VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
Device Facts
| Record ID | K181368 |
|---|---|
| Device Name | VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) |
| Applicant | bioMerieux, Inc. |
| Product Code | NGZ · Microbiology |
| Decision Date | Jun 20, 2018 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
Intended Use
VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin 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 antimicrobial agents. VITEK® 2 Yeast Micafungin 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 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., S. pneumoniae, and clinically significant yeast.
Device Story
VITEK 2 AST-YS Micafungin is an automated, quantitative antimicrobial susceptibility test (AST) for Candida species. Used in clinical laboratories with VITEK 2 or VITEK 2 COMPACT systems. Device processes isolated yeast colonies to determine in vitro susceptibility to micafungin. System provides quantitative results to clinicians, aiding in the selection of appropriate antifungal therapy. This specific submission modifies the expected quality control (QC) range for C. parapsilosis ATCC 22019 (0.5-2 µg/mL to 0.25-1 µg/mL) based on CLSI M23 study data. No changes to fundamental technology or device design.
Clinical Evidence
Bench testing only. Validation of the modified QC range for C. parapsilosis ATCC 22019 was performed following CLSI M23 guidelines to establish the new expected range of 0.25-1 µg/mL.
Technological Characteristics
Automated yeast antifungal susceptibility test; uses VITEK 2 AST-YS07 cards; saline suspension inoculum; Discriminate Analysis algorithm; VITEK 2/VITEK 2 Compact instrument platform; manual dilution method.
Indications for Use
Indicated for antifungal susceptibility testing of Candida species (C. albicans, C. glabrata, C. guilliermondii, C. krusei, C. parapsilosis, C. tropicalis) using isolated colonies to determine in vitro susceptibility to antimicrobial agents.
Regulatory Classification
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.
Predicate Devices
- VITEK2 AST-YS Micafungin (K151923)
Related Devices
- K151923 — VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) · bioMerieux, Inc. · Mar 25, 2016
Submission Summary (Full Text)
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June 20, 2018
bioMerieux, Inc. Jolyn Tenllado Regulatory Affairs Expert 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K181368
Trade/Device Name: VITEK 2 AST-YS Micafungin (≤0.06 - ≥8 µg/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: NGZ, LRG, LTT, LTW Dated: May 22, 2018 Received: May 23, 2018
Dear Jolyn Tenllado:
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 Part 801 and Part 809); medical device 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
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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
#### 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
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# Indications for Use
510(k) Number (if known) K181368
#### Device Name
VITEK® 2 AST-YS Micafungin (≤0.06 ->8 ug/mL)
#### Indications for Use (Describe)
VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin 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 antimicrobial agents. VITEK® 2 Yeast Micafungin 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 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., S. pneumoniae, and clinically significant yeast.
Type of Use (Select one or both, as applicable)
| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------|
| <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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Image /page/3/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a blue semi-circle at the top with the company name "BIOMÉRIEUX" in white letters. Below the blue semi-circle is a yellow semi-circle that transitions into a green color on the right side.
## 510(k) SUMMARY
## VITEK 2 AST-YS Micafungin Special 510(k): Device Modification
## 510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|----------------------|-----------------------------------------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Jolyn Tenllado<br>RA Expert, Global Regulatory Affairs Microbiology |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | May 22, 2018 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK 2 AST-Yeast Micafungin (≤0.06 – ≥8 µg/mL) |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device, 21 CFR 866.1645 |
| Common Name: | VITEK 2 AST-YS Micafungin |
| C. Predicate Device: | VITEK 2 AST-YS Micafungin (K151923) |
### D. 510(k) Summary:
VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test 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 aqents. VITEK® 2 Yeast Micafungin 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 clinical infections: Candida albicans Candida qlabrata Candida quilliermondii 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 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.
## bioMérieux, Inc.
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The intended use of the VITEK 2 AST-YS Micafungin, as described in its labeling (package insert), has not changed as a result of this modification to change the expected QC range for QC organism C. parapsilosis ATCC 22019 from 0.5-2 µg/mL to 0.25-1 µg/mL based on a completed CLSI M23 study to establish the new QC range. This modification does not affect the fundamental scientific technology of this device. The device design was not altered in any way.
The VITEK 2 AST-YS Micafungin modified device, to change the QC organism C. parapsilosis ATCC 22019 expected QC range from 0.5-2 µg/mL to 0.25-1 µg/mL, demonstrated acceptable performance during risk assessment validation studies. Validation of the modified QC range and QC performance with the modified range has now been established. This Special 510(k) Device Modification presents data in support of the VITEK AST-YS Micafungin QC organism expected range change, and corresponding labeling changes, allowing a substantial equivalence decision when compared with the VITEK 2 AST-YS Micafungin unmodified device cleared under K151923.
