510(k) · Cleared
ClearedVariant II Turbo Link Hemoglobin A1C Program/Testing System
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 Jun 25, 2014 as substantially equivalent to K070819 (Bio-Rad Laboratories Inc., Clinical Systems Divisi, 2007) after an 86-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Jun 25, 2014
- Review
- 86 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K926469 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK926469 Variant (TM) Hemoglobin a 1C ProgramBio-Rad · 1993
- 4 generations backK984268 Variant II Hemoglobin A1C ProgramBio-Rad · 1998 · Recalled
- 3 generations backK040872 Variant II Hemoglobin A1CBio-Rad Laboratories, Inc. · 2004 · Recalled
- 2 generations backK063400 Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System…Bio-Rad Laboratories, Inc. · 2006 · Recalled
- 1 generation backK070819 Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2007 · Recalled
- This deviceK140801 Variant II Turbo Link Hemoglobin A1C Program/Testing SystemBio-Rad Laboratories, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K926469 | Variant (TM) Hemoglobin a 1C Program | Bio-Rad | 1993 | — |
| −4 | K984268 | Variant II Hemoglobin A1C Program | Bio-Rad | 1998 | 2 |
| −3 | K040872 | Variant II Hemoglobin A1C | Bio-Rad Laboratories, Inc. | 2004 | 4 |
| −2 | 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 |
| 0 (this device) | K140801 | Variant II Turbo Link Hemoglobin A1C Program/Testing System | Bio-Rad Laboratories, Inc. | 2014 | — |
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 |
|---|---|---|---|
| * | K070819 | Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin…Summary page 2…Bio-Rad VARIANT-iN 1I TURBO Link yatreLik emglobin Ale Program Hemogilobin Alecrogram, k(070819 K(140801 Similarities Technolog… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Link 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 VARIANT II TURBO Link Hemoglobin A1c Program is for use with the VARIANT II TURBO Link Hemoglobin Testing System interfaced with an automated sample transport system.
The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program is Professional Use Only.
Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140801: Variant II Turbo Link Hemoglobin A1C Program/Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140801
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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