510(k) · Cleared
ClearedCapi 3 Hemoglobin (E)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sebia · GKA Abnormal Hemoglobin Quantitation
Cleared on Dec 14, 2018 as substantially equivalent to K112550 (Sebia, 2012) after a 266-day review. Its family tree reaches back 1 generation to 2012.
- Decided
- Dec 14, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- GKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K112550 (2012). No later device cites it as a predicate yet.
- Root · 1 generation backK112550 Capillarys Hemoglobin, Capillarys Flex Piercing SystemSebia · 2012
- This deviceK180762 Capi 3 Hemoglobin (E)Sebia · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K112550 | Capillarys Hemoglobin, Capillarys Flex Piercing System | Sebia | 2012 | — |
| 0 (this device) | K180762 | Capi 3 Hemoglobin (E) | Sebia | 2018 | — |
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? (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 |
|---|---|---|---|
| * | K112550 | Capillarys Hemoglobin, Capillarys Flex Piercing SystemSummary page 7…510(k) number CAPILLARYS HEMOGLOBIN(E) using the CAPILLARYS 2 FLEX-PIERCING instrument, K112550 GKA 864.7415 510(k) Summary 4… | 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?
- Its one ancestor has no recall.
How does its category compare?
All GKA devicesGKA Abnormal Hemoglobin Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 CAPI 3 HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human venous 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 3 TERA instrument. The CAPILLARYS 3 TERA instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal…
Read the full statement (135 words)
The CAPI 3 HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human venous 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 3 TERA instrument.
The CAPILLARYS 3 TERA 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 whole blood samples collected in tubes containing K2ZEDTA or K3EDTA as anticoagulant. The CAPI 3 HEMOGLOBIN(E) is intended to be used in conjunction with other laboratory and clinical findings.
For In Vitro Diagnostic Use
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180762 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180762: Capi 3 Hemoglobin (E).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180762
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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