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510(k) Data Aggregation

    K Number
    K171224
    Device Name
    Arctic Sperm Cryopreservation Medium
    Manufacturer
    Irvine Scientific Sales Co., Inc.
    Date Cleared
    2017-08-31

    (127 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Irvine Scientific Sales Co., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Arctic™ Sperm Cryopreservation Medium is intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm.
    Device Description
    The Arctic™ Sperm Cryopreservation Medium is a modified version of the predicate device (K991337). It is a defined medium consisting of salts, buffering materials, cryoprotectants, vitamins, amino acids, minerals, carbohydrates, surfactant, energy source, and human serum albumin. The Arctic™ Sperm Cryopreservation Medium is a single-use device that is aseptically filled into sterilized vials and has a sterility assurance level (SAL) of 10-3. This medium is supplied in a fill volume of 5 mL. and twelve (12) 5mL vials are included in a package, The product is tested for pH, osmolality, sperm cyrosurvival, endotoxin and sterility before lot release, and has a shelf-life of 18 months.
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    K Number
    K170681
    Device Name
    Continuous Single Culture -NX (CSCM-NX)
    Manufacturer
    Irvine Scientific Sales Co., Inc.
    Date Cleared
    2017-06-08

    (94 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Irvine Scientific Sales Co., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Continuous Single Culture®-NX (CSCM-NX) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.
    Device Description
    The Continuous Single Culture®-NX (CSCM-NX) is a culture medium using a formulation modified from the predicate device. It is intended for culture of embryos from fertilization to blastulation. This medium consists of salts, energy substrates, amino acids, buffering agents, nutrients supplements, and antibiotics. This product is a single-use device supplied in a fill volume of 20 mL and 60 mL. It is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10⁻⁶. The product is tested for pH, osmolality, embryotoxicity, spermtoxicity, endotoxin, and sterility before lot release. The product has a four-month shelf-life and remains stable for four weeks after opening/closing of the bottle when it is stored at 2-8°C.
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    K Number
    K170602
    Device Name
    Continuous Single Culture-NX Complete (CSCM-NXC)
    Manufacturer
    Irvine Scientific Sales Co., Inc.
    Date Cleared
    2017-06-07

    (98 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Irvine Scientific Sales Co., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Continuous Single Culture®-NX Complete (CSCM-NXC) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro. This device can be used for transfer of embryos to the uterus.
    Device Description
    The Continuous Single Culture®-NX Complete (CSCM-NXC) is a culture medium using a formulation modified from the predicate device. It is intended for culture of embryos from fertilization to balstulation and transfer of embryos to the uterus. This medium consists of salts, energy substrates, amino acids, buffering agents, nutrients supplements, antibiotics, and human serum albumin. This product is a single-use device supplied in a fill volume of 20 mL. It is aseptically filled into the sterilized bottle and has a sterility assurance level (SAL) of 10-3. The product is tested for pH, osmolality, embryotoxicity, spermtoxicity, endotoxin, and sterility before lot release. The product has a four-month shelf-life and remains stable for four weeks after open/close of bottle, when it is stored at 2-8°C.
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    K Number
    K121572
    Device Name
    CONTINUOUS SINGLE CULTURE COMPLETE
    Manufacturer
    IRVINE SCIENTIFIC SALES CO., INC.
    Date Cleared
    2012-07-19

    (51 days)

    Product Code
    MQL, PRE
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRVINE SCIENTIFIC SALES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Continuous Single Culture™ Complete is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.
    Device Description
    The Continuous Single Culture™ Complete is based upon the Single Step Medium™ (K072609) formulation that is supplemented with Human Serum Albumin, H.S.A. The Continuous Single Culture™ Complete is composed of a balanced mixture of salts, amino acids and other nutrients that have been shown to support embryo development. The Continuous Single Culture™ Complete is designed to be used as a culture media for fertilization and for development of embryos until the desired developmental stage (up to 5/6 days). Selected embryos are then moved to an embryo transfer media prior to transfer to the uterus. The Continuous Single Culture™ Complete is supplied in liquid form, and contains gentamicin sulfate as a preservative and a therapeutic grade of Human Serum Albumin (K983584). Liquid Continuous Single Culture™ Complete is supplied in a fill volume of 20 mL. Continuous Single Culture™ Complete has utility as a culture medium from fertilization through day 5/6 of development. The fertilized oocyte (zygote) is allowed to grow in the culture dish, supported by a culture medium and an appropriate protein supplement, in a carbon dioxide incubator at 37°C until the desired stage of development is achieved. Selected embryos are then moved to an embryo transfer media prior to transfer to the uterus. Continuous Single Culture™ Complete is supplied as a ready to use liquid in 20 mL bottles.
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    K Number
    K121128
    Device Name
    MULTIPURPOSE HANDLING MEDIUM
    Manufacturer
    IRVINE SCIENTIFIC SALES CO., INC.
    Date Cleared
    2012-06-06

