510(k) · Cleared
ClearedAfinion Hbalc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Poc AS · LCP Assay, Glycosylated Hemoglobin
Cleared on Jul 22, 2005 as substantially equivalent to K951361 (Heraeus Kulzer, Inc., 1995) after a 137-day review. Its family tree reaches back 1 generation to 1995. 9 later devices descend from it.
- Decided
- Jul 22, 2005
- Review
- 137 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951361 (1995). 9 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK951361 Dca 2000 System for Hemoglobin A1CHeraeus Kulzer, Inc. · 1995 · Recalled
- This deviceK050574 Afinion HbalcAxis-Shield Poc AS · 2005
- Descendant · cites it directly · 8 of its ownK110056 Afinion AnalyzerAxis-Shield Poc AS · 2011
- Descendant · cites it directly · 6 of its ownK151809 Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS · 2015
- Descendant · cites it directly · 2 of its ownK171650 Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK221326 Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK214117 Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K110056Afinion AnalyzerAxis-Shield Poc AS · 2011 · cites it directly8descendants
- K151809Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS · 2015 · cites it directly6descendants
- K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics · 2017 · cites it directly2descendants
- K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024 · 2 generations on0descendants
- K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951361 | Dca 2000 System for Hemoglobin A1C | Heraeus Kulzer, Inc. | 1995 | 1 |
| 0 (this device) | K050574 | Afinion Hbalc | Axis-Shield Poc AS | 2005 | — |
| +1 | K110056 | Afinion Analyzer | Axis-Shield Poc AS | 2011 | — |
| +1 | K151809 | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | Alere Technologies AS | 2015 | — |
| +1 | K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | 2017 | 2 |
| +2 | K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024 | — |
| +2 | K214117 | Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer | Abbott Diagnostics Technologies AS | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K951361 | Dca 2000 System for Hemoglobin A1CSummary page 3…The substantial equivalence, safety and efficacy of the Axis-Shield PoC AfinionTM HbAlc assay to Bayer DCA 2000 ® Hemoglobin Ale assay (K951361), 510(k) cleared 05/05/1995, CLIA Waived 11/12/1997, was evaluated internally and externally at three study sites.… | 1995 |
What descends from it? (9)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
AfinionTM AS I00 Analyzer System, consisting of the AfinionTM AS 100 Analyzer AfinionTM Test Cartridges and AfinionTM Controls is for in-vitro diagnostic use only. AfinionTM AS 100 Analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion TM Test Cartridges. The AfinionTM Analyzer System is easy to use, rapid and gives reliable and accurate results. AfinionTM HbAlc is an in-vitro test for quantitative…
Read the full statement (135 words)
AfinionTM AS I00 Analyzer System, consisting of the AfinionTM AS 100 Analyzer
AfinionTM Test Cartridges and AfinionTM Controls is for in-vitro diagnostic use only.
AfinionTM AS 100 Analyzer is a compact multi-assay analyzer for point-of-care testing,
designed to analyze the Afinion TM Test Cartridges. The AfinionTM Analyzer System is easy
to use, rapid and gives reliable and accurate results.
AfinionTM HbAlc is an in-vitro test for quantitative determination of glycated hemoglobin
in human blood. The measurement of% HbAlc is recommended as a marker of long-term
metabolic control in persons with diabetes mellitus.
AfinionTM HbAlc Controls have been designed for use with the Afinion TM AS100
Analyzer System. Quality control using the AfinionTM HbA I c Control should be done to
confirm that the AfinionTM AS 100 Analyzer System is working properly and provides
reliable results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050574: Afinion Hbalc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050574
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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