# K203035: Eonis SCID-SMA kit

- Pathway: 510(k) (Traditional)
- Applicant: Perkinelmer, Inc.
- Decided: Nov 9, 2022 after 765 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
Longest line of descent: 1 generation back to DEN140010 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140010: Perkinelmer Enlite Neonatal Trec Test System, Wallac OY (2014) Summary page 4.

## Indications for use
The Eonis™ SCID-SMA kit is intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) as an aid in screening newborns for Severe Combined Immunodeficiency (SCID) and for the semi-quantitative determination of KREC (Kappa-deleting recombination excision circle) as an aid in screening newborns for X-linked agammaglobulinemia (XLA). The test is intended for DNA from blood specimens dried on a filter paper and for use on the QuantStudio™ Dx Real-Time PCR instrument. This test is not intended 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. The test is not indicated for screening B-cell deficiency disorders other than XLA, such as atypical XLA, or for screening of XLA carriers. This test is not intended for use as a diagnostic test and a positive screening result should be followed by confirmatory testing.

Source page: https://510kreport.com/device/K203035
Methodology: https://510kreport.com/methodology