# K111387: Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Iquum, Inc.
- Decided: Aug 4, 2011 after 79 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN070013 (2008). 8 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103766: Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 and 4.0, Cepheid (2011) Summary page 1.

## Most influential descendants
- K141520: Alere I Influenza a & B (2014), 11 descendants of its own
- K151464: Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (2015), 8 descendants of its own
- K163266: Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument (2016), 7 descendants of its own
- K171792: Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (2017), 6 descendants of its own
- K191729: Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System (2019), 4 descendants of its own

## Recalls of this device
- Nov 16, 2021 · Class II · Z-0828-2022: 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
- May 17, 2016 · Class III · Z-2203-2016: Kit labeled with the incorrect expiration date.
- May 9, 2016 · Class II · Z-2216-2016: 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 erro
- Jul 24, 2015 · Class II · Z-2543-2015: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K111387
Methodology: https://510kreport.com/methodology