# K102045: Dimension Visa HBA1C, Model K3105A

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Heatlhcare Diagnostics, Inc.
- Decided: Feb 14, 2011 after 208 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010496 (2001). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062128: The Dimension Vista Flex Reagent Cartridges / Kit Assays, Dade Behring, Inc. (2006) Summary page 1.

## Recalls of this device
- Sep 30, 2014 · Class II · Z-0420-2015: Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycoh
- Aug 14, 2014 · Class II · Z-0127-2015: In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole b
- Apr 22, 2013 · Class II · Z-0626-2014: Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.

## Indications for use
The HbA1c assay used on the Dimension Vista® system is an in vitro diagnostic assay for the quantitative determination of percent hemoglobin A1c in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. HbA1c calibrator is intended for use in the calibration of the Hemoglobin A1c (HbA1c) method on the Dimension Vista® system.

Source page: https://510kreport.com/device/K102045
Methodology: https://510kreport.com/methodology