacturer's instructions for use. Examples of specimen types are as follows: Whole blood, Serum. Plasma. Urine, Stool. Spinal fluid, Saliva, and Swabs from antigen sites.
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    K Number
    K960072
    Device Name
    SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX
    Manufacturer
    BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
    Date Cleared
    1997-03-06

    (426 days)

    Product Code
    GKZ, GKL, GKX
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHEM IMMUNOSYSTEMS (U.S.), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirit " , is a computerized, enhanced electronic Hematology System designed for clinical applications to allow 16 whole blood parameters to be measured by a small table top computer driven instrument.
    Device Description
    The Spirit" Hematology System is a microprocessor based device which is designed to provide identical function as the System 9000 Plus, (Model 9018). This compact device sits on any desktop. It provides a fathful analysis and display of key blood cells parameters by automatic processing and analyzing test results via a structured computer program. Both the System 9000 Plus, (Model 9018) retain an electronically stored data and act on that data using mathematical computations {proprietary algorithm}and computer programming {stored in a Electronic media and PROM}to provide blood parameters.
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    K Number
    K954065
    Device Name
    BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
    Manufacturer
    BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
    Date Cleared
    1996-07-10

    (315 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHEM IMMUNOSYSTEMS (U.S.), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955102
    Device Name
    BIODATA TESTOSTERONE MAIA KIT
    Manufacturer
    BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
    Date Cleared
    1996-06-24

    (229 days)

    Product Code
    CDZ
    Regulation Number
    862.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHEM IMMUNOSYSTEMS (U.S.), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biodata Testosterone Maia Kit is a radioimmunoassay for the quantitative determination of testosterone in human serum or plasma. The device is intended to be used for the diagnosis of elevated or depressed levels of testosterone. It is FOR IN VITRO DIAGNOSTIC USE ONLY. Neoplasms of the testes and adrenal cortex and hyperthyroidism may result in elevated levels of testosterone in the male. Elevated testosterone levels are observed in females with endometrial carcinoma, hirsutism, neoplasms of the ovaries, and Cushing syndrome. Patients with hypogonadism of pituitary origin, anorchia, gonadel dysgenesis, Klinefelter syndrome, and pseudohermaphroditism have decreased testosterone levels.
    Device Description
    The Biodata Testosterone Maia kit is based on the competitive binding principles of radioimmunoassay. Testosterone (unlabeled antigen) in samples, standards, or controls competes with testosterone labeled with radioactive 1251 ("testosterone - 1251") (labeled antigen) for a limited number of testosterone antibody sites. The amount of testosterone - 1251 bound by the antibody is inversely proportional to the amount of testosterone present in the sample, standard, or control. Testosterone Maia Separation Reagent (an antibody covalently bound to a magnetic particle capable of binding the testosterone antibody) is added to the reaction mixture to facilitate the separation of the bound and free fractions of labeled testosterone. The bound fraction of each standard, sample and control is sedimented in a magnetic separator. Each bound fraction is then counted in a gamma counter calibrated to detect 125]. The concentration of testosterone in the samples can be determined by comparing the relative percent binding of the standards with known concentrates of testosterone on the standard curve. The testosterone concentration in the sample is then compared to the reference range of testosterone concentrations established by each laboratory or the expected volumes listed in the package insert.
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