# K171771: ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Dec 4, 2017 after 173 days
- Product code: PDJ (Hemoglobin A1c Test System)
- Device class: 2
- Regulation: 21 CFR 862.1373
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K934070 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130255: Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls, Abbott Laboratories (2014) Summary page 4.

## Most influential descendants
- K200256: ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (2021), 0 descendants of its own

## Recalls of this device
- Feb 9, 2022 · Class II · Z-0929-2022: Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

## Indications for use
The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c_E) assay is an in vitro diagnostic assay for the quantitative determination of mmol/mol HbA1c (IFCC) and % HbA1c (DCCT/NGSP) in human anticoagulated venous whole blood and hemolysate for use on the ADVIA® Chemistry systems. Measurement of Hemoglobin A1c is used as an aid in the diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus, and as an aid in the identification of patients at risk for developing diabetes mellitus.

Source page: https://510kreport.com/device/K171771
Methodology: https://510kreport.com/methodology