510(k) · Cleared
ClearedAbbott Plex-ID Flu Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Dec 21, 2012 as substantially equivalent to K073029 (Prodesse, Inc., 2008) and 1 other predicate after a 263-day review. Its family tree reaches back 5 generations to 2008.
- Decided
- Dec 21, 2012
- Review
- 263 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to DEN070013 (2008). 10 ancestors in all, the oldest DEN060008 (2006). No later device cites it as a predicate yet.
- Root · 5 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 4 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 3 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 2 generations backK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
- 1 generation backK101855 Profast+ AssayGen-Probe Prodesse, Inc. · 2010
- This deviceK121003 Abbott Plex-ID Flu AssayAbbott Laboratories · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −4 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −3 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −2 | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | — |
| −1 | K101855 | Profast+ Assay | Gen-Probe Prodesse, Inc. | 2010 | — |
| 0 (this device) | K121003 | Abbott Plex-ID Flu Assay | Abbott Laboratories | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
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 OCC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OCC device
- #1 K262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K073029 | Proflu+ AssaySummary page 2…* Classification Name: Respiratory viral panel multiplex nucleic acid assay 5.8 Predicate Devices * Prodesse ProFLU± T assay (K073029) * Prodesse ProFAST+ TM assay (K101855) PLEX-ID Flu 510(k) K(121003… | 2008 |
| * | K101855 | Profast+ AssaySummary page 2…lex nucleic acid assay 5.8 Predicate Devices * Prodesse ProFLU± T assay (K073029) * Prodesse ProFAST+ TM assay (K101855) PLEX-ID Flu 510(k) K(121003 510(k) Summary December 2012… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 2 of the 10 ancestors have a recall of any class.
- 9 other devices also cite its predicate K073029.
How does its category compare?
All OCC devicesOCC Respiratory Virus Panel Nucleic Acid Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCC
31in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCC
2in 2025
MAUDE reports naming product code OCC, 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 | 0 | — | 0 | 0 |
| 2008 | 4 | 28 | 0 | 0 |
| 2009 | 6 | 24 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 9 | 82 | 0 | 2 |
| 2012 | 6 | 125 | 0 | 1 |
| 2013 | 6 | 79 | 0 | 0 |
| 2014 | 4 | 94 | 1 | 52 |
| 2015 | 8 | 85 | 0 | 1 |
| 2016 | 7 | 92 | 0 | 36 |
| 2017 | 10 | 136 | 0 | 1 |
| 2018 | 4 | 134 | 1 | 1 |
| 2019 | 5 | 31 | 1 | 2 |
| 2020 | 2 | — | 0 | 17 |
| 2021 | 1 | — | 0 | 686 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 3 | 130 | 0 | — |
What is it indicated for?
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…
Read the full statement (182 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121003 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121003: Abbott Plex-ID Flu Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121003
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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