# K143178: FilmArray 2.0 System

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Diagnostics, LLC
- Decided: Jan 30, 2015 after 87 days
- Product code: NSU (Instrumentation For Clinical Multiplex Test Systems)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN070013 (2008). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103175: Filmarray Respiratory Panel (RP), Idaho Technology, Inc. (2011) Summary page 4.

## Recalls of this device
- Aug 7, 2024 · Class II · Z-3122-2024: Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to repor

## Indications for use
The FilmArray 2.0 is an automated in vitro diagnostic (IVD) device designed for use with FilmArray panels. The FilmArray 2.0 is intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical specimens. The FilmArray 2.0 instrument interacts with the reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis. The software automatically determines the results and provides a test report. The FilmArray 2.0 is composed of one to eight instruments connected to a computer running FilmArray 2.0 software, which controls the function of each instrument and collects, analyzes, and stores data generated by each instrument.

Source page: https://510kreport.com/device/K143178
Methodology: https://510kreport.com/methodology