SOFIA INFLUENZA A+B FIA

K131606 · Quidel Corp. · GNX · Jul 5, 2013 · Microbiology

Device Facts

• Record ID: K131606
• Device Name: SOFIA INFLUENZA A+B FIA
• Applicant: Quidel Corp.
• Product Code: GNX · Microbiology
• Decision Date: Jul 5, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3330
• Device Class: Class 1

Indications for Use

The Sofia Influenza A+B FJA employs immunofluorescence to detect influenza B viral nucleoprotein antigens in nasal swab, and nasopharyngeal aspiratelwash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negalive test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use. Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California/7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the oredominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entiled "Update: Influenza Activity-United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine". Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza 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. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Device Story

Sofia Influenza A+B FIA is an immunofluorescence-based lateral flow assay for qualitative detection of influenza A and B antigens. Device uses Sofia Analyzer to process test cassettes; results displayed on screen or printed. Modification adds analytical reactivity data for H7N9 influenza A (A/Anhui/1/2013) to package insert. Testing performed using non-infectious beta-propiolactone inactivated virus to determine Limit of Detection (LoD). Device does not differentiate influenza A subtypes. Intended for use in clinical settings to aid in diagnosis of respiratory infection.

Clinical Evidence

Bench testing only. Analytical study performed to assess detection of Influenza A virus H7N9 (A/Anhui/1/2013). Results established a minimum detectable level of 3.95 x 10^4 EID50/mL.

Technological Characteristics

Lateral-flow immunofluorescence immunoassay. Uses monoclonal antibodies specific to influenza A and B nucleoproteins. Employs Sofia Analyzer for automated scanning and fluorescent signal measurement. Includes calibration cassette and QC card.

Indications for Use

Indicated for the qualitative detection of influenza A and influenza B nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens from patients with signs and symptoms of respiratory infection.

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

• Sofia® Influenza A+B FIA (K112177)

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: K131606

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:

Sofia® Influenza A+B FIA

510(k) number: K112177

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 Sofia Influenza A+B FIA 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 10⁶ EID₅₀/mL
- 3.95 x 10⁶ EID₅₀/mL
- 1.98 x 10⁶ EID₅₀/mL
- 7.90 x 10⁵ EID₅₀/mL
- 7.90 x 10⁴ EID₅₀/mL

The LoD was determined to be 3.95 x 10⁶ EID₅₀/ml. The Sofia Influenza A+B FIA 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

| Features | Proposed Device | Predicate Device |
| --- | --- | --- |
| Features | Sofia Influenza A+B FIA | Sofia Influenza A+B FIA |
| Read Results | Read results on instrument screen or print with optional printer | Read results on instrument screen or print with optional printer |
| Instrument | Sofia Analyzer | Sofia Analyzer |
| Calibrator | Yes – Calibration cassette and QC card provided | Yes – Calibration cassette and QC card provided |
| Specimen Types | Nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash | Nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash |
| Read Result Time | 15 Minutes | 15 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 - 3.95x10 $^6$ EID $_{50}$ /mL

Although this test has been shown to detect inactivated A/Anhui/1/2013 H7N9 virus cultured from positive human respiratory specimens, the performance characteristics of this device with clinical specimens that are positive for H7N9 influenza viruses have not been established. The Sofia Influenza A+B FIA 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:

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. 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.