MALDI BIOTYPER CA (MBT-CA) SYSTEM is an AI-enabled medical device from BRUKER DALTONICS, INC that the U.S. FDA cleared through 510(k) K130831 on November 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 | K130831 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | BRUKER DALTONICS, INC |
| Lead review panel | Microbiology |
| Primary product code | PEX — System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Applicant (openFDA) | Bruker Daltonics, Inc. |
| Applicant location | Beverly, MA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 866.3361 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. MALDI BIOTYPER CA (MBT-CA) SYSTEM went through this pathway (K130831).
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 #2 of 2 under that code. BRUKER DALTONICS, 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.