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510(k) Data Aggregation

    K Number
    K993577
    Device Name
    CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Date Cleared
    1999-12-01

    (41 days)

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

    BECTON DICKINSON MICROBIOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Antimicrobial susceptibility test discs are used for semi-quantitative susceptibility testing of bacteria by standardized agar diffusion. Cefotaxime/Clavulanic Acid, BBL™ Sensi-Disc™ and Ceftazidime/Clavulanic Acid BBL™ Sensi-Disc™ are intended for use for confirmatory tests for organisms that secrete Extended-spectrum ß-lactamases (ESBL)s as indicated in the Results section of the package insert and indicated below. Use of Cefotaxime/Clavulanic Acid, BBL™ Sensi-Disc™ and Ceftazidime/Clavulanic Acid BBL ™ Sensi-Disc™ together with Cefotaxime and Ceftazidime susceptibility discs for in vitro agar diffusion susceptibility testing are indicated when there is a need to perform a confirmatory test for ESBLs in Klebsiella spp. and Escherichia coli.
    Device Description
    Cefotaxime/Clavulanic Acid and Ceftazidime/Clavulanic Acid susceptibility test discs are prepared by impreanating high quality absorbent paper with accurately determined amounts of Cefotaxime, supplied by Marion Roussel, Inc., Kansas City, MO, and Ceftazidime, supplied by Glaxo Wellcome Operations, Cumbria, UK, respectively. Both discs are also impregnated with specific amounts of Clavulanic Acid supplied by SmithKline Beecham Pharmaceuticals, Piscataway, NJ. The disks are clearly marked with the agents: CTX/CLA and CAZ/CLA. Cefotaxime/Clavulanic Acid and Ceftazidime/Clavulanic Acid susceptibility test discs are provided in cartridges of 50 disks each and packaged separately. Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium. Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U. S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A6' (1/97) and M100-S92 (1/99). Disks containing an antimicrobial agent are applied to the surface of Mueller Hinton Agar plates inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for the antimicrobial agents in order to determine which is most suitable for use in therapy. The determination as to whether the organism is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to the interpretive criteria defined in the tables of NCCLS document M100-S9.
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    K Number
    K984631
    Device Name
    BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Date Cleared
    1999-11-04

    (309 days)

    Product Code
    LSL, MKZ
    Regulation Number
    866.3390
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECTON DICKINSON MICROBIOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BDProbeTec™ ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BDProbeTec™ ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females for the BDProbeTec ET CT and GC Assays, from symptomatic or asymptomatic males for the BDProbeTec ET CT Assay, and from symptomatic males for the BDProbeTec ET GC Assay. A separate Amplification Control is an option for inhibition testing (BDProbeTec ET CT/GC/AC Reagent Pack).
    Device Description
    The BDProbeTec™ ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) amplified DNA assays utilize homogeneous SDA technology as the amplification method and fluorescent energy transfer (ET) as the detection method to test for the presence of CT and GC in clinical specimens. For each assay, the SDA reagents are dried in two separate microwell strips. First, the processed sample is added to the Priming Microwell which contains the amplification primers, fluorescent labeled detector probe, and other reagents necessary for amplification. However, because no enzymes are present in the priming microwell strips, no amplification occurs at this step. After incubation, the reaction mixture is transferred to the Amplification Microwell, which contains two enzymes (a DNA polymerase and a restriction endonuclease) necessary for SDA. It is in this latter microwell in which amplification and detection occurs. The Amplification Microwells are sealed to prevent contamination and then incubated in a thermally controlled fluorescent reader which monitors each test well for the generation of amplified products. The presence of CT and GC is determined by relating the BDProbeTec ET MOTA (Method Other Than Acceleration) scores for the sample to pre-determined cutoff values. The MOTA score is a metric used to assess the magnitude of signal generated as a result of the reaction. If the CT/GC Reagent Pack is used, each sample and control are tested in two discrete microwells: C. trachomatis and N. gonorrhoeae. Results are reported through an algorithm as positive or negative. If the CT/GC/AC Reagent Pack is used, each sample and control are tested in three discrete microwells: C. trachomatis, N. gonorthoeae, and the Amplification Control. The purpose of the Amplification Control is to identify a sample that may inhibit the SDA reaction. Results are reported through an algorithm as positive, negative, or indeterminate.
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    K Number
    K981517
    Device Name
    CEFDINIR, 5 UG, SENSI-DISC
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Date Cleared
    1998-06-09

    (42 days)

