510(k) · Cleared
ClearedAfinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diagnostics Technologies AS · LCP Assay, Glycosylated Hemoglobin
Cleared on Sep 27, 2023 as substantially equivalent to K171650 (Abbott Rapid Diagnostics, 2017) and 1 other predicate after a 636-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Sep 27, 2023
- Review
- 636 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K951361 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK951361 Dca 2000 System for Hemoglobin A1CHeraeus Kulzer, Inc. · 1995 · Recalled
- 4 generations backK050574 Afinion HbalcAxis-Shield Poc AS · 2005
- 3 generations backK110056 Afinion AnalyzerAxis-Shield Poc AS · 2011
- 2 generations backK151809 Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS · 2015
- 1 generation backK171650 Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics · 2017 · Recalled
- This deviceK214117 Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951361 | Dca 2000 System for Hemoglobin A1C | Heraeus Kulzer, Inc. | 1995 | 1 |
| −4 | K050574 | Afinion Hbalc | Axis-Shield Poc AS | 2005 | — |
| −3 | K110056 | Afinion Analyzer | Axis-Shield Poc AS | 2011 | — |
| −2 | 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 |
| 0 (this device) | K214117 | Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer | Abbott Diagnostics Technologies AS | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzerSummary page 4…Class II 21 CFR 864.7470 Hematology JQT Class I 21 CFR 862.2400 Chemistry Predicate Device: Afinion™ HbA1c (k171650) with Afinion™ 2 and Alere Afinion™ HbA1c ( k151809) with Alere Afinion™ AS100 Analyzer. 510(k) Summary… | 2017 |
| * | K151809 | Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerSummary page 4…Hematology JQT Class I 21 CFR 862.2400 Chemistry Predicate Device: Afinion™ HbA1c (k171650) with Afinion™ 2 and Alere Afinion™ HbA1c ( k151809) with Alere Afinion™ AS100 Analyzer. 510(k) Summary… | 2015 |
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 28 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K171650.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Afinionm HbAlc is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin Alc, HbAlc) in venous and capillary human whole blood. The measurement of % HbAlc is recommended as a marker of long- term metabolic control in persons with diabetes mellitus. Afinionm 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinionm test cartridges. AfinionTm 2 system, consisting…
Read the full statement (169 words)
Afinionm HbAlc is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin Alc,
HbAlc) in venous and capillary human whole blood. The measurement of % HbAlc is recommended as a marker of long-
term metabolic control in persons with diabetes mellitus.
Afinionm 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinionm test
cartridges. AfinionTm 2 system, consisting ofAfmion~m 2 analyzer and AfmionTM test cartridges is for in vitro diagnostic
use only.
Alere Afmionm AS100 Analyzer with Alere AfinionTm Data Connectivity Converter (ADCC) is a compact multi-assay
analyzer for point-of-care testing, designed to analyze the AfinionTM Test Cartridges. The ADCC is a small device for
automatic transfer of data, including patient and control assay results, from the Alere Afinionm Analyzer to a laboratory
information system or another electronic journal system.
Alere Afmionm AS100 Analyzer System, consisting ofAlere Afinionm AS100 Analyzer with Alere Afinionm Data
Connectivity Converter (ADCC), Afinionm Test Cartridges and Afinionm Controls is for in vitro diagnostic use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K214117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214117: Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214117
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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