FDA product code PJI: Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
PJI is the FDA product code for severe combined immunodeficiency disorder (scid) newborn screening test system. It is a Class II device, regulated under 21 CFR 866.5930 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under PJI, 1 in the last five years. The average 510(k) review took 765 days (median 765). 1 De Novo request was granted under it. FDA has posted 1 recall for PJI devices.
Definition
A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper. It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID).
Classification
| Field | Value |
|---|---|
| Device name | Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System |
| Device class | Class II |
| Regulation | 21 CFR 866.5930 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PJI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 765 |
Compare with all 510(k) review times · Search every PJI clearance
Top PJI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Perkinelmer, Inc. | 1 | 2022-11-09 |
Most recent PJI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203035 | Perkinelmer, Inc. | Eonis SCID-SMA kit | 2022-11-09 | 765 |
Recalls for PJI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-12-05.
Frequently asked questions
What is FDA product code PJI?
PJI is the FDA product code for severe combined immunodeficiency disorder (scid) newborn screening test system. It is a Class II device, regulated under 21 CFR 866.5930 and reviewed by the Immunology panel.
What device class is PJI?
Class II, regulation 21 CFR 866.5930. Typical premarket route: 510(k).
How long does a 510(k) take for product code PJI?
Across 1 cleared submissions the average was 765 days from receipt to decision (median 765).
Which companies have the most PJI clearances?
Perkinelmer, Inc. (1).
Have PJI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-12-05.
Next steps
- Run an FDA pathway report with predicate devices for product code PJI
- Run a recall and safety report across every PJI manufacturer
- Watch product code PJI 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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