# K121003: Abbott Plex-ID Flu Assay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Dec 21, 2012 after 263 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN070013 (2008). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073029: Proflu+ Assay, Prodesse, Inc. (2008) Summary page 2.
- K101855: Profast+ Assay, Gen-Probe Prodesse, Inc. (2010) Summary page 2.

## Indications for use
The PLEX-ID3 Flu assay is a qualitative nucleic acid in vitro diagnostic test intended for the detection and differentiation of influenza A HINI (2009), influenza A HIMi (seasonal), influenza A H3N2 (seasonal) and influenza B viral nucleic acids in nasopharyngeal swab specimens from patients symptomatic for respiratory tract infection. The PLEX-ID Flu assay is intended for use on the PLEX-ID3 System (version 1.2) as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological information. This assay is not intended to detect influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3-I facility is available to receive and culture specimens.

Source page: https://510kreport.com/device/K121003
Methodology: https://510kreport.com/methodology