(306 days)
Not Found
No
The description focuses on a traditional microdilution technique and automated reading of growth, with no mention of AI or ML in the device description, performance studies, or key metrics.
No
This device is an in vitro diagnostic (IVD) device used to determine antimicrobial susceptibility, which aids in treatment decisions but does not directly provide therapy.
Yes
Explanation: The device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents" and is used "as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents." This indicates its role in providing information for diagnostic purposes, specifically in identifying effective treatments based on susceptibility.
No
The device description clearly details a physical card with wells containing premeasured portions of antibiotic and culture media, which is a hardware component. The system also involves automated or manual filling, sealing, and incubation, indicating a hardware-dependent process.
Based on the provided information, 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 "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" is a key indicator of an IVD. It also mentions being used "in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents".
- Device Description: The description details a test performed on a sample (bacterial isolate) outside of the body, using a specific card with premeasured reagents to determine susceptibility. This aligns with the definition of an in vitro test.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard laboratory technique for in vitro susceptibility testing. The metrics reported (Essential Agreement, Category Agreement, Errors) are typical for evaluating the performance of IVDs used for antimicrobial susceptibility testing.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K191766) indicates that this device is being compared to a previously cleared medical device, which is a common process for IVDs seeking regulatory approval.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Gram Negative Ceftazidime 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 test. Ceftazidime 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 species Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia species
In vitro data are available, but clinical significance is unknown:
Acinetobacter species Citrobacter koseri (formerly Citrobacter diversus) Citrobacter freundii Providencia species (including Providencia rettgeri) Salmonella species Shigella species Yersinia enterocolitica
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(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 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 Ceftazidime (≤0.5 - ≥32 ug/mL) has the following concentrations in the card: 1, 2. 4. 8. and 32ug/mL (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 Ceftazidime 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)
The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GN Ceftazidime. 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 Ceftazidime 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.
The VITEK® 2 AST-GN Ceftazidime demonstrated acceptable performance as presented in Table 2.
For Ceftazidime (Overall): Essential Agreement 96.3% (1054/1095), Category Agreement 97.0% (1062/1095), VME 3.9% (9/228), ME 0.7% (6/863), mE 1.6% (18/1095), Reproducibility 97.04%.
For Enterobacteriaceae: Essential Agreement 97.9% (592/605), Category Agreement 97.7% (591/605), VME 0.0% (0/46), ME 0.5% (3/557), mE 1.8% (11/605).
For Pseudomonas aeruginosa: Essential Agreement 94.6% (400/423), Category Agreement 97.2% (411/423), VME 5.8% (9/155)*, ME 1.1% (3/268).
For Acinetobacter spp.: Essential Agreement 93.1% (54/58), Category Agreement 89.7% (52/58), VME 0.0% (0/25), ME 0.0% (0/33), mE 10.3% (6/58).
- The overall categorical very major error rate for Ceftazidime when testing Pseudomonas aeruginosa with the VITEK ®2 system was 5.8% (9/155). The MIC values of five of the nine very major errors were one doubling dilution from the MIC value obtained from the reference method. Based on the essential agreement and lack of an intermediate breakpoint for ceftazidime with P. aeruginosa, the adjusted very major error rate for P. aeruginosa is 2.6% (4/155). Seven of the nine very major errors had MIC values of 8 µg/mL; therefore, alternative testing is required prior to reporting results for P. aeruginosa when the VITEK® 2 MIC value is 8 µg/mL.
VITEK® 2 AST-Gram Negative Ceftazidime values tended to be in exact agreement or at least one doubling dilution lower when testing Yersinia enterocolitica compared to the CLSI reference broth microdilution.
A limited number of Acinetobacter isolates were available for testing with the manual dilution. Of the 18 isolates tested, 8 had MIC values that were not evaluable for essential agreement. Of the 10 evaluable MIC values, there were 2 minor categorical errors that were not in essential agreement.
Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement, Category Agreement, VME (Very Major Error), ME (Major Error), mE (minor Error), Reproducibility
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 AST-GN Eravacycline (≤0.12 - ≥4 µg/mL) (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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the U.S. Department of Health & Human Services. To the right of that is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo is in blue and white.
