FDA product code PRI: Procalcitonin Assay
PRI is the FDA product code for procalcitonin assay. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel. FDA has cleared 8 510(k) submissions under PRI, 1 in the last five years, from 7 different applicants. The average 510(k) review took 124 days (median 116). FDA has posted 1 recall for PRI devices.
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).
Classification
| Field | Value |
|---|---|
| Device name | Procalcitonin Assay |
| 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 PRI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 86 |
| 2018 | 2 | 140 |
| 2020 | 1 | 160 |
| 2022 | 1 | 207 |
Compare with all 510(k) review times · Search every PRI clearance
Top PRI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics | 2 | 2020-03-09 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 2022-08-26 |
| DiaSorin, Inc. | 1 | 2018-02-27 |
| Fujirebio Diagnostics,Inc. | 1 | 2017-12-10 |
| Fisher Diagnostics | 1 | 2017-06-01 |
2 more applicants have PRI clearances. See the full list in Caduvo.
Most recent PRI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220262 | Siemens Healthcare Diagnostics, Inc. | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) | 2022-08-26 | 207 |
| K192815 | Roche Diagnostics | Elecsys BRAHMS PCT | 2020-03-09 | 160 |
| K173927 | Roche Diagnostics | Elecsys BRAHMS PCT | 2018-07-06 | 192 |
| K173683 | DiaSorin, Inc. | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers | 2018-02-27 | 88 |
| K172713 | Fujirebio Diagnostics,Inc. | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set | 2017-12-10 | 93 |
Recalls for PRI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-09-22.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code PRI?
PRI is the FDA product code for procalcitonin assay. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel.
What device class is PRI?
Class II, regulation 21 CFR 866.3215. Typical premarket route: 510(k).
How long does a 510(k) take for product code PRI?
Across 8 cleared submissions the average was 124 days from receipt to decision (median 116).
Which companies have the most PRI clearances?
Roche Diagnostics (2); Siemens Healthcare Diagnostics, Inc. (1); DiaSorin, Inc. (1); Fujirebio Diagnostics,Inc. (1); Fisher Diagnostics (1).
Have PRI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-09-22.
Next steps
- Run an FDA pathway report with predicate devices for product code PRI
- Run a recall and safety report across every PRI manufacturer
- Watch product code PRI 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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