# K102510: Dimensions HB1C Kit, Model DF105A

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: May 13, 2011 after 259 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- 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 K926469 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070452: Variant II Hemoglobin A1C Program with Models 270-2101NU, Bio-Rad Laboratories, Inc. (2007) 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

## Indications for use
The Hb1C assay on the Dimension® clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. The HbC CAL is an in vitro diagnostic product for the calibration of the Hemoglobin A1c (Hb1C) method on the Dimension® clinical chemistry system.

Source page: https://510kreport.com/device/K102510
Methodology: https://510kreport.com/methodology