# K200256: ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jul 2, 2021 after 515 days
- Product code: PDJ (Hemoglobin A1c Test System)
- Device class: 2
- Regulation: 21 CFR 862.1373
- 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: 4 generations back to K934070 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171771: ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay, Siemens Healthcare Diagnostics, Inc. (2017) Summary page 6.

## Recalls of this device
- Jun 8, 2026 · Class II · Z-2703-2026: The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
- Feb 23, 2026 · Class II · Z-1657-2026: A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall.

## Indications for use
The ADVIA@ Chemistry Enzymatic Hemoglobin AIc (AlcE) assay is an in vitro diagnostic assay for the quantitative determination of mmol/mol HbAlc (IFCC) and % HbAlc (DCCT/NGSP) in human anticoagulated venous whole blood and hemolysate for use on the ADVIA@ Chemistry Systems. Measurement of Hemoglobin Alc 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/K200256
Methodology: https://510kreport.com/methodology