Antigen, Inflammatory Response Marker, Sepsis
The Sepsis Inflammatory Response Marker Antigen device is an immunoluminometric assay used to determine the concentration of procalcitonin (PCT) in human serum and plasma, serving as a biomarker for the assessment of sepsis and bacterial infections. PCT levels are used to aid clinical decisions regarding antibiotic therapy and to monitor the course of infection. It is an FDA Class 2 device regulated under 21 CFR 866.3210 in the Microbiology specialty, with product code NTM, requiring 510(k) clearance. It is not an implant and does not carry a life-sustaining support flag.
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Basic Information
- Product Code
- NTM
- Device Class
- FDA class 2
- Regulation Number
- 866.3210
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070310 | B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM | Mar 31, 2008 | Substantially Equivalent | Brahms Aktiengesellschaft |
| K071146 | VIDAS B.R.A.H.M.S. PCT ASSAY | Oct 11, 2007 | Substantially Equivalent | bioMerieux, Inc. |
| K040887 | B-R-A-H-M-S PCT LIA | Jan 07, 2005 | Substantially Equivalent | Brahms Aktiengesellschaft |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.