December 15, 2020
BioMerieux, Inc. Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K193299
Trade/Device Name: VITEK 2 AST-Gram Negative Ceftazidime (≤0.5 - ≥32 µg/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
Dear Cherece Jones:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 28, 2020. Specifically, FDA is updating this SE Letter (i.e., correct inaccuracies in the Indications for Use form, 510(k) Summary, and device labeling) as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ribhi Shawar, Ph.D., OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-6698, Ribhi.Shawar@fda.hhs.gov.
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
1
Image /page/1/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, 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.
September 28, 2020
bioMérieux, Inc. Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K193299
Trade/Device Name: VITEK 2 AST-Gram Negative Ceftazidime (≤0.5 - ≥32 µg/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: November 26, 2019 Received: November 27, 2019
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/cfpmp/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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
2
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) 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
3
Indications for Use
510(k) Number (if known)
Device Name
VITEK® 2 AST-Gram Negative Ceftazidime (≤ 0.5 - ≥ 32 µg/mL)
Indications for Use (Describe)
VITEK® 2 AST-Gram Negative Ceftazidime 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 test. Ceftazidime 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 species Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia species
In vitro data are available, but clinical significance is unknown:
Acinetobacter species Citrobacter koseri (formerly Citrobacter diversus) Citrobacter freundii Providencia species (including Providencia rettgeri) Salmonella species Shigella species Yersinia enterocolitica
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)
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
B.
C.
VITEK® 2 AST-Gram Negative Ceftazidime (≤0.5 - ≥32 µg/mL)
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 26, 2019 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Gram Negative Ceftazidime (≤0.5 - ≥32 |
| µg/mL) | |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code: LON | |
| Common Name: | VITEK® 2 AST-GN Ceftazidime (≤0.5 - ≥32 µg/mL) |
| Predicate Device: | VITEK® 2 AST-GN Eravacycline (≤0.12 - ≥4 |
| µg/mL) (K191766) |
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(0). The VITEK @2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3).
5
Image /page/5/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a yellow-green gradient bottom half. The word "BIOMÉRIEUX" is written in white letters in 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 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 Ceftazidime (≤0.5 - ≥32 ug/mL) has the following concentrations in the card: 1, 2. 4. 8. and 32ug/mL (equivalent standard method concentration by efficacy in ug/mL).
E. Substantial Equivalence Information:
The similarities and differences of the VITEK® 2 AST-GN Ceftazidime (≤0.5 - ≥32 µg/mL) when compared to the predicate device, VITEK® 2 AST-GN Eravacycline ( ≤ 0.12 –> 4 µg/mL), are described in the Table 1 below.
| Table 1: Substantial Equivalence | ||
|---|---|---|
| Item | Device: | |
| VITEK® 2 AST-Gram Negative | ||
| Ceftazidime | ||
| ( $\leq$ 0.5 - $\geq$ 32 µg/mL) | Predicate: | |
| VITEK® 2 AST-GN Eravacycline | ||
| ( $\leq$ 0.12 - $\geq$ 4 µg/mL) | ||
| (K191766) | ||
| Intended Use | VITEK® 2 AST-Gram Negative | |
| Ceftazidime 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 Ceftazidime is a | ||
| quantitative test. Ceftazidime 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 species
Enterobacter species
Escherichia coli | 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. 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 |
| Item | Device:
VITEK® 2 AST-Gram Negative
Ceftazidime
(≤0.5 - ≥32 µg/mL) | Predicate:
VITEK® 2 AST-GN Eravacycline
( ≤ 0.12 – ≥ 4 µg/mL)
(K191766) |
| Similarities | | |
| | Klebsiella species | Klebsiella oxytoca |
| | Proteus mirabilis | Klebsiella pneumoniae |
| | Proteus vulgaris | |
| | Pseudomonas aeruginosa | In vitro data are available, but |
| | Serratia species | clinical significance is unknown: |
| | | Citrobacter koseri |
| | In vitro data are available, but | Klebsiella (Enterobacter) aerogenes |
| | clinical significance is unknown: | |
| | Acinetobacter species | The VITEK® 2 Gram-Negative |
| | Citrobacter koseri (formerly | Susceptibility Card is intended for use |
| | Citrobacter diversus) | with the VITEK® 2 Systems in clinical |
| | Citrobacter freundii | laboratories as an in vitro test to |
| | Providencia species (including | determine the susceptibility of |
| | Providencia rettgeri) | clinically significant aerobic Gram- |
| | Salmonella species | negative bacilli to antimicrobial agents |
| | Shigella species | when used as instructed. |
| | Yersinia enterocolitica | |
| | 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. | |
| 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)
Susceptibility Card | Same |
| Analysis Algorithms | Growth Pattern Analysis | Same |
| Instrument | VITEK® 2 and VITEK® 2 Compact
Systems | Same |
| Differences | | |
| Antimicrobial Agent | Ceftazidime | Eravacycline |
Table 1: Substantial Equivalence
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F. Intended Use:
VITEK® 2 AST-Gram Negative Ceftazidime 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 Ceftazidime is a quantitative test. Ceftazidime 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 species Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia species
In vitro data are available, but clinical significance is unknown:
Acinetobacter species Citrobacter koseri (formerly Citrobacter diversus) Citrobacter freundii Providencia species (including Providencia rettgeri) Salmonella species Shigella species Yersinia enterocolitica
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 Ceftazidime 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).
