# K011852: Dimension Haic Assay, Model DF105

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 15, 2001 after 156 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Roche Tina-quant® HBA1C II: named in the summary without a submission number

## Most influential descendants
- K062128: The Dimension Vista Flex Reagent Cartridges / Kit Assays (2006), 1 descendant of its own
- K102045: Dimension Visa HBA1C, Model K3105A (2011), 0 descendants of its own

## Recalls of this device
- Apr 22, 2013 · Class II · Z-0625-2014: 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 HA1C assay used on the Dimension® clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of percent hemoglobin Alc (HbAlc) in anticoagulated whole blood. Measurements of percent hemoglobin Alc are effective in monitoring long term glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K011852
Methodology: https://510kreport.com/methodology