(90 days)
Not Found
No
The device description and performance studies focus on a microdilution technique and comparison to a reference method, with no mention of AI or ML.
No.
This device is an in vitro diagnostic test for antimicrobial susceptibility, providing information to aid in determining treatment but not directly treating a condition.
Yes
Explanation: The VITEK® 2 AST-Gram Negative Plazomicin is designed for "antimicrobial susceptibility testing" to determine "in vitro susceptibility to antimicrobial agents" and is intended for use in "clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic bacilli to antimicrobial agents." This information is used to guide treatment decisions, which directly aligns with the definition of a diagnostic device.
No
The device description clearly outlines a physical AST card with wells containing premeasured antibiotic and culture media, which is a hardware component. The system also involves automated or manual filling, sealing, and incubation, indicating a significant hardware element.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "designed for antimicrobial susceptibility testing of Gram negative bacilli" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a test performed on a sample (bacterial isolate) outside of the body, using a specific card containing culture media and antibiotics. This is characteristic of an in vitro test.
- Clinical Laboratories: The "Intended User / Care Setting" is listed as "clinical laboratories," which are the typical settings where IVD tests are performed.
- Performance Studies: The description of performance studies mentions testing "clinical isolates," further confirming the use of the device on samples derived from patients.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Gram Negative Plazomicin is designed for antimicrobial susceptibility testing of Gram negative bacilli 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 Negative Plazomicin is a quantitative test. Plazomicin 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: Escherichia coli Klebsiella pneumoniae Enterobacter cloacae
In vitro data are available, but their clinical significance is unknown:
Citrobacter freundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Proteus vulgaris Serratia marcescens
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 clinicaly significant aerobic bacilli 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(4) and Gerlach(2). 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-GN Plazomicin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-24 hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL) demonstrated substantially equivalent performance when compared with the CLSI Broth Microdilution 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 VITEK® 2 AST-GN Plazomicin MIC values tended to be in exact agreement or at least one doubling dilution lower when testing E. coli, and S. marcescens compared to the CLSI reference broth microdilution.
The VITEK® 2 AST-GN Plazomicin MIC values tended to be one doubling dilution higher when testing K. pneumoniae compared to the CLSI reference broth microdilution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: (847/858) 98.7%
Category Agreement: (853/858) 99.4%
Very Major Error (VME): (0/57) 0.0%
Major Error (ME): (1/797) 0.1%
Minor Error (mE): (4/858) 0.5%
Reproducibility: 97.0%
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
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February 16, 2023
bioMerieux, Inc Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K223478
Trade/Device Name: VITEK 2 AST-Gram Negative Plazomicin (16 µg/mL); VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL); VITEK 2 AST-GN Plazomicin 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: November 17, 2022 Received: November 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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) Branch Chief. General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K223478
Device Name
VITEK® 2 AST-GN Plazomicin (16 ug/mL)
Indications for Use (Describe)
VITEK® 2 AST-Gram Negative Plazomicin is designed for antimicrobial susceptibility testing of Gram negative bacilli 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 Negative Plazomicin is a quantitative test. Plazomicin 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: Escherichia coli Klebsiella pneumoniae Enterobacter cloacae
In vitro data are available, but their clinical significance is unknown:
Citrobacter freundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Proteus vulgaris Serratia marcescens
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 clinicaly significant aerobic bacilli 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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Image /page/3/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a gradient bottom half that transitions from yellow to green. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue portion of the circle.
510(k) SUMMARY
VITEK® 2 AST-Gram Negative Plazomicin (≤0.5 - ≥16 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: | November 17, 2022 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Gram Negative Plazomicin (≤0.5 - ≥16 |
| 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-GN Plazomicin (≤0.5 - ≥16 µg/mL) |
| C. Predicate Device: | VITEK® 2 AST-GN Gentamicin (≤ 1 –≥16 µg/mL) |
| (K163563) |
D. 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(4) and Gerlach(2). 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, a French multinational biotechnology company. The logo is a circle divided into two sections. The top half of the circle is dark blue, and the bottom half transitions from yellow to green. The company name, "BIOMÉRIEUX", is written in white, sans-serif font in the center of the blue section.
