(265 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
This device is an in vitro diagnostic test that provides susceptibility information to aid in determining the appropriate antifungal treatment; it does not directly treat or prevent a disease.
Yes
The device is intended for antifungal susceptibility testing of Candida species and provides in vitro susceptibility to antifungal agents, which aids in the determination of proper treatment. This laboratory aid directly informs patient care.
No
The device description clearly details a physical AST card with wells containing premeasured antibiotic and culture media, which is a hardware component. The VITEK 2 and VITEK 2 Compact Systems are also hardware systems used to process these cards.
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 antifungal susceptibility testing of Candida species" 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 antifungal agents." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a test performed on a sample (yeast isolate) outside of the body ("in vitro") using a specific card containing reagents.
- Clinical Laboratories: The "Intended User / Care Setting" is listed as "clinical laboratories," which are typical settings for performing IVD tests.
- Performance Studies: The performance studies involve testing clinical isolates and comparing the results to a reference method, which is standard practice for validating IVD performance.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK 2 AST-Yeast Voriconazole is designed for antifungal susceptibility testing of Candida species 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 antifungal agents. VITEK 2 AST-Yeast Voriconazole is a quantitative test. Voriconazole has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal.
Active in vitro and in clinical infections: Candida krusei Candida parapsilosis Candida tropicalis
The VITEK 2 Fungal 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 yeasts to antifungal agents when used as instructed.
Product codes (comma separated list FDA assigned to the subject device)
NGZ, LON, LRG, 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() 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-YS Voriconazole has the following concentrations in the card: 0.03125, 0.125, 0.25, 1, and 2 (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- YS Voriconazole by comparing its performance with the CLSI broth microdilution reference method incubated for 24 hours (up to 48 hours that are not growing well).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-YS Voriconazole 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 (Traditional 510[k]) presents data in support of VITEK® 2 AST-YS Voriconazole. 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- YS Voriconazole by comparing its performance with the CLSI broth microdilution reference method incubated for 24 hours (up to 48 hours that are not growing well). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
VITEK® 2 AST-YS Voriconazole demonstrated acceptable performance as presented in the table below.
| Antimicrobial | Antimicrobial Code | Antibiotic Version | Bp1 | Comment | Essential Agreement % Error | Category Agreement % Error | % Reproducibility | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % EA | VME | ME | mE | % CA | VME | ME | mE | ||||||
| Voriconazole | VRC | vrc02n | CLSI (FDA) | #, E C.albicans * | (228/257) 88.7 | N/A | N/A | N/A | (221/257) 86.0 | (4/12) 33.3 | (3/237) 1.3 | (29/257) 11.3 | 100 |
| #, E C.krusei | (76/76) 100.0 | N/A | N/A | N/A | (75/76) 98.7 | (0/0) 0.0 | (0/74) 0.0 | (1/76) 1.3 | |||||
| #, E C.parapsilosis | (70/74) 94.6 | N/A | N/A | N/A | (70/74) 94.6 | (0/1) 0.0 | (1/68) 1.5 | (3/74) 4.1 | |||||
| #, E C.tropicalis | (85/87) 97.7 | N/A | N/A | N/A | (79/87) 90.8 | (0/2) 0.0 | (2/77) 2.6 | (6/87) 6.9 |
VITEK® 2 Voriconazole MIC values for C. parapsilosis tended to be in exact agreement or at least one doubling dilution higher than the reference MIC values. Voriconazole MIC values for C. krusei tended to be in exact agreement or at least one doubling dilution lower than the reference MIC values.
Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA), Category Agreement (CA), 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-Yeast Fluconazole (K213241)
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
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
June 12, 2024
bioMerieux, Inc. Esther Hernandez Regulatory Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K232967
Trade/Device Name: VITEK 2 AST-Yeast Voriconazole ( 4 us/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: NGZ, LON, LRG, LTT, LTW Dated: May 7, 2024 Received: May 7, 2024
Dear Esther Hernandez:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Natasha Griffin -S
o.b.o. Ribhi Shawar, Ph.D. (ABMM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232967
Device Name VITEK 2 AST-Yeast Voriconazole ( 4 ug/mL)
Indications for Use (Describe)
VITEK 2 AST-Yeast Voriconazole is designed for antifungal susceptibility testing of Candida species 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 antifungal agents. VITEK 2 AST-Yeast Voriconazole is a quantitative test. Voriconazole has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal.
Active in vitro and in clinical infections: Candida krusei Candida parapsilosis Candida tropicalis
The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinicant yeasts to antifungal 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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3
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510(k) SUMMARY
VITEK® 2 AST-YS Voriconazole
A. 510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Esther Hernandez |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8841 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | May 07, 2024 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Yeast Voriconazole (≤ 0.03125-≥4 |
| µg/mL) | |
| Classification Name: | 21 CFR 866.1640 |
| Antimicrobial Susceptibility test powder | |
| Product Code NGZ, LRG, LTT, LTW, LON | |
| Common Name: | VITEK® 2 AST-YS Voriconazole |
| C. Predicate Device: | VITEK® 2 AST-Yeast Fluconazole (K213241) |
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() 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
4
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-YS Voriconazole has the following concentrations in the card: 0.03125, 0.125, 0.25, 1, and 2 (equivalent standard method concentration by efficacy in ug/mL).
E. Substantial Equivalence Information
The similarities and differences of the VITEK 2 AST-YS Voriconazole when compared to the predicate device, VITEK 2 AST-YS Fluconazole (K213241), are described in the following table. The only difference between both devices are the Indications for Use and the breakpoints used to analyze the data performance. The below table provides the similarities and differences:
| Item | Device:
VITEK® 2 AST-YS Voriconazole
(K232967) | Predicate:
VITEK® 2 AST-YS Fluconazole
(K213241) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended
Use | VITEK 2 AST-Yeast Voriconazole is
designed for antifungal susceptibility
testing of Candida species 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 antifungal
agents. VITEK 2 AST-Yeast
Voriconazole is a quantitative test.
