De Novo · Granted
GrantedPerkinelmer Enlite Neonatal Trec Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallac OY · PJI Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Granted on Dec 15, 2014 as a new device type through De Novo after a 299-day review. 1 later device descends from it.
- Decided
- Dec 15, 2014
- Review
- 299 days
- Class
- Class II
- Product code
- PJI
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN140010 Perkinelmer Enlite Neonatal Trec Test SystemWallac OY · 2014
- Descendant · cites it directly · 0 of its ownK203035 Eonis SCID-SMA kitPerkinelmer, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K203035Eonis SCID-SMA kitPerkinelmer, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN140010 | Perkinelmer Enlite Neonatal Trec Test System | Wallac OY | 2014 | — |
| +1 | K203035 | Eonis SCID-SMA kit | Perkinelmer, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 PJI? 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 PJI device
- #1 K203035 Eonis SCID-SMA kitscore 4.3 · 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 |
|---|---|---|---|
| K203035 | Eonis SCID-SMA kit | 2022 | 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, K203035 (Perkinelmer, Inc., 2022) has gone furthest, with 0 descendants of its own.
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. 2014, 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 EnLite™ Neonatal TREC Kit is an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR™ EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). The test is not intended for use as a diagnostic test or 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN140010 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN140010: Perkinelmer Enlite Neonatal Trec Test System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN140010
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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