Procalcitonin Assay
The Procalcitonin Assay is an in vitro diagnostic device that measures procalcitonin levels in blood to aid in decision-making regarding antibiotic therapy initiation and discontinuation for inpatients or emergency department patients with suspected or confirmed lower respiratory tract infections, including community-acquired pneumonia, acute bronchitis, and acute exacerbation of COPD. It is classified as FDA Class 2 under 21 CFR 866.3215 in the Microbiology specialty, requiring 510(k) clearance. Product code PRI; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PRI
- Device Class
- FDA class 2
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220262 | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) | Aug 26, 2022 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K192815 | Elecsys BRAHMS PCT | Mar 09, 2020 | Substantially Equivalent | Roche Diagnostics |
| K173927 | Elecsys BRAHMS PCT | Jul 06, 2018 | Substantially Equivalent | Roche Diagnostics |
| K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers | Feb 27, 2018 | Substantially Equivalent | DiaSorin, Inc. |
| K172713 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set | Dec 10, 2017 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls | Jun 01, 2017 | Substantially Equivalent | Fisher Diagnostics |
| K171338 | B R A H M S PCT sensitive KRYPTOR | May 31, 2017 | Substantially Equivalent | Brahms GmbH |
| K162827 | VIDAS B.R.A.H.M.S. PCT (PCT) | Feb 23, 2017 | Substantially Equivalent | bioMerieux, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.