Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
The Device To Detect And Measure Procalcitonin (PCT) In Human Clinical Specimens (product code PMT) is a Class 2 microbiology in vitro diagnostic device that determines the level of procalcitonin in human serum and plasma as an aid in assessing mortality risk for patients diagnosed with severe sepsis or septic shock, regulated under 866.3215. It requires 510(k) clearance. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PMT
- Device Class
- FDA class 2
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K200236 | VITROS BRAHMS PCT Reagent Pack and Calibrators | Feb 25, 2020 | Substantially Equivalent | Ortho Clinical Diagnostics |
| K181002 | Atellica IM BRAHMS Procalcitonin (PCT) | Jul 16, 2018 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K160911 | VIDAS B.R.A.H.M.S. PCT (PCT) | Jun 28, 2016 | Substantially Equivalent | bioMerieux, Inc. |
| K160729 | Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 | Jun 13, 2016 | Substantially Equivalent | Roche Diagnostics |
| DEN150009 | B.R.A.H.M.S PCT sensitive KRYPTOR | Feb 20, 2016 | Unknown | Brahms GmbH |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.