510(k) · Cleared
Recalled · 2010Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0
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 Dec 1, 2006 as substantially equivalent to K040872 (Bio-Rad Laboratories, Inc., 2004) after a 22-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 1, 2006
- Review
- 22 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K926469 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK926469 Variant (TM) Hemoglobin a 1C ProgramBio-Rad · 1993
- 2 generations backK984268 Variant II Hemoglobin A1C ProgramBio-Rad · 1998 · Recalled
- 1 generation backK040872 Variant II Hemoglobin A1CBio-Rad Laboratories, Inc. · 2004 · Recalled
- This deviceK063400 Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System…Bio-Rad Laboratories, Inc. · 2006
- 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 2 of 2 · See all- 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 |
|---|---|---|---|---|---|
| −3 | K926469 | Variant (TM) Hemoglobin a 1C Program | Bio-Rad | 1993 | — |
| −2 | K984268 | Variant II Hemoglobin A1C Program | Bio-Rad | 1998 | 2 |
| −1 | K040872 | Variant II Hemoglobin A1C | Bio-Rad Laboratories, Inc. | 2004 | 4 |
| 0 (this device) | K063400 | Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0 | Bio-Rad Laboratories, Inc. | 2006 | — |
| +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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K040872 | Variant II Hemoglobin A1CSummary page 1…evices: VARIANT II TURBO Hemoglobin Alec Bio-Rad Laboratories, Inc. [K040872, April 15, 2004] '3io-Rad Laboratories, Inc 4-A-I Intended Use: The Bio-Rad VARIAN'Fm II… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070819 | Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin… | 2007 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
| Dec 8, 2009 | Not classified | Z-1898-2011 | Other | Wrong lot number was found on the Hemoglobin Cartridge Insert . The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD. |
| Oct 12, 2009 | Not classified | Z-0867-2010 | Other | Product update kit CD rom will not upload. As a result, the device cannot be run. |
| Oct 17, 2008 | Not classified | Z-1041-2009 | Pending | Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K070819 (Bio-Rad Laboratories Inc., Clinical Systems Divisi, 2007) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K040872.
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 with CDM 4.0 is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
The Bio-Rad VARIANT II TURBO Hemoglobin AiC Program with CDM 4.0 is intended for Professional Use Only. For In Vitro Diagnostic Use.
Measurement of percent hemoglobin AlC 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/K063400 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063400: Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063400
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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