510(k) · Cleared

Cleared

Diazyme Sodium Enzymatic Assay

K042189510(k) TraditionalCleared Oct 7, 200456-day reviewClass II21 CFR 862.1665

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

Diazyme Laboratories · MZU System, Test, Sodium, Enzymatic Method

Cleared on Oct 7, 2004 as substantially equivalent to K023049 (Beckman Coulter, Inc., 2002) after a 56-day review. Its family tree reaches back 2 generations to 2001.

Decided: Oct 7, 2004
Review: 56 days
Class: Class II
Product code: MZU
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K011213 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK011213 Modification to Synchron LX 20 Clinical Chemistry SystemBeckman Coulter, Inc. · 2001 · Recalled
1 generation backK023049 Synchron LX I 725 Clinical SystemBeckman Coulter, Inc. · 2002 · Recalled
This deviceK042189 Diazyme Sodium Enzymatic AssayDiazyme Laboratories · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K011213	Modification to Synchron LX 20 Clinical Chemistry System	Beckman Coulter, Inc.	2001	11
−1	K023049	Synchron LX I 725 Clinical System	Beckman Coulter, Inc.	2002	18
0 (this device)	K042189	Diazyme Sodium Enzymatic Assay	Diazyme Laboratories	2004	—

FIG. 1 — Lineage of K042189, 2001–2004Source: 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 MZU? 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
*	K023049	Synchron LX I 725 Clinical System Summary page 1 …m Device Class: 11 Predicate Device: The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Synchron LX I 725 Clinical System (K023049) manufactured by Beckman Coulter Inc., Brea, CA, USA. Description of the devices In healthy individual, an extracellular fluid…	Beckman Coulter, Inc.	2002	18

Also cleared against K023049: 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
2 of the 2 ancestors have a recall of any class.
2 other devices also cite its predicate K023049.

How does its category compare?

All MZU devices

MZU System, Test, Sodium, Enzymatic Method: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MZU

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MZU

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

Recalls per year · MZU

No recall names MZU since 2007.

Adverse event reports per year · MZU

1in 2009

2007high 1 (2009) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	1	—	0
2009	0	—	1
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	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	—	—

What is it indicated for?

Diazyme Sodium Enzymatic Assay Kit in conjunction with Diazyme Sodium Low and High Calibrators, are intended for the quantitative determination of sodium (NA) in serum.

Diazyme Sodium Enzymatic Assay Kit contains a low level standard and a high level standard. The standards are used to generate a linear graph that will be used in the calculation of sodium concentrations in unknown serum samples.

Diazyme Sodium Enzymatic Assay has controls for normal serum sodium level and abnormal serum sodium level. The controls are used as reference samples for checking the functionality of the Diazyme Sodium Enzymatic Assay.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042189 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042189: Diazyme Sodium Enzymatic Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042189

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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