# K081895: Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions Diagnostics
- Decided: Jan 8, 2009 after 189 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972265 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011434: G7 Automated HPLC Analyzer, Tosoh Medics, Inc. (2001) Summary page 1.
- K041764: The Vitros 5,1 FS Chemistry System, Ortho-Clinical Diagnostics (2004) Summary page 1.

## Most influential descendants
- K110934: Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment Assay (2011), 0 descendants of its own

## Recalls of this device
- Aug 6, 2014 · Class II · Z-2643-2014: 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 limit
- Jul 30, 2013 · Class II · Z-2135-2013: 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, 

## Indications for use
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.

Source page: https://510kreport.com/device/K081895
Methodology: https://510kreport.com/methodology