    (54 days)

    Product Code
    MQL, PRE
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRVINE SCIENTIFIC SALES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Multipurpose Handling Medium™ (MHM™) is intended for use in assisted reproductive procedures which involve the manipulation of gametes or embryos. Specifically, Multipurpose Handling Medium™) is indicated for use as an oocyte retrieval medium during ovarian follicle aspiration procedures (not for flushing ovarian follicles), washing sperm prior to IVF and ICSI fertilization procedures, and for transport of the embryo to the uterus during embryo transfer procedures.
    Device Description
    The Multipurpose Handling Medium™ (MHM™) is based upon the mHTF (K983586) formulation. The formula for the Multipurpose Handling Medium™ (MHM™) is based upon the composition of modified HTF, K983586. The medium uses a buffering system composed of HEPES (N-2-Hydroxyethylpiperazine-N1 - - 2 - - ethanesulfonic acid). MOPS . (3 Morpholinopropane - 1- sulfonic acid) and Sodium Bicarbonate. This buffering system provides pH maintenance over the physiologic range and does not require the use of a CO2 Incubator. - The product also contains 10 ug/mL gentamicin. Multipurpose Handling Medium™ (MHM™) has utility as an oocyte retrieval medium, in procedures that aspirate oocytes from the patient's ovarian follicles. Multipurpose Handling Medium™ (MHM™) is used only in the oocyte collection vessel and is not for use in flushing oocytes from ovarian follicles. Once the oocyte has been retrieved, it is placed into a culture dish with an appropriate amount of a culture medium (does not include MHM™), as specified by the user's internal procedures, and fertilization is allowed to occur. Multipurpose Handling Medium™ (MHM™) can also be used to wash sperm in preparation for fertilization by conventional IVF or ICSI procedures. The fertilized oocyte (zygote) is allowed to grow in the culture dish, supported by a culture medium (does not include MHM™), as specified by the user's internal procedures, and an appropriate protein supplement, in a carbon dioxide incubator at 37°C until the desired stage of development is achieved. The embryo is removed from the culture dish, placed into an appropriate amount of Multipurpose Handling Medium™ (MHM™) for transfer into the uterus. Multipurpose Handling Medium™ (MHM™) is supplied as a ready to use liquid, in 100 and 500 mL bottles.
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    K Number
    K093273
    Device Name
    VIT KIT - FREEZE AND THAW
    Manufacturer
    IRVINE SCIENTIFIC SALES CO., INC.
    Date Cleared
    2010-03-03

    (135 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRVINE SCIENTIFIC SALES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) is intended for use in the vitrification of pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) is intended for use in the thawing and recovery of vitrified pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
    Device Description
    The five (5) media that comprise the two (2) kits, Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) and the Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) are all based upon the modified formulation of Medium 199. The Medium 199 is HEPES buffered and contains 20% (v/v) DSS, 35ug/mL gentamicin and varying concentrations of DMSO, EG and sucrose. The two (2) freeze, ES and VS, media in the Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) are intended to be used sequentially, for the preparation for, and cryopreservation of, PN, day 3 cleavage stage embryos and blastocyst stage embryos. ES is used in preparation for freezing and contains 7.5 % (v/v) DMSO and EG. VS is to be used during cryostorage and contains 15% (v/v) DMSO and EG and 0.5M sucrose. The three (3) thaw, TS, DS and WS, media in the Vit Kit®- Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) are also intended for sequential use in the thawing and recovery of cryopreserved human embryo. The first medium used in the thawing process, TS, contains 1.0M sucrose. The second medium, DS, contains 0.5M sucrose. The third medium, WS, contains no sucrose.
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    K Number
    K072609
    Device Name
    SINGLE STEP MEDIUM
    Manufacturer
    IRVINE SCIENTIFIC SALES CO., INC.
    Date Cleared
    2008-02-12

