(71 days)
K0991810
Not Found
No
The description focuses on automated quantitative susceptibility testing using a miniaturized doubling dilution technique and monitoring growth over time. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is a laboratory aid for in vitro susceptibility testing, which helps determine the effectiveness of antifungal agents but does not directly treat a condition.
Yes
This device is designed for antifungal susceptibility testing of Candida species to determine their in vitro susceptibility to antifungal agents, which aids in diagnosing the effectiveness of specific treatments against the infection.
No
The device description explicitly mentions "VITEK 2 AST Cards" which are physical components containing antifungal medium and are filled, sealed, and incubated by the VITEK 2 System. This indicates the device includes hardware components beyond just software.
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 "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details how the device tests isolated colonies of Candida species in a laboratory setting using a miniaturized microdilution methodology. This process is performed on samples taken from a patient, but the testing itself is done outside the patient's body.
- Performance Studies: The performance studies compare the device's results to a "CLSI reference method," which is a standard laboratory method for susceptibility testing. This further confirms its use in a diagnostic laboratory context.
- Predicate Device: The predicate device listed, YEASTONE® Fluconazole, is also an IVD used for similar susceptibility testing.
Therefore, based on the provided information, the VITEK® 2 Yeast Fluconazole is clearly 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. VITEK 2 Yeast Fluconazole is a quantitative test. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antifungal agents.
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 (comma separated list FDA assigned to the subject device)
NGZ
Device Description
VITEK® 2 Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. The antifungal presented in the VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in ug/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 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 monitors the growth of each well in the card over a defined period of time (up to 36 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 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 Yeast Fluconazole 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 Fluconazole, 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 Fluconazole by comparing its performance with the CLSI reference method incubated at 24 and at 48 hrs. VITEK 2 Yeast Fluconazole demonstrated acceptable performance of 97.6% overall Essential Agreement with the reference method incubated for 24 hrs; and 97.1 % overall Essential Agreement with the reference method incubated for 48 hrs. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
97.6% overall Essential Agreement with the reference method incubated for 24 hrs; and 97.1 % overall Essential Agreement with the reference method incubated for 48 hrs.
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.
K0991810
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).
0
L061945
Image /page/0/Picture/1 description: The image shows the logo for bioMérieux. The logo consists of the company name in a sans-serif font, with a stylized graphic above it. The graphic is a circle that is bisected by a curved line, with one half of the circle filled with vertical lines.
SEP 1 9 2006
510(k) SUMMARY
VITEK® 2 Yeast Fluconazole
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Nancy Weaver |
| Staff Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8695 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | July 6, 2006 |
| Device Name: |
B. De
| Formal/Trade Name: | VITEK® 2 Yeast Fluconazole |
|---|---|
| Classification Name: | 21 CFR 866.1640 |
| Antimicrobial Susceptibility Test | |
| Common Name: | VITEK 2 AST-YS Fluconazole |
| C. Predicate Device: | YEASTONE® (K0991810) Fluconazole |
D. 510(k) Summary:
.
VITEK® 2 Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. The antifungal presented in the VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in ug/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 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 monitors the growth of each well in the card over a defined period of time (up to 36 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 antifungal contained on the card.
1
VITEK 2 Yeast Fluconazole 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 Fluconazole, 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 Fluconazole by comparing its performance with the CLSI reference method incubated at 24 and at 48 hrs. VITEK 2 Yeast Fluconazole demonstrated acceptable performance of 97.6% overall Essential Agreement with the reference method incubated for 24 hrs; and 97.1 % overall Essential Agreement with the reference method incubated for 48 hrs. Reproducibility and Quality Control demonstrated acceptable results.
2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 9 2006
Ms. Nancy Weaver Staff Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
Re: K061945
Trade/Device Name: VITEK® 2 Yeast Fluconazole (1 - 64 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system Regulatory Class: Class II Product Code: NGZ Dated: July 6, 2006
Received: July 10, 2006
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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Sally, artom
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name; VITEK® 2 Yeast Fluconazole (1 - 64 µg/ml)
Indications For Use:
VITEK® 2 Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species. VITEK 2 Yeast Fluconazole is a quantitative test. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antifungal agents.
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 x (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)
Lueddin T. Poole
vision Sign-Of
Office of In Vitro Diagnostic Device Evaluation and Safety
p. 10
510(k) K061945