510(k) · Cleared
ClearedAlere Afinion HbA1c, Alere Afinion AS100 Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere Technologies AS · LCP Assay, Glycosylated Hemoglobin
Cleared on Sep 25, 2015 as substantially equivalent to K050574 (Axis-Shield Poc AS, 2005) and 1 other predicate after an 85-day review. Its family tree reaches back 3 generations to 1995. 6 later devices descend from it.
- Decided
- Sep 25, 2015
- Review
- 85 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K951361 (1995). 6 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK951361 Dca 2000 System for Hemoglobin A1CHeraeus Kulzer, Inc. · 1995 · Recalled
- 2 generations backK050574 Afinion HbalcAxis-Shield Poc AS · 2005
- 1 generation backK110056 Afinion AnalyzerAxis-Shield Poc AS · 2011
- This deviceK151809 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 · cites it directly · 0 of its ownK214117 Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023
- Descendant · cites it directly · 0 of its ownK192987 Aina HbA1c Monitoring System 2Jana Care, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK180509 Quo-Test A1c SystemEkf-Diagnostic GmbH · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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 · cites it directly0descendants
- K192987Aina HbA1c Monitoring System 2Jana Care, Inc. · 2020 · cites it directly0descendants
- K180509Quo-Test A1c SystemEkf-Diagnostic GmbH · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951361 | Dca 2000 System for Hemoglobin A1C | Heraeus Kulzer, Inc. | 1995 | 1 |
| −2 | K050574 | Afinion Hbalc | Axis-Shield Poc AS | 2005 | — |
| −1 | K110056 | Afinion Analyzer | Axis-Shield Poc AS | 2011 | — |
| 0 (this device) | 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 | — |
| +1 | K214117 | Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer | Abbott Diagnostics Technologies AS | 2023 | — |
| +1 | K192987 | Aina HbA1c Monitoring System 2 | Jana Care, Inc. | 2020 | — |
| +1 | K180509 | Quo-Test A1c System | Ekf-Diagnostic GmbH | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K050574 | Afinion HbalcSummary page 4…bA1c test system consists of the Alere Afinion™ AS100 Analyzer and the Alere Afinion HbA1c test cartridge. The system was initially cleared under Pre-Market Notification k050574 and later cleared under Pre-Market Notification k110056. The test is waived under the Clinical Laboratory Improvement Amendment o… | 2005 |
| * | K110056 | Afinion AnalyzerSummary page 4…alyzer and the Alere Afinion HbA1c test cartridge. The system was initially cleared under Pre-Market Notification k050574 and later cleared under Pre-Market Notification k110056. The test is waived under the Clinical Laboratory Improvement Amendment of 1988 (CLIA ’88) for current indications for use (CR140… | 2011 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | 2017 | 2 |
| K214117 | Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer | 2023 | 0 |
| K192987 | Aina HbA1c Monitoring System 2 | 2020 | 0 |
| K180509 | Quo-Test A1c System | 2019 | 0 |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent… | 2018 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K171650 (Abbott Rapid Diagnostics, 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K050574.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion™ Analyzer to a laboratory information system or another electronic journal system. Alere Afinion™AS100 Analyzer System, consisting of…
Read the full statement (251 words)
Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion™ Analyzer to a laboratory information system or another electronic journal system.
Alere Afinion™AS100 Analyzer System, consisting of Alere Afinion™ AS100 Analyzer with Alere Afinion™Data Connectivity Converter (ADCC), Alere Afinion™ Test Cartridges and Alere Afinion™ Controls 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.
Alere Afinion™HbA1c Controls have been designed for use with the Alere Afinion™AS100 Analyzer System. Quality control using the Alere Afinion™HbA1c Control should be done to confirm that the Alere Afinion™AS100 Analyzer System is working properly and provides reliable result.
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 Alere Afinion™ AS100 Analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.
The Alere Afinion™ ACR Control kit contains liquid preparations of albumin and creatinine in citrate buffer. The controls should be used to confirm that the Alere Afinion™AS100 Analyzer System is working properly and provides reliable results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151809 · printed Nov 5, 2026
Cite this page
510(k) Report. “K151809: Alere Afinion HbA1c, Alere Afinion AS100 Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151809
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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