(210 days)
Not Found
No
The description focuses on the microdilution technique and automated monitoring of growth, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is designed for in vitro antifungal susceptibility testing and acts as a laboratory aid to determine susceptibility to antifungal agents, not to provide therapy itself.
Yes
The VITEK® 2 AST-Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species, providing in vitro susceptibility to antifungal agents. This information aids in the determination of appropriate treatment and therefore serves a diagnostic purpose.
No
The device description clearly outlines a physical card with wells containing premeasured portions of an antibiotic and culture media, which is a hardware component. The system also involves automated or manual filling, sealing, and incubation, indicating a significant hardware element.
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 "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, using a specific card containing reagents (antimicrobial agents and culture media). This is characteristic 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.
- Intended User/Care Setting: The device is intended for use in "clinical laboratories," which are the typical setting for performing in vitro diagnostic tests.
The entire description points to a device used to analyze a biological sample (yeast) outside of the body to provide information about its characteristics (susceptibility to antifungal agents), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. VITEK® 2 AST-Yeast Caspofungin is a quantitative test. Caspofungin 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 albicans
Candida guillermondii
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)
LON, LTT, LTW
Device Description
The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh(1) and Gerlach(2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3).
Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured 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 Caspofungin has the following concentrations in the card: 0.125, 0.5, 2, and 8 (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 Caspofungin by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hours (or up to 48 hours for isolates that show insufficient growth at 24 hours). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-YS Caspofungin 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).
VITEK® 2 AST-YS Caspofungin demonstrated acceptable performance of 99.9% overall Essential Agreement and 97.5% overall Category Agreement with the reference method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: (679/680) 99.9
Category Agreement: (663/680) 97.5
VME % Error: (2/2) 100.0
ME % Error: (0/663) 0.0
mE % Error: (15/680) 2.2
Reproducibility: 96.7
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 Caspofungin (K151817)
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.”
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the letters 'FDA' in a blue square and the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 13, 2022
bioMerieux, Inc. Esther Hernandez Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042
Re: K213899
Trade/Device Name: VITEK 2 AST-Yeast Caspofungin (8 ug/mL), VITEK 2 AST-YS Caspofungin (≤0.125 - ≥8 ug/mL), VITEK 2 AST-YS Caspofungin 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 Esther Hernandez:
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 July 12, 2022. Specifically, FDA is updating this SE Letter to provide the correct Indications for Use form (FORM FDA 3881) 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, 301-796-6698, Ribhi.Shawar@fda.hhs.gov.
Sincerelv.
Natasha Griffin -S
Ribhi Shawar, Ph.D. Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration. The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Underneath the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
July 12, 2022
bioMerieux, Inc. Esther Hernandez Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042
Re: K213899
Trade/Device Name: VITEK 2 AST-Yeast Caspofungin (≤0.125 - ≥8 µg/mL), VITEK 2 AST-YS Caspofungin (8 ug/mL), VITEK 2 AST-YS Caspofungin Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, LTT, LTW Dated: December 13, 2021 Received: December 14, 2021
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 (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.
2
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 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,
Natasha Griffin -S
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
3
Indications for Use
510(k) Number (if known) K213899
Device Name
VITEK® 2 AST-Yeast Caspofungin (≤ 0.125 - ≥8 µg/mL)
Indications for Use (Describe)
VITEK® 2 AST-Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. VITEK® 2 AST-Yeast Caspofungin is a quantitative test. Caspofungin 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 albicans Candida guillermondii 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.
| 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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4
Image /page/4/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle divided into two sections. The top section is blue and contains the company name "BIOMÉRIEUX" in white, sans-serif font. The bottom section is a gradient of yellow and green.
510(k) SUMMARY
VITEK® 2 AST-YS Caspofungin
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: | December 8, 2021 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Yeast Caspofungin (≤ 0.125 – ≥8 |
| µg/mL) | |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code LON, LTT, LTW | |
| Common Name: | VITEK® 2 AST-YS Caspofungin |
| Predicate Device: | VITEK® 2 AST-Yeast Caspofungin (K151817) |
D. Device Description:
B.
C.
The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh(1) and Gerlach(2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3).
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
5
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 Caspofungin has the following concentrations in the card: 0.125, 0.5, 2, and 8 (equivalent standard method concentration by efficacy in ug/mL).
E. Substantial Equivalence Information
The similarities and differences of the VITEK 2 AST-YS Caspofungin when compared to the predicate device, VITEK 2 AST-YS Caspofungin (K151817), 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 Caspofungin | Predicate:
VITEK® 2 AST-YS Caspofungin
(K151817) |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | VITEK® 2 AST-Yeast Caspofungin
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 Caspofungin
is a quantitative test. Caspofungin
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 albicans
Candida guilliermondii
Candida krusei
Candida parapsilosis
Candida tropicalis
The VITEK® 2 Fungal Susceptibility
Card is intended for use with the | VITEK® 2 AST-Yeast Caspofungin 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
Caspofungin is a quantitative test.
