PMT — Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens Class II
FDA product code PMT covers "Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens", a Class II medical device regulated under 21 CFR 866.3215. Submissions are reviewed by the Microbiology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PMT
- Device Class
- Class II
- Regulation Number
- 866.3215
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K200236 | ortho clinical diagnostics | VITROS BRAHMS PCT Reagent Pack and Calibrators | February 25, 2020 |
| K181002 | siemens healthcare diagnostics | Atellica IM BRAHMS Procalcitonin (PCT) | July 16, 2018 |
| K160911 | biomerieux | VIDAS B.R.A.H.M.S. PCT (PCT) | June 28, 2016 |
| K160729 | roche diagnostics | Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 | June 13, 2016 |
| DEN150009 | brahms | B.R.A.H.M.S PCT sensitive KRYPTOR | February 20, 2016 |