(325 days)
Not Found
No
The description focuses on a microdilution technique and automated reading of growth, with no mention of AI or ML algorithms for interpretation or analysis.
No.
The device is designed for antimicrobial susceptibility testing and acts as a laboratory aid to determine in vitro susceptibility to antimicrobial agents, not for direct therapeutic intervention.
Yes
The device is designed for antimicrobial susceptibility testing, which provides "a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This information is used by clinical laboratories to determine the susceptibility of clinically significant bacteria to antimicrobial agents, directly influencing treatment decisions.
No
The device description clearly details a physical AST card with wells containing antibiotics and media, which is processed by the VITEK® 2 Systems (hardware). This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states 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." This clearly indicates the device is used to test samples in vitro (outside the body) to provide information for diagnosis or treatment decisions.
- Device Description: The description details how the device works by testing bacterial isolates in a laboratory setting using culture media and antibiotics. This is a typical process for an in vitro diagnostic test.
- Clinical Laboratories: The intended user is specified as "clinical laboratories," which are the settings where IVD tests are performed.
- Performance Studies: The document describes performance studies comparing the device to a reference method (CLSI agar dilution), which is a standard practice for validating IVD devices.
- Key Metrics: The metrics reported (Essential Agreement, Category Agreement, Errors) are standard performance measures for antimicrobial susceptibility testing IVDs.
The entire context of the document points to the VITEK® 2 AST-Gram Negative Levofloxacin being a device used in a laboratory setting to analyze biological samples (bacterial isolates) to provide information about a patient's condition (susceptibility to antibiotics), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Gram Negative Levolloxacin 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 vito susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Levofloxacin is a quantitative test. Levolloxacin 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: Enterchacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens
Active in vitro but clinical significance unknown: Citrobacter freundii, Enterobacter aerogenes, Klebsiella oxytoca, Morganii, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii
VITEK® 2 AST-Gram Negative Levofloxacin also reports the susceptibility for the following additional organism as listed on the FDA Susceptibility Test Interpretive Criteria website: Salmonella spp.
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.
Product codes
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 (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 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 Levofloxacin has the following concentrations in the card: 0.25, 0.5, 2, and 8 (equivalent standard method concentration by efficacy in ug/mL).
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 VITEK® 2 AST-GN Levofloxacin by comparing its performance with the CLSI agar dilution reference method incubated between 16-20 hours. The data is representative of performance on both the VITEK 2 and VITEK® 2 Compact instrument platforms.
Summary of Performance Studies
VITEK® 2 AST-GN Levofloxacin 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).
External performance data for Levofloxacin against Enterobacterales:
Essential Agreement (EA): (345/346) 99.7%
Category Agreement (CA): (339/346) 98.0%
Very Major Error (VME): (0/76) 0.0%
Major Error (ME): (0/262) 0.0%
Minor Error (mE): (7/346) 2.0%
Reproducibility: 100%
External performance data for Levofloxacin against Pseudomonas aeruginosa:
Essential Agreement (EA): (218/225) 96.9%
Category Agreement (CA): (210/225) 93.3%
Very Major Error (VME): (0/76) 0.0%
Major Error (ME): (2/127) 1.6%
Minor Error (mE): (13/225) 5.8%
External performance data for Levofloxacin against Salmonella spp.:
Essential Agreement (EA): (47/48) 97.9%
Category Agreement (CA): (47/48) 97.9%
Very Major Error (VME): (0/4) 0.0%
Major Error (ME): (0/40) 0.0%
Minor Error (mE): (1/48) 2.1%
Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics
Essential Agreement (EA), Category Agreement (CA), Very Major Error (VME), Major Error (ME), Minor Error (mE), Reproducibility
Predicate Device(s)
VITEK® 2 AST-Gram Negative Levofloxacin (K072038)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".
