VITEK MS is an AI-enabled medical device from BIOMERIEUX, INC. that the U.S. FDA granted through De Novo DEN130013 on August 21, 2013. Its lead review panel is Microbiology and its primary product code is PEX (System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates).
Key facts
| Submission number | DEN130013 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | BIOMERIEUX, INC. |
| Lead review panel | Microbiology |
| Primary product code | PEX — System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Applicant (openFDA) | bioMerieux, Inc. |
| Applicant location | Hazelwood, MO, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 866.3361 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. VITEK MS went through this pathway (DEN130013).
openFDA lists it as a Class 2 device under 21 CFR 866.3361. Class II devices are moderate risk and are subject to general and special controls.
Product code PEX covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. BIOMERIEUX, INC. has 1 AI-enabled device on the list, and the Microbiology panel accounts for 7 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.