Search Filters

Search Results

Found 16 results

510(k) Data Aggregation

    K Number
    K222430
    Device Name
    VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
    Manufacturer
    bioMerieux SA, Inc.
    Date Cleared
    2023-03-09

    (210 days)

    Product Code
    LON, LTT, LTW
    Regulation Number
    866.1645
    Why did this record match?
    Applicant Name (Manufacturer) :

    bioMerieux SA, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VITEK® 2 AST-Gram Negative Fosfomycin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Fosfomyoin is a quantitative test. Fosfomycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Escherichia coli The VITEK® 2 Gram-Negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically sigmificant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.
    Device Description
    The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh(1) and Gerlach(0). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3). Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card. VITEK® 2 AST-GN Fosfomycin (≤4 - ≥256 ug/mL) has the following concentrations in the card: 2, 8, 16 and 64 ug/mL (equivalent standard method concentration by efficacy in ug/mL).
    Ask a Question
    K Number
    K210757
    Device Name
    ETEST Fosfomycin (FO) (0.032-512 µg/mL)
    Manufacturer
    bioMerieux SA
    Date Cleared
    2021-11-12

    (242 days)

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

    bioMerieux SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ETEST® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Fosfomycin has been shown to be active against the Gram-positive aerobic microorganisms listed below according to the FDA label for this antimicrobial agent. ETEST® (FO) can be used to determine the MIC of Fosfomycin against the following microorganisms: Active both in vitro and in clinical infections: - Escherichia coli - Enterococcus faecalis
    Device Description
    ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in µg/mL on one side and a predefined antibiotic gradient on the other side. When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip. ETEST® Fosfomycin contains a range of fosfomycin from 0.032 to 512 ug/mL.
    Ask a Question
    K Number
    K192738
    Device Name
    ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
    Manufacturer
    BioMerieux SA
    Date Cleared
    2019-11-26

    (60 days)

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

    BioMerieux SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Delafloxacin has been shown to be active against the aerobic microorganisms listed below according to the FDA label for this antimicrobial agent. ETEST® DFX can be used to determine the MIC of Delafloxacin against the following microorganisms: Active both in vitro and in clinical infections: Gram-positive bacteria: - · Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible strains) - Staphylococcus haemolyticus - Staphylococcus lugdunensis - Enterococcus faecalis Gram-negative bacteria: - Pseudomonas aeruginosa
    Device Description
    ETEST® is a thin, inert and non-porous plastic strip carrying on one side the MIC reading scale in ug/mL, and on the other side a predefined antibiotic gradient. When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip. ETEST® Delafloxacin contains a range of delafloxacin from 0.002 to 32 u2/mL.
    Ask a Question
    K Number
    K192050
    Device Name
    ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
    Manufacturer
    bioMerieux SA
    Date Cleared
    2019-09-27

    (58 days)

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

    bioMerieux SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minibitory Concentration (MC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media using overnight incubation. Eravacycline has been shown to be active against most isolates of the microorganisms listed below according to this antimicrobial agent. ETEST® ERV can be used to determine the MIC of Eravacycline against the following microorganisms: Active both in vitro and in clinical infections: Gram-negative: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Gram-positive: Enterococcus faecalis Enterococcus faecium In vitro data are available for the following microorganisms, but clinical significance is unknown: Citrobacter koseri Klebsiella aerogenes
    Device Description
    ETEST® is a thin, inert and non-porous plastic strip carrying on one side the MIC reading scale in ug/mL, and on the other side a predefined antibiotic gradient. When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip. ETEST® Eravacycline contains a range of eravacycline from 0.002 to 32 µg/mL.
    Ask a Question
    K Number
    K191953
    Device Name
    ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
    Manufacturer
    BioMerieux SA
    Date Cleared
    2019-08-22

    (31 days)

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

    BioMerieux SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Imipenem/Relebactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent. ETEST® IPR can be used to determine the MIC of Imipenem/Relebactam against the following microorganisms: Active both in vitro and in clinical infections: - Citrobacter freundii - Enterobacter cloacae - Escherichia coli - Klebsiella aerogenes - Klebsiella oxytoca - Klebsiella pneumoniae - Pseudomonas aeruginosa
    Device Description
    ETEST® is a thin, inert and non-porous plastic strip carrying on one side the MIC reading scale in ug/mL, and on the other side a predefined antibiotic gradient. When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip. ETEST® Imipenem/Relebactam contains a range of imipenem from 0.002 to 32 µg/mL, overlaid with a fixed concentration of 4ug/mL of relebactam.
    Ask a Question
    K Number
    K190154
    Device Name
    ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
    Manufacturer
    bioMerieux SA
    Date Cleared
    2019-05-01

    (91 days)

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

    bioMerieux SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Piperacillin/Tazobactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent. ETEST® P/T can be used to determine the MIC of Piperacillin/Tazobactam against the following microorganisms: Active both in vitro and in clinical infections: Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa In vitro data are available for the following microorganisms, but clinical significance is unknown: Citrobacter koseri Morganella morganii Proteus mirabilis Proteus vulgaris Serratia marcescens Providencia stuartii Providencia rettgeri Salmonella enterica
    Device Description
    ETEST® is a thin, inert and non-porous plastic strip carrying on one side the MIC reading scale in ug/mL, and on the other side a predefined antibiotic gradient. When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip. ETEST® Piperacillin/Tazobactam contains a range of piperacillin from 0.016 to 256 ug/mL, overlaid with a fixed concentration of 4 ug/mL of tazobactam.
    Ask a Question
    K Number
    K183031
    Device Name
    ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
    Manufacturer
    bioMerieux SA
    Date Cleared
    2019-01-11

