# K041444: Bio-Rad D-10 Dual Program

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Jun 9, 2004 after 8 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K926469 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984268: Variant II Hemoglobin A1C Program, Bio-Rad (1998) Summary page 1.
- K991127: Variant II B-Thalassemia, Bio-Rad (1999) Summary page 1.

## Most influential descendants
- K060001: D-10 Hemoglobin A1C Program; D-10 Dual Program (2006), 0 descendants of its own

## Recalls of this device
- Jul 11, 2011 · Not classified · Z-2889-2011: Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435.
- Nov 17, 2006 · Not classified · Z-0376-2007: The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.

## Indications for use
The Bio-Rad D-10TM Dual Program system is intended for the percent determination of hemoglobins A1c, A2, and F, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high performance liquid chromatography (HPLC). Measurement of the percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus, and measurement of the percent HbA2 and HbF is effective in long-term monitoring of β-thalassemias (i.e., hereditary hemolytic anemias characterized by decreased synthesis of one or more types of abnormal hemoglobin polypeptide chains). Detection of hemoglobin thalassemia variants such as hemoglobins S, C, D and E by HPLC is effective in presumptive identification of these variants. The Bio-Rad D-10 Dual Program is intended for Professional Use Only. For in vitro diagnostics use.

Source page: https://510kreport.com/device/K041444
Methodology: https://510kreport.com/methodology