510(k) · Cleared
Recalled · Class II · 2020Afinion HbA1c Dx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere Technologies AS · PDJ Hemoglobin A1c Test System
Cleared on May 7, 2018 as substantially equivalent to K121610 (Roche Diagnostics Operations, 2013) after a 94-day review. Its family tree reaches back 2 generations to 2013. 1 later device descends from it. It has been recalled once.
- Decided
- May 7, 2018
- Review
- 94 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN130002 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN130002 Tina-Quant HBA1C Gen. 2 Test SystemRoche Diagnostics · 2013
- 1 generation backK121610 Cobas C 501 Tina-Quant HBA1CDX Gen.3 AssayRoche Diagnostics Operations · 2013
- This deviceK180296 Afinion HbA1c DxAlere Technologies AS · 2018
- Descendant · cites it directly · 0 of its ownK182988 Afinion HbA1c Dx on Afinion 2Alere Technologies AS · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K182988Afinion HbA1c Dx on Afinion 2Alere Technologies AS · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN130002 | Tina-Quant HBA1C Gen. 2 Test System | Roche Diagnostics | 2013 | — |
| −1 | K121610 | Cobas C 501 Tina-Quant HBA1CDX Gen.3 Assay | Roche Diagnostics Operations | 2013 | — |
| 0 (this device) | K180296 | Afinion HbA1c Dx | Alere Technologies AS | 2018 | — |
| +1 | K182988 | Afinion HbA1c Dx on Afinion 2 | Alere Technologies AS | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 PDJ? 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 PDJ device
- #1 K252749 Medconn 8K Glycated Hemoglobin Test Systemscore 11.5 · 4 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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182988 | Afinion HbA1c Dx on Afinion 2 | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2020 | Class II | Z-2192-2020 | Device Design | The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K182988 (Alere Technologies AS, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PDJ devicesPDJ Hemoglobin A1c Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PDJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDJ
203in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDJ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDJ
42in 2025
MAUDE reports naming product code PDJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 2 | — | 0 | 10 |
| 2015 | 4 | 234 | 0 | 2 |
| 2016 | 2 | — | 1 | 0 |
| 2017 | 3 | 173 | 0 | 1 |
| 2018 | 5 | 203 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 19 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 1 | — | 0 | 47 |
| 2025 | 2 | — | 0 | 42 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Afinion™ HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human venous and capillary whole blood.
This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
The measurement of % HbA1c¢ is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.
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/K180296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180296: Afinion HbA1c Dx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180296
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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