← Product Code [GNX](/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX) · K131599

# QUICK VUE INFLUENZA (K131599)

_Quidel Corporation · GNX · Jul 5, 2013 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K131599

## Device Facts

- **Applicant:** Quidel Corporation
- **Product Code:** [GNX](/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX.md)
- **Decision Date:** Jul 5, 2013
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.3330
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Indications for Use

The QuickVue Influenza Test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid diagnosis of acute influenza virus infection. The test is not intended to detect influenza C antigens. Negative test results should be confirmed by cell culture; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

## Device Story

QuickVue Influenza Test is a rapid, qualitative lateral flow immunoassay for detection of influenza A and B viral antigens. Input: nasal swab, nasal aspirate, or nasal wash specimens. Operation: specimen extraction in reagent tube disrupts virus particles to expose internal nucleoproteins; extracted sample applied to test strip; viral nucleoproteins react with strip reagents. Output: visual result; pink-to-red test line indicates presence of influenza A or B antigens; blue procedural control line confirms test validity. Used in clinical or laboratory settings by healthcare professionals. Results aid in rapid diagnosis of acute influenza; negative results require confirmation by cell culture and should not be the sole basis for clinical management decisions.

## Clinical Evidence

Bench testing only. Analytical reactivity study performed using non-infectious beta-propiolactone inactivated H7N9 influenza A virus (A/Anhui/1/2013). Limit of Detection (LoD) determined to be 1.98 x 10^7 EID50/mL. No clinical performance data provided for H7N9-positive human specimens.

## Technological Characteristics

Lateral flow immunoassay; visual readout; utilizes extraction reagent for antigen exposure; test strip contains specific reagents for influenza A and B nucleoprotein detection; includes positive and negative control swabs; no electronic components or software.

## Regulatory Identification

Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.

## Predicate Devices

- QuickVue Influenza test

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: Quidel Corporation

RE: K131599

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device:

QuickVue® Influenza Test

510(k) number: K991633

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. Description of the device MODIFICATION(S):

The modification presented in this special 510(k) consisted of expanded reactivity table to include reactivity information for the H7N9 influenza A virus. The firm tested the ability of the QuickVue Influenza test to detect H7N9 influenza A virus. The virus used (A/Anhui/1/2013) was obtained from the Centers for Disease Control and Prevention as non-infectious beta-propiolactone inactivated virus. An LoD study was performed with the A/Anhui/1/2013 influenza strain at the following concentrations:

- 7.90 x 10⁸ EID₅₀/mL
- 7.90 x 10⁷ EID₅₀/mL
- 1.98 x 10⁷ EID₅₀/mL
- 7.90 x 10⁶ EID₅₀/mL
- 3.95 x 10⁶ EID₅₀/mL
- 7.90 x 10⁵ EID₅₀/mL

The LoD was determined to be 1.98 x 10⁷ EID₅₀/ml. The QuickVue Influenza test package insert has been updated to include the additional analytical reactivity information.

4. The FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

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# 5. Comparison Information

Similarities

|   | Proposed Device | Predicate Device  |
| --- | --- | --- |
|  Features | QuickVue Influenza test | QuickVue Influenza test  |
|  Intended Use | The QuickVue Influenza Test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid diagnosis of acute influenza virus infection. The test is not intended to detect influenza C antigens. Negative test results should be confirmed by cell culture; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use. | The QuickVue Influenza Test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid diagnosis of acute influenza virus infection. The test is not intended to detect influenza C antigens. Negative test results should be confirmed by cell culture; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.  |
|  Read Results | Visual | Visual  |
|  Specimen Types | Nasal swab, nasal aspirate, nasal wash | Nasal swab, nasal aspirate, nasal wash  |
|  Read Result Time | 10 Minutes | 10 Minutes  |
|  External Controls | Test kit contains positive and negative control swabs | Test kit contains positive and negative control swabs  |

# Differences

The package insert has been updated to include detection of the A/Anhui/1/2013 H7N9 virus in the analytical reactivity information section:

A/Anhui/1/2013 - A - H7N9 - 1.98x10 $^7$  EID $_{50}$ /mL

Although this test has been shown to detect these 2009 H1N1 and H7N9 viruses cultured from positive human respiratory specimens, the performance characteristics of this device with clinical specimens that are positive for these 2009 H1N1 or H7N9 influenza viruses have not been established. The QuickVue Influenza test can distinguish between influenza A and B viruses, but it cannot differentiate influenza A subtypes.

# 6. Design Control Activities Summary:

Analytical Reactivity Testing was conducted as described in section 11, "Inclusivity and LoD for Influenza A H7/N9".

A "Declaration of Conformity" statement was submitted for the manufacturing facility and validation activities and signed by the Senior Vice President of Clinical and Regulatory Affairs. The statements indicate that:

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1. The manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.
2. The validation activities, as required by the risk analysis, for the modification were performed by the designated individuals and the results demonstrated that the predetermined acceptance criteria were met.

In conclusion, based on the results of the analytical reactivity testing the modified labeling is truthful and accurate. The changes do not affect the performance of the test and it is therefore substantially equivalent to the current cleared test.

7. Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K131599](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K131599)

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