510(k) · Cleared
ClearedClover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023
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 Jan 14, 2010 as substantially equivalent to K071466 (Siemens Medical Solutions Diagnostics, 2007) and 1 other predicate after a 521-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 14, 2010
- Review
- 521 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950727 (1995). 7 ancestors in all, the oldest K951361 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK950727 One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc. · 1995
- 2 generations backK021819 One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2002 · Recalled
- 1 generation backK072369 Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC · 2008
- This deviceK082275 Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor…Infopia Co, Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK121366 Hemocue HBA1C 501Infopia Co, Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK141750 Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring SystemInfopia Co, Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950727 | One Touch Profile Complete Diabetes Tracking System | Lifescan, Inc. | 1995 | — |
| −2 | K021819 | One Touch Ultrasmart Blood Glucose Monitoring System | Lifescan, Inc. | 2002 | 1 |
| −1 | K072369 | Evolution Blood Glucose Monitoring System | Hmd Biomedical, LLC | 2008 | — |
| 0 (this device) | K082275 | Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model… | Infopia Co, Ltd. | 2010 | — |
| +1 | K121366 | Hemocue HBA1C 501 | Infopia Co, Ltd. | 2012 | — |
| +2 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K071466 | Dca Vantage, Model 5075Summary page 1…21 CFR Part 862.1345 Product Code: CGA, LOP 3. Predlcate Device: DCA Vantage Tm, Test system for hemoglobin Alic, albumin and creatinine, K071466 EvolutionTM , Blood glucose monitoring system, K(072369 4. Description: The CLOVER Al cTm is a device which combines a Hemogl… | 2007 |
| * | K072369 | Evolution Blood Glucose Monitoring SystemSummary page 1…CGA, LOP 3. Predlcate Device: DCA Vantage Tm, Test system for hemoglobin Alic, albumin and creatinine, K071466 EvolutionTM , Blood glucose monitoring system, K(072369 4. Description: The CLOVER Al cTm is a device which combines a Hemoglobin Alic monitoring system, and a blood glucose monitor… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121366 | Hemocue HBA1C 501 | 2012 | 1 |
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 15 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K121366 (Infopia Co, Ltd., 2012) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K071466.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 CLOVER A1c™ HbA1c 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 HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus. CLOVER A1c™ is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for…
Read the full statement (140 words)
The CLOVER A1c™ HbA1c 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 HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus. CLOVER A1c™ is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.
The CLOVER A1c™ glucose assay is used for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip by healthcare professionals. The test is for prescription use as an aid in the management of diabetes. CLOVER A1c™ is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082275: Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082275
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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