(315 days)
Not Found
No
The description focuses on a microdilution technique and automated monitoring of bacterial growth, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as an "in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents." It is a laboratory aid for determining susceptibility, not a device that directly treats or prevents disease.
Yes
The device is designed for "antimicrobial susceptibility testing" and provides "in vitro susceptibility to antimicrobial agents," which are diagnostic functions. It also acts as a "laboratory aid in the determination of in vitro susceptibility."
No
The device description clearly details a physical card with wells containing antibiotics and culture media, which is a hardware component. The system also involves automated or manual filling, sealing, and incubation, indicating a hardware system is integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "designed for antimicrobial susceptibility testing of Gram positive microorganisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The phrase "in vitro susceptibility" is a key indicator of an IVD.
- Device Description: The description details a test performed on a sample (microorganism isolate) outside of the body, using a specific card containing reagents (antibiotics and culture media) to determine a characteristic of the sample (susceptibility to antibiotics). This aligns with the definition of an in vitro diagnostic test.
- Care Setting: The intended user is in "clinical laboratories," which are typical settings for performing IVD tests.
- Performance Studies: The performance studies compare the device's results to a reference method for determining susceptibility, further confirming its role as a diagnostic test performed in vitro.
The entire description points to a device used to analyze a biological sample (microorganisms) outside of the body to provide information for diagnosis or treatment decisions (determining susceptibility to antibiotics). This is the core function of an IVD.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Gram Positive Moxifloxacin is designed for antimicrobial susceptibility testing of Gram positive microorganisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Positive Moxifloxacin is a quantitative test. Moxifloxacin has been shown to be active against most strains of the microorganisms listed below. according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections: Enterococcus faecalis Staphylococcus aureus
In vitro data are available, but their clinical significance is unknown: Staphylococcus epidermidis
The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
Product codes (comma separated list FDA assigned to the subject device)
LON, LTT, LTW
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"clinical laboratories"
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of AST-GP Moxifloxacin by comparing its performance with the CLSI agar dilution reference method incubated at 16-20 hours.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GP Moxifloxacin. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of AST-GP Moxifloxacin by comparing its performance with the CLSI agar dilution reference method incubated at 16-20 hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. The VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) demonstrated acceptable performance. The VITEK 2 AST-GP Moxifloxacin MIC values tended to be in exact agreement or at least one doubling dilution higher when testing Enterococcus faecalis and Staphylococcus aureus compared to the CLSI reference agar dilution method. Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement:
Enterococcus faecalis: 98.7%
Staphylococcus spp.: 94.9%
Category Agreement:
Enterococcus faecalis: 99.4%
Staphylococcus spp.: 99.4%
Very Major Error (VME):
Enterococcus faecalis: 0.0%
Staphylococcus spp.: 4.8%
Major Error (ME):
Enterococcus faecalis: 0.6%
Staphylococcus spp.: 0.7%
Minor Error (mE):
Enterococcus faecalis: 0.0%
Staphylococcus spp.: 0.0%
Reproducibility:
Enterococcus faecalis: 100.0%
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 27, 2023
bioMerieux, Inc Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K220803
Trade/Device Name: VITEK 2 AST-Gram Positive Moxifloxacin (≤0.25 - ≥ 8 µg/ml), VITEK 2 AST-GP Moxifloxacin (≤ 0.25 - ≥ 8 µg/mL), VITEK 2 AST-GP Moxifloxacin Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, LTT, LTW Dated: March 17, 2022 Received: March 18, 2022
Dear Cherece Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
VITEK® 2 AST-GP Moxifloxacin (8 ug/mL)
Indications for Use (Describe)
VITEK® 2 AST-Gram Positive Moxifloxacin is designed for antimicrobial susceptibility testing of Gram positive microorganisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Positive Moxifloxacin is a quantitative test. Moxifloxacin has been shown to be active against most strains of the microorganisms listed below. according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections: Enterococcus faecalis Staphylococcus aureus
In vitro data are available, but their clinical significance is unknown: Staphylococcus epidermidis
The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
VITEK® 2 AST Gram-Positive Moxifloxacin (≤0.25 - ≥8 µg/mL)
A. 510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Cherece L. Jones |
| Staff Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8684 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | March 16, 2022 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST Gram-Positive Moxifloxacin (≤0.25 - ≥8 |
| µg/mL) | |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code(s): | LON, LTT, LTW |
| Common Name: | VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) |
| Predicate Device: | VITEK® 2 AST- GP Moxifloxacin (≤0.25 - ≥8 µg/mL) |
| (K032399) |
D. Device Description:
B.
C.
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).
4
Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with the top half being dark blue and the bottom half being yellow-green. The company name, BIOMÉRIEUX, is written in white, sans-serif font in the center of the blue portion of the circle.
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 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.
E. Substantial Equivalence Information:
VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) is substantially equivalent to VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) (K032399). A summary of the similarities and differences of the VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) and VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) (K032399) are provided in Table 1 below:
| Table 1: Substantial Equivalence | ||
|---|---|---|
| New Device and Predicate Device: | New Device: | |
| VITEK® 2 AST-GP Moxifloxacin | ||
| (≤0.25 - ≥8 µg/mL) | Predicate Device: | |
| VITEK® 2 AST-GP Moxifloxacin | ||
| (≤0.25 - ≥8 µg/mL) (K032399) | ||
| General Device Characteristic Similarities | ||
| Intended | ||
| Use/Indications for Use | VITEK® 2 AST-Gram Positive | |
| Moxifloxacin is designed for | ||
| antimicrobial susceptibility testing of | ||
| Gram positive microorganisms and is | ||
| intended for use with the VITEK® 2 | ||
| and VITEK® 2 Compact Systems as | ||
| a laboratory aid in the determination | ||
| of in vitro susceptibility to | ||
| antimicrobial agents. VITEK® 2 | ||
| AST-Gram Positive Moxifloxacin is | ||
| a quantitative test. Moxifloxacin has | ||
| been shown to be active against most | ||
| strains of the microorganisms listed | ||
| below, according to the FDA label | ||
| for this antimicrobial. |
Active both in vitro and in clinical
infections:
Enterococcus faecalis | VITEK 2® Gram Positive
Moxifloxacin is designed for
antimicrobial susceptibility testing of
Staphylococcus aureus (methicillin-
susceptible strains only). It is intended
for use with the VITEK 2® System as
a laboratory aid in the determination
of in vitro susceptibility to
antimicrobial agents.
