(28 days)
No
The document describes an automated system for antifungal susceptibility testing but does not mention AI or ML in its description, intended use, or performance studies. The focus is on the quantitative measurement of susceptibility and comparison to a predicate device.
No
The device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents" and is used for "antifungal susceptibility testing," not for direct treatment or diagnosis of a condition in a patient.
Yes
Explanation: The device is described as 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," which directly supports diagnostic purposes by providing information for the treatment of infections.
No
The device description explicitly states it is a "quantitative test intended for use with the VITEK® 2 and VITEK® 2 COMPACT Systems," which are hardware systems used for automated susceptibility testing. The submission describes a modification to the QC range and labeling, not a standalone software product.
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 antimicrobial agents." This means it is used to test samples outside of the body (in vitro) to help diagnose or monitor a condition (in this case, susceptibility to antifungal agents).
- Device Description: The description reinforces its use for "antifungal susceptibility testing of Candida species," which is a diagnostic process performed in a laboratory.
- Predicate Device: The mention of a predicate device (K151923) which is also an AST (Antimicrobial Susceptibility Test) device further indicates its classification as an IVD. AST devices are a common type of IVD.
- Care Setting: The intended user is described as a "laboratory aid," which aligns with the typical setting for IVD testing.
Therefore, based on the provided information, the VITEK® 2 Yeast Micafungin clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
NGZ, LRG, LTT, LTW
Device Description
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. The modification described in this submission changes 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. The device design was not altered in any way beyond this change in the QC range and corresponding labeling.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
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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
1
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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenllado |
| 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 |
| 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.
4
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.