510(k) · Cleared
Recalled · Class II · 2017Easyra Hbalc Regent Easycal HBLC Calibrator Easyqc Hbalc Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medica Corp. · LCP Assay, Glycosylated Hemoglobin
Cleared on May 14, 2012 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- May 14, 2012
- Review
- 83 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2017 | Class II | Z-1267-2018 | Process design | Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 EasyRA HbAlc Reagent kit is intended for use in the quantitative in-vitro diagnostic determination of hemoglobin Aic (HbAlc) in human whole blood using the EasyRA clinical chemistry analyzer. HbAlc measurements are used for the monitoring of long term blood glucose control in diabetic patients. The EasyCAL HbAlc calibrator is used for calibrating the HbAlc on the EasyRA clinical chemistry analyzer when used in conjunction with EasyRA HbAl c Reagent.…
Read the full statement (130 words)
The EasyRA HbAlc Reagent kit is intended for use in the quantitative in-vitro diagnostic determination of hemoglobin Aic (HbAlc) in human whole blood using the EasyRA clinical chemistry analyzer. HbAlc measurements are used for the monitoring of long term blood glucose control in diabetic patients.
The EasyCAL HbAlc calibrator is used for calibrating the HbAlc on the EasyRA clinical chemistry analyzer when used in conjunction with EasyRA HbAl c Reagent. The HbAl c calibrator is used to establish points of reference that are used in the determination of values in the measurement of HbAlc in human whole blood.
The EasyOC HbAlc OC Materials are intended to use as quality control material for the HbAlc immunoturbidimetric assay, using EasyRA HbAlc Reagent and EasyCAL HbAlc calibrator on the EasyRA clinical chemistry analyzer.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K120497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120497: Easyra Hbalc Regent Easycal HBLC Calibrator Easyqc Hbalc Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120497
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026