# K173909: Dimension Hemoglobin A1c Assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jul 13, 2018 after 203 days
- Product code: PDJ (Hemoglobin A1c Test System)
- Device class: 2
- Regulation: 21 CFR 862.1373
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN130002 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160571: cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay, Roche Diagnostics Operations (Rdo) (2016) Summary page 4.

## Indications for use
The Dimension® Hemoglobin A1c assay is an in vitro diagnostic assay for the quantitative determination of %HbA1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood for use on the Dimension® clinical chemistry system. Measurement of Hemoglobin A1c is used as an aid in 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/K173909
Methodology: https://510kreport.com/methodology