(227 days)
Not Found
No
The description focuses on automated quantitative or qualitative susceptibility testing based on monitoring growth in miniaturized dilution wells, which is a standard microbiological technique, not AI/ML. There is no mention of AI, ML, or related terms in the provided text.
No.
This device is intended for in vitro susceptibility testing as a laboratory aid, not for direct therapeutic intervention on a patient. It helps determine the effectiveness of antifungal agents but does not treat a condition itself.
Yes
The device is designed for antifungal susceptibility testing of Candida species to determine in vitro susceptibility to antimicrobial agents, which aids in diagnosing the susceptibility of microorganisms to certain drugs.
No
The device description clearly details physical components (AST Cards, saline, incubator/reader) and a process involving rehydrating media, filling, sealing, and incubating cards, indicating it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: 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 antimicrobial agents." This clearly indicates it's used to test samples in vitro (outside the body) to provide information about a patient's condition (susceptibility to antifungal agents).
- Device Description: The description details a process of testing an "isolate to be tested" (presumably from a patient sample) 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 determining antimicrobial susceptibility.
- Intended User / Care Setting: The intended user is a "laboratory aid," further confirming its use in a clinical laboratory setting for diagnostic purposes.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-YS 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 antimicrobial agents. VITEK® 2 Yeast Caspofungin is a quantitative test. Caspofungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifyingal.
Active in vitro and clinical infections: Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis
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 spp., S. pneumoniae, and clinically significant yeast.
Product codes
NGZ, LRG, LTT, LTW
Device Description
VITEK® 2 AST-YS 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 antimicrobial agents. VITEK® 2 Yeast Caspofungin is a quantitative test. Caspofungin 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 glabrata, Candida guilliermondii, Candida krusei, 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, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.
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
laboratory aid
Description of the training 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 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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 hrs. 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 99.7% overall essential Agreement and 99.8% overall category agreement for Candida species. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics
99.7% overall essential Agreement and 99.8% overall category agreement for Candida species.
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2016
BIOMÉRIEUX INC KAREN RUSSELL STAFF REGULATORY AFFAIRS SPECIALIST 595 ANGLUM ROAD HAZELWOOD MO 63042
Re: K151817
Trade/Device Name: VITEK® 2 AST-YS Caspofungin ≤ 0.125 - ≥ 8ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: NGZ, LRG, LTT, LTW Dated: February 3, 2016 Received: February 5, 2016
Dear Ms. Russell:
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.
Ribhi Shawar -S
For Uwe Scherf, 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) K151817
Device Name VITEK® 2 AST-YS Caspofungin ( 8 µg/mL)
Indications for Use (Describe)
VITEK® 2 AST-YS 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 antimicrobial agents. VITEK® 2 Yeast Caspofungin is a quantitative test. Caspofungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifyingal.
Active in vitro and clinical infections: Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis
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 spp., S. pneumoniae, and clinically significant yeast.
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
SECTION 8. 510(k) SUMMARY
510(k) SUMMARY VITEK®2 AST-YS Caspofungin
510(k) Submission Information:
Submitter's Name: bioMérieux, Inc.
| Address: | 595 Anglum Road
Hazelwood, MO 63042 | |
| ---------- | ---------------------------------------- | -- |
|---|
| Contact Person: | Karen Russell |
|---|---|
| Staff Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8639 |
| Fax Number: | 314-731-8689 |
Date of Preparation: July 2, 2015
B. Device Name:
Formal/Trade Name: VITEK® 2 AST-YEAST Caspofungin
| Classification Name: | 21 CFR 866.1640
Antimicrobial susceptibility test powder |
|----------------------|-------------------------------------------------------------|
| Product Code | NGZ |
| Common Name: | VITEK® 2 AST-YS Caspofungin |
C. Predicate Device: VITEK® 2 AST-YS Flucytosine (K133952)
D. 510(k) Summary:
VITEK® 2 AST-YS 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 antimicrobial agents. VITEK® 2 Yeast Caspofungin is a quantitative test. Caspofungin 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 krusei |
| Candida glabrata | Candida parapsilosis |
| Candida guilliermondii | Candida tropicalis |
4
VITEK® 2 AST-YS Caspofungin Traditional 510(k) Submission
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, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.
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.
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 (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 hrs. 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 99.7% overall essential Agreement and 99.8% overall category agreement for Candida species. Reproducibility and Quality Control demonstrated acceptable results.