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510(k) Data Aggregation

    K Number
    K061769
    Device Name
    E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2006-07-03

    (10 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIPATH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    e.p.t Certainty® 1-Step Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.
    Device Description
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    K Number
    K060128
    Device Name
    CLEARBLUE EASY DIGITAL PREGNANCY TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2006-05-25

    (127 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIPATH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clearblue Easy Digital Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.
    Device Description
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    K Number
    K051638
    Device Name
    INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2005-12-06

    (169 days)

    Product Code
    GTY
    Regulation Number
    866.3740
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIPATH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Inverness Medical TestPack + Plus Strep A with OBC Test is intended for the qualitative detection of Group A Streptococcal (Group A Strep) antigen in throat swab specimens from patients with suspected Group A Strep associated pharyngitis and for confirmation of presumptive Group A Strep colonies isolated on culture plates. The test is intended for Professional and Laboratory Use only.
    Device Description
    Inverness Medical TestPack + Plus Strep A with OBC Strep A is an immunoassay employing sheep and rabbit polyclonal antibodies and gold colloid particles. The test device uses lateral flow technology; following antigen extraction, the test time is approximately 5 minutes. The Streptococcal Group A specific antigen is extracted from the throat swab using Reagent 1 (2.0 M Sodium Nitrite (& Xylenol Orange) and Reagent 2 (1.0 M Acetic Acid). Following this, Reagent 3 (1.0 M Tris Buffer) is added to neutralise the acid formed by Reagents 1 and 2. The mixture is then dropped into the sample well of the reaction disc from which it migrates through the membrane until it reaches the End of Assay (EOA) Window. As the specimen extract migrates through the membrane, it mobilises the antibody-coated colloid (colloid coated with Rabbit Anti-Strep A antibody). If Group A Streptococcal antigen is present in the specimen it will form a complex with the antibody-colloid. The antibody colloid complex migrates through the membrane and is then captured by the Group A Strep antibody (Sheep polyclonal antibody) in the result window, providing a visual indication of the presence of antigen. The test can be read when the 'End of Assay' (EOA) window has turned pink / red. A pink / red Plus Sign (+) appearing in the result window indicates the presence of the Group A Strep antigen. A Minus Sign (-) indicates no antigen was detected. The device also includes integral Control features.
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    K Number
    K050930
    Device Name
    E.P.T. CERTAINTY PREGNANCY TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2005-05-12

    (28 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIPATH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    e.p.t CertaintyTM Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from the first day of the expected period and thereafter, but can also be used from three days before the expected period.
    Device Description
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    K Number
    K042280
    Device Name
    FACT PLUS ONE-STEP PREGNANCY TEST KIT
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2004-09-10

    (18 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIPATH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fact plus® One-Step Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.
    Device Description
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    K Number
    K041404
    Device Name
    CLEARBLUE EASY EASY READ PREGNANCY TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2004-06-08

    (13 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIPATH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clearblue Easy Easy Read Pregnancy Test is an over-the-counter urine hCC test which is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine. The test is indicated for use from three days before the expected period.
    Device Description
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    K Number
    K040329
    Device Name
    MODIFICATION TO E.P.T. PREGNANCY TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2004-03-08

    (26 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIPATH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    e.p.t.® Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from first day of missed period and onwards.
    Device Description
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    K Number
    K040341
    Device Name
    CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2004-03-08

    (25 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIPATH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clearblue Easy Earliest Results Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.
    Device Description
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    K Number
    K033658
    Device Name
    E.P.T. PREGNANCY TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2004-01-16

    (56 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIPATH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    e.p.t.® Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from first day of missed period and may be used before the expected period.
    Device Description
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    K Number
    K032939
    Device Name
    EPT CERTAINTY PREGNANCY TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2003-10-20

    (28 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIPATH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EPT Certainty™ Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/ml hCG in urine, and can be used from the first day of the missed period.
    Device Description
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