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

    BECTON DICKINSON MICROBIOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of BBL® Cefdinir Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Cefdinir. Cefdinir has been shown to be active against most strains of microorganisms listed below, as described in the Parke-Davis package insert for this antimicrobic. Active In Vitro and In Clinical Infections Against: Aerobic Gram-Positive Microorganisms Staphylococcus aureus (including ß-lactamase producing strains, but excluding methicillin-resistant staphylococci) Streptococcus pneumoniae (penicillin-susceptible strains only) Streptococcus pvogenes Aerobic Gram-Neqative Microorganisms Haemophilus influenzae (including ß-lactamase producing strains) Haemophilus parainfluenzae (including ß-lactamase producing strains) Moraxella catarrhalis (including ß-lactamase producing strains) Active In Vitro Only Against: Aerobic Gram-Positive Microorganisms Staphylococcus epidermidis (methicillin-susceptible strains only) Streptococcus agalactiae Viridans group streptococci Aerobic Gram Negative Microorganisms Citrobacter diversus Escherichia coli Klebsiella pneumoniae Proteus mirabilis
    Device Description
    Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Cefdinir Sensi-Discs® are intended for use in determining the susceptibility to Cefdinir of a wide range of bacteria, as described under Indications For Use below. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Parke-Davis, a Division of Warner-Lambert Co., and received FDA approval under NDA Nos. 50-739 and 50-749. Cefdinir Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Cefdinir supplied by the manufacturer. Parke-Davis. Each Cefdinir disc is clearly marked on both sides with the agent and content. Cefdinir discs are furnished in cartridges of 50 discs each. Cefdinir cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. In order to eliminate or minimize variability in the testing, Bauer et al developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium. Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A6 (1/97) and M100-S8 (1/98). Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Agar with 5% Sheep Blood for Streptococcus pneumoniae] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to those found in the respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A6 ("Performance Standards for Antimicrobial Disk Susceptibility Tests - Sixth Edition, Approved Standard", 1/97) and of NCCLS Document M100-S8 ("Performance Standards for Antimicrobial Susceptibility Testing", Eighth Informational Supplement, 1/98).
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    K Number
    K980683
    Device Name
    TROVAFLOXACIN 10G, SENSI-DISC
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Date Cleared
    1998-05-01

    (67 days)

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

    BECTON DICKINSON MICROBIOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of BBL Trovafloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Trovafloxacin has been shown to be active against most strains of microorganisms listed below, as described in the Roerig package insert for this antimicrobic.
    Device Description
    Trovafloxacin Susceptibility Test Discs are prepared by impregnating high guality paper with accurately determined amounts of Trovafloxacin supplied by the manufacturer, Roerig. Each Trovafloxacin disc is clearly marked on both sides with the agent and content. Trovafloxacin discs are furnished in cartridges of 50 discs each. Trovafloxacin cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium. Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A6 (1/97) and M100-S7 (1/97). Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates {or Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Aqar with 5% Sheep Blood for Streptococcus pneumoniae] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to those found in the respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A6 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Sixth Edition, Approved Standard", 1/97) and of NCCLS Document M100-S8 ("Performance Standards for Antimicrobial Susceptibility Testing", Eighth Informational Supplement, 1/98).
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    K Number
    K974578
    Device Name
    GREPAFLOXACIN, 5 MG, SENSI-DISC
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Date Cleared
    1998-02-23

    (77 days)

