# K213396: SPIFE A1AT kit

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories, Corp.
- Decided: Oct 13, 2022 after 360 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SPIFE A1AT kit is designed for the qualitative detection and identification of the different phenotypes of Alpha-I Antitrypsin (Al AT). 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 semiautomatic SPIFE Touch system followed by immunofixation with anti-Alpha-I Antitrypsin antiserum. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K213396
Methodology: https://510kreport.com/methodology