(63 days)
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No
The device is a culture medium for antimicrobial susceptibility testing, and the description focuses on the biological and chemical aspects of the test, not computational analysis.
No.
This device is an in-vitro diagnostic (IVD) medium used to determine the susceptibility of bacteria to antimicrobial agents, not a device used for therapy.
Yes
The device is a culture medium used for "broth dilution antimicrobial susceptibility testing," which determines whether a bacterial organism is "susceptible, intermediate, or resistant to selected antimicrobial agents," indicating its role in diagnosing the effectiveness of treatments.
No
The device description clearly states it is a liquid culture medium used in tubes or microtiter trays, which are physical components, not software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "broth dilution antimicrobial susceptibility testing of Streptococcus pneumoniae" and is used "in the clinical laboratory" to determine if the organism is "susceptible, intermediate, or resistant to selected antimicrobial agents." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description further clarifies it's an "Antimicrobial Susceptibility Culture Medium used for broth dilution antimicrobial susceptibility testing." This is a classic example of an IVD used in a laboratory setting.
- Indications for Use: The indications for use reinforce its purpose in the clinical laboratory for determining antimicrobial susceptibility of a specific pathogen isolated from a patient.
- Performance Studies: The inclusion of performance studies demonstrating its accuracy and reproducibility in determining MICs against a reference method further supports its role as a diagnostic tool.
- Predicate Device: The mention of a predicate device which is also an antimicrobial susceptibility testing device (AB Biodisk Etest®) indicates that this type of product is regulated as a medical device, specifically an IVD.
Therefore, all the key elements point to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
INTENDED USE: Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood (MHLHB) is intended for use in broth dilution antimicrobial susceptibility testing of Streptococcus pneumoniae with 11 antimicrobial agents; i.e., cefaclor, cefotaxime, ceftriaxone, cefuroxime, chloramphenicol, ervthromvcin, imipenem, penicillin, tetracycline, trimethoprim/ sulfamethoxazole, and vancomycin, according to the protocol described in the Approved Standard M7-A3, "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically - Third Edition", dated 12/93, published by the National Committee for Clinical Laboratory Standards (NCCLS).
INDICATIONS FOR USE; Use of BBL® Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood is indicated when Streptococcus pneumoniae has been isolated in pure culture in the clinical laboratory, and a determination is desired as to whether the organism is susceptible, intermediate, or resistant to selected antimicrobial agents. In cases such as these, broth dilution antimicrobial susceptibility testing may be performed on BBL® Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood, using cefaclor, cefotaxime, ceftrixone, cefuroxime, chloramphenicol, erythromycin, imipenem, penicillin, tetracycline, trimethoprim/sulfamethoxazole, and vancomycin.
Product codes
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Device Description
Broth dilution antimicrobial susceptibility tests (AST) are performed by inoculating serial dilutions (usually 2-fold) of the drug in a suitable liquid medium. The test may be performed in tubes (macrodilution), usually in 1.0 ml volumes, or in microtiter trays in volumes of 0.05 to 0.1 ml. Following incubation, the tubes or wells are examined for the presence of growth (turbidity or pellet). The lowest concentration of an antimicrobial agent at which no visible growth occurs is defined as the minimal inhibitory concentration, or MIC.
The rationale for an MIC susceptibility test rather than the disc diffusion test is that it gives quantitative information. It allows the clinician to correlate the amount of antimicrobial agent required to inhibit the growth of an organism in vitro and the achievable concentrations in the blood, urine, cerebrospinal fluid or bile. Effective antimicrobial therapy, however, also depends on other factors.
Broth dilution ASTs are usually performed in cation-adjusted Mueller Hinton Broth (CAMHB). However, this medium is not satisfactory for fastidious organisms such as S. pneumoniae. CAMHB supplemented with 2 to 5% lysed horse blood is the medium recommended for susceptibility testing of S. pneumoniae.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Antimicrobial broth dilution susceptibility testing using the quality control strain recommended by NCCLS Document M7-A3, Streptococcus pneumoniae ATCC 49619, was performed in-house with cefaclor, ceftriaxone, ceftriaxone, cefuroxime, chloramphenicol, erythromycin, imipenem, penicillin, tetracycline, trimethoprim/ sulfamethoxazole, and vancomycin. Following the test procedures described in M7-A3, twenty tests with the quality control strain and microtitre panels containing the eleven antimicrobics were performed over a period of ten test days.
Reproducibility studies (3x/day for 3 days) were done at two field sites with the antimicrobics listed above against S. pneumoniae ATCC 49619 and nine (9) additional well-characterized S. pneumoniae strains. MIC interpretive standards from Table 2C of NCCLS Supplement M100-S6 were followed for each antimicrobic.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Antimicrobial broth dilution susceptibility testing: Twenty tests (quality control strain and microtitre panels containing eleven antimicrobics) over ten test days. For all eleven antimicrobics, 100% (220/220) of the MIC's fell within the expected MIC ranges published in Table 3C of NCCLS Supplement M100-S6. The standard deviation for all antimicrobics was less than 1 µg/ml.
Reproducibility studies: 3x/day for 3 days, performed at two field sites with S. pneumoniae ATCC 49619 and nine (9) additional well-characterized S. pneumoniae strains. Testing with cefaclor, cefotaxime, ceftriaxone, cefuroxime, chloramphenicol, erythromycin, imipenem, penicillin, and vancomycin resulted in 100% Essential Agreement with the NCCLS reference method. Testing with tetracycline and trimethoprim/sulfamethoxazole resulted in 99% and 98% Essential Agreement respectively with the reference method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% (220/220) of the MIC's fell within the expected MIC ranges.
