FDA product code PMT: Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
PMT is the FDA product code for device to detect and measure procalcitonin (pct) in human clinical specimens. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under PMT, from 4 different applicants. The average 510(k) review took 74 days (median 88). 1 De Novo request was granted under it. FDA has posted 1 recall for PMT devices.
Definition
An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.
Classification
| Field | Value |
|---|---|
| Device name | Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens |
| Device class | Class II |
| Regulation | 21 CFR 866.3215 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PMT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 91 |
| 2020 | 1 | 26 |
Compare with all 510(k) review times · Search every PMT clearance
Top PMT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ortho Clinical Diagnostics | 1 | 2020-02-25 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 2018-07-16 |
| bioMerieux, Inc. | 1 | 2016-06-28 |
| Roche Diagnostics | 1 | 2016-06-13 |
Most recent PMT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200236 | Ortho Clinical Diagnostics | VITROS BRAHMS PCT Reagent Pack and Calibrators | 2020-02-25 | 26 |
| K181002 | Siemens Healthcare Diagnostics, Inc. | Atellica IM BRAHMS Procalcitonin (PCT) | 2018-07-16 | 91 |
| K160911 | bioMerieux, Inc. | VIDAS B.R.A.H.M.S. PCT (PCT) | 2016-06-28 | 88 |
| K160729 | Roche Diagnostics | Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 | 2016-06-13 | 89 |
Recalls for PMT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-22.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code PMT?
PMT is the FDA product code for device to detect and measure procalcitonin (pct) in human clinical specimens. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel.
What device class is PMT?
Class II, regulation 21 CFR 866.3215. Typical premarket route: 510(k).
How long does a 510(k) take for product code PMT?
Across 4 cleared submissions the average was 74 days from receipt to decision (median 88).
Which companies have the most PMT clearances?
Ortho Clinical Diagnostics (1); Siemens Healthcare Diagnostics, Inc. (1); bioMerieux, Inc. (1); Roche Diagnostics (1).
Have PMT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-12-22.
Next steps
- Run an FDA pathway report with predicate devices for product code PMT
- Run a recall and safety report across every PMT manufacturer
- Watch product code PMT 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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