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

    BECTON DICKINSON MICROBIOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Grepafloxacin Sensi-Discs® are intended for use in determining the susceptibility to Grepafloxacin of a wide range of bacteria, including Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus agalactiae, Streptococcus pneumoniae. Streptococcus pyogenes, Citrobacter freundii, Citrobacter (diversus) koseri, Enterobacter aerogenes, Enterobacter cloacae,, Escherichia coli, Haemophilus parainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, and Proteus vulgaris. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, GlaxoWellcome, Inc., and received FDA approval under NDA No. 50-717. Use of BBL® Grepafloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Grepafloxacin. Grepafloxacin has been shown to be active against most strains of microorganisms listed below, both in vitro and in clinical infections, as described in the GlaxoWellcome, Inc., package insert for this antimicrobic. Aerobic Gram-Positive Microorganisms Streptococcus pneumoniae (penicillin-susceptible strains) Aerobic Gram-Negative Microorganisms Haemophilus influenzae Moraxella catarrhalis Neisseria gonorrhoeae Other microorganisms Chlamydia trachomatis Mycoplasma pneumoniae Grepafloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of 1 ug/ml or less against most (≥90%) strains of the microorganisms listed below: however, the safety and effectiveness of Grepafloxacin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials. Aerobic Gram-Positive Microorganisms (/n Vitro Only) Staphylococcus aureus (methicillin-susceptible strains) Staphylococcus epidermidis (methicillin-susceptible strains) Streptococcus agalactiae Streptococcus pneumoniae (penicillin-resistant strains) Streptococcus pyogenes Aerobic Gram-Negative Microorganisms (/n Vitro Only) Citrobacter freundii Citrobacter (diversus) koseri Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus parainfluenzae Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris
    Device Description
    Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Grepafloxacin Sensi-Discs® are intended for use in determining the susceptibility to Grepafloxacin of a wide range of bacteria, including Staphylococcus aureus, Staphylococcus epidermidis. Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Citrobacter freundii, Citrobacter (diversus) koseri, Enterobacter aerogenes, Enterobacter cloacae,, Escherichia coli, Haemophilus parainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, and Proteus vulgaris. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, GlaxoWellcome, Inc., and received FDA approval under NDA No. 50-717. Grepafloxacin Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Grepafloxacin supplied by the manufacturer, GlaxoWellcome, Inc., Research Triangle Park, North Carolina. Each Grepafloxacin disc is clearly marked on both sides with the agent and content. Grepafloxacin discs are furnished in cartridges of 50 discs each. Grepafloxacin cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. In order to eliminate or minimize variability in the testing, Bauer et al, developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium. Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A6 (1/97) and M100-S7 (1/97). Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates for Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Agar with 5% Sheep Blood for Streptococcus pneumoniae] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to those found in the respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A6 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Sixth Edition, Approved Standard", 1/97) and of NCCLS Document M100-S7 ("Performance Standards for Antimicrobial Susceptibility Testing", Seventh Informational Supplement. 1/97).
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    K Number
    K970333
    Device Name
    BACTEC MYCO/F LYTIC CULTURE VIALS
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Date Cleared
    1998-01-28

    (365 days)

    Product Code
    MDB
    Regulation Number
    866.2560
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECTON DICKINSON MICROBIOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BACTEC® MYCO/F Lytic culture vials when used with the 9000 Blood Culture series of instrumentation are intended as an adjunct to routine blood culture for patients suspected of having mycobacteria, yeast and fungi septicemia. Extended incubation times (7 days for yeast, 30 days for fungi, and 42 days for mycobacteria) will permit recovery of mycobacteria and fungi when more rapidly growing organisms are not present. This medium may also be used for the culture of sterile body fluids when yeast or fungi are suspected.
    Device Description
    BACTEC MYCO/F LYTIC Culture medium is a Middlebrook 7H9 and Brain Heart Infusion broth formulation for the recovery of mycobacteria from blood specimens and fungi from blood and sterile body fluids. The range of specimen volume which can be cultured is one to five mL. with optimum recovery obtained at three to five mL. Specific modifications were made to enhance the growth and recovery of mycobacteria, veast, and fungi. These modifications include ferric ammonium citrate to provide an iron source for specific strains of mycobacteria and fungi, the addition of saponin as a blood lysing agent and the addition of specific proteins and sugars to provide nutritional supplements. Each vial contains a sensor which can detect decreases in oxygen concentration in the vial resulting from microorganism and growth. The sensor is monitored by the BACTEC 9000 Blood Culture Systems for increasing fluorescence which is proportional to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.
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    K Number
    K970512
    Device Name
    BACTEC MYCO/F LYTIC CULTURE VIALS
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Date Cleared
    1998-01-08

    (331 days)

    Product Code
    MDB
    Regulation Number
    866.2560
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECTON DICKINSON MICROBIOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BACTEC ® MYCO/F LYTIC Culture vial when used with the BACTEC 9000MB System is a qualitative test for the culture and recovery of mycobacteria in human blood speciments from patients who are suspected of having septicemia.
    Device Description
    BACTEC MYCO/F LYTIC blood culture medium is a non-selective growth medium intended for the culture and recovery of mycobacteria and designed for blood volumes of one to five mL. BACTEC MYCO/F LYTIC culture medium is a Middlebrook 7H9 and Brain Heart Infiusion broth formulation with specific formulation modifications made to enhance the growth of mycobacteria. It is used specifically with the BACTEC 9000MB instrument in the monitoring of clinical blood specimens for the presence of microorganisms. This medium contains the same fluorescence senor as the BACTEC MYCO/F Sputa culture medium and detection is based on changes in oxygen concentration in the vial resulting from metabolism and growth of microorganisms. The sensor is monitored by the BACTEC 9000MB System for increasing fluorescence which is proportinal to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.
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    K Number
    K972758
    Device Name
    BACTEC MYCO/F-SPUTA CULTURE VIALS
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Date Cleared
    1997-08-08

