# DEN140010: Perkinelmer Enlite Neonatal Trec Test System

- Pathway: De Novo (Direct)
- Applicant: Wallac OY
- Decided: Dec 15, 2014 after 299 days
- Product code: PJI (Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System)
- Device class: 2
- Regulation: 21 CFR 866.5930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K203035: Eonis SCID-SMA kit (2022), 0 descendants of its own

## Indications for use
The EnLite™ Neonatal TREC Kit is an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR™ EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). The test is not intended for use as a diagnostic test or for screening of SCID-like syndromes, such as DiGeorge Syndrome, or Omenn Syndrome. It is also not intended to screen for less acute SCID syndromes such as leaky-SCID or variant SCID.

Source page: https://510kreport.com/device/DEN140010
Methodology: https://510kreport.com/methodology