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The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GN Ceftazidime. 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 Ceftazidime 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.
The VITEK® 2 AST-GN Ceftazidime demonstrated acceptable performance as presented in Table 2 below:
| Antimicrobial | Comment | Essential Agreement Category | Category Agreement | % Reproducibility | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| % Error | % Error | |||||||||
| %EA | VME | ME | mE | %CA | VME | ME | mE | |||
| Ceftazidime | #, E | |||||||||
| (Overall) | (1054/1095) | |||||||||
| 96.3 | N/A | N/A | N/A | (1062/1095) | ||||||
| 97.0 | (9/228) | |||||||||
| 3.9 | (6/863) | |||||||||
| 0.7 | (18/1095) | |||||||||
| 1.6 | 97.04 | |||||||||
| #, E | ||||||||||
| Enterobacteri | ||||||||||
| aceae | (592/605) | |||||||||
| 97.9 | N/A | N/A | N/A | (591/605) | ||||||
| 97.7 | (0/46) | |||||||||
| 0.0 | (3/557) | |||||||||
| 0.5 | (11/605) | |||||||||
| 1.8 | ||||||||||
| #,E | ||||||||||
| Pseudomonas | ||||||||||
| aeruginosa | (400/423) | |||||||||
| 94.6 | N/A | N/A | N/A | (411/423) | ||||||
| 97.2 | (9/155) | |||||||||
| 5.8* | (3/268) | |||||||||
| 1.1 | N/A | |||||||||
| #, E | ||||||||||
| Acinetobacter | ||||||||||
| spp. | (54/58) | |||||||||
| 93.1 | N/A | N/A | N/A | (52/58) | ||||||
| 89.7 | (0/25) | |||||||||
| 0.0 | (0/33) | |||||||||
| 0.0 | (6/58) | |||||||||
| 10.3 | ||||||||||
| * The overall categorical very major error rate for Ceftazidime when testing Pseudomonas aeruginosa with the VITEK ®2 system | ||||||||||
| was 5.8% (9/155). The MIC values of five of the nine very major errors were one doubling dilution from the MIC value obtained | ||||||||||
| from the reference method. Based on the essential agreement and lack of an intermediate breakpoint for ceftazidime with P. | ||||||||||
| aeruginosa, the adjusted very major error rate for P. aeruginosa is 2.6% (4/155). Seven of the nine very major errors had MIC | ||||||||||
| values of 8 µg/mL; therefore, alternative testing is required prior to reporting results for P. aeruginosa when the VITEK® 2 MIC | ||||||||||
| value is 8 µg/mL. |
NOTES:
VITEK® 2 AST-Gram Negative Ceftazidime values tended to be in exact agreement or at least one doubling dilution lower when
testing Yersinia enterocolitica compared to the CLSI reference broth microdilution.
A limited number of Acinetobacter isolates were available for testing with the manual dilution. Of the 18 isolates tested, 8 had MIC
values that were not evaluable for essential agreement. Of the 10 evaluable MIC values, there were 2 minor categorical errors that | | | | | | | | | |
Table 2: VITEK® 2 AST-GN Ceftazidime Performance
were not in essential agreement.
9
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= US Food and Drug Administration 510(k) cleared
E = External performance data
Ouality Control demonstrated acceptable results.
H. References:
- MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic 1. 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.