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510(k) Data Aggregation

    K Number
    K051012
    Device Name
    PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.
    Manufacturer
    SALIMETRICS LLC.
    Date Cleared
    2005-07-19

    (89 days)

    Product Code
    JIT, JJY
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    SALIMETRICS LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The salivary progesterone calibrator is a device intended for medical purposes to use in the calibration and to establish points of reference that are used to calibrate the Salimetrics immunoassay in the measurement of free progesterone in saliva. The salivary progesterone controls are devices intended for use in monitoring the performance of the salivary immunoassay of free progesterone in saliva.
    Device Description
    Progesterone Standard Calibrator, one (1)mL of progesterone in a saliva-like matrix at a concentration of 2430 pg/mL with a non-mercury preservative. Progesterone High Control (1000 pg/mL) and Progesterone Low Control (50.6 pg/mL) in a saliva-like matrix with a non-mercury preservative.
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    K Number
    K031348
    Device Name
    HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY
    Manufacturer
    SALIMETRICS LLC.
    Date Cleared
    2003-06-10

    (60 days)

    Product Code
    NHG
    Regulation Number
    862.1205
    Why did this record match?
    Applicant Name (Manufacturer) :

    SALIMETRICS LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Salimetrics HS-Cortisol kit is a competitive immunoassay specifically designed for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's disease. Saliva cortisol accurately reflects the amount of serum cortisol in the circulation. This kit is not intended for use with serum or plasma samples.
    Device Description
    Test Principle- A microtitre plate is coated with rabbit antibodies to cortisol. Cortisol in standards and unknowns compete with cortisol linked to horseradish peroxidase for the antibody binding sites. After incubation, unbound components are washed away. Bound cortisol peroxidase is measured by the reaction of the peroxidase enzyme on the substrate tetramethylbenzidine (TMB). This reaction produces a blue color. A vellow color is formed after stopping the reaction with sulfuric acid. Optical density is read on a standard plate reader at 450 nm. The amount of cortisol peroxidase detected is inversely proportional to the amount of cortisol present. The optical density readings of the calibrators are used to form a standard curve to which the optical densities of the controls and samples are compared. Kit Description- The kit consists of an antibody coated 96 well plate, six calibrators at a concentration of 1.800, 0.600, 0.200, 0.067. 0.022, and 0.007 µg/dL of NIST(National Institute of Standards and Technology) cortisol, two controls representing a high (1.00 ug/dL) and low (0.100 ug/dL) level of salivary cortisol, the enzyme conjugate (1600X concentrate), assay diluent containing a pH indicator, wash buffer(10X concentrate), tetramethylbenzidine substrate solution, stop solution, and kit insert.
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    K Number
    K011323
    Device Name
    HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
    Manufacturer
    SALIMETRICS LLC.
    Date Cleared
    2001-12-17

    (230 days)

    Product Code
    NHG
    Regulation Number
    862.1205
    Why did this record match?
    Applicant Name (Manufacturer) :

    SALIMETRICS LLC.

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