Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

K173502 · Alere Scarborough, Inc. · PSZ · Dec 13, 2017 · Microbiology

Device Facts

• Record ID: K173502
• Device Name: Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
• Applicant: Alere Scarborough, Inc.
• Product Code: PSZ · Microbiology
• Decision Date: Dec 13, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3328
• Device Class: Class 2

Indications for Use

The Alere BinaxNOW Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab 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. Alere BinaxNOW Influenza A & B Card 2 must be read by the Alere Reader. Performance characteristics for influenza A were established during the 2015-2016 influenza season when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A 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. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Device Story

Device consists of Alere BinaxNOW Influenza A & B Card 2 (immunochromatographic assay) and Alere Reader (benchtop instrument). Input: nasopharyngeal or nasal swab specimens eluted in solution, applied to test card. Reader uses camera to capture image of test strip; analyzes intensity of test and control lines; displays qualitative results (positive/negative/invalid). Used in professional medical laboratory or point-of-care settings. Software modification enables 'Walk Away' mode (Reader times test after insertion) alongside existing 'Read Now' mode. Operator enters Subject/Operator ID via barcode scanner or manual entry. Output displayed on screen; can be printed or uploaded to LIS/LIM. Facilitates rapid diagnosis; aids clinical decision-making regarding patient management.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing of the software modification to ensure the new 'Walk Away' mode functions correctly and maintains the performance characteristics of the previously cleared device.

Technological Characteristics

Immunochromatographic membrane assay; cardboard hinged test card. Alere Reader is a camera-based benchtop instrument. Connectivity via USB for printer and LIS/LIM integration. Software-controlled timing and image analysis. Qualitative result output.

Indications for Use

Indicated for qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal and nasal swab specimens to aid in rapid differential diagnosis of influenza A and B viral infections.

Regulatory Classification

Identification

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria: (i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method: (A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent. (B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent. (ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method: (A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent. (B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent. (2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies. (3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria: (i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains. (ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate. (iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by: (A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or (B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access. (4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain: (i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus. (ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by: (A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or (B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.

Predicate Devices

• Alere BinaxNOW Influenza A & B Card 2 and Alere Reader (k162642)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
OIR Review Summary

To: Alere Scarborough, Inc.
RE: K173502

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:
Alere BinaxNOW Influenza A & B Card 2
510(k) number: K162642

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):

A software modification has been added to allow the reader to operate in "Walk-away" mode. In walk-away mode, the operator inserts the test card into the reader instead of manually timing the test for the designated 15 minutes on the benchtop. The reader begins a 15 minute countdown and records the results at precisely 15 minutes after the test card was inserted. The test results are available when the operator returns to the reader. The reader mode (Read Now or Walk-away) is set by the administrator only. The Alere BinaxNOW Influenza A & B Card 2 assay package insert, Alere Reader user manual, and Quick Reference Instructions (QRI) have been updated to include the additional information.

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

5. Comparison Information

A. Similarities

| | Predicate Device | Modified Device |
| --- | --- | --- |
| Features | Alere BinaxNOW Influenza A & B Card 2 (K162642) | Alere BinaxNOW Influenza A & B Card 2 (K173502) |
| Intended Use | The Alere BinaxNOW Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. | Same |

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| | 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. Alere BinaxNOW Influenza A & B Card 2 must be read by the Alere Reader. Performance characteristics for influenza A were established during the 2015-2016 influenza season when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A 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. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. | |
| --- | --- | --- |
| Sample Type | Nasopharyngeal and nasal swabs | Same |
| Assay Target | Nucleoprotein Antigen of Influenza A and B | Same |
| Instrumentation | Alere Reader | Same |
| Detection Format | The camera-based Reader detects the presence and identity of the Alere BinaxNOW Influenza A & B Card 2 assay, analyzes the intensity of the sample and control line and reports the results (positive, negative, or invalid) on a display screen. | Same |
| Internally Controlled? | Yes | Same |
| Assay Result | Qualitative | Same |
| Time to Result | 15 minutes | Same |

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## B. Differences

The assay package insert, Alere Reader user manual, and QRI have been updated to include instructions on the use of the new Walk-away mode.

## 6. Design Control Activities Summary:

A risk assessment of device modification was conducted and documented according to Alere Scarborough, Inc. Quality System requirements. The modification made to the assay does not affect the assay procedure, and this change was not expected to impact the performance of the test or its safety and effectiveness. To confirm assay performance was not negatively impacted, Alere Scarborough Inc. performed the following validation studies:

A. Opening Drawer Study
B. Device Timing Study
C. Walk Away Equivalency Study

### Opening Drawer Study

The purpose of this study was to confirm that the Alere Reader Walk-away mode displays an error message when the test drawer is opened during the device read. Influenza A and B LoD QC controls were tested as positive samples. Elution solution was tested as the negative sample. With the reader in Walk-away mode, for each sample tested, the operator opened the drawer for five seconds and then closed the drawer again. Times tested for the drawer opening study were when the following amounts of time were remaining on the test: 10 minutes before, 5 minutes before, 3 seconds before, and 0 seconds (i.e., immediately before) the result is displayed on the screen. Correct results were obtained for each sample if the drawer was closed again prior to the expiration of the 15 minute reader timer (i.e. when the "read" was performed by the reader). For samples where the drawer was open when the Reader attempted to read the card, an invalid test result error message was presented to the user.

### Device Timing Study

The purpose of this study was to evaluate the effect on performance if the Alere BinaxNOW Influenza A & B Card 2 is not inserted into the Alere Reader immediately after closing the card. Influenza A and B LoD QC controls or elution buffer were tested at n=20 replicates and inserted into the Alere Reader in Walk-away mode at the following times after closing of the card: 0 minutes (SOP), 5 minutes, 10 minutes, 15 minutes, or 30 minutes. The results were read at the completion of the reader time in Walk-away mode. All positive and negative swabs generated the expected results. Assay results do not appear to be affected if the test is delayed by as long as 30 minutes before starting the 15 minute Walk-away mode read method.

### Equivalency Study

The purpose of this study was to confirm the Alere BinaxNOW Influenza A & B Card 2 test performance is equivalent when the tests are read by the Alere Reader in both Read Now and Walk-away mode. To perform this study, Influenza A and Influenza B LoD QC controls were tested with $n = 42$ replicates per sample in Read Now and Walk-away mode. Elution buffer was used for negative samples. Expected results were obtained for all samples tested in both modes with exception to one false positive Influenza A result for an elution buffer sample. The false result was attributed to a discolorization of the nitrocellulose membrane being interpreted as a positive result by the reader. The sample was retested and the expected results were obtained. The results of this study demonstrate that the Alere BinaxNOW Influenza A & B Card 2 yields valid and expected results when the device is read by the Alere Reader using either Read Now or Walk-away mode.

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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 device.