510(k) · Cleared
ClearedHydragel 18 A1AT Isofocusing Kit (PN 4356)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sebia · OBZ Alpha-1-Antitrypsin Kit, Qualitative Phenotype
Cleared on Jun 11, 2007 after a 203-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 11, 2007
- Review
- 203 days
- Class
- Class II
- Product code
- OBZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK063498 Hydragel 18 A1AT Isofocusing Kit (PN 4356)Sebia · 2007
- Descendant · cites it directly · 2 of its ownK171868 A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2017
- Descendant · 2 generations on · 1 of its ownK192858 A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2019
- Descendant · 3 generations on · 0 of its ownK211115 A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2021
Most influential descendants
Showing 3 of 3 · See all- K171868A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2017 · cites it directly2descendants
- K192858A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2019 · 2 generations on1descendant
- K211115A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063498 | Hydragel 18 A1AT Isofocusing Kit (PN 4356) | Sebia | 2007 | — |
| +1 | K171868 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | 2017 | — |
| +2 | K192858 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | 2019 | — |
| +3 | K211115 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 OBZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Alpha-1-Antitrypsin Phenotype Named without a submission number | |
| * | — | Alpha-1-trypsin phenotype without total AAT Named without a submission number | |
| * | — | Alpha-1 Antitrypsin Phenotype test Named without a submission number | |
| * | — | Polyacrylamide gel isoelectric focusing technique Named without a submission number | |
| † | K033277 | Hydragel CSF Isofocusing Kits | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171868 | A1AT Genotyping Test | 2017 | 2 |
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, K171868 (Progenika Biopharma S.A., A Grifols Company, 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All OBZ devicesOBZ Alpha-1-Antitrypsin Kit, Qualitative Phenotype: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OBZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · OBZ
Too few OBZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OBZ
No recall names OBZ since 2007.
Adverse event reports per year · OBZ
No MAUDE report names OBZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HYDRAGEL 18 AlAT ISOFOCUSING kit is designed for the qualitative detection and identification of the different phenotypes of Alpha-1 antitrypsin (A1AT). Phenotyping results in conjunction with clinical findings and other laboratory assays aid in the diagnosis of Alpha-1 antitrypsin deficiency The analysis is performed on human sera separated into electrophoretic patterns ready for qualitative analysis. The procedure includes isoelectrofocusing on…
Read the full statement (133 words)
The HYDRAGEL 18 AlAT ISOFOCUSING kit is designed for the qualitative detection and identification of the different phenotypes of Alpha-1 antitrypsin (A1AT). Phenotyping results in conjunction with clinical findings and other laboratory assays aid in the diagnosis of Alpha-1 antitrypsin deficiency The analysis is performed on human sera separated into electrophoretic patterns ready for qualitative analysis. The procedure includes isoelectrofocusing on agarose gel, performed on the semi-automatic HYDRASYS system, followed by immunofixation with anti-Alpha-1 antitrypsin antiserum. The use of enzyme labeled anti-Alpha-1 antitrypsin antiserum enhanced the detection and identification of the different phenotypes.
For In Vitro Diagnostic Use.
Intended Use
The AMAT Controls are designed for the migration control of the human Alpha-1 antitrypsin isoforms pattern obtained with HYDRAGEL 18 AMAT ISOFOCUSING isoelectric-focusing procedure.
The AlAT Controls should be used as human sera.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063498 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063498: Hydragel 18 A1AT Isofocusing Kit (PN 4356).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063498
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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