510(k) · Cleared
Recalled · Class II · 2018Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls
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 Jan 13, 2003 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 13, 2003
- Review
- 66 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 3
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK023763 Randox Fructosamine, Fructosamine Calibrator, Fructosamine ControlsRandox Laboratories, Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK042193 Diazyme Glycated Serum Protein Enzymatic Assay KitDiazyme Laboratories · 2004
- Descendant · cites it directly · 0 of its ownK170147 Lucica Glycated Albumin-LAsahi Kasei Pharma Corporation · 2017
- Descendant · cites it directly · 0 of its ownK131307 Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine…Siemens Healthcare Diagnostics, Inc. · 2014 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K042193Diazyme Glycated Serum Protein Enzymatic Assay KitDiazyme Laboratories · 2004 · cites it directly1descendant
- K170147Lucica Glycated Albumin-LAsahi Kasei Pharma Corporation · 2017 · cites it directly0descendants
- K131307Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine CalibratorSiemens Healthcare Diagnostics, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023763 | Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls | Randox Laboratories, Ltd. | 2003 | — |
| +1 | K042193 | Diazyme Glycated Serum Protein Enzymatic Assay Kit | Diazyme Laboratories | 2004 | — |
| +1 | K170147 | Lucica Glycated Albumin-L | Asahi Kasei Pharma Corporation | 2017 | — |
| +1 | K131307 | Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine Calibrator | Siemens Healthcare Diagnostics, Inc. | 2014 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
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? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2018 | Class II | Z-1016-2019 | Under Investigation by firm | The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a… |
| Dec 3, 2018 | Class II | Z-1017-2019 | Under Investigation by firm | The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a… |
| Dec 3, 2018 | Class II | Z-1018-2019 | Under Investigation by firm | The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042193 (Diazyme Laboratories, 2004) has gone furthest, with 1 descendant of its own.
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 Fructosamine test kit is an in vitro diagnostic enzymatic assay for the quantitative determination of glycated protein (fructosamine) in human serum or plasma.
Measurement of glycated serum protein is representative of the mean blood glucose levels over the preceding 2-3 weeks.
For calibration of the Fructosamine assay.
To monitor the performance of the Fructosamine assay.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023763 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023763: Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023763
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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