510(k) · Cleared
ClearedEonis SCID-SMA kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perkinelmer, Inc. · PJI Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Cleared on Nov 9, 2022 as substantially equivalent to DEN140010 (Wallac OY, 2014) after a 765-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Nov 9, 2022
- Review
- 765 days
- Class
- Class II
- Product code
- PJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN140010 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backDEN140010 Perkinelmer Enlite Neonatal Trec Test SystemWallac OY · 2014
- This deviceK203035 Eonis SCID-SMA kitPerkinelmer, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN140010 | Perkinelmer Enlite Neonatal Trec Test System | Wallac OY | 2014 | — |
| 0 (this device) | K203035 | Eonis SCID-SMA kit | Perkinelmer, Inc. | 2022 | — |
Sources: FDA 510(k) 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 PJI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN140010 | Perkinelmer Enlite Neonatal Trec Test SystemSummary page 4…on: II Panel: 75 Chemistry Product Code: PJI Predicate device: PerkinElmer ENLITE™ Neonatal TREC Kit (DEN140010) 1… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All PJI devicesPJI Severe Combined Immunodeficiency Disorder (Scid) 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 · PJI
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · PJI
Too few PJI 510(k)s in any year since 2007 to give a median.
Recalls per year · PJI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PJI
No MAUDE report names PJI 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 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 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 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (152 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203035 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203035: Eonis SCID-SMA kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203035
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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