# DEN200044: Eonis SCID-SMA Kit

- Pathway: De Novo (Direct)
- Applicant: Perkinelmer, Inc.
- Decided: Nov 9, 2022 after 854 days
- Product code: QUE (Spinal Muscular Atrophy Newborn Screening Test System)
- Device class: 2
- Regulation: 21 CFR 866.5980
- 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
- K262893: Eonis™ SMA kit (2026), 0 descendants of its own

## Indications for use
The Eonis™ SCID-SMA kit is intended for the qualitative detection of the SMN1 gene exon 7 as an aid in screening newborns for Spinal Muscular Atrophy (SMA). 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 only intended for use for screening of SMA that bear the homozygous deletion of SMN1 exon 7. 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/DEN200044
Methodology: https://510kreport.com/methodology