    (53 days)

    Product Code
    MDB
    Regulation Number
    866.2560
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECTON DICKINSON MICROBIOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MYCO/F-Sputa culture media BACTEC Supplement /F when used with the BACTEC Brand 9000MB fluorescent series instrument is a qualitative procedure for the in vitro culture and recovery of mycobacteria from digested decontaminated clinical specimens and sterile body fluids other than blood. MYCO/F-Sputa culture media with the addition of BACTEC Supplement/F when used with the BACTEC Brand 9000MB fluorescent series instrument is a qualitative test for the in-vitro culture and recovery of mycobacteria from digested decontaminated clinical specimens and sterile body fluids other than blood from patients suspected of pulmonary or disseminated mycobacterial infection.
    Device Description
    BACTEC® MYCO/F-Sputa Culture Vials containing 7H9 Middlebrook broth base with nutrient additives and antimicrobial supplement (Polymyxin B, amphotericin B, nalidixic acid, trimethoprim & azlocillin (PANTA)). Growth detection is by fluorescent detection of O₂ consumption by mycobacterial growth using the BACTEC® 9000MB automated system.
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    K Number
    K972098
    Device Name
    FOSFOMYCIN, 200 MG, SENSI-DISC
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Date Cleared
    1997-07-28

    (54 days)

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

    BECTON DICKINSON MICROBIOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Fosfomycin Sensi-Discs® are intended for use in determining the susceptibility to Fosfomycin of a wide range of bacteria, including Enterococcus faecalis, Enterococcus faeclum, Escherichia coli, Citrobacter diversus, Citerobacter freundii, Entercbacter aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, and Serratia marcesceus. Zone sizes used tor interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Forest Pharmaceuticals, Inc., and received FDA approval under NDA No. 50-717. Use of BBL Fosfomycin Sensi-Discs®.for in .vitro .agar diffusion.susceptibility. testing is indicated when there is a need to determine the susceptibility of bacteria to Fosfomycin. Fosfomycin has been shown to be active against most strains of microorganisms listed below, as described in the Forest Pharmaceuticals, Inc., package insert for this antimicrobic. Active In Vitro and In Clinical Infections Against: Aerobic Gram-Positive Microorganisms Enterococcus faecalis Aerobic Gram-Negative Microorganisms Escherichia coli Active In Vitro Only Against: Aerobic Gram-Positive Microorganisms Enterococcus faeclum Aerobic Gram-Negative Microorganisms Citrobacter diversus Citerobacter freundii Enterobacter aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Serratia marcesceus
    Device Description
    Antimicrobial Susceptibility Test Discs
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    K Number
    K970385
    Device Name
    SPARFLOZACIN, 5 MCG, SENSI-DISC
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Date Cleared
    1997-03-10

    (35 days)

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

    BECTON DICKINSON MICROBIOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Sparfloxacin Sensi-Discs® are intended for use in determining the susceptibility to Sparfloxacin of a wide range of bacteria, including Staphylococcus aureus, Streptococcus pneumoniae (penicillin-susceptible strains), Enterobacter cloacae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, and Mycoplasma pneumoniae. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Rhone Poulenc Rorer Pharmaceuticals, Inc., and received FDA approval under NDA No. 20-677. Use of BBL® Sparfloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Sparfloxacin. Sparfloxacin has been shown to be active against most strains of microorganisms listed below, both in vitro and in clinical infections, as described in the Rhone Poulenc Rorer Pharmaceuticals, Inc., package insert for this antimicrobic.
    Device Description
    Sparfloxacin Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Sparfloxacin supplied by the manufacturer, Rhone Poulenc Rorer Pharmaceuticals, Inc., Collegeville, Pennsylvania. Each Sparfloxacin disc is clearly marked on both sides with the agent and content. Sparfloxacin discs are furnished in cartridges of 50 discs each. Sparfloxacin cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium. Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A5 (12/93) and M100-S6 (12/95). Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Agar for H. influenzae or Mueller Hinton Agar with 5% Sheep Blood for S. pneumoniae] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to those found in the respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A5 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Fifth Edition, Approved Standard", 12/93) and of NCCLS Document M100-S6 ("Performance Standards for Antimicrobial Susceptibility Testing", Sixth Informational Supplement, 12/95).
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