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510(k) Data Aggregation

    K Number
    K162620
    Device Name
    Remel Spectra ESBL
    Manufacturer
    REMEL, INC.
    Date Cleared
    2017-05-01

    (223 days)

    Product Code
    JSO
    Regulation Number
    866.1700
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Remel Spectra™ ESBL is a selective and differential growth medium for use in primary isolation and presumptive identification of Extended Spectrum β Lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca and Proteus mirabilis to aid in prevention and control of these bacteria in a healthcare setting. Testing may be performed from either perirectal swabs or fresh stool specimens. Remel Spectra™ ESBL is not intended to diagnose ESBL infection, or to guide or monitor treatment. Do not report Spectra™ ESBL positive screening results. Subculture of presumptive positive colonies to non-selective medium (e.g. Tryptic Soy Agar with 5% sheep blood) is required for organism identification, confirmatory testing for ESBL, susceptibility testing and epidemiological typing. A lack of growth or the absence of pink, blue-turquoise-green or tan colonies on Spectra™ ESBL does not preclude the presence of ESBL producing organisms.
    Device Description
    Spectra™ ESBL contains a combination of antibacterial agents which aid in inhibiting non-ESBL Enterobacteriaceae and suppress the growth of some AmpC organisms and other non-ESBL flora. Peptones supply amino acids and essential nutrients which promote the growth of enteric gram-negative bacilli. Sodium chloride is a source of essential electrolytes and maintains osmotic equilibrium. Phosphate buffers are added to maintain the pH. A mixture of chromogens forms a substrate for two enzymes: βgalactosidase and glucuronidase that are differentially expressed in different species of bacteria resulting in blue/turquoise-green or pink colonies. Other ESBL-producing organisms that do not utilize the chromogenic substrates may produce tan colonies through deamination of tryptophan. Non-target organisms generally appear cream colored or are naturally pigmented green or brown.
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    K Number
    K131804
    Device Name
    REMEL XPECT FLU A&B
    Manufacturer
    REMEL, INC.
    Date Cleared
    2013-07-12

    (23 days)

    Product Code
    GNX
    Regulation Number
    866.3330
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Remel Xpect® Flu A&B is a in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigens (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay.
    Device Description
    The Xpect® Flu A&B is a chromatographic immunoassay for the qualitative detection of influenza A and influenza B viral antigens. The test device incorporates separate membrane strips for influenza A and for influenza B. To perform the test, the patient specimen is diluted and added to the sample wells of the device. The mixture moves along the membranes by capillary action. If present, influenza A or B viral antigens in the patient sample bind anti-influenza A or B conjugated antibodies. A visible line forms as a complex of antibody-antigen-antibody coated colored particles is captured in the test region (T). Antibody coated colored particles not bound at the test line are later captured in the control region (C) containing goat anti-mouse antibody. A visible line will always appear in the control region indicating that the test is working properly. The presence of a control line combined with the absence of a visible test line is interpreted as a negative test result.
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    K Number
    K092407
    Device Name
    REMEL SPECTRA MRSA
    Manufacturer
    REMEL, INC.
    Date Cleared
    2010-10-08

    (428 days)

    Product Code
    JSO
    Regulation Number
    866.1700
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K072827
    Device Name
    RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
    Manufacturer
    REMEL, INC.
    Date Cleared
    2007-11-26

    (54 days)

    Product Code
    MJE
    Regulation Number
    866.1700
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Remel RPMI 1640 Agar w/ MOPS and 2% Glucose is a solid medium recommended for use with antibiotic gradient-based systems for quantitative determination of susceptibility to antifungal agents when testing Candida spp. directly from colonies grown on nonselective media.
    Device Description
    RPMI-1640 was developed by Moore et al. at Roswell Park Memorial Institute. The formulation is based on the RPMI- 1630 series of media utilizing a bicarbonate buffering system and alterations in the amounts of amino acids and vitamins. RPMI-1640 medium has demonstrated wide applicability in cell culture and also as the reference method for antifungal broth microdilution recommended by Clinical Laboratory Standards Institute (CLSI). When properly supplemented with MOPS, glucose, and agar RPMI-1640 has demonstrated accuracy for use with gradient-based systems with results comparable to that obtained with the CLSI reference method for testing Candida spp. against antifungal agents. The gradient method is based on a combination of the concepts of both dilution and diffusion tests, but differs from conventional disk methods by the use of a preformed, stable antibiotic gradient strip. When the strip is applied to the inoculated agar plate, there is an immediate release of the antibiotic into the agar matrix. A continuous and exponential gradient of antibiotic concentration is created beneath the carrier. After incubation a symmetrical inhibition ellipse centered along the carrier is seen. The zone edge intersects the strip at the minimum inhibitory concentration (MIC) value given in ug/ml. For antifungal testing, due to trailing effect, MICs should be read at approximately 90% inhibition of growth, ignoring faint hazes and minute colonies for flucytosine and 80% inhibition for fluconazole and itraconazole.
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    K Number
    K981391
    Device Name
    PAR-ONE
    Manufacturer
    REMEL, INC.
    Date Cleared
    1998-07-14

    (88 days)

    Product Code
    LIO
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REMEL's Par-One™ is a medium recommended for use in qualitative procedures for the transportation, preservation, and examination of stool specimens for intestinal parasites. Concentration, permanent stained smear, and immunoassay procedures can be performed from this single vial transport system.
    Device Description
    Not Found
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    K Number
    K970832
    Device Name
    PYR SWAB
    Manufacturer
    REMEL, INC.
    Date Cleared
    1997-04-24

    (48 days)

    Product Code
    JTO
    Regulation Number
    866.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970834
    Device Name
    GRAM SWAB
    Manufacturer
    REMEL, INC.
    Date Cleared
    1997-04-17

    (41 days)

    Product Code
    JTO
    Regulation Number
    866.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970830
    Device Name
    REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
    Manufacturer
    REMEL, INC.
    Date Cleared
    1997-04-02

    (26 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970831
    Device Name
    REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
    Manufacturer
    REMEL, INC.
    Date Cleared
    1997-04-02

    (26 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970833
    Device Name
    INDOLE SWAB
    Manufacturer
    REMEL, INC.
    Date Cleared
    1997-04-02

    (26 days)

    Product Code
    JTO
    Regulation Number
    866.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMEL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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