(148 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 interpretation or analysis.
No
This device is designed for in vitro antifungal susceptibility testing to determine how susceptible certain yeast species are to antifungal agents. It is a laboratory aid for diagnosis and does not directly treat or prevent disease in a patient.
Yes
The device is designed for "antifungal susceptibility testing of Candida species" and is intended "as a laboratory aid in the determination of in vitro susceptibility to antifungal agents," which directly contributes to diagnosing how effectively antifungal agents will work against a patient's infection.
No
The device description clearly details a physical card with wells containing premeasured portions of antibiotic and culture media, which is a hardware component. The system also involves automated or manual filling, sealing, and incubation of this card.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it 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 term "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 specialized card containing reagents (antifungal agent 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 testing. The metrics reported (Essential Agreement, Category Agreement, Errors) are also typical for evaluating the performance of IVD devices.
- Care Setting: The intended user is specified as "clinical laboratories," which are the typical settings where IVD tests are performed.
All of these factors strongly indicate that the VITEK® 2 AST-Yeast Fluconazole is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Active in vitro and in clinical infections:
Candida albicans
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
LON
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 Fluconazole has the following concentrations in the card: 2, 4, 8, 16, 32, and 64 (equivalent standard method concentration by efficacy in us/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 Fluconazole by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hours (or up to 48 hours for isolates that are not growing well at 24 hours).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-YS Fluconazole 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 (Special 510[k]) presents data in support of VITEK® 2 AST-YS Fluconazole. 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 Fluconazole by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hours (or up to 48 hours for isolates that are not growing well at 24 hours). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-YS Fluconazole demonstrated acceptable performance of 96.2% overall Essential Agreement and 93.7% overall Category Agreement with the reference method when testing C. albicans. C. parapsilosis, and C. tropicalis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: (425/442) 96.2%
Category Agreement: (414/442) 93.7%
VME: (2/26) 7.7%
ME: (12/398) 3.0%
mE: (14/442) 3.2%
%Reproducibility: 100%
An overall essential agreement rate of 99.1% and an overall category agreement rate of 94.5% were observed for Candida parapsilosis when tested with VITEK 2 Fluconazole. Compared to the reference broth microdilution, two of 14 results for Candida parapsilosis (one of which was in essential agreement) resulted in very major errors.
VITEK 2 Fluconazole MIC values tended to be in exact agreement or at least one doubling dilution higher when testing C. albicans, C parapsilosis, and C. tropicalis compared to the broth microdilution reference method.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
February 25, 2022
BioMerieux, Inc. Esther Hernandez Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042
Re: K213241
Trade/Device Name: VITEK 2 AST-Yeast Fluconazole (=64 ug/mL), VITEK 2 AST-YS Fluconazole (=64 ug/mL), VITEK 2 AST-YS Fluconazole Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON Dated: September 29, 2021 Received: September 30, 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.
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 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,
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K213241
Device Name
VITEK® 2 AST-Yeast Fluconazole (≤0.5 - ≥64 ug/mL)
Indications for Use (Describe)
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.
Active in vitro and in clinical infections: Candida albicans 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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3
510(k) SUMMARY
VITEK® 2 AST-YS Fluconazole
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: | September 29, 2021 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Yeast Fluconazole (≤ 0.5 – ≥64 µg/mL) |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code LON | |
| Common Name: | VITEK® 2 AST-YS Fluconazole |
| C. Predicate Device: | VITEK® 2 AST-Yeast Fluconazole (K133817) |
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 (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
4
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 Fluconazole has the following concentrations in the card: 2, 4, 8, 16, 32, and 64 (equivalent standard method concentration by efficacy in us/mL).
E. Substantial Equivalence Information
The similarities and differences of the VITEK 2 AST-YS Fluconazole when compared to the predicate device, VITEK 2 AST-YS Fluconazole (K133817), 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 Fluconazole | Predicate:
VITEK® 2 AST-GN Fluconazole
(K133817) |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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.
