510(k) · Cleared
Recalled · 2011Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories Inc., Clinical Systems Divisi · LCP Assay, Glycosylated Hemoglobin
Cleared on Jun 25, 2007 as substantially equivalent to K040872 (Bio-Rad Laboratories, Inc., 2004) and 1 other predicate after a 91-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Jun 25, 2007
- Review
- 91 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 4 generations to K926469 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK926469 Variant (TM) Hemoglobin a 1C ProgramBio-Rad · 1993
- 3 generations backK984268 Variant II Hemoglobin A1C ProgramBio-Rad · 1998 · Recalled
- 2 generations backK040872 Variant II Hemoglobin A1CBio-Rad Laboratories, Inc. · 2004 · Recalled
- 1 generation backK063400 Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System…Bio-Rad Laboratories, Inc. · 2006 · Recalled
- This deviceK070819 Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2007
- Descendant · cites it directly · 0 of its ownK140801 Variant II Turbo Link Hemoglobin A1C Program/Testing SystemBio-Rad Laboratories, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140801Variant II Turbo Link Hemoglobin A1C Program/Testing SystemBio-Rad Laboratories, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926469 | Variant (TM) Hemoglobin a 1C Program | Bio-Rad | 1993 | — |
| −3 | K984268 | Variant II Hemoglobin A1C Program | Bio-Rad | 1998 | 2 |
| −2 | K040872 | Variant II Hemoglobin A1C | Bio-Rad Laboratories, Inc. | 2004 | 4 |
| −1 | K063400 | Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0 | Bio-Rad Laboratories, Inc. | 2006 | 4 |
| 0 (this device) | K070819 | Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link… | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2007 | — |
| +1 | 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 |
|---|---|---|
| 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? (2)
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 2…ycosylated Hemoglobin, 81LCP Predicate Device(s): VARIANTTM II TURBO Hemoglobin A c Program (k) 040872 Bio-Rad Laboratories, Inc. VARIANT… | 2004 |
| * | K063400 | Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0Summary page 2…gram run on the VARIANT II TURBO Hemoglobin Testing System with CDM 4.0 (k) 063400 Bio-Rad Laboratories, Inc. Intended Use: The Bio… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140801 | Variant II Turbo Link Hemoglobin A1C Program/Testing System | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 25, 2011 | Not classified | Z-0399-2012 | Process control | It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point. |
| Sep 12, 2011 | Not classified | Z-0027-2012 | 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-0026-2012 | 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… |
| Jul 28, 2011 | Not classified | Z-3159-2011 | Employee error | The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle. |
| Feb 19, 2010 | Not classified | Z-1259-2011 | Nonconforming Material/Component | The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantitation of the blood results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K140801 (Bio-Rad Laboratories, Inc., 2014) has gone furthest, with 0 descendants 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. 2007, 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 IITURBO Link Hemoglobin Alc Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). Measurement of percent hemoglobin Al c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
The VARIANT IITURBO Link Hemoglobin Alc Program is for use with the VARIANT II TURBO Link Hemoglobin Testing System interfaced with an automated sample transport system.
The Bio-Rad VARIANT IITURBO Link Hemoglobin Alc Program is intended for Professional Use Only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070819: Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070819
Report an extraction error
Are you the manufacturer?
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