510(k) · Cleared
Recalled · 2003Synchron Systems Hemoglobin A1C 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 10, 2001 after a 119-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 10, 2001
- Review
- 119 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK010748 Synchron Systems Hemoglobin A1C ReagentBeckman Coulter, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK121492 Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) ReagentBeckman Coulter, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK140829 Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) ReagentBeckman Coulter, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK120199 Glycosylated Hemoglobin Assay; Clinical ChemistryBeckman Coulter, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK042459 Synchron LX Systems Hemoglobin A1C2 (HBA1C2) ReagentBeckman Coulter, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K121492Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) ReagentBeckman Coulter, Inc. · 2012 · cites it directly1descendant
- K140829Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) ReagentBeckman Coulter, Inc. · 2014 · 2 generations on0descendants
- K120199Glycosylated Hemoglobin Assay; Clinical ChemistryBeckman Coulter, Inc. · 2012 · cites it directly0descendants
- K042459Synchron LX Systems Hemoglobin A1C2 (HBA1C2) ReagentBeckman Coulter, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010748 | Synchron Systems Hemoglobin A1C Reagent | Beckman Coulter, Inc. | 2001 | — |
| +1 | K121492 | Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) Reagent | Beckman Coulter, Inc. | 2012 | — |
| +2 | K140829 | Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) Reagent | Beckman Coulter, Inc. | 2014 | — |
| +1 | K120199 | Glycosylated Hemoglobin Assay; Clinical Chemistry | Beckman Coulter, Inc. | 2012 | — |
| +1 | K042459 | Synchron LX Systems Hemoglobin A1C2 (HBA1C2) Reagent | Beckman Coulter, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2003 | Not classified | Z-1156-04 | Other | Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values. |
| Aug 15, 2003 | Not classified | Z-1155-04 | Other | LDL Cholesterol component in controls are unstable. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121492 (Beckman Coulter, Inc., 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K010748 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010748: Synchron Systems Hemoglobin A1C Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010748
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026