510(k) · Cleared

Cleared

'Tdxflx Analyzer

K904226510(k) TraditionalCleared Oct 29, 199046-day reviewClass II21 CFR 862.3450

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

Abbott Laboratories · LCQ Fluorescent Immunoassay Gentamicin

Cleared on Oct 29, 1990 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided: Oct 29, 1990
Review: 46 days
Class: Class II
Product code: LCQ
Recalls: None
Predicates: 0

8 later devices descend from it, 6 citing it directly.

This deviceK904226 'Tdxflx AnalyzerAbbott Laboratories · 1990
Descendant · cites it directly · 1 of its ownK962519 Emit 2000 Gentamicin Assay and CalibratorsBehring Diagnostics, Inc. · 1996
Descendant · cites it directly · 1 of its ownK961256 Synchron Systems Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1996
Descendant · cites it directly · 0 of its ownK060709 Multigent GentamicinSeradyn, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK042479 Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros…Ortho-Clinical Diagnostics, Inc. · 2005 · Recalled
Descendant · 2 generations on · 0 of its ownK031870 Synchron Systems Valproic Acid (V-PA) ReagentBeckman Coulter, Inc. · 2003

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1996high 2 (1996) · low 0 (1998)2026

Most influential descendants

Showing 5 of 8 · See all

K962519Emit 2000 Gentamicin Assay and CalibratorsBehring Diagnostics, Inc. · 1996 · cites it directly1descendant
K961256Synchron Systems Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1996 · cites it directly1descendant
K060709Multigent GentamicinSeradyn, Inc. · 2006 · cites it directly0descendants
K042479Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products…Ortho-Clinical Diagnostics, Inc. · 2005 · 2 generations on0descendants
K031870Synchron Systems Valproic Acid (V-PA) ReagentBeckman Coulter, Inc. · 2003 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K904226	'Tdxflx Analyzer	Abbott Laboratories	1990	—
+1	K962519	Emit 2000 Gentamicin Assay and Calibrators	Behring Diagnostics, Inc.	1996	—
+1	K961256	Synchron Systems Valproic Acid (Vpa) Reagent	Beckman Instruments, Inc.	1996	—
+1	K060709	Multigent Gentamicin	Seradyn, Inc.	2006	—
+2	K042479	Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr…	Ortho-Clinical Diagnostics, Inc.	2005	1
+2	K031870	Synchron Systems Valproic Acid (V-PA) Reagent	Beckman Coulter, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1997	2	0
2002	1	0
2003	1	0
2005	1	0
2006	1	0

FIG. 1 — Lineage of K904226, 1990–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LCQ? 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K962519	Emit 2000 Gentamicin Assay and Calibrators	Behring Diagnostics, Inc.	1996	1
K961256	Synchron Systems Valproic Acid (Vpa) Reagent	Beckman Instruments, Inc.	1996	1
K060709	Multigent Gentamicin	Seradyn, Inc.	2006	0
K013959	Bayer Valproic Acid Assay for the Acs:180 and Advia Centaur Analyzers	Bayer Diagnostics Corp.	2002	0
K964009	Immage Immunochemistry System Gentamicin (Gen)/Tobramycin (Tob) Reagent / Beckman Drug…	Beckman Instruments, Inc.	1997	0
K963673	Immage Immunochemistry System TDM (Car,Phe,Phy, & the) Reagents	Beckman Instruments, Inc.	1997	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, K962519 (Behring Diagnostics, Inc., 1996) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LCQ devices

LCQ Fluorescent Immunoassay Gentamicin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCQ

FDA has decided no LCQ device since 2007.

Median 510(k) review, days · LCQ

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

Recalls per year · LCQ

1in 2015

2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · LCQ

2in 2008

2007high 3 (2007) · low 0 (2009)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	3
2008	—	0	2
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	1	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K904226 · printed Nov 6, 2026

Cite this page

510(k) Report. “K904226: 'Tdxflx Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904226

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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