Standard deviation for all antimicrobics was less than 1 µg/ml.
100% Essential Agreement with the NCCLS reference method for cefaclor, cefotaxime, ceftriaxone, cefuroxime, chloramphenicol, erythromycin, imipenem, penicillin, and vancomycin.
99% Essential Agreement for tetracycline.
98% Essential Agreement for trimethoprim/sulfamethoxazole.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AB Biodisk Etest® for Susceptibility Testing of Pneumococci (K913459)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.1700 Culture medium for antimicrobial susceptibility tests.
(a)
Identification. A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.(b)
Classification. Class II (performance standards).
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SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTED BY:
K963036 OCT -7 19
Virginia C. Weinknecht Regulatory Affairs Specialist Becton Dickinson Microbiology Systems 250 Schilling Circle Cockevsville, MD 21030-0243
NAME OF DEVICE:
| Trade Name: | Mueller Hinton II Broth (Cation-Adjusted)
with Lysed Horse Blood
Catalog Number 4320500 |
|--------------------------|-----------------------------------------------------------------------------------------------|
| Common Name/Description: | Antimicrobial Susceptibility Culture Medium |
| Classification Name: | Culture Medium for Antimicrobial
Susceptibility Tests |
| PREDICATE DEVICE: | AB Biodisk Etest® for Susceptibility Testing
of Pneumococci (K913459) |
DEVICE DESCRIPTION:
INTENDED USE: Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood (MHLHB) is intended for use in broth dilution antimicrobial susceptibility testing of Streptococcus pneumoniae with 11 antimicrobial agents; i.e., cefaclor, cefotaxime, ceftriaxone, cefuroxime, chloramphenicol, ervthromvcin, imipenem, penicillin, tetracycline, trimethoprim/ sulfamethoxazole, and vancomycin, according to the protocol described in the Approved Standard M7-A3, "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically - Third Edition", dated 12/93, published by the National Committee for Clinical Laboratory Standards (NCCLS).
INDICATIONS FOR USE; Use of BBL® Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood is indicated when Streptococcus pneumoniae has been isolated in pure culture in the clinical laboratory, and a
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determination is desired as to whether the organism is susceptible, intermediate, or resistant to selected antimicrobial agents. In cases such as these, broth dilution antimicrobial susceptibility testing may be performed on BBL® Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood, using cefaclor, cefotaxime, ceftrixone, cefuroxime, chloramphenicol, erythromycin, imipenem, penicillin, tetracycline, trimethoprim/sulfamethoxazole, and vancomycin.
PRODUCT DESCRIPTION:
The development of laboratory tests to determine the activity of antimicrobial agents has paralleled the development of these agents. Fleming used a serial dilution technique to measure the lowest concentration of penicillin that prevented growth of a test organisms in broth. Ericsson and Sherris have published an excellent review of the various methods for susceptibility testing and the relationship of dilution and diffusion methods.
Broth dilution antimicrobial susceptibility tests (AST) are performed by inoculating serial dilutions (usually 2-fold) of the drug in a suitable liquid medium. The test may be performed in tubes (macrodilution), usually in 1.0 ml volumes, or in microtiter trays in volumes of 0.05 to 0.1 ml. Following incubation, the tubes or wells are examined for the presence of growth (turbidity or pellet). The lowest concentration of an antimicrobial agent at which no visible growth occurs is defined as the minimal inhibitory concentration, or MIC.
The rationale for an MIC susceptibility test rather than the disc diffusion test is that it gives quantitative information. It allows the clinician to correlate the amount of antimicrobial agent required to inhibit the growth of an organism in vitro and the achievable concentrations in the blood, urine, cerebrospinal fluid or bile. Effective antimicrobial therapy, however, also depends on other factors.
Broth dilution ASTs are usually performed in cation-adjusted Mueller Hinton Broth (CAMHB). However, this medium is not satisfactory for fastidious organisms such as S. pneumoniae. CAMHB supplemented with 2 to 5% lysed horse blood is the medium recommended for susceptibility testing of S. pneumoniae.
Interpretive criteria for the antimicrobial susceptibility testing of S. pneumoniae are provided in the NCCLS Standard, M7-A3. This document and NCCLS Informational Supplement M100-S6 should be consulted for further details.
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PERFORMANCE DATA:
Antimicrobial broth dilution susceptibility testing using the quality control strain recommended by NCCLS Document M7-A3, Streptococcus pneumoniae ATCC 49619, was performed in-house with cefaclor, ceftriaxone, ceftriaxone, cefuroxime, chloramphenicol, erythromycin, imipenem, penicillin, tetracycline, trimethoprim/ sulfamethoxazole, and vancomycin. Following the test procedures described in M7-A3, twenty tests with the quality control strain and microtitre panels containing the eleven antimicrobics were performed over a period of ten test days. For all eleven antimicrobics, 100% (220/220) of the MIC's fell within the expected MIC ranges published in Table 3C of NCCLS Supplement M100-S6. The standard deviation for all antimicrobics was less than 1 µg/ml.
Reproducibility studies (3x/day for 3 days) were done at two field sites with the antimicrobics listed above against S. pneumoniae ATCC 49619 and nine (9) additional well-characterized S. pneumoniae strains. MIC interpretive standards from Table 2C of NCCLS Supplement M100-S6 were followed for each antimicrobic. Testing with cefaclor, cefotaxime, ceftriaxone, cefuroxime, chloramphenicol, erythromycin, imipenem, penicillin, and vancomycin resulted in 100% Essential Agreement with the NCCLS reference method. Testing with tetracycline and trimethoprim/sulfamethoxazole resulted in 99% and 98% Essential Agreement respectively with the reference method.
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