Caspofungin 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 albicans
Candida glabrata
Candida guilliermondii
Candida krusei
Candida parapsilosis
Candida tropicalis
The VITEK® 2 Antimicrobial |
6
| | 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. | Susceptibility Test (AST) is intended to
for use with the VITEK 2 Systems for
the automated quantitative or qualitative
susceptibility testing of isolated colonies
for most clinically significant aerobic
Gram-negative bacilli, Staphylococcus
spp., Enterococcus spp., Streptococcus
spp. and clinical significant yeast. |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 yeast. | Same |
| Antimicrobial Agent | Caspofungin | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | VITEK® 2 Yeast (AST) Susceptibility
Test Card | Same |
| Analysis Algorithms | Discriminant Analysis | Same |
| Instrument | VITEK® 2 and VITEK® 2 Compact
Systems | Same |
| Concentrations | 0.125, 0.5, 2, 8 | Same |
| | Differences | |
| Indications for Use | Candida albicans
Candida guilliermondii
Candida krusei
Candida parapsilosis
Candida tropicalis | Candida albicans
Candida glabrata
Candida guilliermondii
Candida krusei
Candida parapsilosis
Candida tropicalis |
| Breakpoints for Candida
spp. | Candida albicans: ≤0.25 (S), 0.5 (I),
≥1 (R)
Candida guilliermondii: ≤2 (S), 4
(I), ≥8 (R)
Candida krusei: ≤0.25 (S), 0.5 (I),
≥1 (R)
Candida parapsilosis: ≤2 (S), 4 (I),
≥8 (R)
Candida tropicalis: ≤0.25 (S), 0.5
(I), ≥1 (R) | Candida spp.: ≤2 (S), - (I), - (R) |
F. Intended Use:
VITEK® 2 AST-Yeast Caspofungin 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 Caspofungin is a quantitative test. Caspofungin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal.
7
Active in vitro and in clinical infections: Candida albicans Candida guilliermondii 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.
G. Performance Overview:
VITEK® 2 AST-YS Caspofungin 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 Caspofungin. 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 Caspofungin by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hours (or up to 48 hours for isolates that show insufficient growth at 24 hours). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
VITEK® 2 AST-YS Caspofungin demonstrated acceptable performance of 99.9% overall Essential Agreement and 97.5% overall Category Agreement with the reference method.
| Antimicrobial | Anti-
microbial
Code | Antibiotic
Version | Bp1 | Comment | Essential Agreement | | | | Category Agreement | | | | %Repro-
ducibility | | | |
|-----------------|----------------------------|-----------------------|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----|-----|-----|--------------------|----------------|----------------|-----------------|-----------------------|--|--|--|
| | | | | | % Error | | | | % Error | | | | | | | |
| | | | | | % EA | VME | ME | mE | % CA | VME | ME | mE | | | | |
| Caspofungi
n | CAS | cas02n | CLSI
(FDA) | #, E, | (679/680)
99.9 | N/A | N/A | N/A | (663/680)
97.5 | (2/2)
100.0 | (0/663)
0.0 | (15/680)
2.2 | 96.7 | | | |
| | | | | VITEK 2 Caspofungin MIC values tended to be in exact agreement or at least one doubling dilution lower when
testing Candida albicans, Candida guilliermondii, Candida krusei, Candida parapsilosis, and Candida
tropicalis compared to the broth microdilution reference method. One very major error was observed for C.
albicans and one very major error was observed for C. tropicalis using the VITEK 2 (both the automatic and
manual dilution methods). Each very major error was the only resistant isolate tested and was within essential
agreement with the reference method. One very major error was observed for C. tropicalis using the VITEK 2
Compact. This very major error was the only resistant isolate tested and was not within essential agreement with
the reference method | | | | | | | | | | | | |
' Abbreviations - Bo=breakpont committee; EA=estegory.ggeement; VME=Very Major Eror(susceptibleresulty: ME=Septibleressult; ME Major Enor (resistant result); mE = minor Error (susceptible or resistant result with an internediate reference result, or an internediate result, or an internediate result with a susceptible or resistant reference result).
#=US Food and Drug Administration 510(k) cleared
CLSI = Clinical and Laboratory Standards Institute
8
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-Yeast Caspofungin (≤ 0.125 ->8 µg/mL) is substantially equivalent to VITEK® 2 AST-Yeast Caspofungin (K151817).
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.