510(k) · Cleared
ClearedVariant (TM) II Turbo HBA1C Kit - 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc., Clinical Systems Divis · LCP Assay, Glycosylated Hemoglobin
Cleared on May 9, 2013 as substantially equivalent to K122472 (Bio-Rad Laboratories, Inc., Clinical Systems Divis, 2012) after a 29-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- May 9, 2013
- Review
- 29 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 backK070452 Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc. · 2007 · Recalled
- 2 generations backK090699 Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set…Bio-Rad Laboratories, Inc. · 2009
- 1 generation backK122472 Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing…Bio-Rad Laboratories, Inc., Clinical Systems Divis · 2012
- This deviceK130990 Variant (TM) II Turbo HBA1C Kit - 2.0Bio-Rad Laboratories, Inc., Clinical Systems Divis · 2013
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 | K070452 | Variant II Hemoglobin A1C Program with Models 270-2101NU | Bio-Rad Laboratories, Inc. | 2007 | 1 |
| −2 | K090699 | Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models… | Bio-Rad Laboratories, Inc. | 2009 | — |
| −1 | K122472 | Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing System | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2012 | — |
| 0 (this device) | K130990 | Variant (TM) II Turbo HBA1C Kit - 2.0 | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2013 | — |
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 |
|---|---|---|---|
| * | K122472 | Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing SystemSummary page 1…Iic Number Code IVARIANT-- 11TURBO HbA Ic Kit -2.O K122472 21 CFR 864.7470 [LCPJ Intended and The Bio-Rad VARIANTTM 11 TURBO HbAlIc Kit - 2.0 is intended for the Indications q… | 2012 |
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 20 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 2 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. 2013, 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 11TURBO HbAlc Kit - 2.0 is intended for the quantitative determination of hemoglobin Alic in human whole blood using ion-exchange high performance liquid chromatography (HPLC) on the VARIANT 11 TURBO Hemoglobin Testing System. Measurement of hemoglobin Aic is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The Bio-Rad VARIANT 11TURBO HbAlc Kit -2.0 is intended for Professional Use Only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130990: Variant (TM) II Turbo HBA1C Kit - 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130990
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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