510(k) · Cleared
ClearedSynchron LX Systems Hemoglobin A1C2 (HBA1C2) 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 Nov 17, 2004 as substantially equivalent to K010748 (Beckman Coulter, Inc., 2001) after a 68-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Nov 17, 2004
- Review
- 68 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010748 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010748 Synchron Systems Hemoglobin A1C ReagentBeckman Coulter, Inc. · 2001 · Recalled
- This deviceK042459 Synchron LX Systems Hemoglobin A1C2 (HBA1C2) ReagentBeckman Coulter, Inc. · 2004
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) | K042459 | Synchron LX Systems Hemoglobin A1C2 (HBA1C2) Reagent | Beckman Coulter, Inc. | 2004 | — |
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 |
|---|---|---|---|
| * | K010748 | Synchron Systems Hemoglobin A1C ReagentSummary page 1…_ _____ _ __ ___ ___ ___ ___ ___ _I N u m b er SYNCHRON LX SYNCHRON Beckman K01 0748 Systems Systems Coulter, Inc. HbAlc2 Reagent… | 2001 |
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K010748.
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 | — |
What is it indicated for?
The Hemoglobin Alc2 (HbAlc2) reagent kit, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems HbAlc2 Calibrators, is intended for the quantitative determination of hemoglobin Alc (HbAlc2) concentration as a percentage of total hemoglobin in human whole blood. Measurement of hemoglobin Alc is accepted as a method to measure long-term glucose control in patients with diabetes mellitus (a chronic disorder associated with disturbances…
Read the full statement (98 words)
The Hemoglobin Alc2 (HbAlc2) reagent kit, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems HbAlc2 Calibrators, is intended for the quantitative determination of hemoglobin Alc (HbAlc2) concentration as a percentage of total hemoglobin in human whole blood.
Measurement of hemoglobin Alc is accepted as a method to measure long-term glucose control in patients with diabetes mellitus (a chronic disorder associated with disturbances in carbohydrate, fat, and protein metabolism and characterized by hyperglycemia). Determination of hemoglobin Alc provides an important diagnostic tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042459: Synchron LX Systems Hemoglobin A1C2 (HBA1C2) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042459
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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