(232 days)
K05002
No
The description focuses on automated quantitative/qualitative susceptibility testing using a miniaturized dilution technique and monitoring growth, with no mention of AI or ML algorithms for analysis or interpretation.
No.
This device is designed for antifungal susceptibility testing to determine the in vitro susceptibility of microorganisms to antifungal agents, acting as a laboratory aid. It does not directly treat or diagnose a patient, which is characteristic of a therapeutic device.
Yes
This device is designed for antifungal susceptibility testing of Candida species, providing quantitative results to determine in vitro susceptibility to antifungal agents, which aids in diagnosing the effectiveness of treatments for infections.
No
The device description explicitly mentions "VITEK 2 AST Cards" which are physical components containing antimicrobial medium. The process involves rehydrating this medium and placing the card into a VITEK 2 System, indicating a hardware component is integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "laboratory aid in the determination of in vitro susceptibility to antifungal agents." "In vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Device Description: The description details how the device tests isolated colonies of yeast in a laboratory setting using a miniaturized microdilution technique.
- Function: The device determines the susceptibility of microorganisms to antifungal agents, which is a classic function of an IVD used to guide treatment decisions.
- Performance Studies: The performance studies compare the device's results to a reference laboratory method (CLSI broth microdilution), further confirming its use in a laboratory setting for diagnostic purposes.
Therefore, based on the provided information, the VITEK® 2 Yeast Fluconazole device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species and is a quantitative test 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 Yeast Fluconazole has been shown to be active against most isolates 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 guilliermii Candida lusitaniae
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococus spp., Enterococcus spp. and clinically significant yeast.
Product codes
NGZ
Device Description
VITEK 2 AST - Yeast Fluconazole is designed for an antifungal susceptibility testing of Candida species and is a quantitative test intended for use with the VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The 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.
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
Not Found
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 and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK AST - Yeast Fluconazole for Candida species by comparing its performance with the CLSI broth microdilution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 AST - Yeast Fluconazole for Candida species demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued August 28, 2009. The data is representative of performance on both the VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), k05002. VITEK 2 AST - Yeast Fluconazole for Candida species demonstrated acceptable performance of 96.0% overall Essential Agreement and 94.6% overall Category Agreement.
Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: 96.0%
Category Agreement: 94.6%
Predicate Device(s)
Reference Device(s)
K05002
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BIOMERIEUX, INC. JOCELYN JENNINGS, M.S., R.A.C. SENIOR MANAGER, REGULATORY AFFAIRS 100 RODOLPHE ST DURHAM NC 27712
August 5, 2014
Re: K133817
Trade/Device Name: VITEK 2 AST - Yeast Fluconazole Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: NGZ Dated: July 17, 2014 Received: July 18, 2014
Dear Ms. Jennings:
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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Uwe Scherf -S for
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K133817
Device Name VITEK® 2 AST-YS Fluconazole ( ≤ 0.5 -> 64 ug/mL)
Indications for Use (Describe)
VITEK® 2 Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species and is a quantitative test 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 Yeast Fluconazole has been shown to be active against most isolates 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
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococus spp., Enterococcus spp. and clinically significant yeast.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Ribhi Shawar -S 2014.08.04 11:23:39 -0
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Section 8. 510(k) SUMMARY
VITEK® 2 AST- Yeast Fluconazole
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 100 Rodolphe Street |
| Durham, NC 27712 | |
| Contact Person: | Jocelyn Jennings |
| Senior Manager, Regulatory Affairs | |
| Phone Number: | 919-620-2894 |
| Fax Number: | 919-620-2548 |
| Date of Preparation: | December 13, 2013 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST - Yeast Fluconazole |
| Classification Name: | 21 CFR 866.1640 |
| Antimicrobial Susceptibility Test Powder | |
| Susceptibility Test Plate, Antifungal | |
| Product Code NGZ | |
| Common Name: | VITEK® 2 AST - Yeast Fluconazole |
| C. Predicate Device: | VITEK® 2 AST - Yeast Voriconazole (K092454) |
D. 510(k) Summary:
VITEK 2 AST - Yeast Fluconazole is designed for an antifungal susceptibility testing of Candida species and is a quantitative test intended for use with the VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The 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 - Yeast Fluconazole for Candida species demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued August 28, 2009.
5
The Premarket Notification (510(k)) presents data in support of VITEK 2 AST - Yeast Fluconazole for Candida species. An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK AST - Yeast Fluconazole for Candida species by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), k05002. VITEK 2 AST - Yeast Fluconazole for Candida species demonstrated acceptable performance of 96.0% overall Essential Agreement and 94.6% overall Category Agreement. Due to performance obtained for Fluconazole with C. glabrata the following limitation will appear on the second page of the package insert:
"Perform an alternative method of testing prior to reporting of results for the following antibiotic/orqanism combination(s)":
- Fluconazole: C. glabrata, C. kefyr ●
Reproducibility and Quality Control demonstrated acceptable results.