510(k) · Cleared
ClearedCapillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sebia · LCP Assay, Glycosylated Hemoglobin
Cleared on Dec 6, 2012 as substantially equivalent to K071132 (Tosoh Bioscience, Inc., 2008) and 1 other predicate after a 143-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- Dec 6, 2012
- Review
- 143 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K972265 (1997). 5 ancestors in all, the oldest K831478 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK972265 A1C 2.2 Plus - Automated Glycohemoglobin AnalyzerTosoh Medics, Inc. · 1997
- 2 generations backK011434 G7 Automated HPLC AnalyzerTosoh Medics, Inc. · 2001 · Recalled
- 1 generation backK071132 G8 Automated HPLC Analyzer, Model HLC-723 G8Tosoh Bioscience, Inc. · 2008 · Recalled
- This deviceK122101 Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys…Sebia · 2012
- Descendant · cites it directly · 1 of its ownK133344 Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls…Sebia · 2014
- Descendant · cites it directly · 0 of its ownK162281 CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)Sebia · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972265 | A1C 2.2 Plus - Automated Glycohemoglobin Analyzer | Tosoh Medics, Inc. | 1997 | — |
| −2 | K011434 | G7 Automated HPLC Analyzer | Tosoh Medics, Inc. | 2001 | 2 |
| −1 | K071132 | G8 Automated HPLC Analyzer, Model HLC-723 G8 | Tosoh Bioscience, Inc. | 2008 | 1 |
| 0 (this device) | K122101 | Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C… | Sebia | 2012 | — |
| +1 | K133344 | Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C… | Sebia | 2014 | — |
| +1 | K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | Sebia | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K071132 | G8 Automated HPLC Analyzer, Model HLC-723 G8Summary page 4…comparative studies, commercially available materials and standard procedures were used with the predicate device: TOSOH G8 Automated Glycohemoglobin Analyzer HLC-723G8 (K071132), which are based on high performance liquid chromatography (HPLC) of blood samples for Hb Ai c analysis. The SEBIA CAPILLARYS Hb… | 2008 |
| * | K021484 | Hemoglobin A1C ControlSummary page 8…The predicate device for the Hb Aic CAPILLARY controls is Tosoh Hemoglobin Aic Controls, it has been FDA cleared by the manufacturer Canterbury Scientific under (K021484). TOSOH SEBIA… | 2002 |
What descends from it? (2)
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)
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 15 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K133344 (Sebia, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K071132.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 CAPILLARYS Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human whole blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 FLEX-PIERCING instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The CAPILLARYS Hb A1c kit is designed for Professional Use Only. The Hb A1c CAPILLARY…
Read the full statement (156 words)
The CAPILLARYS Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human whole blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 FLEX-PIERCING instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The CAPILLARYS Hb A1c kit is designed for Professional Use Only.
The Hb A1c CAPILLARY Calibrators are designed for the calibration and migration control of human glycated hemoglobin A1c quantification with SEBIA CAPILLARYS Hb A1c electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb A1c CAPILLARY Calibrators are designed for Professional Use Only.
The Hb A1c CAPILLARY Controls are designed for the quality control of human glycated hemoglobin A1c quantification with CAPILLARYS Hb A1c electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb A1c CAPILLARY Controls are designed for Professional Use Only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122101: Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122101
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