Active in vitro and in clinical
infections:
Candida albicans
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 | VITEK® 2 AST-Yeast Fluconazole is
designed for antifungal susceptibility
testing of Candida species and is a
quantitative test 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
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 parapsilosis
Candida tropicalis
The following in vitro data are
available, but their clinical
significance is unknown:
Candida dubliniensis
Candida guilliermondii
Candida lusitaniae |
5
| | clinically significant yeasts to
antifungal agents when used as
instructed. | The VITEK® 2 Antimicrobial
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 | Fluconazole | 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 | 2, 4, 8, 16, 32, 64 | Same |
| | Differences | |
| Indications for Use | Candida albicans
Candida parapsilosis
Candida tropicalis | Candida albicans
Candida parapsilosis
Candida tropicalis
Candida dubliniensis
Candida guilliermondii
Candida lusitaniae |
| Breakpoints for Candida
spp. | Candida albicans: ≤2 (S), 4 (I), ≥8 (R)
Candida parapsilosis: ≤2 (S), 4 (I),
≥8 (R)
Candida tropicalis: ≤2 (S), 4 (I), ≥8
(R) | Candida spp.: ≤8 (S), 16-32 (I), ≥64
(R) |
F. Intended Use:
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 antifiungal 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.
Active in vitro and in clinical infections:
6
Image /page/6/Picture/0 description: The image shows the logo for bioMerieux. The logo consists of a stylized circular graphic with vertical lines on the left half and a curved line extending from the right side. Below the graphic, the word "BIOMERIEUX" is written in a sans-serif font, with the letters evenly spaced.
Candida albicans 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 veasts to antifungal agents when used as instructed.
G. Performance Overview:
VITEK® 2 AST-YS Fluconazole 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 (Special 510[k]) presents data in support of VITEK® 2 AST-YS Fluconazole. 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 Fluconazole by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hours (or up to 48 hours for isolates that are not growing well at 24 hours). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
VITEK® 2 AST-YS Fluconazole demonstrated acceptable performance of 96.2% overall Essential Agreement and 93.7% overall Category Agreement with the reference method when testing C. albicans. C. parapsilosis, and C. tropicalis.
| Antimicrobial | Anti-
microbial
Code | Antibiotic
Version | Bp1 | Comment | Essential Agreement | | | | Category Agreement | | | | %Repro-
ducibility |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------|---------------|---------|---------------------|-----|-----|-----|--------------------|---------------|-----------------|-----------------|-----------------------|
| | | | | | % EA | VME | ME | mE | % CA | VME | ME | mE | |
| Fluconazole | FLU | flu02n | CLSI
(FDA) | #, E, | (425/442)
96.2 | N/A | N/A | N/A | (414/442)
93.7 | (2/26)
7.7 | (12/398)
3.0 | (14/442)
3.2 | 100 |
| An overall essential agreement rate of 99.1% and an overall category
agreement rate of 94.5% were observed for Candida parapsilosis when
tested with VITEK 2 Fluconazole. Compared to the reference broth
microdilution, two of 14 results for Candida parapsilosis (one of which
was in essential agreement) resulted in very major errors.
VITEK 2 Fluconazole MIC values tended to be in exact agreement or at
least one doubling dilution higher when testing C. albicans, C
parapsilosis, and C. tropicalis compared to the broth microdilution
reference method. | | | | | | | | | | | | | |
7
Abbreviations - Bo = breakpoint committee; EA = essential agreement; VME = Very Major Error(susceptbleresult withesistantreferenceresult; ME Major Enror (resistant with succeptible reference result); mE = minor (susceptible or resistant result, or an intermediate result, or an internediate result, or an internedia 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-Yeast Fluconazole (≤ 0.5 –>64 µg/mL) is substantially equivalent to VITEK® 2 AST-Yeast Fluconazole (K133817).
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.