510(k) · Cleared
Recalled · Class II · 2024FilmArray 2.0 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics, LLC · NSU Instrumentation For Clinical Multiplex Test Systems
Cleared on Jan 30, 2015 as substantially equivalent to K103175 (Idaho Technology, Inc., 2011) after an 87-day review. Its family tree reaches back 4 generations to 2008. It has been recalled once.
- Decided
- Jan 30, 2015
- Review
- 87 days
- Class
- Class II
- Product code
- NSU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN070013 (2008). No later device cites it as a predicate yet.
- Root · 4 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 3 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 2 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 1 generation backK103175 Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 2011
- This deviceK143178 FilmArray 2.0 SystemBiofire Diagnostics, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −3 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −2 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −1 | K103175 | Filmarray Respiratory Panel (RP) | Idaho Technology, Inc. | 2011 | — |
| 0 (this device) | K143178 | FilmArray 2.0 System | Biofire Diagnostics, LLC | 2015 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NSU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103175 | Filmarray Respiratory Panel (RP)Summary page 4…Classification: Trade Name: FilmArray 2.0 Regulation Number: 21 CFR 862.2570 Classification Name: Instrumentation for clinical multiplex test systems Predicate Device: K103175 – FilmArray Intended Use: The FilmArray 2.0 is an automated in vitro diagnostic (IVD) device designed for use with FilmArray pa… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2024 | Class II | Z-3122-2024 | Under Investigation by firm | 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 report higher melting temperatures, which… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 4 other devices also cite its predicate K103175.
How does its category compare?
All NSU devicesNSU Instrumentation For Clinical Multiplex Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NSU
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · NSU
77in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NSU
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NSU
18in 2025
MAUDE reports naming product code NSU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 85 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 3 | 77 | 0 | 30 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 4 | 3 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 1 | 24 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 2 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (125 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143178: FilmArray 2.0 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143178
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026