(209 days)
Not Found
No
The description details a microdilution technique with optical monitoring and automated result calculation based on predetermined growth thresholds and forcing rules. There is no mention of AI or ML algorithms being used for interpretation or prediction.
No.
The device is an in vitro diagnostic (IVD) test designed to determine antimicrobial susceptibility, which aids in diagnosis and treatment decisions, but it does not directly treat or prevent a disease or condition.
Yes
Explanation: The device is intended for use in clinical laboratories to determine the susceptibility of various Staphylococcus, Enterococcus, and Streptococcus species to antimicrobial agents, which is a diagnostic purpose.
No
The device description clearly indicates the use of physical VITEK® 2 AST cards containing premeasured portions of antibiotics and culture media, which are inoculated and incubated within the VITEK® 2 Systems. While software is used for monitoring growth, calculating results, and generating reports, the core of the device involves physical components and biological processes.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it 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 term "in vitro" is a key indicator of an IVD.
- Device Description: It describes a test performed on a sample (bacterial isolate) outside of the body, using a system to monitor growth and determine susceptibility. This aligns with the definition of an in vitro test.
- Intended User/Care Setting: It is intended for use in "clinical laboratories," which are common settings for performing IVD tests.
- Performance Studies: The studies described involve testing clinical isolates to evaluate the device's performance in determining susceptibility, which is typical for IVD validation.
- Predicate Device: The mention of a predicate device (K053097; VITEK® 2 Gram Positive Cefoxitin Screen) further confirms its classification as a medical device, and given its function, specifically an IVD.
The device performs a test on a biological sample (bacterial isolate) outside of the body to provide information about the susceptibility of that organism to antimicrobial agents, which directly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Gram Positive Cefoxitin Screen is designed to predict mecA-mediated oxacillin resistance in Staphylococcus spp. It 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 VITEK® 2 Gram-Positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and Streptococcus agalactiae to antimicrobial agents when used as instructed.
Product codes (comma separated list FDA assigned to the subject device)
LON, LTW, LTT
Device Description
VITEK® 2 AST-GP Cefoxitin Screen is designed to predict mecA-mediated oxacillin resistance in Staphylococcus spp. The cefoxitin screen and oxacillin work in combination to determine the final interpretation reported for oxacillin. The VITEK® 2 AST-GP Cefoxitin Screen is a qualitative test based on the CLSI, "Disk Diffusion Test for Prediction of mecAmediated resistance in Staphylococci." The VITEK® 2 AST-GP Cefoxitin Screen test 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 VITEK® 2 card is inoculated with a standardized organism suspension, and growth inside the card is optically monitored throughout the incubation cycle. Results are automatically calculated once a predetermined growth threshold is reached and a report is generated that contains the MIC result and the interpretive category result.
The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh('') 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. For the VITEK 2 Cefoxitin Screen, the report will list either a positive or negative result. The VITEK 2 Cefoxitin Screen and oxacillin work in combination to determine the final oxacillin interpretation based on the CLSI recommendations.
NOTE: Final determination of the oxacillin interpretation is based on forcing rules as managed by the VITEK 2 Systems software. Both the VITEK 2 AST-GP Cefoxitin Screen test and Oxacillin test must finalize before any forcing rules are applied.
VITEK® 2 AST-GP Cefoxitin Screen has the following concentrations in the card: 4 and 5 ug/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
Optically monitored growth
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-GP Cefoxitin Screen by comparing its performance with the CLSI test for detecting methicillin (oxacillin) resistance with cefoxitin disk diffusion incubated at 33-35°C for 16-18 hrs with S. aureus and S. lugdunensis, and 24 hours for other Staphylococcus (excluding S. pseudintermedius & S. schleiferi).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-GP Cefoxitin Screen demonstrated substantially equivalent performance when compared with the CLSI disk diffusion method, as defined "Performance Standards for Antimicrobial Disk Susceptibility Tests", Approved Standard -13th Edition (January 2018).
The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GP Cefoxitin Screen. 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-GP Cefoxitin Screen by comparing its performance with the CLSI test for detecting methicillin (oxacillin) resistance with cefoxitin disk diffusion incubated at 33-35°C for 16-18 hrs with S. aureus and S. lugdunensis, and 24 hours for other Staphylococcus (excluding S. pseudintermedius & S. schleiferi). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
Reproducibility and Quality Control demonstrated acceptable results.
