(385 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 analysis or interpretation.
No.
This device is an in vitro diagnostic test designed to determine the susceptibility of microorganisms to antimicrobial agents, which is a laboratory aid and does not directly treat or cure any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for antimicrobial susceptibility testing of Gram positive microorganisms 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." This indicates its role in providing information for diagnosis and treatment.
No
The device description clearly states that the VITEK® 2 AST card is a physical component containing wells with antibiotic and culture media, and the system involves automated or manual filling, sealing, and incubation of these cards. This indicates a significant hardware component beyond just software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "designed for antimicrobial susceptibility testing of Gram positive microorganisms" 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." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a test performed on a sample (microorganisms diluted in saline) outside of the body, using a specific card with pre-measured reagents. This aligns with the nature of an in vitro test.
- Clinical Laboratories: The "Intended User / Care Setting" is listed as "clinical laboratories," which are the typical settings for performing IVD tests.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard method for in vitro susceptibility testing.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K190616) indicates that this device has gone through a regulatory process, likely with the FDA, which is required for IVDs.
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 Positive Telavancin is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Telavancin is a quantitative test. Telavancin 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 Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis (vancomycin-susceptible isolates only)
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 S. agalactiae 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 isolate to be tested is diluted to a standardized concentration with 0.45 – 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
An external evaluation was conducted with contemporary and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of AST-GP Telavancin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours for Staphylococci and Enterococci. 20-24 hours for Streptococci.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-GP Telavancin (≤0.015 - ≥1 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-GP Telavancin. An external evaluation was conducted with contemporary and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of AST-GP Telavancin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours for Staphylococci and Enterococci. 20-24 hours for Streptococci. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
The VITEK® 2 AST-GP Telavancin (≤0.015 - ≥1 µg/mL) demonstrated acceptable performance as presented in Table 2:
Enterococcus faecalis:
- %EA: 89.9 (331/368)
- %CA: 92.9 (342/368)
- VME: 0.0 (0/1)
- ME: 7.1 (26/367)*
- mE: N/A
Staphylococcus aureus:
-
%EA: 94.2 (490/520)
-
%CA: 98.8 (514/520)
-
VME: 0.0 (0/0)
-
ME: 1.2 (6/520)
-
mE: N/A
-
% Reproducibility: 100.0
-
Five major errors for Enterococcus faecalis were within essential agreement with the reference method; due to the lack of an intermediate breakpoint these five major errors were considered acceptable and the major error rate is adjusted to 5.7% which will still require retesting of non-susceptible strains with an alternate method.
VITEK 2 AST-Gram Positive Telavancin MIC values tended to be in exact agreement or at least one doubling dilution higher when testing E. faecalis, and S. aureus compared to the CLSI reference broth microdilution method.
Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement, Category Agreement, Very Major Error (VME), Major Error (ME), Minor Error (mE), 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- GP Dalbavancin (≤0.015 - ≥1 µg/mL) (K190616)
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
August 8, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The seal features an eagle with its wings spread, and the FDA part includes the acronym in a blue square and the full name "U.S. Food & Drug Administration" in blue text.
bioMérieux, Inc Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K212243
Trade/Device Name: VITEK 2 AST- Gram Positive Telavancin (≤0.015 - ≥1 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: July 14, 2021 Received: July 19, 2021
Dear Cherece Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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.
Uwe Scherf, M.Sc., 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
VITEK® 2 AST-GP Telavancin (1 ug/mL)
Indications for Use (Describe)
VITEK® 2 AST-Gram Positive Telavancin is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Telavancin is a quantitative test. Telavancin 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 Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis (vancomycin-susceptible isolates only)
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 S. agalactiae 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
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510(k) SUMMARY
B.
C.
VITEK® 2 AST Gram-Positive Telavancin (≤0.015 - ≥1 µg/mL)
A. 510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Cherece L. Jones |
| Staff Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8684 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | July 14, 2021 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST Gram-Positive Telavancin (≤0.015 - ≥1 |
| µg/mL) | |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code(s): | LON, LTT, LTW |
| Common Name: | VITEK® 2 AST-GP Telavancin (≤0.015 - ≥1 µg/mL) |
| Predicate Device: | VITEK® 2 AST- GP Dalbavancin (≤0.015 - ≥1 µg/mL) |
| (K190616) |
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).
4
Image /page/4/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 word "BIOMÉRIEUX" in white, sans-serif font. The bottom half is yellow and green.
Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The isolate to be tested is diluted to a standardized concentration with 0.45 – 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.
