PJI · Class II · 21 CFR 866.5930

FDA Product Code PJI: Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System

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).

Leading manufacturers include Wallac OY and Perkinelmer, Inc..

2
Total
1
Cleared
532d
Avg days
2014
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System Devices (Product Code PJI)

2 devices
1–2 of 2
Cleared Nov 09, 2022
Eonis SCID-SMA kit
K203035
Perkinelmer, Inc.
Medical Genetics · 765d
Not Cleared Dec 15, 2014
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
DEN140010
Wallac OY
Pathology · 299d

About Product Code PJI - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code PJI since 2014, with 1 receiving FDA clearance (average review time: 532 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.