510(k) · Cleared
ClearedGSP Neonatal Irt Kit (3306-001U)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallac Oy, Subsidiary of Perkinelmer · JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
Cleared on Dec 16, 2010 as substantially equivalent to K003668 (Wallac OY, 2001) after a 113-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Dec 16, 2010
- Review
- 113 days
- Class
- Class I
- Product code
- JNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003668 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003668 Autodelfia Neonatal Irt Kit, Model B005-112Wallac OY · 2001
- This deviceK102419 GSP Neonatal Irt Kit (3306-001U)Wallac Oy, Subsidiary of Perkinelmer · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003668 | Autodelfia Neonatal Irt Kit, Model B005-112 | Wallac OY | 2001 | — |
| 0 (this device) | K102419 | GSP Neonatal Irt Kit (3306-001U) | Wallac Oy, Subsidiary of Perkinelmer | 2010 | — |
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 JNO? 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 |
|---|---|---|---|
| * | K003668 | Autodelfia Neonatal Irt Kit, Model B005-112Summary page 1…Trypsin Test System Product Code: JNO Predicate Device: AutoDELFIAe Neonatal IRT kit, 510(k) Number (K0003668) Device Description: The GSP Neonatal IRT assay is a solid phase, two-site fluoroimmunom… | 2001 |
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.
- 2 other devices also cite its predicate K003668.
How does its category compare?
All JNO devicesJNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JNO
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · JNO
Too few JNO 510(k)s in any year since 2007 to give a median.
Recalls per year · JNO
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JNO
No MAUDE report names JNO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GSP Neonatal IRT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) in blood specimens (dried on filter paper) as an aid in screening newborns for Cystic Fibrosis using the GSP instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102419 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102419: GSP Neonatal Irt Kit (3306-001U).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102419
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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