510(k) · Cleared

Cleared

Synchron Systems Valproic Acid (Vpa) Reagent

K961256510(k) TraditionalCleared May 15, 199644-day reviewClass II21 CFR 862.3645

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

Beckman Instruments, Inc. · LEG Enzyme Immunoassay, Valproic Acid

Cleared on May 15, 1996 as substantially equivalent to K904226 (Abbott Laboratories, 1990) after a 44-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: May 15, 1996
Review: 44 days
Class: Class II
Product code: LEG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K904226 (1990). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK904226 'Tdxflx AnalyzerAbbott Laboratories · 1990
This deviceK961256 Synchron Systems Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1996
Descendant · cites it directly · 0 of its ownK031870 Synchron Systems Valproic Acid (V-PA) ReagentBeckman Coulter, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all

K031870Synchron Systems Valproic Acid (V-PA) ReagentBeckman Coulter, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K904226	'Tdxflx Analyzer	Abbott Laboratories	1990	—
0 (this device)	K961256	Synchron Systems Valproic Acid (Vpa) Reagent	Beckman Instruments, Inc.	1996	—
+1	K031870	Synchron Systems Valproic Acid (V-PA) Reagent	Beckman Coulter, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K961256, 1990–2003Source: 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 LEG? 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? (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
*	K904226	'Tdxflx Analyzer Summary page 1 …es: Valproic Acid Test System (Not Classified) Calibrator (21 CFR §862.1150) Predicate Devices: PREDICATE DEVICE SELECTION Valproic Acid TDxFLx®** Valpreoic \| Abbott* K904226 Reagent Acid Reagent Laboratories, Inc. Abbott Laboratories, Abbott Park, iL 60064 * Trademark of Abbott Laboratories, Inc. D…	Abbott Laboratories	1990	—

Also cleared against K904226: 5 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K031870	Synchron Systems Valproic Acid (V-PA) Reagent	Beckman Coulter, Inc.	2003	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?

Its one ancestor has no recall.
Of its descendants, K031870 (Beckman Coulter, Inc., 2003) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K904226.

How does its category compare?

All LEG devices

LEG Enzyme Immunoassay, Valproic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LEG

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LEG

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

Recalls per year · LEG

1in 2018

2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · LEG

5in 2025

2007high 38 (2008) · low 1 (2023)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	1	12
2008	0	—	0	38
2009	1	—	0	18
2010	0	—	0	13
2011	0	—	1	38
2012	0	—	0	29
2013	0	—	0	29
2014	0	—	0	20
2015	0	—	0	3
2016	0	—	0	25
2017	0	—	0	8
2018	0	—	1	24
2019	0	—	0	13
2020	0	—	0	9
2021	0	—	0	12
2022	0	—	0	19
2023	0	—	0	1
2024	0	—	0	14
2025	0	—	0	5
2026	0	—	0	—

What is it indicated for?

The SYNCHRON Systems Valproic Acid reagent in conjunction with the SYNCHRON Drug Calibrator 1 is intended for use in the quantitative determination of valproic acid in human serum and plasma. This assay is designed for use with the family of SYNCHRON System analyzers which include the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K961256 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961256: Synchron Systems Valproic Acid (Vpa) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961256

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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