    (71 days)

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

    bioMerieux SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Meropenem/Vaborbactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent. ETEST® MEV can be used to determine the MIC of Meropenem/Vaborbactam against the following microorganisms: Active both in vitro and in clinical infections: Enterobacter cloacae complex Escherichia coli Klebsiella pneumoniae In vitro data are available for the following microorganisms, but clinical significance is unknown: - Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Providencia spp. Serratia marcescens
    Device Description
    ETEST® is a thin, inert and non-porous plastic strip carrying on one side (A) the MIC reading scale in ug/mL, and on the other side (B) a predefined antibiotic gradient. When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip. ETEST® Meropenem/Vaborbactam contains a range of meropenem from 0.004 to 64 ug/mL, overlaid with a fixed concentration of 8 µg/mL of vaborbactam.
    Ask a Question
    K Number
    K181092
    Device Name
    CHROMID CARBA agar (CARB)
    Manufacturer
    bioMerieux SA
    Date Cleared
    2018-07-06

    (72 days)

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

    bioMerieux SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CHROMID® CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID® CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID® CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID® CARBA agar with colonies that appear pink to burgundy or blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-grey colonies does not preclude the carriage of carbapenemase producing organisms.
    Device Description
    CHROMID® CARBA agar consists of a nutritive base combining different peptones, 3 chromogenic substrates and antibiotics. These components enable the screening and presumptive identification of E. coli: spontaneous coloration (pink to burgundy) of strains producing ß-glucuronidase (ß-GUR) and/or ß-galactosidase (ß-GAL) and K. pneumoniae: spontaneous blue-green to bluish-grey coloration of strains producing ß-glucosidase (ß-GLU) from rectal swabs.
    Ask a Question
    K Number
    K180936
    Device Name
    ETEST Telavancin (TLA) (0.002-32 ug/mL)
    Manufacturer
    bioMerieux SA
    Date Cleared
    2018-07-03

    (84 days)

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

    bioMerieux SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ETEST® is a quantitative technique for determination of antimicrobial susceptibility of non-fasticious Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ug/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Telavancin has been shown to be active against the Gram positive aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent. Active both in vitro and in clinical infections: Staphylococcus aureus (including methicillin resistant isolates) Enterococcus faecalis (vancomycin susceptible isolates only)
    Device Description
    ETEST® is a thin, inert and non-porous plastic strip carrying on one side (A) the MIC reading scale in ug/mL, and on the other side (B) a predefined antibiotic gradient. When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
    Ask a Question
    K Number
    K162385
    Device Name
    RAPIDEC CARBA NP
    Manufacturer
    BIOMERIEUX SA
    Date Cleared
    2017-04-27

    (245 days)

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

    BIOMERIEUX SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RAPIDEC® CARBA NP is a phenotypic (colorimetric) in vitro diagnostic test for the qualitative detection of carbapenemase enzymes in Enterobacteriaceae and Pseudomonas aeruginosa colonies that have elevated MIC values to any carbapenem. RAPIDEC® CARBA NP is performed on pure colonies grown on non-selective sheep blood agar culture media. RAPIDEC® CARBA NP is intended as an aid in the prevention and control of infection caused by carbapenemase-producing Enterobacteriaceae and Pseudomonas aeruginosa. RAPIDEC® CARBA NP is not intended to guide or monitor the treatment for these bacterial infections. A negative result does not preclude the presence of carbapenemase enzymes. The ability of RAPIDEC® CARBA NP to detect carbapenemase enzymes encoded by genetic markers other than KPC, NDM, OXA-48, VIM, and IMP has not been established. RAPIDEC® CARBA NP testing should be used in conjunction with other laboratory tests including antimicrobial susceptibility testing.
    Device Description
    The RAPIDEC® CARBA NP strip is composed of 5 wells prepared with premeasured portions of the necessary substrates for the reactions. In addition, the kit contains the necessary accessories for performing the test. In order to rehydrate the dry reagents and initiate the reactions, wells a, b and c are filled with 100 uL of API Suspension Medium (purified water). The strip is left at room temperature for 4-10 minutes to allow the dry reagents to reconstitute in the wells. The bacterial inoculum suspension is prepared in well c until the turbidity equals well b. Well c contains the lysis buffer. In order to achieve lysis of the inoculum suspension, which enables the extraction of the enzyme, the strip is left at room temperature for additionally 30 minutes. As the next step, 25 uL of the lysed inoculum suspension is transferred to wells d and e and 25 µL from well a (phenol red solution) is also transferred to wells d and e. The strip is incubated for 30 minutes at 33-38°C to allow for the hydrolysis to occur and change in color of the phenol red solution in case of presence of a carbapenemase enzyme. The initial reading is performed after 30 minutes of incubation. In case of a negative or doubtful reaction, the strip is re-incubated for an additional 1 hour and 30 minutes before performing the final reading. The hydrolysis acidifies the medium which results in the change in color of the pH indicator. Reading is performed by comparing the colors in wells d and e. The test is positive when a significant variation in color is observed between the two wells. For example, the control well is red and the test well has changed to yellow.
    Ask a Question

    Page 1 of 2