510(k) Report

510(k) · Cleared

Cleared

GSP Neonatal Thyroxine (T4)

K103484510(k) TraditionalCleared Apr 22, 2011147-day reviewClass II21 CFR 862.1700

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. · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Cleared on Apr 22, 2011 as substantially equivalent to K943416 (Wallac OY, 1995) after a 147-day review. Its family tree reaches back 1 generation to 1995.

Decided
Apr 22, 2011
Review
147 days
Class
Class II
Product code
KLI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K943416 (1995). No later device cites it as a predicate yet.

K943416 · Delfia Neonatal Thyroxine Kit · Wallac OY · 19951995200020052010
K943416 · Delfia Neonatal Thyroxine Kit · Wallac OY · 19950
  1. Root · 1 generation backK943416 Delfia Neonatal Thyroxine KitWallac OY · 1995
  2. This deviceK103484 GSP Neonatal Thyroxine (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K943416Delfia Neonatal Thyroxine KitWallac OY1995—
0 (this device)K103484GSP Neonatal Thyroxine (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.2011—
FIG. 1 — Lineage of K103484, 1995–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KLI? 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.

TypeNumberDeviceApplicantDecidedRecalls
*K943416Delfia Neonatal Thyroxine Kit
Summary page 1
…Test System Product Code: KLI Predicate Device: AutoDELFIA® Neonatal Thyroxine T4 5 10(k) Number (K943416) Device Description: The GSP Neonatal T4 assay is a solid phase time-resolved fluoroimmunoassay…
Wallac OY1995—

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 KLI devices

KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KLI

1in 2016

2009: 12011: 12013: 12016: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLI

Too few KLI 510(k)s in any year since 2007 to give a median.

Recalls per year · KLI

2in 2021

2010: 12011: 12021: 22026 (partial year): 1
2007high 2 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KLI

3in 2021

2010: 32011: 72012: 22014: 52018: 32019: 12021: 3
2007high 7 (2011) · low 0 (2007)2025

MAUDE reports naming product code KLI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—13
20111—17
20120—02
20131—00
20140—05
20150—00
20161—00
20170—00
20180—03
20190—01
20200—00
20210—23
20220—00
20230—00
20240—00
20250—00
20260—1—

What is it indicated for?

The GSP Neonatal Thyroxine (T4) kit is intended for the quantitative determination of

human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening

newborns for congenital (neonatal) hypothyroidism using the GSP instrument.

Indications for use as stated in the FDA summary.

More from Wallac Oy, A Subsidiary of…

3 FDA decisions under this applicant name. See the company

  • K133652GSP Neonatal Total Galactose KitWallac Oy, A Subsidiary of Perkinelmer, Inc. · 2014
  • K110274Autodelfia Neonatal Irt KitWallac Oy, A Subsidiary of Perkinelmer, Inc. · 20111 recall

Recent decisions in KLI

The KLI category page

  • K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc. · 20161 recall
  • K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013
  • K082638Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 20093 recalls
  • K030860Accubind Neonatal T4 Microplate Eia, Model 2625-300Monobind · 2003
  • K023369Access Total T4 AssayBeckman Coulter, Inc. · 20025 recalls

https://510kreport.com/device/K103484 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103484: GSP Neonatal Thyroxine (T4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103484

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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