FDA product code PRJ: Capillary Blood Collection Device For Alternative Site Collection
PRJ is the FDA product code for capillary blood collection device for alternative site collection. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under PRJ. The average 510(k) review took 266 days (median 266).
Definition
A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.
Classification
| Field | Value |
|---|---|
| Device name | Capillary Blood Collection Device For Alternative Site Collection |
| Device class | Class II |
| Regulation | 21 CFR 862.1675 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for PRJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 259 |
| 2019 | 1 | 273 |
Top PRJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Seventh Sense Biosystems, Inc. | 2 | 2019-11-05 |
Most recent PRJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190225 | Seventh Sense Biosystems, Inc. | TAP Blood Collection Device | 2019-11-05 | 273 |
| K161521 | Seventh Sense Biosystems, Inc. | TAP Blood Collection Device | 2017-02-16 | 259 |
Recalls for PRJ devices
openFDA lists no recalls for product code PRJ.
Frequently asked questions
What is FDA product code PRJ?
PRJ is the FDA product code for capillary blood collection device for alternative site collection. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel.
What device class is PRJ?
Class II, regulation 21 CFR 862.1675. Typical premarket route: 510(k).
How long does a 510(k) take for product code PRJ?
Across 2 cleared submissions the average was 266 days from receipt to decision (median 266).
Which companies have the most PRJ clearances?
Seventh Sense Biosystems, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PRJ
- Run a recall and safety report across every PRJ manufacturer
- Watch product code PRJ 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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