Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K970302
    Device Name
    APO-TEK LP(A)
    Manufacturer
    PERIMMUNE, INC.
    Date Cleared
    1997-11-10

    (287 days)

    Product Code
    DFC
    Regulation Number
    866.5600
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERIMMUNE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Apo-Tek Lp(a)™ is an Apo(a) isoform independent enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma. The measurement of Lp(a), in conjunction with other lipoprotein tests, is of diagnostic significance when assessing atherosclerotic cardiovascular disease in specific populations.
    Device Description
    Apo-Tek Lp(a)™ is an apolipoprotein(a) [Apo(a)] isoform independent in vitro diagnostic enzyme-linked immunosorbent assay (ELISA) intended for the quantitiative assessment of lipoprotein(a) [Lp(a)] in human serum or plasma. This test utilizes a sandwich ELISA format in which the Lp(a) particle is captured with a specific anti-Apo(a) monoclonal antibody and, after washing away nonbound serum or plasma components, is detected with a peroxidase conjugated anti-apolipoprotein B [Apo B] polyclonal antibody.
    Ask a Question
    K Number
    K970353
    Device Name
    AURA TEK FDP
    Manufacturer
    PERIMMUNE, INC.
    Date Cleared
    1997-04-30

    (90 days)

    Product Code
    MMW
    Regulation Number
    866.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERIMMUNE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AuraTek FDP is a rapid one-step gold dye particle lateral flow immunoassay indicated for the in vitro qualitative measurement of fibringen and fibrinogen degradation products (FDP) in human urine, to be used with standard cystoscopic examination to aid in the management of patients with a history of bladder cancer.
    Device Description
    AuraTek FDP is a one-step gold dye particle immunoassay on a porous carrier. Mobile purple-red dye particles labeled with anti-FDP and fibrinogen antibody and immobile capture anti-FDP and fibringgen antibodies are coated as discrete zones on the porous carrier. In addition a test control zone with antimurine IgG (Reaction Control 2) is coated on the carrier. A sample placed on the device is absorbed by the porous carrier. The rehydrated colored sol particles move through the porous carrier to the capture anti-FDP and then to the anti-murine IgG. If the sample contains FDP and/or fibrinogen, the antibodylabeled sol particles will bind in a sandwich-type reaction to the capture anti-FDP and fibrinogen antibody producing a purple-red dot in the test result window. With a negative sample, the white test result window remains unchanged at the time of reading. AuraTek FDP has the unique feature that the test run validity is double-checked with the appearance and disappearance of color in the Reaction Control 1 window and development of a purple-red dot in the Reaction Control 2 window.
    Ask a Question

    Page 1 of 1