510(k) · Cleared
ClearedCapillary's Hemoglobin (E) (PN 2007)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sebia · GKA Abnormal Hemoglobin Quantitation
Cleared on Jun 27, 2006 after a 308-day review. The FDA summary names no predicate by number.
- Decided
- Jun 27, 2006
- Review
- 308 days
- Class
- Class II
- Product code
- GKA
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All GKA devicesGKA Abnormal Hemoglobin Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 detection and the characterization of hemoglobins in human blood with the Sebia CAPILLARYS system, for capillary electrophoresis. The CAPILLARYS performs all procedural sequences automatically to obtain a hemoglobin profile. The CAPILLARYS system automatically mixes the blood sample with hemolysing solution The hemoglobins, separated in silica capillaries, are directly detected by their absorbance at…
Read the full statement (114 words)
The CAPILLARYS HEMOGLOBIN(E) kit is designed for the detection and the characterization of hemoglobins in human blood with the Sebia CAPILLARYS system, for capillary electrophoresis. The CAPILLARYS performs all procedural sequences automatically to obtain a hemoglobin profile. The CAPILLARYS system automatically mixes the blood sample with hemolysing solution The hemoglobins, separated in silica capillaries, are directly detected by their absorbance at 415 nm. The electrophoregrams are evaluated visually for the pattern abnormalities. Direct detection of the hemoglobins provides relative quantification of individual hemoglobin fraction of the normal hemoglobin fractions A, A2, F and for the detection of major hemoglobin variants as S, C, E and D using Capillarys electrophoresis
For in vitro diagnostic use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052291 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052291: Capillary's Hemoglobin (E) (PN 2007).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052291
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026