E. Substantial Equivalence Information:
The similarities and differences of the VITEK® 2 AST-GP Telavancin (≤0.015 - ≥1 µg/mL) when compared to the predicate device, VITEK® 2 AST-GP Dalbavancin (≤0.015 - ≥1 µg/mL) (K190616), are described in the Table 1 below.
| Item | Device:
VITEK® 2 AST-GP Telavancin
(≤0.015 - ≥1 µg/mL) | Predicate:
VITEK® 2 AST-GP Dalbavancin
(≤0.015 - ≥1 µg/mL) (K190616) |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | VITEK® 2 AST-Gram Positive
Telavancin is designed for
antimicrobial susceptibility testing of
Gram positive microorganisms 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 Positive Telavancin is a
quantitative test. Telavancin 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
Staphylococcus aureus (including
methicillin-resistant isolates)
Enterococcus faecalis (vancomycin- | VITEK® 2 AST-Gram Positive
Dalbavancin is designed for
antimicrobial susceptibility testing of
Gram positive microorganisms 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 Positive
Dalbavancin is a quantitative test.
Dalbavancin 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
Staphylococcus aureus (including
methicillin-resistant isolates)
Enterococcus faecalis (vancomycin- |
Table 1: Substantial Equivalence
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| Item | Device:
VITEK® 2 AST-GP Telavancin
(≤0.015 - ≥1 µg/mL) | Predicate:
VITEK® 2 AST-GP Dalbavancin
(≤0.015 - ≥1 µg/mL) (K190616) |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| | susceptible isolates only) | susceptible isolates only)
Streptococcus agalactiae |
| | 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 S. agalactiae to
antimicrobial agents when used as
instructed. | 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 S. agalactiae 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-Positive (AST-GP)
Susceptibility Card | Same |
| Analysis Algorithms | Growth Pattern Analysis | Same |
| Instrument | VITEK® 2 and VITEK® 2 Compact
Systems | Same |
| Differences | | |
| Antimicrobial Agent | Telavancin | Dalbavancin |
| Concentrations | 0.015, 0.125, 0.25, 0.5 | 0.0625, 0.125, 0.25, 0.5 |
F. Indications for Use:
VITEK® 2 AST-Gram Positive Telavancin is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Telavancin is a quantitative test. Telavancin 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 Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis (vancomycin-susceptible isolates only)
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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 upper half and a yellow-green lower half. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue portion of the circle.
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 S. agalactiae to antimicrobial agents when used as instructed.
G. Performance Overview and Conclusion:
VITEK® 2 AST-GP Telavancin (≤0.015 - ≥1 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-GP Telavancin. An external evaluation was conducted with contemporary and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of AST-GP Telavancin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours for Staphylococci and Enterococci. 20-24 hours for Streptococci. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
The VITEK® 2 AST-GP Telavancin (≤0.015 - ≥1 µg/mL) 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 | ||||
| #, E | |||||||||||
| Enterococcus | |||||||||||
| faecalis | 89.9 | ||||||||||
| (331/368) | N/A | N/A | N/A | 92.9 | |||||||
| (342/368) | 0.0 | ||||||||||
| (0/1) | 7.1 | ||||||||||
| (26/367)* | N/A | ||||||||||
| Telavancin | #,E | ||||||||||
| Staphylococcus | |||||||||||
| aureus | 94.2 | ||||||||||
| (490/520) | N/A | N/A | N/A | 98.8 | |||||||
| (514/520) | 0.0 | ||||||||||
| (0/0) | 1.2 | ||||||||||
| (6/520) | N/A | 100.0 | |||||||||
| * Five major errors for Enterococcus faecalis were within essential agreement with the reference method; due to | |||||||||||
| the lack of an intermediate breakpoint these five major errors were considered acceptable and the major error rate | |||||||||||
| is adjusted to 5.7% which will still require retesting of non-susceptible strains with an alternate method. |
VITEK 2 AST-Gram Positive Telavancin MIC values tended to be in exact agreement or at least one doubling
dilution higher when testing E. faecalis, and S. aureus compared to the CLSI reference broth microdilution
method. | | | | | | | | | | |
Table 2: VITEK® 2 AST-GP Telavancin Performance
Kev:
= US Food and Drug Administration 510(k) cleared
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Image /page/7/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with two different colors. The top half of the circle is dark blue, and the bottom half is yellow-green. The company name, "BIOMÉRIEUX", is written in white letters in the center of the blue portion of the circle.
E = External performance data
Quality Control demonstrated acceptable results.
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 Febiger, Philadelphia, PA, 1976.