# K063498: Hydragel 18 A1AT Isofocusing Kit (PN 4356)

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Jun 11, 2007 after 203 days
- Product code: OBZ (Alpha-1-Antitrypsin Kit, Qualitative Phenotype)
- Device class: 2
- Regulation: 21 CFR 866.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Alpha-1-Antitrypsin Phenotype: named in the summary without a submission number
- (no number) Alpha-1-trypsin phenotype without total AAT: named in the summary without a submission number
- (no number) Alpha-1 Antitrypsin Phenotype test: named in the summary without a submission number
- (no number) Polyacrylamide gel isoelectric focusing technique: named in the summary without a submission number

## Most influential descendants
- K171868: A1AT Genotyping Test (2017), 2 descendants of its own
- K192858: A1AT Genotyping Test (2019), 1 descendant of its own
- K211115: A1AT Genotyping Test (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K063498
Methodology: https://510kreport.com/methodology