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-GN Plazomicin (16 ug/mL) is substantially equivalent to VITEK® 2 AST-GN Gentamicin (≤ 1 - ≥16 ug/mL) (K163563). A summary of the similarities and differences of the VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL) and VITEK® 2 AST-GN Gentamicin (≤ 1 ->16 ug/mL) (K163563) are provided in Table 1 below:
| New Device and
Predicate Device: | New Device:
VITEK® 2 AST-Gram Negative
Plazomicin ( $\le 0.5 - \ge 16$ µg/mL) | Predicate Device:
VITEK® 2 AST-GN Gentamicin
( $\le 1 - \ge 16$ µg/mL) (K163563) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Device Characteristic Similarities | | |
| Intended Use | 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 significant aerobic Gram-
negative bacilli to antimicrobial
agents when used as instructed. | The VITEK® 2 Antimicrobial
Susceptibility Test (AST) is intended
to be used with the VITEK® 2 Systems
for the automated quantitative or
qualitative susceptibility testing of
isolated colonies for the most
clinically significant aerobic gram-
negative bacilli, Staphylococcus spp.,
Enterococcus spp., Streptococcus spp.
and clinically significant yeast. |
| 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 |
| Inoculum | Saline suspension of organism | Same |
| Test Card | Gram-Negative (AST-GN) | Same |
| New Device and Predicate Device: | New Device:
VITEK® 2 AST-Gram Negative
Plazomicin (≤0.5 - ≥16 µg/mL) | Predicate Device:
VITEK® 2 AST-GN Gentamicin
(≤1–≥16 µg/mL) (K163563) |
| | Susceptibility Card | |
| Analysis Algorithms | Growth Pattern Analysis (GPA) | Same |
| Instrument | VITEK® 2 and VITEK® 2 Compact Systems | Same |
| General Device Characteristic Differences | | |
| Indications for Use | VITEK® 2 AST-Gram Negative
Plazomicin is designed for
antimicrobial susceptibility testing of
Gram negative bacilli 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
Negative Plazomicin is a quantitative
test. Plazomicin has been shown to
be active against most strains of the
microorganisms listed below,
according to the FDA label for this
antimicrobial. | VITEK® 2 Gram Negative Gentamicin
is designed for antimicrobial
susceptibility testing of Gram negative
bacilli 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
Gram Negative Gentamicin is a
quantitative test. Gentamicin 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:
Escherichia coli
Klebsiella pneumoniae
Enterobacter cloacae | Active in vitro and in clinical
infections
Citrobacter species
Enterobacter species
Escherichia coli
Klebsiella species
Proteus species
Serratia species
Pseudomonas aeruginosa |
| | In vitro data are available, but their
clinical significance is unknown:
Citrobacter freundii
Citrobacter koseri
Klebsiella (Enterobacter) aerogenes
Klebsiella oxytoca
Proteus vulgaris
Serratia marcescens | |
| | 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 significant aerobic Gram-
negative bacilli to antimicrobial | The VITEK® 2 Antimicrobial
Susceptibility Test (AST) is intended
to be used with the VITEK® 2 Systems
for the automated quantitative or
qualitative susceptibility testing of
isolated colonies for the most
clinically significant aerobic gram-
negative bacilli, Staphylococcus spp.,
Enterococcus spp., Streptococcus spp.
and clinically significant yeast. |
Table 1: Substantial Equivalence
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Image /page/5/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle divided into two halves. The top half is a dark blue color, and the bottom half is a gradient of yellow and green. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle.