    (148 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRVINE SCIENTIFIC SALES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.
    Device Description
    Single Step Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to be used during fertilization and culture of zygote/embryo through the desired development stage (up to 5/6 days) in vitro.
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    K Number
    K072608
    Device Name
    LYOPHILIZED MULTIBLAST MEDIUM KIT
    Manufacturer
    IRVINE SCIENTIFIC SALES CO., INC.
    Date Cleared
    2008-01-30

    (135 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRVINE SCIENTIFIC SALES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lyophilized MultiBlast Medium Kit is intended for use in the culture of human embryos from day three (3) to the blastocyst stage of development.
    Device Description
    Lyophilized MultiBlast Medium Kit is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to support embryonic growth and blastocyst development in vitro.
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    K Number
    K072607
    Device Name
    LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT
    Manufacturer
    IRVINE SCIENTIFIC SALES CO., INC.
    Date Cleared
    2008-01-25

    (130 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRVINE SCIENTIFIC SALES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lyophilized Early Cleavage Medium Kit is for use in assisted reproduction technology (ART) that involved the manipulation of gametes or embryos. Specifically, Lyophilized Early Cleavage Medium Kit is intended for use as a culture medium from fertilization through day three (3) of embryo development.
    Device Description
    Lyophilized Early Cleavage Medium Kit is a synthetic, defined medium composed of a balanced mixture of salts and other nutrient substances designed to support early stages of embryonic growth (up to three days post-fertilization).
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    K Number
    K061549
    Device Name
    AMNIOSTAT-FLM-PG
    Manufacturer
    IRVINE SCIENTIFIC SALES CO., INC.
    Date Cleared
    2006-10-18

    (135 days)

    Product Code
    JHG
    Regulation Number
    862.1455
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRVINE SCIENTIFIC SALES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AmnioStat-FLM-PG Kit is intended to be used for the immunological detection of phosphatidylglycerol (PG) in amniotic fluid to determine fetal lung maturity of the fetus collected from transabdominal or vaginal pool samples.
    Device Description
    The AmnioStat-FLM-PG Kit is an immunological semi-quantitative agglutination test for determining the presence of phosphatidylglycerol in human amniotic fluid at concentrations indicative of fetal lung maturity. The AmnioStat-FLM-PG Kit is comprised of five (5) components and a disposable agglutination cards (cardboard with laminate). The five (5) components that comprise the kit include three (3) kit controls, Negative Control, Catalog #91013, Low Positive Control, Catalog #91027, High Positive Control, Catalog #91028, two (2) reagents, Reagent A, Catalog #91012 and Reagent B, Catalog #91029, and one (1) Buffer, Catalog #91011. The three (2) controls (negative, low positive, and high positive) in the AmnioStat-FLM-PG Kit are run with each test. The AmnioStat-FLM-PG Kit can be used to run six (6) patient test samples. Each patient sample is run on an individual agglutination card with a set of controls. The AmnioStat-FLM-PG Kit is a next generation kit based upon the same immunological agglutination test as AmnioStat-FLM (K822150) previously cleared for marketing. The immunological agglutination reaction is the same between the AmnioStat-FLM (K822150) and the AmnioStat-FLM-PG kit. The AmnioStat-FLM-PG Kit incorporates the use of Sudan Black B into one of the kit reagents which makes the differentiation of the three (3) kit controls more distinguishable. The AmnioStat-FLM (K822150) is performed on a glass slide that requires the use of a mirror to distinguish and differentiate the kit controls based upon clarity of the background and the size of the agglutinated particles. The AmnioStat-FLM-PG is performed on a disposable agglutination card that is white and does not require the use of a mirror to distinguish and differentiate the kit controls.
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