510(k) · Cleared
ClearedLucica Glycated Albumin-L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Kasei Pharma Corporation · LCP Assay, Glycosylated Hemoglobin
Cleared on Oct 12, 2017 as substantially equivalent to K023763 (Randox Laboratories, Ltd., 2003) after a 268-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Oct 12, 2017
- Review
- 268 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023763 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK023763 Randox Fructosamine, Fructosamine Calibrator, Fructosamine ControlsRandox Laboratories, Ltd. · 2003 · Recalled
- This deviceK170147 Lucica Glycated Albumin-LAsahi Kasei Pharma Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023763 | Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls | Randox Laboratories, Ltd. | 2003 | 3 |
| 0 (this device) | K170147 | Lucica Glycated Albumin-L | Asahi Kasei Pharma Corporation | 2017 | — |
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 |
|---|---|---|---|
| * | K023763 | Randox Fructosamine, Fructosamine Calibrator, Fructosamine ControlsSummary page 5…tional 510(k) Predicate Device The Lucica® Glycated Albumin-L is equivalent to the following FDA-cleared assay: • Fructosamine Test Kit [Randox Laboratories, Ltd (K023763) Device Description Lucica® Glycated Albumin-L: Lucica® Glycated Albumin-L contains two glycated albumin reagents and two albu… | 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 a recall.
- 2 other devices also cite its predicate K023763.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Lucica® Glycated Albumin-L is intended to be used for the quantitative measurement of glycated albumin in human serum on compatible clinical chemistry analyzers. The measurement of glycated albumin is useful for the intermediate term (preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170147 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170147: Lucica Glycated Albumin-L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170147
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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