510(k) · Cleared
ClearedSebia Capillarys Hemoglobin (E) with Capillarys 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sebia · GKA Abnormal Hemoglobin Quantitation
Cleared on May 24, 2012 after a 269-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 24, 2012
- Review
- 269 days
- Class
- Class II
- Product code
- GKA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK112491 Sebia Capillarys Hemoglobin (E) with Capillarys 2Sebia · 2012
- Descendant · cites it directly · 0 of its ownK192931 V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlHelena Laboratories, Corp. · 2022
Most influential descendants
Showing 1 of 1 · See all- K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlHelena Laboratories, Corp. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K112491 | Sebia Capillarys Hemoglobin (E) with Capillarys 2 | Sebia | 2012 | — |
| +1 | K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | Helena Laboratories, Corp. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKA? 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 GKA device
- #1 K232027 CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrumentscore 7.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | 2022 | 0 |
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?
- Of its descendants, K192931 (Helena Laboratories, Corp., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GKA devicesGKA Abnormal Hemoglobin Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GKA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GKA
Too few GKA 510(k)s in any year since 2007 to give a median.
Recalls per year · GKA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKA
2in 2013
MAUDE reports naming product code GKA, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 5 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CAPILLARYS HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 2 instrument. The CAPILLARYS HEMOGLOBIN(E) kit is designed for laboratory use. The CAPILLARYS 2 instrument is an automated analyzer which performs a complete hemoglobin…
Read the full statement (125 words)
The CAPILLARYS HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 2 instrument. The CAPILLARYS HEMOGLOBIN(E) kit is designed for laboratory use.
The CAPILLARYS 2 instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A,A2 and. F and for the detection of major hemoglobin variants S, C. E and D. The assay is performed on the hemolysate of packed red blood cells from blood samples collected in tubes containing K2EDTA or K3EDTA as anticoagulant.
For/In V/tmo Diagnostic Use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K112491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112491: Sebia Capillarys Hemoglobin (E) with Capillarys 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112491
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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