# K031043: D-10 Hemoglobin A1C

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Aug 27, 2003 after 148 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 6 (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). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 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.

## Most influential descendants
- K090737: Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection System (HCCS), 5 Tests, Hemoglobi (2009), 0 descendants of its own
- K060001: D-10 Hemoglobin A1C Program; D-10 Dual Program (2006), 0 descendants of its own

## Recalls of this device
- Feb 27, 2014 · Class II · Z-1299-2014: On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.
- Nov 22, 2013 · Class III · Z-0965-2014: D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D
- Sep 12, 2011 · Not classified · Z-0018-2012: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision
- Sep 12, 2011 · Not classified · Z-0019-2012: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision
- Sep 12, 2011 · Not classified · Z-0017-2012: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision
- Sep 8, 2010 · Not classified · Z-1969-2011: The firm discovered that the Update Kit Floppy Diskette included in the reorder pack was mislabeled with an incorrect Lot Number for the Calibrator/Diluent Set as: S01819; The correct Lot Number for t

## Indications for use
The Bio-Rad D-10 Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c Program is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K031043
Methodology: https://510kreport.com/methodology