(284 days)
No
The description focuses on automated quantitative susceptibility testing based on growth monitoring and comparison to a reference method, with no mention of AI or ML algorithms for analysis or interpretation.
No.
This device is designed for in vitro diagnostic (IVD) use to determine antifungal susceptibility, aiding in the selection of appropriate antifungal agents, but it does not directly treat or prevent a disease or condition in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for antifungal susceptibility testing of Candida species" and "a laboratory aid in the determination of in vitro susceptibility to antifungal agents." This indicates its use in identifying the susceptibility of microorganisms to specific drugs, which is a diagnostic function.
No
The device description explicitly mentions physical components like "VITEK 2 AST Cards" containing antifungal medium, and the process involves rehydrating this medium with a diluted isolate, filling and sealing cards, and incubation. This indicates a hardware component (the cards and the VITEK 2 system) is integral to the device's function, not just software.
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 a "laboratory aid in the determination of in vitro susceptibility to antifungal agents." This clearly indicates that the device is used to perform tests on samples taken from the human body (in this case, isolated colonies of Candida species) outside of the body (in vitro) to provide information for diagnosis or treatment.
- Device Description: The description details how the device works by testing isolated colonies in a miniaturized microdilution methodology. This process is a standard in vitro diagnostic technique for determining antimicrobial susceptibility.
- Performance Studies: The performance studies compare the device's results to a "CLSI reference method," which is a recognized standard for in vitro diagnostic testing in microbiology. The metrics used (Essential Agreement and category agreement) are also standard metrics for evaluating the performance of IVD susceptibility tests.
- Predicate Device: The predicate device listed (K061945; VITEK® 2 Yeast Fluconazole) is also an IVD for antifungal susceptibility testing, further supporting the classification of this device as an IVD.
- Intended User / Care Setting: The intended user is a "laboratory aid," which aligns with the use of IVDs in clinical laboratories.
The device performs a test on a biological sample (isolated colonies of microorganisms) outside of the body to provide information relevant to a patient's condition (susceptibility to antifungal agents), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Yeast Voriconazole is designed for antifungal susceptibility testing of Candida species. VITEK 2 Yeast Voriconazole 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. Voriconazole has been shown to be active against most strains of the following microorganisms listed below according to the FDA label for the antifungal.
Active in vitro and in clinical infections Candida albicans Candida krusei Candida parapsilosis Candida tropicalis
Active in vitro but their clinical significance is uknown: Candida lusitaniae Candida guilliermondii
The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, S. pneumoniae and clinically significant yeast.
Product codes
NGZ
Device Description
The antifungal 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 isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antifungal medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 36 hours for yeast). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antifungal 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
laboratory aid
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® 2 Yeast Voriconazole by comparing its performance with the CLSI reference method incubated at 24 and at 48 hrs.
Summary of Performance Studies
VITEK 2 Yeast Voriconazole demonstrated substantially equivalent performance when compared with the CLSI reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued Feb. 5, 2003.
The Premarket Notification (510(k)) presents data in support of VITEK® 2 Yeast Voriconazole. 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® 2 Yeast Voriconazole by comparing its performance with the CLSI reference method incubated at 24 and at 48 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK® 2 Yeast Voriconazole demonstrated acceptable performance of 99.2% overall Essential Agreement and 99.2% overall category agreement with the reference method incubated for 24 hrs. With the reference method incubated 48 hrs the overall Essential Agreement was 96.9% and overall category agreement was 98.7%. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics
99.2% overall Essential Agreement and 99.2% overall category agreement (24 hrs)
96.9% overall Essential Agreement and 98.7% overall category agreement (48 hrs)
Predicate Device(s)
Reference Device(s)
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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Image /page/0/Picture/0 description: The image shows the logo for bioMerieux. The logo consists of a stylized circle that is split into two halves. The left half of the circle has horizontal lines, while the right half is solid black. The text "BIOMERIEUX" is written in a stylized font below the circle.
X092454
510(k) SUMMARY
VITEK® 2 Yeast Voriconazole
510(k) Submission Information:
MAY 2 1 2010
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Nancy Weaver |
| Associate Director, Regulatory Affairs | |
| Phone Number: | 314 -731-8695 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | August 06, 2009 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Yeast Voriconazole |
| Classification Name: | 21 CFR 866.1640 |
| Antimicrobial Susceptibility Test | |
| Product Code NGZ | |
| Common Name: | VITEK® 2 AST-YS Voriconazole |
| C. Predicate Device: | VITEK® 2 Yeast Fluconazole (K061945) |
D. 510(k) Summary:
VITEK® 2 Yeast Voriconazole is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Voriconazole is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a Íaboratory aid in the determination of in vitro susceptibility to antifungal agents. Voriconazole has been shown to be active against most strains of the following microorganisms listed below according to the FDA label for the antifungal.
| Candida albicans | Candida tropicalis |
|---|---|
| Candida krusei | Candida lusitaniae |
| Candida parapsilosis | Candida guilliermondii |
The antifungal 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 isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antifungal medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 36 hours for
bioMérieux, Inc. 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700 http://www.biomerieux-usa.com
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yeast). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antifungal contained on the card.
VITEK 2 Yeast Voriconazole demonstrated substantially equivalent performance when compared with the CLSI reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued Feb. 5, 2003.
The Premarket Notification (510(k)) presents data in support of VITEK® 2 Yeast Voriconazole. 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® 2 Yeast Voriconazole by comparing its performance with the CLSI reference method incubated at 24 and at 48 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK® 2 Yeast Voriconazole demonstrated acceptable performance of 99.2% overall Essential Agreement and 99.2% overall category agreement with the reference method incubated for 24 hrs. With the reference method incubated 48 hrs the overall Essential Agreement was 96.9% and overall category agreement was 98.7%. Reproducibility and Quality Control demonstrated acceptable results.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Biomerieux, Inc. c/o Nancy Weaver Associate Director, Regulatory Affairs 595 Anglum Rd. Hazelwood, Missouri 63042
MAY 2 1 2010
| Re: | K092454 |
|---|---|
| Trade/Device Name: | Vitek ®2 Yeast Voriconazole |
| Regulation Number: | 21CFR §866.1640 |
| Regulation Name: | Antifungal susceptibility of Candida species to Voriconazole |
| Regulatory Class: | Class II |
| Product Code: | NGZ |
| Dated: | May 10, 2010 |
| Received: | May 11, 2010 |
Dear Ms. Weaver:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such 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. This letter will allow you to begin marketing your device as described in your Section
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510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Saly aath
Sally A. Hojvat, M.Sc., Ph.I Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_ KO9 2 459
Device Name: VITEK 2 Yeast Voriconazole (0.12 - 8 µg/ml)
Indications For Use:
VITEK® 2 Yeast Voriconazole is designed for antifungal susceptibility testing of Candida species. VITEK 2 Yeast Voriconazole 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. Voriconazole has been shown to be active against most strains of the following microorganisms listed below according to the FDA label for the antifungal.
Active in vitro and in clinical infections Candida albicans Candida krusei Candida parapsilosis Candida tropicalis
Active in vitro but their clinical significance is uknown: Candida lusitaniae Candida guilliermondii
The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, S. pneumoniae and clinically significant yeast.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD)
Freddie M. Cooke
Luvision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KD92454
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