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510(k) Data Aggregation

    K Number
    K051727
    Device Name
    AIMSTICK URINE REAGENT STRIPS
    Manufacturer
    GERMAINE LABORATORIES, INC.
    Date Cleared
    2005-10-26

    (120 days)

    Product Code
    CEN, CDM, JIL, JIN, JIO, JIR, JJB, JMT, LJX
    Regulation Number
    862.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    GERMAINE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AimStick® Urine Reagent Strips are intended for detection of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leukocytes in urine. The AimStick® Urine Reagent Strips are intended for the qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine for persons to test by visual comparison with a color chart on the bottle label. This product is for professional use. Test results may provide information regarding the status of carbohydrate metabolism, kidney function, liver function, acid-base balance, and bacturia.
    Device Description
    Plastic strips with reagent pads which provide a color change when exposed to urine. The AimStick® Urine Reagent Strips are plastic strips to which Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte reagent pads are affixed. The reagent pads react with the urine and provide a visible color reaction. The product is packaged with a drying agent in a plastic bottle. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. The directions must be followed exactly. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. Laboratory instrumentation is not required.
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    K Number
    K013857
    Device Name
    AIMSTEP PREGNANCY
    Manufacturer
    GERMAINE LABORATORIES, INC.
    Date Cleared
    2002-01-22

    (62 days)

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

    GERMAINE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AimStep™ Pregnancy is intended for non-professional use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
    Device Description
    The test utilizes a combination of monochonal and polyclonal antibody reagents to selectively devect elevated levels of hCG. The assay is conducted by adding urine to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membranc to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line on the "Test Region" of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Region will always appear regardless of the presence or absence of hCG.
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    K Number
    K991369
    Device Name
    ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
    Manufacturer
    GERMAINE LABORATORIES, INC.
    Date Cleared
    1999-05-10

    (20 days)

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

    GERMAINE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy is intended for non-professional over-the-counter use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
    Device Description
    The test utilizes a combination of monoclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by dipping the absorbent wick of the test in urine and observing for the formation of colored liness. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specific antibody-hCG-colored conjugate and form a colored line on the Specimen portion of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Zone will always appear regardless of the presence or absence of hCG.
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    K Number
    K981165
    Device Name
    AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
    Manufacturer
    GERMAINE LABORATORIES, INC.
    Date Cleared
    1998-04-16

    (16 days)

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

    GERMAINE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AimStep™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination of pregnancy. This test is for professional use.
    Device Description
    The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding specimen to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored coningate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line in the Specimen Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.
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    K Number
    K980531
    Device Name
    AIMSTEP PREGNANCY
    Manufacturer
    GERMAINE LABORATORIES, INC.
    Date Cleared
    1998-03-06

    (23 days)

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

    GERMAINE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AimStep™ Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the early determination of pregnancy. This test is for professional use.
    Device Description
    The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.
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    K Number
    K974368
    Device Name
    AIMSTICK PBD PREGNANCY
    Manufacturer
    GERMAINE LABORATORIES, INC.
    Date Cleared
    1998-01-02

    (43 days)

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

    GERMAINE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AimStick™ PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. This test is for professional use.
    Device Description
    The test utilizes a combination of momelonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence of hCG.
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    K Number
    K974512
    Device Name
    AIMSTICK PBD COMBO PREGNANCY
    Manufacturer
    GERMAINE LABORATORIES, INC.
    Date Cleared
    1998-01-02

    (32 days)

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

    GERMAINE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AimStick™ PBD Combo Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine or serum to aid in the determination of pregnancy. This test is for professional use.
    Device Description
    The test utilizes a combination of monoclonal antibodies to selectively detect elevated levels of hCG. The test strip is inserted into the specimen and the formation of colored bands is observed. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.
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    K Number
    K973825
    Device Name
    MIDSTREAM HOME REGNANCY TEST
    Manufacturer
    GERMAINE LABORATORIES, INC.
    Date Cleared
    1997-12-19

    (73 days)

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

    GERMAINE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MidStream™ Home Pregnancy Test is intended for nonprofessional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
    Device Description
    The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by urinating on the absorbent wick and observing for the formation of colored bands. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.
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