510(k) · Cleared
Recalled · Class II · 2017Randox Haemoglobin A1C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · LCP Assay, Glycosylated Hemoglobin
Cleared on Nov 26, 2002 after a 169-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Nov 26, 2002
- Review
- 169 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 |
|---|---|---|---|---|
| Jun 7, 2017 | Class II | Z-0285-2018 | Under Investigation by firm | Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product. |
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.
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 Randox Laboratories Limited Haemoglobin A, Test Kit is an in vitro diagnostic reagent for the quantitative determination of haemoglobin AI, (HbA1,) in whole blood. The method is an immunological assay. Both the concentration of HbAl, and the concentration of total haemoglobin are measured. The reported HbAl, result is calculated as a percentage of the total haemoglobin concentration. Measurements of percentage HbA1, are effective in monitoring…
Read the full statement (101 words)
The Randox Laboratories Limited Haemoglobin A, Test Kit is an in vitro diagnostic reagent for the quantitative determination of haemoglobin AI, (HbA1,) in whole blood. The method is an immunological assay. Both the concentration of HbAl, and the concentration of total haemoglobin are measured. The reported HbAl, result is calculated as a percentage of the total haemoglobin concentration.
Measurements of percentage HbA1, are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
This application sheet has been developed for the Hitachi 717 clinical chemistry analyser and must be used by suitably qualified laboratory personnel under appropriate clinical laboratory conditions.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021897 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021897: Randox Haemoglobin A1C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021897
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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