PJI — Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System Class II

FDA Device Classification

Classification Details

Product Code: PJI
Device Class: Class II
Regulation Number: 866.5930
Submission Type
Review Panel: IM
Medical Specialty: Immunology
Implant: No

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).

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K203035	perkinelmer	Eonis SCID-SMA kit	November 9, 2022
DEN140010	wallac	PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM	December 15, 2014