510(k) · Cleared
Recalled · Class II · 2021Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iquum, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Aug 4, 2011 as substantially equivalent to K103766 (Cepheid, 2011) after a 79-day review. Its family tree reaches back 5 generations to 2008. 18 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 4, 2011
- Review
- 79 days
- Class
- Class II
- Product code
- OCC
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN070013 (2008). 8 ancestors in all, the oldest DEN060008 (2006). 18 later devices descend from it, 3 citing it directly.
- 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 backK100148 Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010
- 1 generation backK103766 Xpert Flu, Genexpert DX Systems, Genexpert Infinity System…Cepheid · 2011 · Recalled
- This deviceK111387 Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 2011
- Descendant · cites it directly · 11 of its ownK141520 Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 8 of its ownK151464 Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B…Alere Scarborough, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK163266 Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit…Alere Scarborough, Inc. · 2016
- Descendant · 4 generations on · 6 of its ownK171792 Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A &…Alere Scarborough, Inc. · 2017 · Recalled
- Descendant · cites it directly · 4 of its ownK191729 Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat SystemRoche Molecular Systems, Inc. · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K141520Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. · 2014 · cites it directly11descendants
- K151464Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc. · 2015 · 2 generations on8descendants
- K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc. · 2016 · 3 generations on7descendants
- K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc. · 2017 · 4 generations on6descendants
- K191729Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat SystemRoche Molecular Systems, Inc. · 2019 · cites it directly4descendants
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 | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | Focus Diagnostics, Inc. | 2010 | — |
| −1 | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System… | Cepheid | 2011 | 1 |
| 0 (this device) | K111387 | Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer | Iquum, Inc. | 2011 | — |
| +1 | K141520 | Alere I Influenza a & B | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014 | 3 |
| +2 | K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control… | Alere Scarborough, Inc. | 2015 | — |
| +3 | K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i… | Alere Scarborough, Inc. | 2016 | — |
| +4 | K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control… | Alere Scarborough, Inc. | 2017 | 1 |
| +1 | K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System | Roche Molecular Systems, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software…Summary page 1…a A, B Panel Regulation Number 21 CFR 866.3980 Classification Name Respiratory Viral Panel Multiplex Nucleic Acid Assay Predicate Device: Cepheid Xpert® Flu Assay (K1 03766) Intended Use The LQuum LiatTM Influenza A/B Assay performed on the LiatTM Analyzer is an automated multiplex real-time RT-PCR… | 2011 |
What descends from it? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 16, 2021 | Class II | Z-0828-2022 | Nonconforming Material/Component | Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of… |
| May 17, 2016 | Class III | Z-2203-2016 | Incorrect or no expiration date | Kit labeled with the incorrect expiration date. |
| May 9, 2016 | Class II | Z-2216-2016 | Under Investigation by firm | Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results. |
| Jul 24, 2015 | Class II | Z-2543-2015 | Nonconforming Material/Component | Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K141520 (Alere Scarborough, Inc D/B/A Binax, Inc., 2014) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K103766.
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. 2011, 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 IQuum LiatTM Influenza A/B Assay performed on the LiatTM Analyzer is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of influenza A virus and influenza B virus RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is intended for use as an aid in the differential diagnosis…
Read the full statement (233 words)
The IQuum LiatTM Influenza A/B Assay performed on the LiatTM Analyzer is an automated
multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination
of influenza A virus and influenza B virus RNA in nasopharyngeal swab specimens from
patients with signs and symptoms of respiratory infection in conjunction with clinical and
epidemiological risk factors. The test is intended for use as an aid in the differential diagnosis of
influenza A and influenza B in humans and is not intended to detect influenza C.
Negative results do not preclude influenza virus infection and should not be used as the sole
basis for treatment or other patient management decisions. Conversely, positive results do not
rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the
definite cause of disease.
Performance characteristics for influenza A were established when influenza A/H1 and A/H3
were the predominant influenza A viruses in circulation. When other influenza A viruses are
emerging, performance characteristics may vary.
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 department for testing. Viral culture should not be attempted in
these cases unless a BSL 3+ 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/K111387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111387: Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111387
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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