In conclusion the performance data presented in this submission supports a substantial equivalence decision.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Oxacillin + Cefoxitin Screen:
S. aureus & S. lugdunensis: Category Agreement (CA) = 98.7% (525 / 532); VME = 0.6% (1 / 177); ME = 1.7% (6 / 355); mE = N/A.
Other Staphylococcus species (not including S. Pseudinterme- dius or S. Schleiferi): Category Agreement (CA) = 97.8% (261 / 267); VME = 0.0 % (0 / 125); ME = 4.2% (6 / 142); mE = N/A.
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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October 13, 2022
bioMérieux, Inc Nathan Hardesty Associate Director, Regulatory Affairs Clinical Microbiology 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K220805
Trade/Device Name: VITEK 2 AST-Gram Positive Cefoxitin Screen Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, LTW, LTT Dated: March 17, 2022 Received: March 18, 2022
Dear Nathan Hardesty:
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,
For: Uwe Scherf, Ph.D. Director 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)
Device Name
Indications for Use (Describe)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
VITEK® 2 AST-Gram Positive Cefoxitin Screen
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Nathan Hardesty |
| Associate Director Regulatory Affairs, Microbiology | |
| Phone Number: | 314-731-8666 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | January 31, 2022 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Gram Positive Cefoxitin Screen |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code: LON, LTW, LTT | |
| Common Name: | VITEK® 2 AST-GP Cefoxitin Screen |
| C. Predicate Device: | VITEK® 2 Gram Positive Cefoxitin Screen (K053097) |
D. Device Description:
VITEK® 2 AST-GP Cefoxitin Screen is designed to predict mecA-mediated oxacillin resistance in Staphylococcus spp. The cefoxitin screen and oxacillin work in combination to determine the final interpretation reported for oxacillin. The VITEK® 2 AST-GP Cefoxitin Screen is a qualitative test based on the CLSI, "Disk Diffusion Test for Prediction of mecAmediated resistance in Staphylococci." The VITEK® 2 AST-GP Cefoxitin Screen test 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.
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 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.
The VITEK® 2 card is inoculated with a standardized organism suspension, and growth inside the card is optically monitored throughout the incubation cycle. Results are automatically calculated once a predetermined growth threshold is reached and a report is generated that contains the MIC result and the interpretive category result.
The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh('') 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. For the VITEK 2 Cefoxitin Screen, the report will list either a positive or negative result. The VITEK 2 Cefoxitin Screen and oxacillin work in combination to determine the final oxacillin interpretation based on the CLSI recommendations.
NOTE: Final determination of the oxacillin interpretation is based on forcing rules as managed by the VITEK 2 Systems software. Both the VITEK 2 AST-GP Cefoxitin Screen test and Oxacillin test must finalize before any forcing rules are applied.
VITEK® 2 AST-GP Cefoxitin Screen has the following concentrations in the card: 4 and 5 ug/mL (equivalent standard method concentration by efficacy in ug/mL).
E. Substantial Equivalence Information:
The similarities and differences of the VITEK® 2 AST-GP Cefoxitin Screen when compared to the predicate device, VITEK® 2 Cefoxitin Screen (K053097), are described in the Table 1 below.
