QUICKVUE INFLUENZA A+B

K131619 · Quidel Corp. · GNX · Jun 28, 2013 · Microbiology

Device Facts

• Record ID: K131619
• Device Name: QUICKVUE INFLUENZA A+B
• Applicant: Quidel Corp.
• Product Code: GNX · Microbiology
• Decision Date: Jun 28, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3330
• Device Class: Class 1

Indications for Use

The QuickVue Influenza A+B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. Negative 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 A+B test is a rapid, qualitative lateral flow immunoassay for detection of influenza A and B viral antigens. Device utilizes nasal/nasopharyngeal swabs, nasal aspirates, or nasal washes as input. Test is performed by professional laboratory personnel; results are read visually after 10 minutes. Modification adds analytical reactivity data for H7N9 (A/Anhui/1/2013) influenza strain to package insert. Device distinguishes between influenza A and B but does not differentiate subtypes. Negative results require confirmation by cell culture. Output aids clinicians in rapid differential diagnosis of acute influenza infections.

Clinical Evidence

Bench testing only. Analytical study performed to assess detection of influenza A virus H7N9 (A/Anhui/1/2013). Limit of Detection established at 7.90 x 10^5 EID50/mL.

Technological Characteristics

Lateral flow immunoassay; visual read; manual test strip format. No electronic components, software, or connectivity. Sterilization not specified.

Indications for Use

Indicated for rapid, qualitative detection of influenza A and B antigens in patients with suspected acute viral infection. Specimens include nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash. Intended for professional/laboratory use; not for influenza C detection.

Regulatory Classification

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 A+B test (K131619)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification Decision Summary

To: Quidel Corporation

RE: K131619

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II device requiring 510(k). The following items are present and acceptable

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

Trade Name: QuickVue® Influenza A+B test

510(k) number: K092698, K053146, K031899

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.

3. A description of the device MODIFICATION(S). The modification presented in this 510(k) consisted of expanded reactivity table to include reactivity information for the H7N9 influenza A virus. The submitter tested the ability of the QuickVue® Influenza A+B 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 concentrations:

- 7.90x10⁸ EID₅₀/mL
- 7.90x10⁷ EID₅₀/mL
- 7.90x10⁶ EID₅₀/mL
- 3.95x10⁶ EID₅₀/mL

The LoD was determined to be 7.90x10⁶ EID₅₀/mL.

The QuickVue® Influenza A+B 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.

5. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics:

Similarities

| | | |
| --- | --- | --- |
| Features | QuickVue Influenza A+B test | QuickVue Influenza A+B test |
| Intended Use | The QuickVue Influenza A+B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. | The QuickVue Influenza A+B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. |

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| | Negative 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. | Negative 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, nasopharyngeal swab, nasal aspirate, and nasal wash | Nasal swab, nasopharyngeal swab, nasal aspirate, and 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 - 7.90x10⁶ EID₅₀/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 A+B Test can distinguish between influenza A and B viruses, but it cannot differentiate influenza A subtypes.

## 6. Design Control Activities Summary:

a) Analytical Reactivity Testing was conducted as described in section 3, Device Modifications.

b) Declaration of Conformity

A "Declaration of Conformity" statement was submitted for the manufacturing facility and validation activities and signed by the Director of Quality Assurance and the Senior Director of Technical Operations respectively. The statements indicate that;

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.

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7. A Truthful and Accurate Statement, a 510(k) Summary, 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 and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. On this basis, I recommend the device be determined substantially equivalent to the previously cleared device.