(239 days)
Not Found
No
The description details a miniaturized doubling dilution technique and automated monitoring of growth, which are standard laboratory methods and do not indicate the use of AI or ML. There is no mention of AI, ML, or related terms in the document.
No.
The device is described as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents, specifically for antimicrobial susceptibility testing of yeast species. It does not administer treatment.
Yes
The device is designed for antimicrobial susceptibility testing of clinically significant yeast species, specifically to aid in the determination of in vitro susceptibility to antimicrobial agents. This process involves the analysis of biological samples (yeast isolates) to provide information about the susceptibility of microorganisms to drugs, which directly contributes to diagnosing and guiding treatment decisions for infections.
No
The device description explicitly details physical components like "AST Cards," "wells," and the "VITEK® 2 and VITEK® 2 Compact Systems" which are instruments that fill, seal, incubate, and read the cards. This indicates a hardware component is integral to the device's function.
Based on the provided information, the VITEK® 2 Yeast Flucytosine is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it is "designed for antimicrobial susceptibility testing of clinically significant yeast species" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates testing is performed in vitro (outside the body) on biological samples (yeast isolates) to provide information for diagnosis or treatment decisions.
- Device Description: The description details a method for testing isolates in a laboratory setting using a miniaturized microdilution technique.
- 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.
- Predicate Device: The mention of a predicate device (K092454; VITEK® 2 AST-YS Voriconazole) which is also an AST card, further supports its classification as an IVD.
The core function of the device is to perform a test on a biological sample in vitro to provide information relevant to a clinical condition (susceptibility to an antimicrobial agent), which is the definition of an IVD.
N/A
Intended Use / Indications for Use
VITEK® 2 Yeast Flucytosine is designed for antimicrobial susceptibility testing of clinically significant yeast 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 antimicrobial agents. VITEK® 2 Yeast Flucytosine is a quantitative test. Flucytosine 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
The following in vitro data are available, but their clinical significance is unknown. Candida dubliniensis Candida glabrata Candida guilliermondii Candida lusitaniae Candida parapsilosis Candida tropicalis
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 (comma separated list FDA assigned to the subject device)
NGZ
Device Description
VITEK® 2 Yeast Flucytosine is designed for antimicrobial 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 antimicrobial agents. VITEK® 2 Yeast Flucytosine is a quantitative test. Flucytosine 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
The following in vitro data are available, but their clinical significance is unknown. Candida dubliniensis Candida qlabrata Candida quilliermondii Candida Iusitaniae Candida parapsilosis Candida tropicalis
The antimicrobial presented in VITEK® 2 AST-YS 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 - 0.50% saline before being used to rehydrate the antimicrobial 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 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial 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, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-YS Flucytosine by comparing its performance with the CLSI broth microdilution reference method incubated at 48 hrs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-YS Flucytosine 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.
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 Flucytosine by comparing its performance with the CLSI broth microdilution reference method incubated at 48 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-YS Flucitosine demonstrated acceptable performance of 98.8% overall Essential Agreement and 98.5% overall Category Agreement for Candida species. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
98.8% overall Essential Agreement and 98.5% overall Category Agreement for Candida species.
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-YS Voriconazole (K092454)
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2014
BIOMERIEUX, INC. JOCELYN JENNINGS, M.S., R.A.C. SENIOR MANAGER, REGULATORY AFFAIRS 100 RODOLPHE ST DURHAM NC 27712
Re: K133952
Trade/Device Name: VITEK 2 AST - Yeast Flucytosine Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: NGZ Dated: August 5, 2014 Received: August 6, 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,
Sally A. Hojvat -S
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) K133952
Device Name VITEK® 2 AST-YS Flucytosine ( ≤ 1 -> 64 ug/mL )
Indications for Use (Describe)
VITEK® 2 Yeast Flucytosine is designed for antimicrobial susceptibility testing of clinically significant yeast 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 antimicrobial agents. VITEK® 2 Yeast Flucytosine is a quantitative test. Flucytosine 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
The following in vitro data are available, but their clinical significance is unknown. Candida dubliniensis Candida glabrata Candida guilliermondii Candida lusitaniae Candida parapsilosis Candida tropicalis
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)
Sally A. Hojvat -S 2014.08.19 15:09:22 -04
3
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4
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510(k) SUMMARY
VITEK® 2 AST-YS Flucytosine
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 19, 2013 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-YS Flucytosine |
| Classification Name: | 21 CFR 866.1640 |
| Antimicrobial Susceptibility Test | |
| Product Code: NGZ | |
| Common Name: | VITEK® 2 AST-YS Flucytosine |
| C. Predicate Device: | VITEK® 2 AST-YS Voriconazole (K092454) |
D. 510(k) Summary:
VITEK® 2 Yeast Flucytosine is designed for antimicrobial 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 antimicrobial agents. VITEK® 2 Yeast Flucytosine is a quantitative test. Flucytosine 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
The following in vitro data are available, but their clinical significance is unknown. Candida dubliniensis Candida qlabrata Candida quilliermondii Candida Iusitaniae Candida parapsilosis Candida tropicalis
The antimicrobial presented in VITEK® 2 AST-YS Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized
bioMérieux, Inc.
5
2
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 - 0.50% saline before being used to rehydrate the antimicrobial 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 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.
VITEK® 2 AST-YS Flucytosine 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 510(k) presents data in support of VITEK® 2 AST-YS Flucytosine. 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 Flucytosine by comparing its performance with the CLSI broth microdilution reference method incubated at 48 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-YS Flucitosine demonstrated acceptable performance of 98.8% overall Essential Agreement and 98.5% overall Category Agreement for Candida species. Reproducibility and Quality Control demonstrated acceptable results.
•