510(k) · Cleared

Recalled · Class III · 2017

Autodelfia Neonatal Irt Kit

K110274510(k) TraditionalCleared Jun 10, 2011130-day reviewClass I21 CFR 862.1725Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wallac Oy, A Subsidiary of Perkinelmer, Inc. · JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin

Cleared on Jun 10, 2011 as substantially equivalent to K003668 (Wallac OY, 2001) after a 130-day review. Its family tree reaches back 1 generation to 2001. It has been recalled once.

Decided: Jun 10, 2011
Review: 130 days
Class: Class I
Product code: JNO
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K003668 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK003668 Autodelfia Neonatal Irt Kit, Model B005-112Wallac OY · 2001
This deviceK110274 Autodelfia Neonatal Irt KitWallac Oy, A Subsidiary of Perkinelmer, Inc. · 2011

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)	K110274	Autodelfia Neonatal Irt Kit	Wallac Oy, A Subsidiary of Perkinelmer, Inc.	2011	—

FIG. 1 — Lineage of K110274, 2001–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K003668	Autodelfia Neonatal Irt Kit, Model B005-112 Summary page 1 …Product Code: JNO Predicate Device: AutoDELFIA® Neonatal IRT kit, BOO5-I112 510(k) Number (K0003668) Device Description: The AutoDELFIA Neonatal IRT assay is a solid phase, two-s…	Wallac OY	2001	—

Also cleared against K003668: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 25, 2017	Class III	Z-1220-2018	Process control	The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.

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 devices

JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · JNO

1in 2011

2007high 1 (2010) · low 0 (2007)2026

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

2007high 1 (2007) · low 0 (2008)2026

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 AutoDELFIA Neonatal IRT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110274 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110274: Autodelfia Neonatal Irt Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110274

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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