510(k) · Cleared
ClearedUnicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Jul 14, 2014 as substantially equivalent to K121492 (Beckman Coulter, Inc., 2012) after a 104-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jul 14, 2014
- Review
- 104 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010748 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK010748 Synchron Systems Hemoglobin A1C ReagentBeckman Coulter, Inc. · 2001 · Recalled
- 1 generation backK121492 Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) ReagentBeckman Coulter, Inc. · 2012
- This deviceK140829 Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) ReagentBeckman Coulter, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010748 | Synchron Systems Hemoglobin A1C Reagent | Beckman Coulter, Inc. | 2001 | 2 |
| −1 | K121492 | Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) Reagent | Beckman Coulter, Inc. | 2012 | — |
| 0 (this device) | K140829 | Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) Reagent | Beckman Coulter, Inc. | 2014 | — |
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
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 | Decided |
|---|---|---|---|
| * | K121492 | Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) ReagentSummary page 1…Number UniCel DxC UniCel DxC SYNCHRON Systems SYNCHRON Systems Beckman K1 21492 Hemoglobin Aic Hemoglobin Aic- Coulter, Inc. (HbAlc3) Reagent (Hb lc-)… | 2012 |
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 13 years and passes through 1 company; a new generation was cleared every 11.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LCP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LCP
269in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCP
22in 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 UniCel DxC Synchron Systems Hemoglobin A1c3 (HbA1c3) Reagent, when used in conjunction with UniCel DxC 600/800 SYNCHRON Systems, UniCel DxC SYNCHRON Systems HbA1c3 Calibrators and HbDIL reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood.
The A1c3 and Hb3 values generated as part of the HbA1c3 assay are intended for use in the calculation of the A1c3/Hb3 ratio and must not be used individually.
Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140829: Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140829
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