510(k) · Cleared
Recalled · Class II · 2014Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions Diagnostics · LCP Assay, Glycosylated Hemoglobin
Cleared on Jan 8, 2009 as substantially equivalent to K011434 (Tosoh Medics, Inc., 2001) and 1 other predicate after a 189-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jan 8, 2009
- Review
- 189 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972265 (1997). 4 ancestors in all, the oldest K904768 (1990). 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 deviceK081895 Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics · 2009
- Descendant · cites it directly · 0 of its ownK110934 Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment AssaySiemens Healthcare Diagnostics · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K110934Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment AssaySiemens Healthcare Diagnostics · 2011 · 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) | K081895 | Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C Calibrators | Siemens Medical Solutions Diagnostics | 2009 | — |
| +1 | K110934 | Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment Assay | Siemens Healthcare Diagnostics | 2011 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (2)
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 1…Device Device Name G7 Automated HPLC Analyzer - HbAl c Variant Analysis Mode Common name Glycosylated Hemoglobin Test 510(k) Number k011434 Manufacturer Tosoh Medics, Inc. Calibrator Predicate Device:… | 2001 |
| * | K041764 | The Vitros 5,1 FS Chemistry SystemSummary page 1…Predicate Device Device Name VITROS Chemistry Products Calibrator Kit 18 Common name Calibrator 510(k) Number k041764 Manufacturer Ortho-Clinical Diagnostics Siemens Healthcare Diagnostics (formerly Siemens Medical Solutions Diagnostic… | 2004 |
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 |
|---|---|---|---|
| K110934 | Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment Assay | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2014 | Class II | Z-2643-2014 | Software design | The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and 3LD068. Depending on quality control limits, this issue may not have been… |
| Jul 30, 2013 | Class II | Z-2135-2013 | Software design | Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K110934 (Siemens Healthcare Diagnostics, 2011) 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. 2009, 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 ADVIA® Chemistry Hemoglobin A1c method is 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 glycemic control of persons with diabetes. The A1c and total hemoglobin (tHb) values generated as part of the HbA1cN and HbA1cI results are intended for use in the calculation of the A1c / total hemoglobin…
Read the full statement (125 words)
The ADVIA® Chemistry Hemoglobin A1c method is 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 glycemic control of persons with diabetes. The A1c and total hemoglobin (tHb) values generated as part of the HbA1cN and HbA1cI results are intended for use in the calculation of the A1c / total hemoglobin ratio, and must not be used individually for diagnostic purposes.
*Note: HbA1cN reports HbA1c in % and HbA1cI reports HbA1c in mmol/mol
The ADVIA® Chemistry A1c Calibrators are for in vitro diagnostic use in the calibration of the A1c and total hemoglobin methods (Automated and Manual Pretreatment) on the ADVIA Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081895 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081895: Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081895
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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