FDA product code PJE: Blood/Plasma Collection Device For Dna Testing
PJE is the FDA product code for blood/plasma collection device for dna testing. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel. FDA has cleared 8 510(k) submissions under PJE, 1 in the last five years, from 6 different applicants. The average 510(k) review took 144 days (median 111).
Definition
A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
Classification
| Field | Value |
|---|---|
| Device name | Blood/Plasma Collection Device For Dna Testing |
| 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 PJE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 30 |
Compare with all 510(k) review times · Search every PJE clearance
Top PJE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Preanalytix GmbH | 2 | 2023-06-21 |
| Greiner Vacuette North America, Inc. | 2 | 2002-02-01 |
| Greiner Bio-One Vacuette North America | 1 | 2005-04-15 |
| Sarstedt, Inc. | 1 | 2003-09-12 |
| Izon Business Products, Inc. | 1 | 2001-04-09 |
1 more applicants have PJE clearances. See the full list in Caduvo.
Most recent PJE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231469 | Preanalytix GmbH | PAXgene® Blood DNA Tube | 2023-06-21 | 30 |
| K142821 | Preanalytix GmbH | PAXgene Blood DNA Tube | 2015-09-09 | 344 |
| K042927 | Greiner Bio-One Vacuette North America | VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES | 2005-04-15 | 175 |
| K031359 | Sarstedt, Inc. | S-MONOVETTE EDTA K2-GEL | 2003-09-12 | 135 |
| K014104 | Greiner Vacuette North America, Inc. | VACUETTE EDTA K2 TUBES | 2002-02-01 | 50 |
Recalls for PJE devices
openFDA lists no recalls for product code PJE.
Frequently asked questions
What is FDA product code PJE?
PJE is the FDA product code for blood/plasma collection device for dna testing. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel.
What device class is PJE?
Class II, regulation 21 CFR 862.1675. Typical premarket route: 510(k).
How long does a 510(k) take for product code PJE?
Across 8 cleared submissions the average was 144 days from receipt to decision (median 111).
Which companies have the most PJE clearances?
Preanalytix GmbH (2); Greiner Vacuette North America, Inc. (2); Greiner Bio-One Vacuette North America (1); Sarstedt, Inc. (1); Izon Business Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PJE
- Run a recall and safety report across every PJE manufacturer
- Watch product code PJE 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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