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Image /page/6/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a yellow-green bottom half. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue half of the circle.
| New Device and
Predicate Device: | New Device:
VITEK® 2 AST-Gram Negative
Plazomicin (≤0.5 - ≥16 µg/mL) | Predicate Device:
VITEK® 2 AST-GN Gentamicin
(≤ 1 –≥16 µg/mL) (K163563) |
|-------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| | agents when used as instructed. | |
| Antimicrobial Agent | Plazomicin | Gentamicin |
| Concentrations | 2, 4, 8 µg/mL | 4, 8, 32 µg/mL |
F. Intended Use:
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 significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.
G. Performance Overview and Conclusion:
VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL) demonstrated substantially equivalent performance when compared with the CLSI Broth Microdilution 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-GN Plazomicin (≤0.5 - >16 ug/mL). 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-GN Plazomicin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-24 hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
The VITEK® 2 AST-GN Plazomicin (16 µg/mL) demonstrated acceptable performance as presented in Table 2 below:
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Image /page/7/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a green bottom half. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle.
Table 2: VITEK® 2 AST-GN Plazomicin Performance
| Antimicrobi
al | Antimicrobial
Code | Antibiotic
Version | Bp1 | Comment | Essential Agreement Category
% Error | | | | Category Agreement
% Error | | | | %
Reprodu
cibility |
|-------------------|-----------------------|-----------------------|---------------|----------------------------|-----------------------------------------|-----|-----|-----|-------------------------------|---------------|----------------|----------------|--------------------------|
| | | | | | %EA | VME | ME | mE | %CA | VME | ME | mE | |
| Plazomicin | PLZ | (plz01n) | FDA
(CLSI) | #, E
Enterobacteriaceae | (847/858)
98.7 | N/A | N/A | N/A | (853/858)
99.4 | (0/57)
0.0 | (1/797)
0.1 | (4/858)
0.5 | 97.0 |
The VITEK® 2 AST-GN Plazomicin MIC values tended to be in exact agreement or at least one doubling dilution lower when testing E. coli, and S. marcescens compared to the CLSI reference broth microdilution.
The VITEK® 2 AST-GN Plazomicin MIC values tended to be one doubling dilution higher when testing K. pneumoniae compared to the CLSI reference broth microdilution.
1 Abbreviations - Bp = breakpoint committee; EA = essential agreement; CA = category agreement; VME = Very Major Error (susceptible result with resistant reference result); ME = Major Error (resistant with susceptible reference result); mE = minor Error (susceptible or resistant result with an intermediate reference result, or an intermediate result with a susceptible or resistant reference result).
Key: # = US Food and Drug Administration 510(k) cleared
E = External performance data
H. Quality Control:
| CLSI® Quality Control Organisms VITEK® 2 Results | |||
|---|---|---|---|
| Antimicrobic | Code | E. coli | |
| ATCC® 25922™ | P. aeruginosa | ||
| ATCC® 27853™ | |||
| Plazomicin | plz01n | ≤0.5 - 2*◊ | |
| (*FDA/CLSI broth dilution expected | |||
| QC range = 0.25 – 2 μg/mL) | 1 - 4 |
Numerical values are expressed in ug/mL
· Does not include the full CLSI/FDA-recommended dilution range for QC testing with this organism.
Results for the VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL) were within the expected QC results range >95% of the time for both dilution options of the VITEK® 2 and manual dilution on the VITEK® 2 Compact.
I. Limitations:
Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combination(s):
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Image /page/8/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle with a blue upper half and a yellow-green lower half. The company name, "BIOMÉRIEUX", is written in white, sans-serif font in the blue portion of the circle.
-
Plazomicin (plz01n): Morganella morganii, Proteus mirabilis, Providencia stuartii ●
The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing: -
Plazomicin (plz01n): Citrobacter freundii, Citrobacter koseri, Klebsiella (Enterobacter) aerogenes, Klebsiella oxytoca, Proteus vulgaris, and Serratia marcescens
J. 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 2. Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL, 1974.
- Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, 3. Philadelphia, PA, 1976.