Voriconazole has been shown to be
active against most strains of the
microorganisms listed below,
according to the FDA label for this
antifungal.
The VITEK 2 Fungal 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 yeasts to
antifungal agents when used as
instructed. | VITEK 2 AST-Yeast Fluconazole is
designed for antifungal susceptibility
testing of Candida species 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 antifungal
agents. VITEK 2 AST-Yeast
Fluconazole is a quantitative test.
Fluconazole has been shown to be
active against most strains of the
microorganisms listed below,
according to the FDA label for this
antifungal.
The VITEK 2 Fungal 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 yeasts to
antifungal agents when used as
instructed. |
| Test | Automated quantitative antimicrobial | Automated quantitative antimicrobial |
5
| Methodo-
logy | susceptibility test for use with the
VITEK 2 and VITEK 2 Compact
Systems to determine the in vitro
susceptibility of yeast. | susceptibility test for use with the
VITEK 2 and VITEK 2 Compact
Systems to determine the in
vitro susceptibility of yeast |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Inoculum | Saline suspension of organism | Saline suspension of organism |
| Test Card | VITEK 2 Yeast Susceptibility Test
Card | VITEK 2 Yeast Susceptibility Test Card |
| Instrument | VITEK 2 and VITEK 2 Compact
Systems | VITEK 2 and VITEK 2 Compact
Systems |
| Analysis
Algorithms | Discriminant Analysis | Discriminant Analysis |
| Differences | | |
| Antifungal
Agent | Voriconazole | Fluconazole |
| Anti-
microbial
Concentra-
tions | 0.03125, 0.125, 0.25, 1, 2 | 2, 4, 8, 16, 32, 64 |
| Indications
for Use | Active in vitro and in clinical
infections:
Candida krusei
Candida parapsilosis
Candida tropicalis | Active in vitro and in clinical
infections:
Candida albicans
Candida parapsilosis
Candida tropicalis |
F. Intended Use:
VITEK 2 AST-Yeast Voriconazole is designed for antifungal susceptibility testing of Candida species 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 antifungal agents. VITEK 2 AST-Yeast Voriconazole is a quantitative test. Voriconazole has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal.
Active in vitro and in clinical infections: Candida krusei Candida parapsilosis
6
Candida tropicalis
The VITEK 2 Fungal 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 yeasts to antifungal agents when used as instructed.
G. Performance Overview:
VITEK® 2 AST-YS Voriconazole 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 (Traditional 510[k]) presents data in support of VITEK® 2 AST-YS Voriconazole. 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- YS Voriconazole by comparing its performance with the CLSI broth microdilution reference method incubated for 24 hours (up to 48 hours that are not growing well). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
VITEK® 2 AST-YS Voriconazole demonstrated acceptable performance as presented in the table below.
| Antimicro
bial | Antimic
robial
Code | Antibiot
ic
Version | Bp1 | Comment | Essential Agreement
% Error | | | | Category Agreement
% Error | | | | %
Repro- duc-
ibility
y |
|-------------------|---------------------------|---------------------------|---------------|-----------------------------|--------------------------------|-----|-----|-----|-------------------------------|----------------|----------------|------------------|----------------------------------|
| | | | | | % EA | VME | ME | mE | % CA | VME | ME | mE | |
| Voriconazole | VRC | vrc02n | CLSI
(FDA) | #, E
C.albicans * | (228/257)
88.7 | N/A | N/A | N/A | (221/257)
86.0 | (4/12)
33.3 | (3/237)
1.3 | (29/257)
11.3 | 100 |
| | | | | #, E
C.krusei | (76/76)
100.0 | N/A | N/A | N/A | (75/76)
98.7 | (0/0)
0.0 | (0/74)
0.0 | (1/76)
1.3 | |
7
| #, E
C. paraps
ilosis | (70/74)
94.6 | N/A | N/A | N/A | (70/74)
94.6 | (0/1)
0.0 | (1/68)
1.5 | (3/74)
4.1 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----|-----|-----|-----------------|--------------|---------------|---------------|
| #, E
C. tropic
alis | (85/87)
97.7 | N/A | N/A | N/A | (79/87)
90.8 | (0/2)
0.0 | (2/77)
2.6 | (6/87)
6.9 |
| VITEK® 2 Voriconazole MIC values for C. parapsilosis
tended to be in exact agreement or at least one doubling
dilution higher than the reference MIC values. Voriconazole
MIC values for C. krusei tended to be in exact agreement or
at least one doubling dilution lower than the reference MIC
values.
*C. albicans is not an FDA Indicated for Use species. An
alternative testing method should be performed prior to reporting
results. | | | | | | | | |
1 Abbreviations - Bp = breakpoint committee; EA = essential agreement; CA = category agreement; VME=Very Major Error (susceptible result with resistant reference result); ME Major Error (resistant result with susceptible reference result); mE = minor Error (susceptible or resistant result with an intermediate reference result, or an intermediate result with a susceptible or resistant reference result).
= US Food and Drug Administration 510(k) cleared
CLSI = Clinical and Laboratory Standards Institute
E = External performance data
N/A = Not applicable
Reproducibility and Quality Control demonstrated acceptable results.
H. Conclusion:
The performance data presented in this submission support a substantial equivalence decision. VITEK® 2 AST-YS Voriconazole (≤ 0.03215 - ≥4 µg/mL) is substantially equivalent to VITEK® 2 AST-YS Fluconazole (K213241).
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.
8
-
- 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.