FDA product code PEX: System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
PEX is the FDA product code for system, mass spectrometry, maldi tof, microorganism identification, cultured isolates. It is a Class II device, regulated under 21 CFR 866.3361 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under PEX, from 3 different applicants. The average 510(k) review took 230 days (median 231). 1 De Novo request was granted under it. FDA has posted 3 recalls for PEX devices, 3 initiated in the last five years.
Definition
A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
Classification
| Field | Value |
|---|---|
| Device name | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Device class | Class II |
| Regulation | 21 CFR 866.3361 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PEX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 246 |
Compare with all 510(k) review times · Search every PEX clearance
Top PEX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bruker Daltonics, Inc. | 2 | 2015-03-27 |
| Bruker Daltonik GmbH | 1 | 2017-07-26 |
| bioMerieux, Inc. | 1 | 2017-07-22 |
Most recent PEX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163536 | Bruker Daltonik GmbH | MALDI Biotyper CA (MBT-CA) System, MBT smart CA System | 2017-07-26 | 222 |
| K162950 | bioMerieux, Inc. | VITEK MS | 2017-07-22 | 271 |
| K142677 | Bruker Daltonics, Inc. | MALDI Biotyper CA System | 2015-03-27 | 189 |
| K130831 | Bruker Daltonics, Inc. | MALDI BIOTYPER CA (MBT-CA) SYSTEM | 2013-11-21 | 240 |
Recalls for PEX devices
3 product recalls in 1 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2022 | 3 |
Frequently asked questions
What is FDA product code PEX?
PEX is the FDA product code for system, mass spectrometry, maldi tof, microorganism identification, cultured isolates. It is a Class II device, regulated under 21 CFR 866.3361 and reviewed by the Microbiology panel.
What device class is PEX?
Class II, regulation 21 CFR 866.3361. Typical premarket route: 510(k).
How long does a 510(k) take for product code PEX?
Across 4 cleared submissions the average was 230 days from receipt to decision (median 231).
Which companies have the most PEX clearances?
Bruker Daltonics, Inc. (2); Bruker Daltonik GmbH (1); bioMerieux, Inc. (1).
Have PEX devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code PEX
- Run a recall and safety report across every PEX manufacturer
- Watch product code PEX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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