510(k) · Cleared
ClearedMultigent Hemoglobin A1C (Reagents), HB A1C Calibrators and HB A1C Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seradyn, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Feb 9, 2004 as substantially equivalent to K011434 (Tosoh Medics, Inc., 2001) after a 77-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Feb 9, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972265 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK972265 A1C 2.2 Plus - Automated Glycohemoglobin AnalyzerTosoh Medics, Inc. · 1997
- 1 generation backK011434 G7 Automated HPLC AnalyzerTosoh Medics, Inc. · 2001 · Recalled
- This deviceK033674 Multigent Hemoglobin A1C (Reagents), HB A1C Calibrators and HB A1C…Seradyn, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K011434 | G7 Automated HPLC Analyzer | 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 4 other devices also cite its predicate K011434.
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 MULTIGENT Hb A1c assay is used in clinical laboratories for the quantitative in vitro measurement of percent Hb A1c (hemoglobin fraction) in human whole blood on the AEROSET® System and ARCHITECT® c8000™ System. The Hb A1c assay is intended to aid in the monitoring of long-term blood glucose control and compliance in individuals with diabetes mellitus. The MULTIGENT Hb A1c assay is not intended for use in diagnosing diabetes mellitus. The MULTIGENT…
Read the full statement (139 words)
The MULTIGENT Hb A1c assay is used in clinical laboratories for the quantitative in vitro measurement of percent Hb A1c (hemoglobin fraction) in human whole blood on the AEROSET® System and ARCHITECT® c8000™ System. The Hb A1c assay is intended to aid in the monitoring of long-term blood glucose control and compliance in individuals with diabetes mellitus. The MULTIGENT Hb A1c assay is not intended for use in diagnosing diabetes mellitus.
The MULTIGENT Hb A1c Calibrators are intended for in vitro diagnostic use with the AEROSET® System and the ARCHITECT® c8000™ System for the calibration of the assays in the MULTIGENT Hb A1c Reagent Kit.
The MULTIGENT Hb A1c Controls are intended for in vitro diagnostic use with the AEROSET® System and the ARCHITECT® c8000™ System for quality control of the assays in the MULTIGENT Hb A1c Reagent Kit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033674 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033674: Multigent Hemoglobin A1C (Reagents), HB A1C Calibrators and HB A1C Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033674
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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