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510(k) Data Aggregation

    K Number
    K043589
    Device Name
    MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
    Manufacturer
    DADE MICROSCAN, INC.
    Date Cleared
    2005-02-14

    (48 days)

    Product Code
    JWY, LTT, LTW
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE MICROSCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci. After inoculation, panels are incubated for 16-20 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the addition of the antimicrobial Ertapenem at concentrations of 0.002 to 32 mcg/ml to the test panel. The gram-positive organisms which may be used for Ertapenem susceptibility testing in this panel are: Staphylococcus aureus (methicillin-susceptible strains) Streptococcus agalactiae
    Device Description
    MicroScan® Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
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    K Number
    K023202
    Device Name
    MICROSCAN SYNERGIES PLUS
    Manufacturer
    DADE MICROSCAN, INC.
    Date Cleared
    2002-10-23

    (28 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE MICROSCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroScan® Synergies plus™ Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility for Gram-Negative organisms and screening for suspected ESBL production in E. coli, K. oxytoca and K. pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CO2 incubator, and read visually, according to the Package Insert. This particular submission is for the antimicrobials cefpodoxime (0.015-64 ug/ml) and ceftazidime (0.5-64 ug/ml). The Gram-Negative organisms which may be used for screening for suspected ESBL production in this panel are: Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae
    Device Description
    MicroScan® Synergies plus™ Dried Gram-Negative MIC/Combo Panels with Cefpodoxime (0.015-64 ug/ml) and Ceftazidime (0.5-64 ug/ml)
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    K Number
    K021184
    Device Name
    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
    Manufacturer
    DADE MICROSCAN, INC.
    Date Cleared
    2002-06-20

    (66 days)

    Product Code
    LTT
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE MICROSCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroScan ® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae . After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Clindamycin at concentrations of 0.015 to 2 mcg/ml to the test panel. The organisms which may be used for Clindamycin susceptibility testing in this panel are: Streptococci. The MicroScan ® MICroSTREP plus™ Panel with Clindamycin is not intended for use with: Streptococcus pneumoniae.
    Device Description
    The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
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    K Number
    K021181
    Device Name
    MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
    Manufacturer
    DADE MICROSCAN, INC.
    Date Cleared
    2002-06-17

    (63 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE MICROSCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To determine bacterial antimicrobial agent susceptibility. The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20-24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Clarithromycin at concentrations of 0.015 to 2 mcg/ml to the test panel. The organisms which may be used for Clarithromycin susceptibility testing in this panel are: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococci (Groups C, F, G), viridans group streptococci.
    Device Description
    The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20-24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
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    K Number
    K021018
    Device Name
    MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
    Manufacturer
    DADE MICROSCAN, INC.
    Date Cleared
    2002-06-11

    (74 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE MICROSCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To determine bacterial antimicrobial agent susceptibility. The MicroScan ® MICroSTREP plus ™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Chloramphenicol at concentrations of 1 to 32 mcg/ml to the test panel. The organisms which may be used for Chloramphenicol susceptibility testing in this panel are: Susceptible streptococci, including Streptococcus pneumoniae.
    Device Description
    The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20-24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
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    K Number
    K021078
    Device Name
    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
    Manufacturer
    DADE MICROSCAN, INC.
    Date Cleared
    2002-06-06

    (64 days)

    Product Code
    LTT
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE MICROSCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To determine bacterial antimicrobial agent susceptibility. The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Erythromycin at concentrations of 0.015 to 2 mcg/ml to the test panel. The organisms which may be used for Erythromycin susceptibility testing in this panel are: Streptococcus pneumoniae, Streptococcus pyogenes, viridans group streptococci.
    Device Description
    The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water. buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% brsed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-COincubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
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    K Number
    K021110
    Device Name
    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE
    Manufacturer
    DADE MICROSCAN, INC.
    Date Cleared
    2002-06-06

    (62 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE MICROSCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To determine bacterial antimicrobial agent susceptibility The MicroScan ® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae . After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Ceftriaxone at concentrations of 0.015 to 8 mcg/ml to the test panel The organisms which may be used for Ceftriaxone susceptibility testing in this panel are: Streptococcus pneumoniae Streptococcus pyogenes viridans group streptococci
    Device Description
    The MicroScan® MICroSTREP plus™ is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% bysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
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    K Number
    K021111
    Device Name
    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
    Manufacturer
    DADE MICROSCAN, INC.
    Date Cleared
    2002-06-06

    (62 days)

    Product Code
    LTT
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE MICROSCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To determine bacterial antimicrobial agent susceptibility. The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae . After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Cefotaxime at concentrations of 0.015 to 8 mcg/ml to the test panel. The organisms which may be used for Cefotaxime susceptibility testing in this panel are: Streptococcus pyogenes (Group A beta-hemolytic streptococci), Streptococcus agalactiae (Group B streptococci), Streptococcus pneumoniae (formerly Diplococcus pneumoniae).
    Device Description
    The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
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    K Number
    K021169
    Device Name
    MICROSTREP PLUS PANEL, AZITHROMYCIN
    Manufacturer
    DADE MICROSCAN, INC.
    Date Cleared
    2002-06-06

    (56 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE MICROSCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. To determine bacterial antimicrobial agent susceptibility This particular submission is for the addition of the antimicrobial Azithromycin at concentrations of 0.12 to 4 mcg/ml to the test panel The organisms which may be used for Azithromycin susceptibility testing in this panel are: Streptococcus pneumoniae Streptococcus pyogenes Streptococcus agalactiae streptococci (Groups C. F. G) viridans group streptococci
    Device Description
    The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
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    K Number
    K021188
    Device Name
    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME
    Manufacturer
    DADE MICROSCAN, INC.
    Date Cleared
    2002-06-06

    (52 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE MICROSCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To determine bacterial antimicrobial agent susceptibility. The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Cefepime at concentrations of 0.015 to 8 mcg/ml to the test panel. The organisms which may be used for Cefepime susceptibility testing in this panel are: Streptococcus pneumoniae, Streptococcus pyogenes (Lancefield's Group A streptococci), Streptococcus agalactiae (Lancefield's Group B streptococci), Viridans group streptococci.
    Device Description
    The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
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