510(k) · Cleared
Recalled · Class II · 2014D-10 Hemoglobin A1C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Aug 27, 2003 as substantially equivalent to K984268 (Bio-Rad, 1998) after a 148-day review. Its family tree reaches back 2 generations to 1993. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- Aug 27, 2003
- Review
- 148 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926469 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK926469 Variant (TM) Hemoglobin a 1C ProgramBio-Rad · 1993
- 1 generation backK984268 Variant II Hemoglobin A1C ProgramBio-Rad · 1998 · Recalled
- This deviceK031043 D-10 Hemoglobin A1CBio-Rad Laboratories, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK090737 Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin…Bio-Rad Laboratories, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK060001 D-10 Hemoglobin A1C Program; D-10 Dual ProgramBio-Rad Laboratories, Inc. · 2006 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926469 | Variant (TM) Hemoglobin a 1C Program | Bio-Rad | 1993 | — |
| −1 | K984268 | Variant II Hemoglobin A1C Program | Bio-Rad | 1998 | 2 |
| 0 (this device) | K031043 | D-10 Hemoglobin A1C | Bio-Rad Laboratories, Inc. | 2003 | — |
| +1 | K090737 | Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary… | Bio-Rad Laboratories, Inc. | 2009 | — |
| +1 | K060001 | D-10 Hemoglobin A1C Program; D-10 Dual Program | Bio-Rad Laboratories, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LCP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCP device
- #1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984268 | Variant II Hemoglobin A1C ProgramSummary page 1…Assay, Glycosylated Hemoglobin, 8 lLCP Predicate Device: VARIANTTM I1 Hemoglobin AI, Program K984268 Bio-Rad Laboratories, Inc. Statement of Intended Use: The Bio-Rad… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2014 | Class II | Z-1299-2014 | Nonconforming Material/Component | 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 | Software design | 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-10 Hemoglobin Testing System. |
| Sep 12, 2011 | Not classified | Z-0018-2012 | Process control | 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 was made to field correct these… |
| Sep 12, 2011 | Not classified | Z-0019-2012 | Process control | 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 was made to field correct these… |
| Sep 12, 2011 | Not classified | Z-0017-2012 | Process control | 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 was made to field correct these… |
| Sep 8, 2010 | Not classified | Z-1969-2011 | Other | 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 the Calibrator/Diluent Set is: S01704. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K090737 (Bio-Rad Laboratories, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K984268.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LCP
269in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCP
22in 2025
MAUDE reports naming product code LCP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 133 | 1 | 5 |
| 2008 | 5 | 206 | 3 | 11 |
| 2009 | 6 | 158 | 6 | 15 |
| 2010 | 2 | — | 5 | 4 |
| 2011 | 10 | 176 | 51 | 27 |
| 2012 | 9 | 143 | 0 | 51 |
| 2013 | 2 | — | 4 | 193 |
| 2014 | 8 | 127 | 2 | 182 |
| 2015 | 3 | 239 | 2 | 64 |
| 2016 | 2 | — | 6 | 29 |
| 2017 | 5 | 218 | 1 | 149 |
| 2018 | 2 | — | 1 | 1,911 |
| 2019 | 4 | 269 | 0 | 114 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 1 | 8 |
| 2023 | 2 | — | 0 | 27 |
| 2024 | 1 | — | 1 | 39 |
| 2025 | 0 | — | 1 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031043: D-10 Hemoglobin A1C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031043
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026