REMEL XPECT FLU A&B

K131804 · Remel, Inc. · GNX · Jul 12, 2013 · Microbiology

Device Facts

• Record ID: K131804
• Device Name: REMEL XPECT FLU A&B
• Applicant: Remel, Inc.
• Product Code: GNX · Microbiology
• Decision Date: Jul 12, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3330
• Device Class: Class 1

Indications for Use

Remel Xpect® Flu A&B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigens (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay.

Device Story

Xpect® Flu A&B is a lateral flow immunochromatographic assay for qualitative detection of influenza A and B nucleoprotein antigens. Patient specimen (nasal wash, nasal swab, or throat swab) is diluted and applied to device sample wells. Capillary action moves sample across membrane strips containing anti-influenza A and B conjugated antibodies. If antigens are present, they bind to conjugated antibodies; the complex is captured at the test region (T) forming a visible line. Control region (C) captures unbound particles to verify test function. Results are interpreted visually by healthcare providers after 15 minutes. Device aids in rapid diagnosis; negative results require confirmatory testing. Does not differentiate influenza subtypes.

Clinical Evidence

Bench testing only. Analytical sensitivity evaluated using 17 influenza strains (11 influenza A, 6 influenza B). Detection limits established for various strains including H1N1, H3N2, H5N1, H9N2, and H7N9. No clinical performance data with human specimens provided for the H7N9 strain.

Technological Characteristics

Immunochromatographic membrane assay; visual read. Detects influenza A and B viral nucleoprotein antigens. No changes to materials or physical design. Standalone diagnostic test; no software or electronic components.

Indications for Use

Indicated for symptomatic patients requiring rapid qualitative detection of influenza A and B viral nucleoprotein antigens from nasal wash, nasal swab, and throat swab specimens as an aid in diagnosis.

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

• Remel Xpect® Flu A&B (K031565, K092423)

Submission Summary (Full Text)

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SPECIAL 510(k)

Device Modification Decision Summary

To: Remel Inc. RE: K131804

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: Remel Xpect® Flu A&B

510(k) number: K031565, K092423

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) is the inclusion of the H7N9 influenza A virus strain A/Anhui/1/2013 to the analytical sensitivity information. The submitter tested the ability of the Remel Xpect® Flu A&B Test to detect the H7N9 influenza A virus. The viral stock (A/Anhui/1/2013) was obtained from the Centers for Disease Control and Prevention. It was diluted, tested in triplicate and the analytical sensitivity was reported as the lowest dilution/concentration of the H7N9 virus that the Remel Xpect® Flu A&B Test was able to detect. An LoD study was performed with the A/Anhui/1/2013 influenza strain at the following concentrations:

- 1.26 x 10⁶ TCID₅₀/mL
- 1.26 x 10⁵ TCID₅₀/mL
- 1.26 x 10⁴ TCID₅₀/mL
- 1.26 x 10³ TCID₅₀/mL
- 1.26 x 10² TCID₅₀/mL
- 1.26 x 10¹ TCID₅₀/mL
- 1.26 x 10⁰ TCID₅₀/mL

The LoD was determined to be 1.26 x 10⁵ TCID₅₀/mL.

The Remel Xpect® Flu A&B Test package insert has been updated to include the additional analytical sensitivity 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:

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# Similarities

| Device Characteristics | Predicate Device: Remel Xpect® Flu A&B Test (K031565, K092423) | New Device: Remel Xpect® Flu A&B Test (K131804) |
| --- | --- | --- |
| Intended Use | REMEL Xpect® Flu A&B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigen (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. Negative tests should be confirmed by cell culture. | REMEL Xpect® Flu A&B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigen (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay. |
| Sample | Qualitative; Influenza A and B viral antigens with differentiation | Qualitative; Influenza A and B viral antigens with differentiation |
| Test Methodology | Immunochromotographic membrane assay | Immunochromotographic membrane assay |
| Specimen Type | Nasal wash, nasal swab, and throat swab specimen | Nasal wash, nasal swab, and throat swab specimen |
| Interpretation | Visual read | Visual read |
| Incubation | 15 minutes | 15 minutes |

# Differences

The package insert has been updated to include detection of the following H7N9 virus in the analytical sensitivity information section:

A/Anhui/1/2013(H7N9)**

**Although this test has been shown to detect the influenza A/California/04/2009 (H1N1) and A/Anhui/1/2013 (H7N9) viruses cultured from positive human specimens. The performance characteristics of this device with human specimens infected with these influenza viruses have not been established. Xpect® Flu A&B can distinguish between influenza A and B viruses, but it does not differentiate influenza subtypes.**

(Note: A/California/04/2009** was added in 2009, K092423-Special 510(k))

# 6. Design Control Activities Summary:

## Summary:

1. The Xpect Flu A&B Test device design has not been modified in any way. New Analytical Sensitivity testing was performed and resulting data is submitted with this Special 510(k) application demonstrating ability of the device to detect the novel influenza A/Anhui/112013 (H7N9) virus cultured from positive human specimens. No performance characteristics were

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established, modified, or removed based on this analytical testing. The intended use for this device has not changed.

2. The method used for the Risk Analysis for the Xpect Flu A&B test was Failure Mode Effects Analysis (FMEA). The methods of risk analysis were consistent with 21 CFR 820.30. The following table summarizes the risk analysis:

| Modification | Hazard | Cause/s | Effect/s |
| --- | --- | --- | --- |
| Addition of H7N9 Influenza A strain: A/Anhui/1/2013 | Environmental Contamination | Improper sterilization of specimens, containers, and test devices after use | Risk of disease associated with microbial hazards |
| | False Positive | Improper specimen transport and handling, failure to follow procedure for use, improper test interpretation Non-specific binding due to antigens in host samples other than influenza | Potential side effects of antiviral therapy, unnecessary patient isolation, inappropriate patient management |
| | False Negative | Poor quality of specimen collected, stage of illness, infecting subtype, improper transport, failure to follow procedure for use, improper test interpretation, Improper storage, use beyond expiration date, compromised during shipping/storage/use Manufacturing processing breach, mishandling by end-user Infecting subtype has nucleoprotein not detected or below the limit of detection of the assay | Potential lack of infection control, unnecessary antibiotic use, inappropriate management of patients with underlying conditions or those with an increased risk of serious complications |

a. For environmental hazards risk types, the effects of these common device risks were addressed with labeling and industry standards for disposal of biological and environmental waste (either bi-products or actual devices). The risks were deemed reduced to acceptable levels based on federal, state, and local regulations.

b. For false positive and false negative test results, the effects of the risks to patients were addressed through labeling, training for users, internal and external quality control, and recommendation that negative results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay. Complaint investigations and associated trend analysis are used on an ongoing basis to evaluate overall residual risk.

3. Declaration of Conformity to Design Control

A "Declaration of Conformity" statement was submitted for the manufacturing facility and validation activities and signed by the Senior Manager Regulatory Affairs, Americas. The statements indicate that;

1. All verification and validation activities, as specified In the Risk Analysis, were performed by designated individuals and the results demonstrate that the predetermined acceptance criteria were met.

2. Remel Inc., as the manufacturing facility, is in conformance with the design control procedures stated in 21 CFR Parts 820.30. Remel Inc. has established and maintains procedures to control the design of the device and ensures that specified design requirements are met through design planning, design input and output, design review and verification, design validation, design change evaluation, and design history file.

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In conclusion, based on both the results of the analytical sensitivity testing and the risk management report, 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. 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.