510(k) · Cleared
Recalled · Class II · 2016Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · LCP Assay, Glycosylated Hemoglobin
Cleared on Aug 25, 2011 as substantially equivalent to K081895 (Siemens Medical Solutions Diagnostics, 2009) after a 143-day review. Its family tree reaches back 3 generations to 1997. It has been recalled 2 times.
- Decided
- Aug 25, 2011
- Review
- 143 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972265 (1997). 5 ancestors in all, the oldest K904768 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK972265 A1C 2.2 Plus - Automated Glycohemoglobin AnalyzerTosoh Medics, Inc. · 1997
- 2 generations backK011434 G7 Automated HPLC AnalyzerTosoh Medics, Inc. · 2001 · Recalled
- 1 generation backK081895 Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics · 2009 · Recalled
- This deviceK110934 Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment AssaySiemens Healthcare Diagnostics · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972265 | A1C 2.2 Plus - Automated Glycohemoglobin Analyzer | Tosoh Medics, Inc. | 1997 | — |
| −2 | K011434 | G7 Automated HPLC Analyzer | Tosoh Medics, Inc. | 2001 | 2 |
| −1 | K081895 | Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C Calibrators | Siemens Medical Solutions Diagnostics | 2009 | 2 |
| 0 (this device) | K110934 | Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment Assay | Siemens Healthcare Diagnostics | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K081895 | Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSummary page 1…Hematology (81) F. Predicate Device: 1. Device Name: ADVIAC Chemistry Hemoglobin Aic (Alc) 2. Common Name: ADVIAS Chemistry Hemoglobin Aic (Alc) 3. 510(k) Number k081895 4. Manufacturer: Siemens Healthcare Diagnostics Inc. G.Intended Use: For in vitro diagnostic use in the quantitative determina… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2016 | Class II | Z-2704-2016 | Software design | Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343 and 11222123). This issue affects only the ADVIA Chemistry Hemoglobin A1c_3… |
| Sep 24, 2015 | Class II | Z-0340-2016 | Under Investigation by firm | Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c units. The maximum bias was observed at higher %HbA1c concentrations. QC… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All LCP devicesLCP 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
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?
For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems. Such measurements are used for monitoring the long-term care of persons with diabetes. The A1c-3 and total hemoglobin (tHb-3) values generated as part of the ADVIA Chemistry HbA1c% and HbA1cR assays are intended for use in the calculation of the A1c/total hemoglobin ratio, and must not be used individually for diagnostic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110934: Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110934
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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