June 26, 2023
bioMerieux, Inc. Esther Hernandez Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042
Re: K222378
Trade/Device Name: VITEK 2 AST-Gram Negative Levofloxacin (8 ug/mL) 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: August 4, 2022 Received: August 5, 2022
Dear Esther Hernandez:
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222378
Device Name
VITEK® 2 AST-Gram Negative Levofloxacin (50.125 - ≥8 µg/mL)
Indications for Use (Describe)
VITEK® 2 AST-Gram Negative Levolloxacin 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 vito susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Levofloxacin is a quantitative test. Levolloxacin 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: Enterchacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens
Active in vitro but clinical significance unknown: Citrobacter freundii, Enterobacter aerogenes, Klebsiella oxytoca, Morganii, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii
VITEK® 2 AST-Gram Negative Levofloxacin also reports the susceptibility for the following additional organism as listed on the FDA Susceptibility Test Interpretive Criteria website: Salmonella spp.
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.
| 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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3
510(k) SUMMARY
B.
C.
VITEK® 2 AST-GN Levofloxacin
A. 510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Esther Hernandez |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8841 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | August 4, 2022 |
| Formal/Trade Name: | VITEK® 2 AST-Gram Negative Levofloxacin (≤ |
| $0.125 -≥8$ µg/mL) | |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code LON, LTT, LTW. | |
| Common Name: | VITEK® 2 AST-GN Levofloxacin |
| Predicate Device: | VITEK® 2 AST-Gram Negative Levofloxacin |
| (K072038) |
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 (1) 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 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
4
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 Levofloxacin has the following concentrations in the card: 0.25, 0.5, 2, and 8 (equivalent standard method concentration by efficacy in ug/mL).
E. Substantial Equivalence Information
The similarities and differences of the VITEK 2 AST-GN Levofloxacin when compared to the predicate device, VITEK 2 AST-GN Levofloxacin (K072038), are described in the following table. The only difference between both devices are the Indications for Use and the breakpoints used to analyze the data performance. The below table provides the similarities and differences:
| Item | Device:
VITEK® 2 AST-GN Levofloxacin | Predicate:
VITEK® 2 AST-GN Levofloxacin
(K072038) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use | VITEK® 2 AST-Gram Negative
Levofloxacin 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 Levofloxacin is a
quantitative test. Levofloxacin has
been shown to be active against most
strains of the microorganisms listed
below, according to the FDA label
for this antimicrobial. | VITEK® 2 AST-Gram Negative
Levofloxacin 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 Levofloxacin is a
quantitative test. Levofloxacin 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:
Enterobacter cloacae
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa
Serratia marcescens | Active in vitro and in clinical
infections:
Enterobacter cloacae
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa
Serratia marcescens
Citrobacter koseri
Citrobacter freundii
Enterobacter aerogenes |
| | Active in vitro but clinical significance
unknown | |
| Citrobacter koseri
Citrobacter freundii
Enterobacter aerogenes
Klebsiella oxytoca
Morganella morganii
Pantoea agglomerans
Proteus vulgaris
Providencia rettgeri
Providencia stuartii
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. | Klebsiella oxytoca
Morganella morganii
Pantoea agglomerans
Proteus vulgaris
Providencia rettgeri
Providencia stuartii
The VITEK® 2 Antimicrobial
Susceptibility Test (AST) is intended to
for use with the VITEK® 2 and VITEK
® 2 Compact Systems for the automated
quantitative or qualitative susceptibility
testing of isolated colonies for most
clinically significant aerobic Gram-
negative bacilli, Staphylococcus spp.,
Enterococcus spp., Streptococcus
agalactiae , and S. pneumoniae . | |
| 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 Gram-negative bacilli. | Same |
| Antimicrobial Agent | Levofloxacin | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | VITEK® 2 Gram-negative Susceptibility
Test Card | Same |
| Analysis Algorithms | Discriminant Analysis | Same |
| Instrument | VITEK® 2 and VITEK® 2 Compact
Systems | Same |
| Concentrations | 0.25, 0.5, 2, 8 | Same |
| Differences | | |
| Indications for Use | VITEK® 2 AST-Gram Negative
Levofloxacin also reports the
susceptibility for the following
additional organism as listed on the
FDA Susceptibility Test Interpretive
Criteria website:
Salmonella spp. | Acinetobacter baumannii
Acinetobacter hvoffii
Enterobacter sakazakii
Pseudomonas fluorescens |
| Breakpoints | Enterobacterales : ≤0.5 (S), 1 (I), ≥2
(R)
Pseudomonas aeruginosa : ≤1 (S), 2
(I), ≥4 (R)
Salmonella spp.: ≤0.125 (S), 0.25-1
(I), ≥2 (R) | Acinetobacter : ≤2 (S), 4 (I), 8 (R)
Enterobacteriaceae : ≤2 (S), 4 (I), 8
(R)
Pseudomonas : ≤2 (S), 4 (I), 8 (R) |
5
F. Intended Use:
6
VITEK® 2 AST-Gram Negative Levofloxacin 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 Levofloxacin is a quantitative test. Levofloxacin 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:
Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens
Active in vitro but clinical significance unknown:
- Citrobacter koseri Citrobacter freundii Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Pantoea agglomerans Proteus vulgaris Providencia rettgeri Providencia stuartii
VITEK® 2 AST-Gram Negative Levofloxacin also reports the susceptibility for the following additional organism as listed on the FDA Susceptibility Test Interpretive Criteria website:
Salmonella spp.
