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510(k) Data Aggregation

    K Number
    K232904
    Device Name
    Access Ostase
    Manufacturer
    Beckman Coulter
    Date Cleared
    2024-04-15

    (210 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Why did this record match?
    Product Code :

    CIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access Ostase assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
    Device Description
    The Access Ostase assay is a one-step sandwich immunoenzymatic assay. The Access Ostase assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access Ostase assay reagent pack, Access Ostase assay calibrators, Access Ostase QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
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    K Number
    K200475
    Device Name
    IDS-iSYS Ostase BAP
    Manufacturer
    Immunodiagnostic Systems Ltd.
    Date Cleared
    2020-09-30

    (217 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Why did this record match?
    Product Code :

    CIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget's disease.
    Device Description
    The IDS-iSYS Ostase® BAP assay consists of one reagent cartridge and one set of calibrators (CAL A & CAL B). The reagent cartridge contains multiple reagents: - MPM1 (Magnetic particles coated with streptavidin in a phosphate buffer with sodium azide as preservative); - Ab-BIOT Monoclonal anti-BAP labelled with biotin, in buffer containing horse serum with bovine and mouse proteins and sodium azide as a preservative (<0.1 %) - -SUBS (p-nitrophenyl phosphate in a stabilising buffer containing preservatives). Calibrators A and B are buffered bovine protein matrix containing human BAP with sodium azide as preservative (<0.1 %).
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    K Number
    K043125
    Device Name
    ORION DIAGNOSTICA UNIQ PINP RIA
    Manufacturer
    ORION DIAGNOSTICA OY
    Date Cleared
    2005-05-04

    (173 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Why did this record match?
    Product Code :

    CIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orion Diagnostica UniQ™ PINP RIA is a quantitative radioimmunoassay designed for the measurement of intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum. The test is intended to be used an aid in the management of postmenopausal osteoporosis. For in vitro diagnostic use.
    Device Description
    Not Found
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    K Number
    K020625
    Device Name
    SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2002-05-06

    (69 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Why did this record match?
    Product Code :

    CIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The test system will be used in laboratories to separate serum ALP isoenzymes. Elevated bone isoenzyme can be found in conditions of physiologic bone growth, metastatic carcinoma and as rickets. Increased liver isoenzyme values can be seen in hepatitis and cirrhosis of the liver. Intestinal isoenzymes can be seen in patients with intestinal disease in particular after a meal. Intestinal Isoenzymes occur in blood type O or B after a meal.
    Device Description
    Not Found
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    K Number
    K011113
    Device Name
    HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
    Manufacturer
    SEBIA
    Date Cleared
    2001-06-13

    (63 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Why did this record match?
    Product Code :

    CIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994278
    Device Name
    ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2000-03-28

    (99 days)

    Product Code
    CIN, JIS
    Regulation Number
    862.1050
    Why did this record match?
    Product Code :

    CIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Beckman Coulter, Inc's Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
    Device Description
    The Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma.
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    K Number
    K981373
    Device Name
    ALKPHASE-B ASSAY KIT
    Manufacturer
    METRA BIOSYSTEMS, INC.
    Date Cleared
    1998-05-27

    (41 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Why did this record match?
    Product Code :

    CIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Measurement of BAP is intended for use as an aid in the: management of postmenopausal osteoporosis and Paget's disease. monitoring of postmenopausal women on hormonal or bisphosphonate therapy prediction of skeletal response to hormonal therapy in postmenopausal women.
    Device Description
    Not Found
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    K Number
    K972666
    Device Name
    TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
    Manufacturer
    HYBRITECH, INC.
    Date Cleared
    1997-09-11

    (57 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Why did this record match?
    Product Code :

    CIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tandem-MP Ostase Immunoenzymetric Assay is an in vitro device indicated for the quantitative measurement of skeletal alkaline phosphatase (sALP), an indicator of osteoblastic activity, in human serum. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
    Device Description
    Tandem-MP Ostase is an in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum. The assay is a solid-phase, immunoenzymetric assay. Serum samples containing sALP are reacted in a microwell with the biotinylated capture antibody. Following binding of the biotinylated antibody/antigen complex to the streptavidin coated wells, the microwells are washed and incubated with an enzyme substrate. The captured sALP enzyme turns over the substrate and the amount of sALP bound to the microwell is determined colorimetrically by measuring the absorbance of the quenched reaction at 405 nm in a microplate reader. The calculation of the sALP concentration in the sample is based on concurrent testing of the Ostase Calibrators and Zero/Diluent.
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    K Number
    K964764
    Device Name
    OPUS BONE ALP
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Date Cleared
    1997-01-24

    (58 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Why did this record match?
    Product Code :

    CIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OPUS Bone ALP is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum as an aid in the management of patients with diagnosed Paget's disease. OPUS Bone ALP is intended for use with the OPUS analyzers.
    Device Description
    OPUS Bone ALP is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum.
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    K Number
    K961573
    Device Name
    TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
    Manufacturer
    HYBRITECH, INC.
    Date Cleared
    1996-08-19

    (118 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Why did this record match?
    Product Code :

    CIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    an indicator of osteoblastic activity which is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease
    Device Description
    Tandem®-R Ostase® is an in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum. The assay is a solid-phase, two-site immunoradiometric assay. Samples containing sALP are reacted with a plastic bead (solid phase) that is coated with a monoclonal antibody directed toward a specific site on the sALP molecule and, simultaneously, with a second radiolabeled monoclonal antibody directed toward a different antigenic site on the sALP molecule. Following formation of the solidphase/sALP/radiolabeled antibody sandwich, the bead is washed to remove unbound labeled antibody. The radioactivity bound to the solid phase is measured in a gamma counter. The amount of radioactivity measured is directly proportional to the concentration of sALP in the test sample, which is determined from a standard curve. The standard curve is based on the concurrent testing of Tandem-R Ostase calibrators ranging from 0 to 120 µg sALP/L.
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