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510(k) Data Aggregation

    K Number
    K091287
    Device Name
    VS-SENSE TEST
    Manufacturer
    COMMON SENSE, LTD.
    Date Cleared
    2009-08-31

    (122 days)

    Product Code
    CEN
    Regulation Number
    862.1550
    Why did this record match?
    Product Code :

    CEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VS-SENSE™ TEST is a qualitative, visually-read swab for clinicians who wish to evaluate women with vaginal symptoms. The device is a vaginal pH indicator swab intended to be used in conjunction with other clinical examinations, such as the Amsel criteria or the Nugent Gram stain, to aid in determining conditions characterized by elevated vaginal pH, such as bacterial vaginosis.
    Device Description
    The VS-SENSE™ comprises a regular vaginal swab with its tip coated by an indicating polymer. When the indicating tip has been in contact with vaginal secretion, with elevated pH level, the user will observe a blue or green stain on the yellow background of the tip. The stains on the tip are caused by the sensitivity of a proprietary polymer, which coats the tip and contains the traditional indicator - Nitrazine Yellow. The VS-SENSE™ polymer matrix has a specific composition of ingredients that changes color when the pH of the vaginal discharge is greater than 4.7 +0.3/-0.2.
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    K Number
    K071100
    Device Name
    AMNISCREEN HOME DETECTION LINER KIT
    Manufacturer
    COMMON SENSE, LTD.
    Date Cleared
    2007-10-15

    (179 days)

    Product Code
    CEN
    Regulation Number
    862.1550
    Why did this record match?
    Product Code :

    CEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AmniScreen Home Detection Liner Kit is intended to detect possible leakage of amniotic fluid when vaginal wetness is experienced during pregnancy by indicating pH level. pH levels greater than or equal to 5.2 produce a blue-green color. Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care.
    Device Description
    The AmniScreen™ Home Detection Liner Kit contains a Testing Panty-Liner (TPL) and a Drying Tray (DT). The TPL comprises a regular panty-liner and an indicator strip assembled into the panty-liner, covered with two layers of one-way perforated film. The indicator strip is removed after use and placed in the DT for 30 minutes before reading the test results. When the indicator strip has been in contact with amniotic fluid, the user will observe a blue-green stain on the yellow background of the strip. An elevated pH level of the fluid causes the stain. The stains on the strip are caused by the sensitivity of a proprietary polymer, which coats the strip and contains the traditional indicator - Nitrazine Yellow, to pH levels above 5.2 units. The proprietary polymer is also sensitive to certain concentrations of ammonium in the tested fluid, and when the color changes are created by fluids with a certain concentration level of ammonium, and pH levels up to 7.0 units, these color changes are reversible and during a drying period of 30 minutes the blue-green stains fade back to yellow.
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    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?
    Product Code :

    CEN

    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
    K040008
    Device Name
    QUICKVUE ADVANCE PH AND AMINES GLL TEST
    Manufacturer
    QUIDEL CORP.
    Date Cleared
    2004-04-29

    (118 days)

    Product Code
    CEN
    Regulation Number
    862.1550
    Why did this record match?
    Product Code :

    CEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QuickVue Advance pH and Amines gll test contains two colorimetric tests intended for the qualitative detection of elevated vaginal fluid pH (pH ≥ 4.7) and the presence of volatile vaginal fluid amines. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.
    Device Description
    The QuickVue Advance pH and Amines gll test contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaqinal fluid pH < 4.7 from vaginal fluid pH > 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.
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    K Number
    K030650
    Device Name
    STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
    Manufacturer
    URIDYNAMICS, INC.
    Date Cleared
    2003-04-14

    (45 days)

    Product Code
    CEN, JJW, JRE
    Regulation Number
    862.1550
    Why did this record match?
    Product Code :

    CEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UriDynamics StoneGuard™ II Test Strips are intended for semiquantitative measurement of pH and specific gravity in fresh urine. They can be used to monitor conditions that may cause the formation of kidney stones, namely trends in urinary pH and hydration status. Confirm Low™ and Confirm High™ Control Solutions are intended for in vitro (external) use only, for use as control materials for StoneGuard™ II Test Strips only.
    Device Description
    UriDynamics StoneGuard™ II Test Strips consist of plastic carriers with two reagent pads attached. The pads respond to pH and specific gravity. StoneGuard™ II Test Strips are stored in an opaque vial with desiccant and are ready to use. Results may be read between 30 and 60 seconds after wetting with a freshly-voided urine sample. Results are obtained by comparing the color developed on the pads with a printed color chart. The results are semi-quantitative. Control solutions, Confirm Low™ and Confirm High™, intended for use with StoneGuard™ II Test Strips, are also included in this submission. Confirm Low™ and Confirm High™ contain buffers and salts that give a known response with StoneGuard™ II Test Strips. Confirm Low™ and Confirm High™ Control Solutions are ready to use in dispensers, and contain no biological ingredients.
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    K Number
    K962718
    Device Name
    FEMEXAM TESTCARD
    Manufacturer
    LITMUS CONCEPTS, INC.
    Date Cleared
    1997-02-07

    (210 days)

    Product Code
    CEN
    Regulation Number
    862.1550
    Why did this record match?
    Product Code :

    CEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemExam® TestCard™ contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaginal fluid pH less than pH 4.7 from vaginal fluid pH equal to or greater than pH 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid.
    Device Description
    The FemExam® TestCard™ contains two qualitative, colorimetric tests: a pH test and an amine test. The pH test uses nitrazine yellow to produce a visual color change within two minutes of specimen application, indicating pH less than or greater than 4.7. It includes a positive procedural control and a negative background control. The amine test uses bromocresol green (BCG) and sodium aluminate to produce a visual color change within two minutes of specimen application, indicating the presence of alkali volatilizable amines. It also includes a positive procedural control and a negative background control.
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