FDA product code PJC: Newborn Screening Specimen Collection Paper
PJC is the FDA product code for newborn screening specimen collection paper. 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 PJC, from 2 different applicants. The average 510(k) review took 654 days (median 654). FDA has posted 3 recalls for PJC devices.
Definition
Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.
Classification
| Field | Value |
|---|---|
| Device name | Newborn Screening Specimen Collection Paper |
| Device class | Class II |
| Regulation | 21 CFR 862.1675 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every PJC clearance
Top PJC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Perkinelmer, Inc. | 1 | 2013-03-12 |
| Whatman Specialty Products, Inc. | 1 | 1996-04-17 |
Most recent PJC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121864 | Perkinelmer, Inc. | PERKINELMER 226 SAMPLE COLLECTION DEVICES | 2013-03-12 | 259 |
| K932661 | Whatman Specialty Products, Inc. | WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 | 1996-04-17 | 1050 |
Recalls for PJC devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-19.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code PJC?
PJC is the FDA product code for newborn screening specimen collection paper. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel.
What device class is PJC?
Class II, regulation 21 CFR 862.1675. Typical premarket route: 510(k).
How long does a 510(k) take for product code PJC?
Across 2 cleared submissions the average was 654 days from receipt to decision (median 654).
Which companies have the most PJC clearances?
Perkinelmer, Inc. (1); Whatman Specialty Products, Inc. (1).
Have PJC devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2017-12-19.
Next steps
- Run an FDA pathway report with predicate devices for product code PJC
- Run a recall and safety report across every PJC manufacturer
- Watch product code PJC 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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