510(k) · Cleared
ClearedHemocue HBA1C 501
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infopia Co, Ltd. · LCP Assay, Glycosylated Hemoglobin
Cleared on Sep 7, 2012 as substantially equivalent to K082275 (Infopia Co, Ltd., 2010) after a 123-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Sep 7, 2012
- Review
- 123 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950727 (1995). 8 ancestors in all, the oldest K951361 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK950727 One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc. · 1995
- 3 generations backK021819 One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2002 · Recalled
- 2 generations backK072369 Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC · 2008
- 1 generation backK082275 Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor…Infopia Co, Ltd. · 2010
- This deviceK121366 Hemocue HBA1C 501Infopia Co, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK141750 Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring SystemInfopia Co, Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K141750Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring SystemInfopia Co, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950727 | One Touch Profile Complete Diabetes Tracking System | Lifescan, Inc. | 1995 | — |
| −3 | K021819 | One Touch Ultrasmart Blood Glucose Monitoring System | Lifescan, Inc. | 2002 | 1 |
| −2 | K072369 | Evolution Blood Glucose Monitoring System | Hmd Biomedical, LLC | 2008 | — |
| −1 | K082275 | Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model… | Infopia Co, Ltd. | 2010 | — |
| 0 (this device) | K121366 | Hemocue HBA1C 501 | Infopia Co, Ltd. | 2012 | — |
| +1 | K141750 | Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring System | Infopia Co, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
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 |
|---|---|---|---|
| * | K082275 | Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023Summary page 1…system * Classification regulation: 21 CFR 864.7470 * Product Code: LCP 4. Predicate Device: CLOVER Aicm Glycosylated Hemoglobin Monitoring System (K082275) Infopia Co., Ltd. 10 Infopia Co.,Ltd. Glycosylated Hemoglo… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141750 | Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring System | 2014 | 0 |
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K141750 (Infopia Co, Ltd., 2014) has gone furthest, with 0 descendants 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. 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 Hemocue®8 Hbal c 501 assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbAlc is used to monitor long-term glucose control in individuals with diabetes mellitus. Hemocue® Hbalc 501 is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.
The test is for prescription use as an aid in the management of diabetes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121366: Hemocue HBA1C 501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121366
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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