510(k) · Cleared
Recalled · Class II · 2025Alere Afinion HbA1c and ACR on Afinion 2 analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Rapid Diagnostics · LCP Assay, Glycosylated Hemoglobin
Cleared on Nov 21, 2017 as substantially equivalent to K151809 (Alere Technologies AS, 2015) and 3 other predicates after a 169-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 21, 2017
- Review
- 169 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 4 generations to K951361 (1995). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK951361 Dca 2000 System for Hemoglobin A1CHeraeus Kulzer, Inc. · 1995 · Recalled
- 3 generations backK050574 Afinion HbalcAxis-Shield Poc AS · 2005
- 2 generations backK110056 Afinion AnalyzerAxis-Shield Poc AS · 2011
- 1 generation backK151809 Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS · 2015
- This deviceK171650 Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics · 2017
- Descendant · cites it directly · 0 of its ownK221326 Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
- Descendant · cites it directly · 0 of its ownK214117 Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023
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 |
|---|---|---|---|---|---|
| −4 | K951361 | Dca 2000 System for Hemoglobin A1C | Heraeus Kulzer, Inc. | 1995 | 1 |
| −3 | K050574 | Afinion Hbalc | Axis-Shield Poc AS | 2005 | — |
| −2 | K110056 | Afinion Analyzer | Axis-Shield Poc AS | 2011 | — |
| −1 | K151809 | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | Alere Technologies AS | 2015 | — |
| 0 (this device) | K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | 2017 | — |
| +1 | K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K151809 | Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerSummary page 5…21 CFR 862.2400 Chemistry Predicate Device: Alere Afinion™ HbA1c and Alere Afinion™ AS100 Analyzer (k151809) The following are the legally marketed devices covered under the predicate device clearance, k151809, and their prior clearances… | 2015 |
| * | K050574 | Afinion HbalcSummary page 5…vice clearance, k151809, and their prior clearances: The Alere Afinion™ HbA1c assay with HbA1c controls for use with the Alere Afinion™ AS100 Analyzer was cleared under k050574. The Alere Afinion™ ACR assay with ACR controls for use with the Alere Afinion™ AS100 Analyzer was cleared under k072409. The sys… | 2005 |
| * | K072409 | Afinion Acr and Acr ControlSummary page 5…Alere Afinion™ AS100 Analyzer was cleared under k050574. The Alere Afinion™ ACR assay with ACR controls for use with the Alere Afinion™ AS100 Analyzer was cleared under k072409. The system, including both HbA1c and ACR assays and the Afinion AS100 Analyzer, was cleared under k110056 for the addition of a… | 2008 |
| * | K110056 | Afinion AnalyzerSummary page 5…r use with the Alere Afinion™ AS100 Analyzer was cleared under k072409. The system, including both HbA1c and ACR assays and the Afinion AS100 Analyzer, was cleared under k110056 for the addition of a new accessory, the Afinion Data Connectivity Converter. A modification to the Afinion HbA1c assay with the… | 2011 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2025 | Class II | Z-1830-2025 | Storage | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test… |
| Jun 17, 2024 | Class II | Z-2736-2024 | Reprocessing Controls | Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K221326 (Nova Biomedical Corporation, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K151809.
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?
Afinion™ 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ test cartridges. Afinion™ 2 system, consisting of Afinion™ 2 analyzer and Alere Afinion™ test cartridges is for in vitro diagnostic use only. Alere Afinion™ HbA1c is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, % HbA1c) in human whole blood. The measurement of % HbA1c is recommended as a…
Read the full statement (126 words)
Afinion™ 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ test
cartridges. Afinion™ 2 system, consisting of Afinion™ 2 analyzer and Alere Afinion™ test cartridges is for in vitro
diagnostic use only.
Alere Afinion™ HbA1c is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (%
hemoglobin A1c, % HbA1c) in human whole blood. The measurement of % HbA1c is recommended as a marker of long
term metabolic control in persons with diabetes mellitus.
The Alere Afinion™ ACR assay is an in vitro diagnostic test for quantitative determination of albumin, creatinine and
albumin/creatinine ratio (ACR) in human urine using the Afinion™ 2 analyzer. The measurement of urine albumin,
creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171650: Alere Afinion HbA1c and ACR on Afinion 2 analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171650
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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