FDA product code PRH: Positive Blood Culture Identification And Ast Kit
PRH is the FDA product code for positive blood culture identification and ast kit. It is a Class II device, regulated under 21 CFR 866.1650 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under PRH. The average 510(k) review took 356 days (median 356). 1 De Novo request was granted under it. FDA has posted 4 recalls for PRH devices, 2 initiated in the last five years.
Definition
Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.
Classification
| Field | Value |
|---|---|
| Device name | Positive Blood Culture Identification And Ast Kit |
| Device class | Class II |
| Regulation | 21 CFR 866.1650 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PRH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 356 |
Compare with all 510(k) review times · Search every PRH clearance
Top PRH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Accelerate Diagnostics, Inc. | 1 | 2020-09-15 |
Most recent PRH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192665 | Accelerate Diagnostics, Inc. | Accelerate Pheno System, Accelerate PhenoTest BC Kit | 2020-09-15 | 356 |
Recalls for PRH devices
4 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2022-10-17.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code PRH?
PRH is the FDA product code for positive blood culture identification and ast kit. It is a Class II device, regulated under 21 CFR 866.1650 and reviewed by the Microbiology panel.
What device class is PRH?
Class II, regulation 21 CFR 866.1650. Typical premarket route: 510(k).
How long does a 510(k) take for product code PRH?
Across 1 cleared submissions the average was 356 days from receipt to decision (median 356).
Which companies have the most PRH clearances?
Accelerate Diagnostics, Inc. (1).
Have PRH devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2022-10-17.
Next steps
- Run an FDA pathway report with predicate devices for product code PRH
- Run a recall and safety report across every PRH manufacturer
- Watch product code PRH 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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