ALERE BINAXNOW INFLUENZA A & B CARD

K133411 · Alere Scarborough, Inc D/B/A Binax, Inc. · GNX · Dec 5, 2013 · Microbiology

Device Facts

• Record ID: K133411
• Device Name: ALERE BINAXNOW INFLUENZA A & B CARD
• Applicant: Alere Scarborough, Inc D/B/A Binax, Inc.
• Product Code: GNX · Microbiology
• Decision Date: Dec 5, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3330
• Device Class: Class 1

Indications for Use

The Alere BinaxNOW® Influenza A & B Card is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Caution: Assay sensitivity for nasal wash/aspirate samples was determined primarily using archived specimens. Users may wish to establish the sensitivity of these specimens on fresh samples.

Device Story

The Alere BinaxNOW® Influenza A & B Card is a lateral flow immunochromatographic assay used for rapid differential diagnosis of influenza A and B. Input consists of respiratory specimens (NP swab, nasal swab, or nasal wash/aspirate). The device utilizes monoclonal antibodies immobilized on a membrane support to capture viral nucleoprotein antigens. The test strip is housed in a hinged cardboard card. After sample application, results are visually interpreted at 15 minutes by the presence of colored lines. A blue control line indicates a valid assay. The device is intended for use in clinical settings by healthcare professionals. Results are qualitative and presumptive; negative results require confirmation by cell culture or molecular assays. The device aids clinical decision-making but should not be the sole basis for patient management.

Clinical Evidence

Clinical performance established via prospective and retrospective studies. Prospective study (n=846) compared device to cell culture/DFA; overall sensitivity for Flu A was 81% (95% CI: 74-86%) and specificity 97% (95% CI: 96-98%). Flu B sensitivity was 65% (95% CI: 39-85%) and specificity 100% (95% CI: 99-100%). Retrospective study (n=293) showed Flu A sensitivity 83% (95% CI: 73-90%) and specificity 93% (95% CI: 88-96%). Analytical sensitivity (LOD) and specificity (cross-reactivity with 36 microorganisms) were also evaluated.

Technological Characteristics

Lateral flow immunochromatographic membrane assay. Employs monoclonal antibodies immobilized on a membrane support. Form factor is a hinged, book-shaped cardboard test card. No external energy source required. Standalone manual test. No software or electronic components.

Indications for Use

Indicated for qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal swabs, nasal swabs, and nasal wash/aspirate specimens to aid in rapid differential diagnosis of influenza A and B viral infections.

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

• Alere BinaxNOW® Influenza A & B Card (K092223)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: Alere Scarborough Inc.

RE: K133411

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:

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

Alere BinaxNOW® Influenza A & B Card

510(k) number: K092223

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 BinaxNOW Influenza A & B Card 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. A reactivity study was performed with the A/Anhui/1/2013 influenza strain at three different dilutions run in triplicate. Each result was interpreted by two operators for a total of six determinations per dilution. The lowest level that generated positive results in all six determinations was identified as the reactivity concentration.

The reactivity concentration was determined to be $1.94 \times 10^{6} \mathrm{EID}_{50} / \mathrm{ml}$. The BinaxNOW Influenza A & B 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

| | Predicate Device | Modified Device |
| --- | --- | --- |
| | Alere BinaxNOW Influenza A & B Card (K092223) | Alere BinaxNOW Influenza A & B Card (K133411) |
| Intended Use | The Alere BinaxNOW® Influenza A & B Card is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. It is | The Alere BinaxNOW® Influenza A & B Card is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and |

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| | intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by cell culture.

**Caution:** Assay sensitivity for nasal wash/aspirate samples was determined primarily using archived specimens. Users may wish to establish the sensitivity of these specimens on fresh samples. | and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.

**Caution:** Assay sensitivity for nasal wash/aspirate samples was determined primarily using archived specimens. Users may wish to establish the sensitivity of these specimens on fresh samples. |
| --- | --- | --- |
| Organism Detected | Influenza A virus and Influenza B virus | Same |
| Specimen Types | Nasopharyngeal swabs, nasal swabs, nasal wash/aspirates | Same |
| Device Technology | Lateral flow immunochromatography | Same |
| Detection Mechanism | Solid phase immobilized nucleoprotein specific antibodies | Same |

## 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 - 1.94x10⁵ EID₅₀/mL

Although this test has been shown to detect 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 BinaxNOW Influenza A & B Card 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 on Page 57 of the submission, "Analytical Reactivity".

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.

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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 device.