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510(k) Data Aggregation

    K Number
    K170232
    Device Name
    AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
    Manufacturer
    BODITECH MED INC.
    Date Cleared
    2017-10-13

    (261 days)

    Product Code
    JLW, KHO
    Regulation Number
    862.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    BODITECH MED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites for the quantitative measurement of thyroid stimulating hormone (TSH) levels in serum, sodium-heparinized plasma samples. The test system is intended for use as an aid in the diagnosis of thyroid or pituitary disorders. AFIAS-6/SP Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Pointof-Care (POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassays for measuring the concentration of designated analytes in serum or plasma samples. AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites for the quantitative measurement of thyroid stimulating hormone (TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid individuals. AFIAS-6/VB Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Pointof-Care (POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassays for measuring the concentration of designated analytes in venous whole blood samples.
    Device Description
    AFIAS TSH-SP as well as AFIAS TSH-VB Test Cartridge is a plastic structure molded in the form of a disposable, self-contained, unitized device which houses the 'lyophilized detection buffer', the 'diluent i.e. reconstitution buffer' as well as the 'test strip'; all of which are integral components of the test. The test cartridge is an elongated structure having 140 mm length. 17 mm width and 17 mm height. 'AFIAS TSH-SP ID Chip' as well as 'AFIAS TSH-VB ID Chip' is a flat, rectangular device with its main body measuring 24 mm × 20 mm × 3 mm. Another rectangular portion measuring 12 mm × 10 mm × 2 mm protrudes out from the apical side of the main body. The ID Chip is an electronic memory device fitted into a plastic matrix. Lot-specific 'ID Chip' is an integral component of the test. AFIAS-6/SP as well as AFIAS-6/VB analyzer is a compact, bench-top, automated, fluorometric analyzer measuring 42 cm (L) x 33.6 cm (W) x 29.3 cm (H). AFIAS-6 weighs 15.1 kg. Either analyzer is a flourometer instrument of closed-system analyzer type.
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    K Number
    K132167
    Device Name
    I-CHROMA IFOB WITH I-CHROMA READER
    Manufacturer
    Boditech Med Inc.
    Date Cleared
    2014-05-02

    (294 days)

    Product Code
    OOX, JJX
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Boditech Med Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    i-CHROMA iFOB in conjunction with i-CHROMA Reader is a fluorescence immuno-chromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples. i-CHROMA iFOB is an in vitro diagnostic test used by laboratories and physician offices for routine physical examination when gastrointestinal bleeding may be suspected.
    Device Description
    i-CHROMA iFOB in conjunction with i-CHROMA Reader is a fluorescence immunochromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.
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