510(k) · Cleared
ClearedAxsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Diagnostics, Ltd. · LCP Assay, Glycosylated Hemoglobin
Cleared on Mar 17, 2008 as substantially equivalent to K011434 (Tosoh Medics, Inc., 2001) after a 175-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Mar 17, 2008
- Review
- 175 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972265 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK972265 A1C 2.2 Plus - Automated Glycohemoglobin AnalyzerTosoh Medics, Inc. · 1997
- 1 generation backK011434 G7 Automated HPLC AnalyzerTosoh Medics, Inc. · 2001 · Recalled
- This deviceK072686 Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C ControlsAxis-Shield Diagnostics, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK121842 Architect HBA1C, Architect HBA1C, and Architect HBA1CAxis-Shield Diagnostics, Ltd. · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K121842Architect HBA1C, Architect HBA1C, and Architect HBA1CAxis-Shield Diagnostics, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972265 | A1C 2.2 Plus - Automated Glycohemoglobin Analyzer | Tosoh Medics, Inc. | 1997 | — |
| −1 | K011434 | G7 Automated HPLC Analyzer | Tosoh Medics, Inc. | 2001 | 2 |
| 0 (this device) | K072686 | Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls | Axis-Shield Diagnostics, Ltd. | 2008 | — |
| +1 | K121842 | Architect HBA1C, Architect HBA1C, and Architect HBA1C | Axis-Shield Diagnostics, Ltd. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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 |
|---|---|---|---|
| * | K011434 | G7 Automated HPLC AnalyzerSummary page 2…inical Chemistry Product Code: JJX Legally marketed device to which equivalency is claimed: G7 Automated Glycosylated Hemoglobin HPLC Analyzer (TSKgel G7 Variant Hsi); K011434. Intended Use of Device: The AxSYM HbAlc assay is an immunoassay for the quantitative determination of percent hemoglobin Alc… | 2001 |
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 |
|---|---|---|---|
| K121842 | Architect HBA1C, Architect HBA1C, and Architect HBA1C | 2012 | 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 11 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K121842 (Axis-Shield Diagnostics, Ltd., 2012) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K011434.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Reagents The AxSYM HbAlc assay is an immunoassay for the quantitative determination of percent hemoglobin Alc (HbAlc) in whole blood samples on the AxSYM System. Percent HbAlc measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control. Calibrators The AxSYM HbAlc Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of percent HbAlc in…
Read the full statement (114 words)
Reagents
The AxSYM HbAlc assay is an immunoassay for the quantitative determination of
percent hemoglobin Alc (HbAlc) in whole blood samples on the AxSYM System. Percent
HbAlc measurements are used in the clinical management of diabetes to assess the
long-term efficacy of diabetic control.
Calibrators
The AxSYM HbAlc Standard Calibrators are for the standard calibration of the AxSYM
System when used for the quantitative determination of percent HbAlc in whole blood
samples.
Controls
The AxSYM HbAlc Controls are for the use in quality control to monitor the accuracy and
precision of the AxSYM HbAlc assay when used for the quantitative determination of
percent hemoglobin Alc (HbAlc) in whole blood samples on the AxSYM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072686: Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072686
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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