De Novo · Granted
GrantedEonis SCID-SMA Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perkinelmer, Inc. · QUE Spinal Muscular Atrophy Newborn Screening Test System
Granted on Nov 9, 2022 as a new device type through De Novo after an 854-day review. 1 later device descends from it.
- Decided
- Nov 9, 2022
- Review
- 854 days
- Class
- Class II
- Product code
- QUE
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN200044 Eonis SCID-SMA KitPerkinelmer, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK262893 Eonis™ SMA kitRevvity, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262893Eonis™ SMA kitRevvity, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200044 | Eonis SCID-SMA Kit | Perkinelmer, Inc. | 2022 | — |
| +1 | K262893 | Eonis™ SMA kit | Revvity, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QUE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QUE device
- #1 K262893 Eonis™ SMA kitscore 12.1 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262893 | Eonis™ SMA kit | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K262893 (Revvity, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QUE devicesQUE Spinal Muscular Atrophy Newborn Screening Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QUE
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QUE
Too few QUE 510(k)s in any year since 2007 to give a median.
Recalls per year · QUE
No recall names QUE since 2007.
Adverse event reports per year · QUE
No MAUDE report names QUE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200044 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200044: Eonis SCID-SMA Kit.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200044
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026