510(k) · Cleared
ClearedQuo-Test A1c System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ekf-Diagnostic GmbH · LCP Assay, Glycosylated Hemoglobin
Cleared on Feb 16, 2019 as substantially equivalent to K151809 (Alere Technologies AS, 2015) after a 354-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Feb 16, 2019
- Review
- 354 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K951361 (1995). No later device cites it as a predicate yet.
- 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 deviceK180509 Quo-Test A1c SystemEkf-Diagnostic GmbH · 2019
View 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) | K180509 | Quo-Test A1c System | Ekf-Diagnostic GmbH | 2019 | — |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151809 | Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerSummary page 5…Code: JJE III. Predicate Device The Quo-Test A1c System is substantially equivalent to the currently marketed Alere Afinion HbA1c (Hb) Testing System, 510(k) number K151809. IV. Device Description The Quo-Test Analyzer and A1c Test Kit (Quo-Test A1c System) are intended for the in-vitro quantita… | 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 24 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 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. 2019, 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?
The Quo-Test A1c System is intended for the in vitro quantitative determination of glycated hemoglobin (%HbA1c) levels in venous whole blood samples (using K2EDTA and lithium heparin anticoagulants).
Measurement of percent glycated hemoglobin (%HbA1c) is effective for monitoring long-term glycemic control in individuals previously diagnosed with diabetes mellitus.
The Quo-Test A1c System is not intended for screening or diagnosis of diabetes or neonatal use. The device is intended for professional use in a clinical laboratory setting.
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/K180509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180509: Quo-Test A1c System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180509
Report an extraction error
Are you the manufacturer?
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