510(k) · Cleared

Cleared

Diazyme Glycated Serum Protein Enzymatic Assay Kit

K042193510(k) TraditionalCleared Oct 29, 200478-day reviewClass II21 CFR 864.7470

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

Diazyme Laboratories · LCP Assay, Glycosylated Hemoglobin

Cleared on Oct 29, 2004 as substantially equivalent to K023763 (Randox Laboratories, Ltd., 2003) after a 78-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.

Decided: Oct 29, 2004
Review: 78 days
Class: Class II
Product code: LCP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K023763 (2003). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK023763 Randox Fructosamine, Fructosamine Calibrator, Fructosamine ControlsRandox Laboratories, Ltd. · 2003 · Recalled
This deviceK042193 Diazyme Glycated Serum Protein Enzymatic Assay KitDiazyme Laboratories · 2004
Descendant · cites it directly · 0 of its ownK131307 Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine…Siemens Healthcare Diagnostics, Inc. · 2014 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K131307Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine CalibratorSiemens Healthcare Diagnostics, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K023763	Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls	Randox Laboratories, Ltd.	2003	3
0 (this device)	K042193	Diazyme Glycated Serum Protein Enzymatic Assay Kit	Diazyme Laboratories	2004	—
+1	K131307	Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine Calibrator	Siemens Healthcare Diagnostics, Inc.	2014	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K042193, 2003–2014Source: 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 LCP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LCP device

#1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K023763	Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls Summary page 1 …ction 862.3560) Device Class: II Predicate Device: The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Randox Fructosamine (K023763) manufactured by Randox Laboratories, Ltd., Antrim, UK. Description of the devices Existing methods for the assay of glycated s…	Randox Laboratories, Ltd.	2003	3

Also cleared against K023763: 2 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
K131307	Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine Calibrator	Siemens Healthcare Diagnostics, Inc.	2014	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 a recall.
Of its descendants, K131307 (Siemens Healthcare Diagnostics, Inc., 2014) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K023763.

How does its category compare?

All LCP devices

LCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCP

1in 2024

2007high 10 (2011) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCP

269in 2019

2007high 269 (2019) · low 127 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LCP

1in 2025

2007high 51 (2011) · low 0 (2012)2026

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

Adverse event reports per year · LCP

22in 2025

2007high 1,911 (2018) · low 4 (2010)2025

MAUDE reports naming product code LCP, 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	7	133	1	5
2008	5	206	3	11
2009	6	158	6	15
2010	2	—	5	4
2011	10	176	51	27
2012	9	143	0	51
2013	2	—	4	193
2014	8	127	2	182
2015	3	239	2	64
2016	2	—	6	29
2017	5	218	1	149
2018	2	—	1	1,911
2019	4	269	0	114
2020	1	—	0	13
2021	0	—	0	7
2022	0	—	1	8
2023	2	—	0	27
2024	1	—	1	39
2025	0	—	1	22
2026	0	—	0	—

What is it indicated for?

Diazyme Glycated Serum Protein Enzymatic Assay Kit in conjunction with Diazyme Glycated Serum Protein single calibrator, are intended for the quantitative determination of glycated serum proteins (fructosamine) in serum. The measurement of glycated serum proteins (fructosamine) is useful for monitoring diabetic patients. Diazyme Glycated Serum Protein Enzymatic Assay Kit contains a single calibrator. The calibrator is used in the calculation of glycated…

Read the full statement (108 words)

Diazyme Glycated Serum Protein Enzymatic Assay Kit in conjunction with

Diazyme Glycated Serum Protein single calibrator, are intended for the

quantitative determination of glycated serum proteins (fructosamine) in serum.

The measurement of glycated serum proteins (fructosamine) is useful for

monitoring diabetic patients.

Diazyme Glycated Serum Protein Enzymatic Assay Kit contains a single

calibrator. The calibrator is used in the calculation of glycated serum protein

concentrations in unknown serum samples.

Diazyme Glycated Serum Protein Enzymatic Assay has controls for normal

glycated serum protein level and abnormal glycated serum protein level. The

controls are used as reference samples for checking the functionality of the

Diazyme Glycated Serum Protein Enzymatic Assay.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042193 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042193: Diazyme Glycated Serum Protein Enzymatic Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042193

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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