# K060001: D-10 Hemoglobin A1C Program; D-10 Dual Program

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Jan 20, 2006 after 17 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). 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)
- K031043: D-10 Hemoglobin A1C, Bio-Rad Laboratories, Inc. (2003) Summary page 2.
- K041444: Bio-Rad D-10 Dual Program, Bio-Rad Laboratories, Inc. (2004) Summary page 2.

## Recalls of this device
- Dec 15, 2015 · Class II · Z-0695-2016: On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.

## Indications for use
Measurements of percent HbAlc are effective in monitoring long-term glucose control in individuals with diabetes mellitus. Measurement of percent HbA 2 and HbF are used for evaluation f3 - thalassemia, a hereditary hemolytic anemia. Detection of hemoglobin variants such as S, C, D and E are effective in presumptive identification.

Source page: https://510kreport.com/device/K060001
Methodology: https://510kreport.com/methodology