510(k) · Cleared
ClearedA1C EZ Glycohemoglobin Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biohermes Co., Ltd. · LCP Assay, Glycosylated Hemoglobin
Cleared on Jun 16, 2017 as substantially equivalent to K090413 (Bayer Healthcare, LLC, 2009) after a 379-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Jun 16, 2017
- Review
- 379 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K033847 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK033847 A1CNOW for Home and Professional UseMetrika, Inc. · 2003
- 2 generations backK051321 InviewMetrika, Inc. · 2005 · Recalled
- 1 generation backK090413 A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test…Bayer Healthcare, LLC · 2009 · Recalled
- This deviceK161533 A1C EZ Glycohemoglobin Analysis SystemBiohermes Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K033847 | A1CNOW for Home and Professional Use | Metrika, Inc. | 2003 | — |
| −2 | K051321 | Inview | Metrika, Inc. | 2005 | 1 |
| −1 | K090413 | A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit… | Bayer Healthcare, LLC | 2009 | 7 |
| 0 (this device) | K161533 | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | 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 |
|---|---|---|---|
| * | K090413 | A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional…Summary page 4…Regulation No. 864.7470;862.2160 3. Legally Marketed Predicate Device Trade Name A1CNow+ (Professional Use) 510(k) Number K090413 Product Code LCP Manufacturer Bayer HealthCare Diabetes Care… | 2009 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K090413.
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?
A1C EZ Glycohemoglobin Analysis System is an in vitro diagnostic test used to quantitatively measure the percent glycohemoglobin A1c or glycohemoglobin A1c fraction mmol/mol in venous whole blood samples. This system is intended for multiple patient use to monitor long term glycemic control in individuals previously diagnosed with diabetes. This test is not to be used for screening or diagnosis of diabetes or for neonatal use. The A1C EZ Glycohemoglobin Analysis System is intended for professional use in clinical laboratories only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161533: A1C EZ Glycohemoglobin Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161533
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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