(113 days)
Not Found
No
The description focuses on a traditional microdilution technique and automated reading of growth, with no mention of AI or ML algorithms for interpretation or analysis.
No.
The device is described as an "in vitro test" used to determine the susceptibility of bacteria to antimicrobial agents, functioning as a "laboratory aid" in determining in vitro susceptibility. It does not directly treat or diagnose a disease.
Yes.
The device is intended for "antimicrobial susceptibility testing of Gram negative bacilli" as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," which directly contributes to diagnosing and guiding treatment for infections.
No
The device description explicitly details a physical card with wells containing premeasured portions of antibiotics and culture media, which is filled, sealed, and placed into a VITEK® 2 System instrument for incubation and reading. This involves significant hardware components and processes.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text explicitly states the device is "designed for antimicrobial susceptibility testing of Gram negative bacilli" and is "intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The phrase "in vitro susceptibility" is a key indicator of an IVD.
- Device Description: The description details a method for testing biological samples (bacterial isolates) outside of the body ("in vitro") to determine their susceptibility to antibiotics.
- Intended User/Care Setting: The device is intended for use in "clinical laboratories," which are typical settings for IVD testing.
- Summary of Performance Studies: The studies compare the device's performance to a "CLSI broth microdilution reference method," which is a standard in vitro diagnostic technique.
All these points strongly indicate that the VITEK® 2 AST-Gram Negative Ciprofloxacin is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Gram Negative Ciprofloxacin (≤ 0.06 -> 4 ug/mL) is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Ciprofloxacin is a quantitative test. Ciprofloxacin 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 Citrobacter Koseri Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Salmonella typhi Serratia marcescens Shigella sonnei
In vitro data available but clinical significance is unknown: Enterobacter aerogenes Klebsiella oxytoca Salmonella enteritidis
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 (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(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 poltions 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 repo1t is generated that contains the MIC value along with the interpretive categoly 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 VITEK® 2 AST-GN Ciprofloxacin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Study Type: External evaluation comparing to CLSI broth microdilution reference method.
- Sample Size: Not specified, but involved fresh and stock clinical isolates and challenge strains.
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results:
- VITEK® 2 AST-GN Ciprofloxacin demonstrated acceptable performance of 97.2% overall Essential Agreement and 95.5% overall Category Agreement with the reference method.
- Reproducibility and Quality Control demonstrated acceptable results.
- Specific performance for Enterobacteriaceae (excluding Salmonella) showed 97.9% Essential Agreement and 95.2% Category Agreement.
- Specific performance for Pseudomonas aeruginosa showed 93.6% Essential Agreement and 96.6% Category Agreement.
- Specific performance for Salmonella showed 100.0% Essential Agreement and 100.0% Category Agreement.
- VITEK® 2 Systems Ciprofloxacin MIC values for Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, Providencia stuartii, Pseudomonas aeruginosa and Salmonella species tended to be in exact ageement or at least one doubling dilution higher than the reference method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: 97.2% (overall), 97.9% (Enterobacteriaceae excluding Salmonella), 93.6% (Pseudomonas aeruginosa), 100.0% (Salmonella)
Category Agreement: 95.5% (overall), 95.2% (Enterobacteriaceae excluding Salmonella), 96.6% (Pseudomonas aeruginosa), 100.0% (Salmonella)
Reproducibility: Acceptable results.
Quality Control: Acceptable results.
VME (Very Major Error): 4.6% (Enterobacteriaceae excluding Salmonella), 0.0% (Pseudomonas aeruginosa), 0.0% (Salmonella)
ME (Major Error): Not specified for overall, N/A (Enterobacteriaceae excluding Salmonella), 3.4% (Pseudomonas aeruginosa), 0.0% (Salmonella)
mE (Minor Error): Not specified for overall, 0.4% (Enterobacteriaceae excluding Salmonella), 0.0% (Pseudomonas aeruginosa), 0.0% (Salmonella)
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.
VITEK® 2 GN Eravacycline (K191766)
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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April 14, 2022
bioMerieux, Inc Kyle Olney Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K214023
Trade/Device Name: VITEK 2 AST-Gram Negative Ciprofloxacin (4 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: December 21, 2021 Received: December 22, 2021
Dear Kyle Olney:
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, 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-GN Ciprofloxacin (≤ 0.06 -> 4 ug/mL)
Indications for Use (Describe)
VITEK® 2 AST-Gram Negative Ciprofloxacin (≤ 0.06 -> 4 ug/mL) is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Ciprofloxacin is a quantitative test. Ciprofloxacin 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 Citrobacter Koseri Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Salmonella typhi Serratia marcescens Shigella sonnei
In vitro data available but clinical significance is unknown: Enterobacter aerogenes Klebsiella oxytoca Salmonella enteritidis
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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4
Image /page/4/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 across the blue half of the circle.
VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 µg/mL) Traditional 510(k) Submission
510(k) SUMMARY
VITEK® 2 AST-GN Ciprofloxacin
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Kyle J. Olney |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8666 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | December 21, 2021 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> |
| µg/mL) | |
| Classification Name: | 21 CFR 866.1645 |
| Product Codes: | LON, LTT, and LTW |
| Common Name: | VITEK® 2 AST-GN Ciprofloxacin |
| Predicate Device: | VITEK® 2 GN Eravacycline (K191766) |
D. 510(k) Summary:
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(2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3).Ciprofloxacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
5
Image /page/5/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle that is split into two halves. The top half is blue and contains the company name "BIOMÉRIEUX" in white sans-serif font. The bottom half of the circle is a gradient of yellow and green.
VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 ug/mL) Traditional 510(k) Submission
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 poltions 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 repo1t is generated that contains the MIC value along with the interpretive categoly result for each antibiotic contained on the card.
E. Substantial Equivalence Information:
VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 µg/mL) is substantially equivalent to VITEK® 2 GN Eravacycline (K191766). A summary of the similarities VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 µg/mL) and VITEK® 2 GN Eravacycline (K191766). are provided in Table 1 below:
| New Device and
Predicate Device: | Device:
VITEK® 2 AST-GN Ciprofloxacin (0.06->4 µg/mL) | Predicate:
VITEK® 2 AST-GN Eravacycline (K191766) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Device Characteristic Similarities | | |
| Intended
Use/Indications for
Use | VITEK® 2 AST-Gram Negative
Ciprofloxacin 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 Ciprofloxacin is a
quantitative test.
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. | VITEK® 2 AST-Gram Negative Eravacycline 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 Eravacycline is a
quantitative test.
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. |
| New Device and
Predicate Device: | Device:
VITEK® 2 AST-GN Ciprofloxacin (0.06 $≥$ 4
µg/mL) | Predicate:
VITEK® 2 AST-GN Eravacycline (K191766) |
| | General Device Characteristic Similarities | |
| 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 |
| Inoculum | Saline suspension of organism | Same |
| Test Card | VITEK®2 Gram Negative Susceptibility Test Card | Same |
| Instrument | VITEK®2 and VITEK®2 Compact Systems | Same |
| Analysis Algorithms | Growth Pattern Analysis | Same |
| Differences | | |
| Antimicrobial
Agent | Ciprofloxacin | Eravacycline |
| Antimicrobial
Concentrations | 0.06, 0.12, 0.5, 1 | 0.25, 1, 2, 4 |
| Indications for
Use | Ciprofloxacin 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:
Citrobacter koseri
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella pneumoniae
Morganella morganii
Proteus mirabilis
Proteus vulgaris
Providencia rettgeri
Providencia stuartii
Pseudomonas aeruginosa
Salmonella typhi
Serratia marcescens
Shigella sonnei
In vitro data available but clinical significance is
unknown:
Klebsiella (Enterobacter) aerogenes | Eravacycline 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:
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
In vitro data are available, but clinical significance is
unknown:
Citrobacter koseri
Klebsiella (Enterobacter) aerogenes) |
Table 1: Substantial Equivalence
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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 green and yellow bottom half. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle.
VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 – ≥ 4 µg/mL)
Traditional 510(k) Submission
7
Image /page/7/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle on top of a yellow and green circle. The word "BIOMÉRIEUX" is written in white letters in the center of the blue circle.
VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 ug/mL) Traditional 510(k) Submission
| Klebsiella oxytoca | |
|---|---|
| Salmonella enteritidis |
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.
The antimicrobial presented in VITEK® 2 AST-GN Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.
Ciprofloxacin 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: Citrobacter koseri Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa
8
Image /page/8/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a circle divided into two sections. The top section is a dark blue color and contains the company name "BIOMÉRIEUX" in white, sans-serif font. The bottom section is a gradient of yellow and green.
Salmonella typhi Serratia marcescens Shigella sonnei
In vitro data available but clinical significance is unknown: Klebsiella aerogenes Klebsiella oxytoca Salmonella enteritidis
G. Performance Overview and Conclusion:
To update the VITEK 2 Gram Negative Ciprofloxacin device labeling to include updated FDArecognized breakpoints for Enterobacterales (excludes Salmonella) and Pseudomonas aeruginosa as published in the FDA STIC website. Breakpoints for Salmonella, as well as the FDA indications for use remain unchanged. Previously obtained QC and reproducibility data is applicable to this reevaluation.
VITEK® 2 AST-GN Ciprofloxacin (4 ug/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 Ciprofloxacin. 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 Ciprofloxacin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. - VITEK® 2 AST-GN Ciprofloxacin demonstrated acceptable performance of 97.2% overall Essential Agreement and 95.5% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
The VITEK® 2 AST-GN Ciprofloxacin (≤0.06 ->4 µg/mL) demonstrated acceptable performance as presented in Table 2 below:
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Image /page/9/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a circle divided into two sections. The top section is a dark blue color and contains the company name "BIOMÉRIEUX" in white, sans-serif font. The bottom section is a gradient of yellow and green.
VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 ug/mL) Traditional 510(k) Submission
100
Table 2: VITEK® 2 AST-GN Ciprofloxacin Performance Essential Agreement Category Agreement % Reproducibility % % Error Antimicrobial Antibiotic Bp1 Comment2 Antimicrobial Code Version % EA VME ME mE % CA VME ME mE CIP cip02n CLSI #, E (FDA)* Enterobacteriaceae 97.9 N/A N/A 95.2 4.6 N/A 0.4 0.1 (excluding Salmonella) #, E Ciprofloxacin 93.6 N/A N/A N/A 96.6 0.0 3.4 0.0 Pseudomonas aeruginosa #, E 100.0 0.0 N/A N/A N/A 100.0 0.0 0.0 Salmonella
- VITEK® 2 Systems Ciprofloxacin MIC values for Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, Providencia stuartii, Pseudomonas aeruginosa and Salmonella species tended to be in exact ageement or at least one doubling dilution higher than the reference method.
*For specific information regarding susceptive criteria and associated test methods and quality controls standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.
Kev:
= US Food and Drug Administration 510(k) cleared
E = External performance data
Quality Control demonstrated acceptable results.
H. References
-
- MacLowly, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic Sensitivity Testing in the Clinical laborato1y, Journal ofLaborato1y Clinical Medicine, 72:685-687, 1968.
-
- Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. CU1Tent 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.