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:
VITEK® 2 AST-GN Levofloxacin demonstrated substantially equivalent performance when compared with the CLSI agar dilution reference method, as defined in the FDA Class II
7
Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009).
The Premarket Notification (Traditional 510[k]) presents data in support of VITEK® 2 AST-GN Levotloxacin. 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 VITEK® 2 AST-GN Levofloxacin by comparing its performance with the CLSI agar dilution reference method incubated between 16-20 hours. The data is representative of performance on both the VITEK 2 and VITEK® 2 Compact instrument platforms.
VITEK® 2 AST-GN Levofloxacin demonstrated acceptable performance as presented in the table below.
| Antimicrobial | An imicrobial
Code | Antibiotic
Version | Bp1 | Comment | Essential Agreement | | | Category Agreement | | | | % Reproducibility | |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------|-----------------------------------|---------------------|-----|-----|--------------------|-------------------|---------------|----------------|-------------------|-----|
| | | | | | % Error | | | % Error | | | | | |
| | | | | | % EA | VME | ME | mE | % CA | VME | ME | mE | |
| Levofloxacin | LEV | lev02n | CLSI
(FDA) | #, E
Enterobacterales | (345/34
6) 99.7 | N/A | N/A | N/A | (339/346)
98.0 | (0/76)
0.0 | (0/262)
0.0 | (7/346)
2.0 | 100 |
| | | | | #, E
Pseudomonas
aeruginosa | (218/22
5) 96.9 | N/A | N/A | N/A | (210/225)
93.3 | (0/76)
0.0 | (2/127)
1.6 | (13/225)
5.8 | |
| | | | | #, E
Salmonella spp. | (47/48)
97.9 | N/A | N/A | N/A | (47/48)
97.9 | (0/4)
0.0 | (0/40)
0.0 | (1/48)
2.1 | |
| | VITEK 2 Levofloxacin MIC values for Escherichia coli, Klebsiella pneumoniae pneumoniae, and
Pseudomonas aeruginosa tended to be in exact agreement or at least one doubling dilution higher
when compared to the reference agar dilution method. VITEK 2 Levofloxacin MIC values for
Serratia marcescens tended to be in exact agreement or at least one doubling dilution lower when
compared to the reference agar dilution method. | | | | | | | | | | | | |
Abbreviations - Bp = breakyout comminee; EA = essental agreement; CA = category agreement; VME = Very Major Error (suscept with reference readt); ME Major Erro (resistantes until); n.E = mor Error (susceptble or resistant result with an micronation reference result, or an intermediate result with a susceptible or resistent reference result)
#=US Food and Drug Administration 510(k) cleared
CI.SI = Clinical and Laboratory Standards Insti
E = External performance data
N/A = Not applicable
Reproducibility and Quality Control demonstrated acceptable results.
H. Conclusion:
The performance data presented in this submission support a substantial equivalence decision. VITEK® 2 AST-Gram Negative Levofloxacin (≤0.125 ->8 µg/mL) is substantially equivalent to VITEK® 2 AST-Gram Negative Levofloxacin (K072038).
8
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.
-
- Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, Philadelphia, PA, 1976.