# K262893: Eonis™ SMA kit

- Pathway: 510(k) (Traditional)
- Applicant: Revvity, Inc.
- Decided: Sep 30, 2026 after 44 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
Longest line of descent: 1 generation back to DEN200044 (2022). 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)
- DEN200044: Eonis SCID-SMA Kit, Perkinelmer, Inc. (2022) Summary page 5.

## Indications for use
The Eonis™ 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 Eonis Q or 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/K262893
Methodology: https://510kreport.com/methodology