510(k) Report

510(k) · Cleared

Cleared

Thyroxine Enzyme Immunoassay

K944703510(k) TraditionalCleared Dec 9, 199477-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

Diagnostic Reagents, Inc. · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Cleared on Dec 9, 1994 after a 77-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Dec 9, 1994
Review
77 days
Class
Class II
Product code
KLI
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2013: 1 descendant cleared2012: 1 descendant cleared1990200020102020
  1. This deviceK944703 Thyroxine Enzyme ImmunoassayDiagnostic Reagents, Inc. · 1994
  2. Descendant · cites it directly · 2 of its ownK981377 Ace T4 Reagent T4 CalibratorsSchiapparelli Biosystems, Inc. · 1998
  3. Descendant · 2 generations on · 1 of its ownK113437 Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
  4. Descendant · 2 generations on · 0 of its ownK131515 Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013

Most influential descendants

Showing 3 of 3 · See all
  • K981377Ace T4 Reagent T4 CalibratorsSchiapparelli Biosystems, Inc. · 1998 · cites it directly2descendants
  • K113437Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012 · 2 generations on1descendant
  • K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944703Thyroxine Enzyme ImmunoassayDiagnostic Reagents, Inc.1994—
+1K981377Ace T4 Reagent T4 CalibratorsSchiapparelli Biosystems, Inc.1998—
+2K113437Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4…Alfa Wassermann Diagnostic Technologies, Inc.2012—
+2K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
201210
201310
FIG. 1 — Lineage of K944703, 1994–2013Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981377Ace T4 Reagent T4 CalibratorsSchiapparelli Biosystems, Inc.19982

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, K981377 (Schiapparelli Biosystems, Inc., 1998) has gone furthest, with 2 descendants of its own.

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.

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—

More from Diagnostic Reagents, Inc.

66 FDA decisions under this applicant name. See the company

  • K983268Modification of Tricyclic Serum Tox Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983812Napa Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983323Digoxin ImmunoassayDiagnostic Reagents, Inc. · 1998
  • K983280Vancomycin Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983159Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998

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
  • K103484GSP Neonatal Thyroxine (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc. · 2011
  • K082638Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 20093 recalls
  • K030860Accubind Neonatal T4 Microplate Eia, Model 2625-300Monobind · 2003

https://510kreport.com/device/K944703 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944703: Thyroxine Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944703

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026