Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
The Severe Combined Immunodeficiency Disorder (SCID) Newborn Screening Test System is a molecular diagnostic device intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn dried blood spot specimens, used as an aid in screening newborns for SCID. It is an FDA Class 2 device regulated under 21 CFR 866.5930, requiring 510(k) premarket notification, within the Immunology (IM) medical specialty. The product code is PJI, and it is eligible for third-party review. Early detection of SCID is critical for timely treatment before infections occur.
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Basic Information
- Product Code
- PJI
- Device Class
- FDA class 2
- Regulation Number
- 866.5930
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.