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510(k) Data Aggregation

    K Number
    K223867
    Device Name
    IDS ACTH II
    Manufacturer
    Immunodiagnostic Systems Limited
    Date Cleared
    2023-08-18

    (238 days)

    Product Code
    CKG
    Regulation Number
    862.1025
    Why did this record match?
    Product Code :

    CKG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IDS ACTH II assay is an automated in vitro diagnostic device intended for the quantitative, determination of ACTH in human K2 and K3 EDTA plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the assessment of pituitary and adrenal gland function and the differential diagnosis of hyper- and hypo-cortisolism.
    Device Description
    The IDS ACTH II assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents: - MP: Magnetic particles coated with mouse monoclonal anti-ACTH antibody and buffer containing phosphate with blocking proteins and ProClin 300 as preservative. - R1: Mouse monoclonal anti-ACTH antibody labelled with an acridinium ester derivative, in buffer containing phosphate with BSA and ProClin 300 as preservative. - R2: Buffer containing phosphate with blocking proteins and ProClin 300 as preservative.
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    K Number
    K111335
    Device Name
    ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
    Manufacturer
    Tosoh BioScience, Inc.
    Date Cleared
    2011-12-01

    (203 days)

    Product Code
    CKG, JIT, JJX
    Regulation Number
    862.1025
    Why did this record match?
    Product Code :

    CKG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ST AIA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome. ST AIA-PACK ACTH Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers ST AIA-PACK ACTH Control Set is designed for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers
    Device Description
    The ST AIA-PACK ACTH is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK ACTH test cups. ACTH present in the test sample is bound with anti-ACTH goat polyclonal antibody immobilized on magnetic beads and enzyme-labeled anti-ACTH goat polyclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled anti-ACTH goat polyclonal antibody and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The enzyme alkaline phosphatase causes oxidation of 4MUP to 4MU. 4MU is excited at 365 nm and comes to ground state at 448 nm releasing florescent energy. The amount of florescent energy is measured by the detector. The amount of enzyme-labeled anti-ACTH goat polyclonal antibody that binds to the beads is directly proportional to the ACTH concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
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    K Number
    K060585
    Device Name
    ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2006-05-03

    (57 days)

    Product Code
    CKG, JIT, JJX
    Regulation Number
    862.1025
    Why did this record match?
    Product Code :

    CKG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Elecsys ACTH Assay: Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome. Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Elecsys immunoassay analyzers. Elecsys ACTH CalCheck: For use in the verification of the calibration established by the Elecsys ACTH reagent on Elecsys 1010/2010 and MODULAR E170 immunoassay analyzers. Elecsys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers.
    Device Description
    (1) The Elecsys ACTH Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. (2) The Elecsys ACTH CalSet is a lyophilized product consisting of equine serum with added ACTH in two concentration range. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. (3) The Elecsys ACTH CalCheck is a lyophilized product consisting of buffered equine serum with added ACTH. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. (4) The Elecsys PreciControl ACTH is a lyophilized product consisting of equine serum with added ACTH in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Note: The reagent, calibrator, calibration verification material and the quality control are all packaged separately.
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    K Number
    K050748
    Device Name
    ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2005-05-20

    (59 days)

    Product Code
    CKG
    Regulation Number
    862.1025
    Why did this record match?
    Product Code :

    CKG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, and the ectopic ACTH syndrome.
    Device Description
    ACTH Immunoradiometric (IRMA) Assay
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    K Number
    K021032
    Device Name
    ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2002-06-03

    (66 days)

    Product Code
    CKG
    Regulation Number
    862.1025
    Why did this record match?
    Product Code :

    CKG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.
    Device Description
    ACTH Immunoradiometric (IRMA) Assav
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    K Number
    K002638
    Device Name
    FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
    Manufacturer
    FUTURE DIAGNOSTICS B.V.
    Date Cleared
    2001-01-17

    (146 days)

    Product Code
    CKG
    Regulation Number
    862.1025
    Why did this record match?
    Product Code :

    CKG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982608
    Device Name
    SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT
    Manufacturer
    SANGUI BIOTECH, INC.
    Date Cleared
    1998-08-19

    (23 days)

    Product Code
    CKG
    Regulation Number
    862.1025
    Why did this record match?
    Product Code :

    CKG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this product is the quantitative determination of ACTH [Adrenocorticotropic Hormone] in human EDTA plasma. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
    Device Description
    Quantitative determination of ACTH in human EDTA plasma. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
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    K Number
    K962601
    Device Name
    NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
    Manufacturer
    NICHOLS INSTITUTE DIAGNOSTICS
    Date Cleared
    1996-12-24

    (175 days)

    Product Code
    CKG
    Regulation Number
    862.1025
    Why did this record match?
    Product Code :

    CKG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960491
    Device Name
    MICRO HAEMATOCRIT CENTRIFUGE
    Manufacturer
    HAWKSLEY & SONS LTD.
    Date Cleared
    1996-10-18

    (260 days)

    Product Code
    CKG
    Regulation Number
    862.1025
    Why did this record match?
    Product Code :

    CKG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960066
    Device Name
    IMMULITE ACTH
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Date Cleared
    1996-02-16

    (42 days)

    Product Code
    CKG
    Regulation Number
    862.1025
    Why did this record match?
    Product Code :

    CKG

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

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