510(k) · Cleared

Cleared

Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) Reagent

K121492510(k) SpecialCleared Sep 11, 2012113-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

Beckman Coulter, Inc. · LCP Assay, Glycosylated Hemoglobin

Cleared on Sep 11, 2012 as substantially equivalent to K010748 (Beckman Coulter, Inc., 2001) after a 113-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Sep 11, 2012
Review: 113 days
Class: Class II
Product code: LCP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010748 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010748 Synchron Systems Hemoglobin A1C ReagentBeckman Coulter, Inc. · 2001 · Recalled
This deviceK121492 Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) ReagentBeckman Coulter, Inc. · 2012
Descendant · cites it directly · 0 of its ownK140829 Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) ReagentBeckman Coulter, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all

K140829Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) ReagentBeckman Coulter, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010748	Synchron Systems Hemoglobin A1C Reagent	Beckman Coulter, Inc.	2001	2
0 (this device)	K121492	Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) Reagent	Beckman Coulter, Inc.	2012	—
+1	K140829	Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) Reagent	Beckman Coulter, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K121492, 2001–2014Source: 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

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
*	K010748	Synchron Systems Hemoglobin A1C Reagent Summary page 1 …Number UniCel DxC SNHO ytm Hemoglobin Aic SYNCHon Sysem Beckman K01 0748 (HbA1 c-) Reagent (HbAlc) Reagent Coulter, Inc 5.0 Description: The UniCel DxC SYNCHR…	Beckman Coulter, Inc.	2001	2

Also cleared against K010748: 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
K140829	Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) Reagent	Beckman Coulter, 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, K140829 (Beckman Coulter, Inc., 2014) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K010748.

How does its category compare?

All LCP devices

LCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

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?

The Hemoglobin Aic- reagent, when used in conjunction with UniCel® DxC 6001800 SYNCHRON® Systems, UniCel® DxC SYNCHRON® Systems HbAlc- Calibrators and SYNCHRON® and AU® Systems Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin Aic concentration in human whole blood.

Measurement of hemoglobin Aic measures long-term glycemic control in patients with diabetes mellitus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121492 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121492: Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121492

Report an extraction error

Are you the manufacturer?

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