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| Table 1: Substantial Equivalence | ||
|---|---|---|
| Item | Device: | |
| VITEK® 2 AST-Gram Positive | ||
| Cefoxitin Screen | Predicate: | |
| VITEK® 2 AST-Gram Positive | ||
| Cefoxitin Screen (K053097) | ||
| Similarities | ||
| Intended Use | VITEK® 2 AST-Gram Positive | |
| Cefoxitin Screen test is designed to | ||
| predict mecA-mediated oxacillin | ||
| resistance in Staphylococcus spp. It 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 VITEK® 2 AST Gram-Positive | ||
| Susceptibility Card is intended for use | ||
| with the VITEK® 2 Systems in clinical | ||
| laboratories as an in vitro test to | ||
| determine the susceptibility of | ||
| Staphylococcus spp., Enterococcus | ||
| spp., and Streptococcus agalactiae to | ||
| antimicrobial agents when used as | ||
| instructed. | VITEK® 2 Gram Positive Cefoxitin | |
| Screen test is designed to predict | ||
| mecA-mediated resistance in | ||
| Staphylococci. It 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 VITEK® 2 AST Gram-Positive | ||
| Susceptibility Card is intended for use | ||
| with the VITEK® 2 Systems in | ||
| clinical laboratories as an in vitro test | ||
| to determine the susceptibility of | ||
| Staphylococcus spp., Enterococcus | ||
| spp., and Streptococcus agalactiae to | ||
| antimicrobial agents when used as | ||
| instructed. | ||
| Test Methodology | Automated qualitative 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 Positive (AST-GP) Susceptibility | |
| Card | Same | |
| Instrument | VITEK® 2 and VITEK® 2 Compact | |
| Systems | Same | |
| Analysis | ||
| Algorithm | Discriminant Analysis | Same |
| Differences | ||
| Concentrations | 4, 5 | 6 |
F. Intended Use:
VITEK® 2 AST-GP Cefoxitin Screen is designed to predict mecA-mediated oxacillin resistance in Staphylococcus spp. It is intended for use with the VITEK® 2 and VITEK® 2
6
Image /page/6/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with the top half being dark blue and the bottom half being a gradient from yellow to green. The word "BIOMÉRIEUX" is written in white letters in the center of the blue portion of the circle.
Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
The VITEK® 2 Gram-Positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and Streptococcus agalactiae to antimicrobial agents when used as instructed.
G. Performance Overview and Conclusion:
VITEK® 2 AST-GP Cefoxitin Screen demonstrated substantially equivalent performance when compared with the CLSI disk diffusion method, as defined "Performance Standards for Antimicrobial Disk Susceptibility Tests", Approved Standard -13th Edition (January 2018).
The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GP Cefoxitin Screen. 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-GP Cefoxitin Screen by comparing its performance with the CLSI test for detecting methicillin (oxacillin) resistance with cefoxitin disk diffusion incubated at 33-35°C for 16-18 hrs with S. aureus and S. lugdunensis, and 24 hours for other Staphylococcus (excluding S. pseudintermedius & S. schleiferi). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
The VITEK® 2 AST-GP Cefoxitin Screen demonstrated acceptable performance as presented in Table 2 below:
| Antimicrobial | Comment2 | Essential Agreement | Category Agreement | ||||||
|---|---|---|---|---|---|---|---|---|---|
| % Error | % Error | ||||||||
| % EA | VME | ME | mE | % CA | VME | ME | mE | ||
| Oxacillin + | |||||||||
| Cefoxitin Screen | S. aureus & S. lugdunensis | ||||||||
| #, E, Ref. = | |||||||||
| CLSI Disk | |||||||||
| Diffusion | - | - | - | - | 98.7% | ||||
| (525 / 532) | 0.6% | ||||||||
| (1 / 177) | 1.7% | ||||||||
| (6 / 355) | N/A |
Table 2
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Image /page/7/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 a dark blue color, and the bottom half is a gradient that transitions from yellow to green. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue half of the circle.
| Other
Staphylococcus
species (not
including S.
Pseudinterme-
dius or S.
Schleiferi )
#, E, Ref. =
CLSI Disk
Diffussion | - | - | - | 97.8%
(261 / 267) | 0.0 %
(0 / 125) | 4.2%
(6 / 142) | N/A |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --- | --- | --- | ---------------------- | -------------------- | ------------------- | ----- |
|---|
Reproducibility and Quality Control demonstrated acceptable results.
In conclusion the performance data presented in this submission supports a substantial equivalence decision. VITEK® 2 AST Gram Positive Cefoxitin Screen test in this 510(k) is substantially equivalent to the predicate VITEK® 2 AST Gram Positive Cefoxitin Screen Test (K053097).
H. References:
-
- MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic Sensitivity Testing in the Clinical laboratory, Journal of Laboratory Clinical Medicine, 72:685-687, 1968.
-
- Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. Current Techniques for Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL, 1974.
- Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and 3. Febiger, Philadelphia, PA, 1976.
- CLSI M02, "Performance Standards for Antimicrobial Disk Susceptibility Tests", Approved 4. Standard -13th Edition (January 2018)
-
- CLSI M100, "Performance Standards for Antimicrobial Susceptibility Testing; 31th Edition", (March 2021)