510(k) · Cleared
Recalled · 2011Variant II 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 Apr 15, 2004 as substantially equivalent to K984268 (Bio-Rad, 1998) after a 13-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 15, 2004
- Review
- 13 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926469 (1993). 3 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 deviceK040872 Variant II Hemoglobin A1CBio-Rad Laboratories, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK063400 Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System…Bio-Rad Laboratories, Inc. · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK070819 Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK140801 Variant II Turbo Link Hemoglobin A1C Program/Testing SystemBio-Rad Laboratories, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K063400Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0Bio-Rad Laboratories, Inc. · 2006 · cites it directly2descendants
- K070819Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2007 · cites it directly1descendant
- K140801Variant II Turbo Link Hemoglobin A1C Program/Testing SystemBio-Rad Laboratories, Inc. · 2014 · 2 generations on0descendants
View 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) | K040872 | Variant II Hemoglobin A1C | Bio-Rad Laboratories, Inc. | 2004 | — |
| +1 | K063400 | Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0 | Bio-Rad Laboratories, Inc. | 2006 | 4 |
| +1 | K070819 | Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link… | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2007 | 5 |
| +2 | K140801 | Variant II Turbo Link Hemoglobin A1C Program/Testing System | Bio-Rad Laboratories, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 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, 81LCP Predicate Device: VARIANT TM II Hemoglobin Alc Program K984268 Bio-Rad Laboratories, Inc. Intended Use: The Bio-Rad VARIANT II T… | 1998 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| Sep 12, 2011 | Not classified | Z-0020-2012 | 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-0021-2012 | 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-0022-2012 | 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… |
| Mar 24, 2010 | Not classified | Z-1342-2011 | Other | The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 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, K063400 (Bio-Rad Laboratories, Inc., 2006) has gone furthest, with 2 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 VARIANT II TURBO 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 Bio-Rad VARIANT II TURBO Hemoglobin A1c Program is intended for Professional Use Only. For In Vitro Diagnostic Use.
Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040872 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040872: Variant II 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/K040872
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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