# K182001: Acucy Influenza A&B Test with the Acucy System

- Pathway: 510(k) (Dual Track)
- Applicant: SEKISUI Diagnostics, LLC
- Decided: Dec 17, 2018 after 144 days
- Product code: PSZ (Devices Detecting Influenza A, B, And C Virus Antigens)
- Device class: 2
- Regulation: 21 CFR 866.3328
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K241188: Acucy® Influenza A&B Test with the Acucy® 2 System (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K182001
Methodology: https://510kreport.com/methodology