The VITEK® 2 Gram Positive
Susceptibility Card is intended for use
with the VITEK® 2 System in clinical
laboratories as an in vitro test to
determine the susceptibility of
Staphylococcus spp., Enterococcus
spp., and S. agalactiae to
antimicrobial agents when used as
instructed in the Online Product |
Table 1: Substantial Equivalonco
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| New Device and
Predicate Device: | New Device:
VITEK® 2 AST-GP Moxifloxacin
(≤0.25 - ≥8 µg/mL) | Predicate Device:
VITEK® 2 AST-GP Moxifloxacin
(≤0.25 - ≥8 µg/mL) (K032399) |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| General Device Characteristic Similarities | | |
| | Staphylococcus aureus | Information. |
| | In vitro data are available, but their
clinical significance is unknown:
Staphylococcus epidermidis | |
| | The VITEK® 2 Gram-positive
Susceptibility Card is intended for
use with the VITEK® 2 Systems in
clinical laboratories as an in vitro test
to determine the susceptibility of
Staphylococcus spp., Enterococcus
spp., and S. agalactiae to
antimicrobial agents when used as
instructed. | |
| Test Methodology | Automated quantitative antimicrobial
susceptibility test for use with the
VITEK® 2 and VITEK® 2 Compact
Systems to determine the in vitro
susceptibility of microorganisms | Same |
| Antimicrobial Agent | Moxifloxacin | Same |
| Concentrations | 0.25, 2, and 8 | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | Gram-Positive (AST-GP)
Susceptibility Card | Same |
| Analysis Algorithms | Discriminant Analysis | Same |
| Instrument | VITEK® 2 and VITEK® 2 Compact
Systems | Same |
| General Device Characteristic Differences | | |
| Breakpoints | Enterococcus faecalis
S ≤ 1, I 2, ≥ 4R
Staphylococcus spp.
S ≤ 0.5, I 1, ≥ 2R | Staphylococcus spp.
S ≤ 2, I 4, ≥ 8R |
F. Intended Use:
VITEK® 2 AST-Gram Positive Moxifloxacin is designed for antimicrobial susceptibility testing of Gram positive microorganisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Positive Moxifloxacin is a quantitative test.
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Moxifloxacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections: Enterococcus faecalis Staphylococcus aureus
In vitro data are available, but their clinical significance is unknown: Staphylococcus epidermidis
The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
G. Performance Overview and Conclusion:
VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 ug/mL) demonstrated substantially equivalent performance when compared with the CLSI agar dilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems: Guidance for Industry and FDA (Issued August 28, 2009).
The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GP Moxifloxacin. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of AST-GP Moxifloxacin by comparing its performance with the CLSI agar dilution reference method incubated at 16-20 hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
The VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) demonstrated acceptable performance as presented in Table 2 below:
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Essential Agreement Catego Antimicrob Category Agreement Antimicrob Code Reprodu al cibility % Error % Error %EA VME ME %CA VME ME mE mE (mxf02n) FDA Moxifloxacir MXF #, E (CLSI) (152/154) (153/154) (0/43) (0/110) (1/154) N/A N/A Enterococcus N/A 98.7 99.4 0.0 0.0 0.6 faecalis 100.0 #. E (329/331) (314/331) (1/152) (0/163) (16/331) Staphylococcus N/A N/A N/A 94.9 4.8 99.4 0.7 0.0 spp The VITEK 2 AST-GP Moxifloxacin MIC values tended to be in exact agreement or at least one doubling dilution higher when testing Enterococcus faecalis and Staphylococcus aureus compared to the CLSI reference agar dilution method.
Key:
#= US Food and Drug Administration 510(k) cleared
E = External performance data
Quality Control demonstrated acceptable results. ●
| Table 3: CLSI® Quality Control Organisms VITEK® 2 Results | ||||||
|---|---|---|---|---|---|---|
| Antimicrobic | Code | E. faecalis | ||||
| ATCC® | ||||||
| 29212™ | S. aureus | |||||
| ATCC® | ||||||
| 29213™ | ||||||
| Moxifloxacin | mxf02n | ≤ 0.25 - 0.5⁰ | ||||
| (FDA/CLSI QC | ||||||
| range is 0.06 – | ||||||
| 0.5) | ≤ 0.25⁰ | |||||
| (FDA/CLSI QC | ||||||
| range is 0.03- | ||||||
| 0.12 ug/mL) |
Numerical values are expressed in µg/mL.
^ Does not include the full CLSI/FDA-recommended dilution range for QC testing with this organism.
H. References:
-
- MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic Sensitivity Testing in the Clinical laboratory, Journal of Laboratory Clinical Medicine, 72:685-687, 1968.
-
- Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. Current Techniques for Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL, 1974.
TTEK® 2 AST-GP Moxifloxacin Performance
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-
- Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, Philadelphia, PA, 1976.