510(k) · Cleared
ClearedElitech Clinical Systems HBA1C Reagent, Elitech Clincal System HBA1C Calibrator Set, Elitech Clinical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seppim S.A.S. · LCP Assay, Glycosylated Hemoglobin
Cleared on May 19, 2011 as substantially equivalent to K031539 (Pointe Scientific, Inc.,, 2003) after a 448-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- May 19, 2011
- Review
- 448 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031539 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK031539 Hemoglobin A1C Reagent SetPointe Scientific, Inc., · 2003
- This deviceK100547 Elitech Clinical Systems HBA1C Reagent, Elitech Clincal System HBA1C…Seppim S.A.S. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031539 | Hemoglobin A1C Reagent Set | Pointe Scientific, Inc., | 2003 | — |
| 0 (this device) | K100547 | Elitech Clinical Systems HBA1C Reagent, Elitech Clincal System HBA1C… | Seppim S.A.S. | 2011 | — |
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 |
|---|---|---|---|
| * | K031539 | Hemoglobin A1C Reagent SetSummary page 1…osylated Hemoglobin (Sec.864.7470) Product code LCP; Assay, Glycosylated Hemoglobin Predicate device Hemoglobin Aic Reagent Set (K031 539) Device description The device for this submission is available as a kit only. It consists of 3 reagents.… | 2003 |
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 no recall.
- 1 other device also cites its predicate K031539.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
ELiTech Clinical Systems HbAlc is intended for use in the quantitative in vitro diagnostic determination of hemoglobin Aic (HbAlc) in human whole blood on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. HbAlc measurements are used for the monitoring of long term blood glucose control in diabetic patients. ELITech Clinical Systems HbAlc Calibrator set is a calibrator with 4 different levels of values for…
Read the full statement (142 words)
ELiTech Clinical Systems HbAlc is intended for use in the quantitative in vitro diagnostic determination of hemoglobin Aic (HbAlc) in human whole blood on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings.
HbAlc measurements are used for the monitoring of long term blood glucose control in diabetic patients.
ELITech Clinical Systems HbAlc Calibrator set is a calibrator with 4 different levels of values for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems HbAl c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.
ELiTech Clinical Systems HbAlc Control L+H is a quality control with .2 levels of values (Low and High values) for in vitro diagnostic use in accuracy control of quantitative ELiech Clinical Systems HbAlc on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100547 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100547: Elitech Clinical Systems HBA1C Reagent, Elitech Clincal System HBA1C Calibrator Set, Elitech Clinical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100547
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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