510(k) Report

510(k) · Cleared

Cleared

Afinion Analyzer

K110056510(k) TraditionalCleared Feb 15, 201136-day reviewClass II21 CFR 864.7470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Axis-Shield Poc AS · LCP Assay, Glycosylated Hemoglobin

Cleared on Feb 15, 2011 as substantially equivalent to K050574 (Axis-Shield Poc AS, 2005) after a 36-day review. Its family tree reaches back 2 generations to 1995. 8 later devices descend from it.

Decided
Feb 15, 2011
Review
36 days
Class
Class II
Product code
LCP
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K951361 (1995). 8 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2017: 1 descendant cleared2020: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant clearedReference device: K072409 · Afinion Acr and Acr Control · Axis-Shield Poc AS · 2008K951361 · Dca 2000 System for Hemoglobin A1C · Heraeus Kulzer, Inc. · 1995 · recalledK050574 · Afinion Hbalc · Axis-Shield Poc AS · 20051995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 5 descendants K050574 · Afinion Hbalc · Axis-Shield Poc AS · 2005K951361 · Dca 2000 System for Hemoglobin A1C · Heraeus Kulzer, Inc. · 1995 · recalled0
  1. Root · 2 generations backK951361 Dca 2000 System for Hemoglobin A1CHeraeus Kulzer, Inc. · 1995 · Recalled
  2. 1 generation backK050574 Afinion HbalcAxis-Shield Poc AS · 2005
  3. This deviceK110056 Afinion AnalyzerAxis-Shield Poc AS · 2011
  4. Descendant · cites it directly · 6 of its ownK151809 Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS · 2015
  5. Descendant · cites it directly · 2 of its ownK171650 Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics · 2017 · Recalled
  6. Descendant · 2 generations on · 0 of its ownK221326 Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
  7. Descendant · 2 generations on · 0 of its ownK214117 Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023
  8. Descendant · 2 generations on · 0 of its ownK192987 Aina HbA1c Monitoring System 2Jana Care, Inc. · 2020

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2015: 22017: 12018: 12019: 12020: 12023: 12024: 1
2015high 2 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 8 · See all
  • 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
  • K192987Aina HbA1c Monitoring System 2Jana Care, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K951361Dca 2000 System for Hemoglobin A1CHeraeus Kulzer, Inc.19951
−1K050574Afinion HbalcAxis-Shield Poc AS2005—
0 (this device)K110056Afinion AnalyzerAxis-Shield Poc AS2011—
+1K151809Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS2015—
+1K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics20172
+2K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation2024—
+2K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS2023—
+2K192987Aina HbA1c Monitoring System 2Jana Care, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201710
201810
201910
202010
202310
202410
FIG. 1 — Lineage of K110056, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K050574Afinion Hbalc
Summary page 1
…AfinionTm HbAlIc AfinionTM HbAlIc Controls Regulatory Information of Previously Cleared Device 5 10(k) no.: k050574 Device Classification: Class 1, 11 Product Codes: JQT, LCP, lAX CLIA complexit…
Axis-Shield Poc AS2005—
†K072409Afinion Acr and Acr ControlAxis-Shield Poc AS2008—

Also cleared against K050574: 2 other devices →

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151809Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS20156
K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics20172
K140827SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control SetSd Biosensor, Inc.20150

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 16 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K151809 (Alere Technologies AS, 2015) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K050574.

How does its category compare?

All LCP devices

LCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LCP

1in 2024

2007: 72008: 52009: 62010: 22011: 102012: 92013: 22014: 82015: 32016: 22017: 52018: 22019: 42020: 12023: 22024: 1
2007high 10 (2011) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCP

269in 2019

2007: 133 days median2008: 206 days median2009: 158 days median2011: 176 days median2012: 143 days median2014: 127 days median2015: 239 days median2017: 218 days median2019: 269 days median
2007high 269 (2019) · low 127 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LCP

1in 2025

2007: 12008: 32009: 62010: 52011: 512013: 42014: 22015: 22016: 62017: 12018: 12022: 12024: 12025: 1
2007high 51 (2011) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LCP

22in 2025

2007: 52008: 112009: 152010: 42011: 272012: 512013: 1932014: 1822015: 642016: 292017: 1492018: 1,9112019: 1142020: 132021: 72022: 82023: 272024: 392025: 22
2007high 1,911 (2018) · low 4 (2010)2025

MAUDE reports naming product code LCP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007713315
20085206311
20096158615
20102—54
2011101765127
20129143051
20132—4193
201481272182
20153239264
20162—629
201752181149
20182—11,911
201942690114
20201—013
20210—07
20220—18
20232—027
20241—139
20250—122
20260—0—

What is it indicated for?

Afinion™ AS 100 Analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The Afinion™ Data Connectivity Converter (ADCC) is a small device for automatic transfer of data, including patient and control assay results, from the Afinion™ Analyzer to a laboratory information system or another electronic journal system. Afinion™ AS100 Analyzer System, consisting of Afinion™ AS100 Analyzer with…

Read the full statement (244 words)

Afinion™ AS 100 Analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The Afinion™ Data Connectivity Converter (ADCC) is a small device for automatic transfer of data, including patient and control assay results, from the Afinion™ Analyzer to a laboratory information system or another electronic journal system.

Afinion™ AS100 Analyzer System, consisting of Afinion™ AS100 Analyzer with Afinion™ Data Connectivity Converter (ADCC), Afinion™ Test Cartridges and Afinion™ Controls is for in vitro diagnostic use only.

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.

Afinion™ HbA1c Controls have been designed for use with the Afinion™ AS 100 Analyzer System. Quality control using the Afinion™ HbA1c Control should be done to confirm that the Afinion™ AS 100 Analyzer System is working properly and provides reliable result.

The 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™ AS 100 Analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.

The Afinion™ ACR Control kit contains liquid preparations of albumin and creatinine in citrate buffer. The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.

Indications for use as stated in the FDA summary.

Also cleared against K050574

2 other devices cite the same predicate.

  • K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics · 20172 recalls
  • K151809Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS · 2015

More from Axis-Shield Poc AS

4 FDA decisions under this applicant name. See the company

  • K132031Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS · 2014
  • K072409Afinion Acr and Acr ControlAxis-Shield Poc AS · 2008
  • K050574Afinion HbalcAxis-Shield Poc AS · 2005

Recent decisions in LCP

The LCP category page

  • K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
  • K231465Q-Pad Test SystemQurasense · 2023
  • K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023
  • K192987Aina HbA1c Monitoring System 2Jana Care, Inc. · 2020
  • K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd. · 2019

https://510kreport.com/device/K110056 · printed Nov 5, 2026

Cite this page

510(k) Report. “K110056: Afinion Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110056

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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