(23 days)
No
The device description and performance studies focus on immunochromatographic assay technology and manual interpretation of results, with no mention of AI or ML.
No.
Explanation: This device is an in vitro diagnostic (IVD) test intended to detect influenza A and B antigens to aid in the diagnosis of viral infections. It does not provide any therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended to aid in the rapid differential diagnosis of influenza A and B viral infections."
No
The device description clearly states it is an "immunochromatographic membrane assay" and a "test strip... mounted inside a cardboard, bookshaped hinged test device," indicating it is a physical hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay.
- Nature of the Test: The test is performed on biological specimens (nasopharyngeal swab and nasal wash/aspirate specimens) outside of the body to detect the presence of influenza antigens. This is the definition of an in vitro diagnostic test.
- Purpose: The test is intended to aid in the rapid differential diagnosis of influenza A and B viral infections, which is a diagnostic purpose.
The device description further clarifies that it's a laboratory test using antibodies to detect antigens in a sample, which aligns with the characteristics of an IVD.
N/A
Intended Use / Indications for Use
The BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) 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 should be confirmed by culture.
Product codes
GNX
Device Description
The BinaxNOW® Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A & B nucleoprotein antigens in nasopharyngeal specimens. These antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. This test strip is mounted inside a cardboard, bookshaped hinged test device.
Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test device is closed. Test results are interpreted at 15 minutes based on the presence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal
Indicated Patient Age Range
children (less than 18 years of age) and adults (18 years or older)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
CLINICAL STUDIES
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture / DFA - Prospective Study
The performance of the BinaxNQW® Influenza A & B Test was compared to cell culture and/or DFA, and to the Binax NOW® Flu A Test and the Binax NOW® Flu B Test, in a prospective study conducted in 2004 outside the US. Nasopharyngeal (NP) swab and nasal wash / aspirate specimens, collected at multiple sites from children (less than 18 years of age) and adults (18 years or older) presenting with influenza-like symptoms, were evaluated in the Binax test at a central testing lab.
One hundred and thirteen (113) NP swab specimens and 1 wash/aspirate specimen were tested. One hundred and eight (108) of the 114 samples tested were influenza negative by culture/DFA, and 6 samples were influenza positive.
BinaxNOW® Influenza A & B Test Performance vs. Binax NOW® Flu A and Flu B Tests:
Performance of the BinaxNOW® Influenza A & B Test was compared to the current NOW® Flu A Test on 306 retrospective frozen clinical samples and to the NOW® Flu B Test on 303 retrospective frozen clinical samples. All clinical samples were collected from symptomatic patients at multiple physician offices, clinics and hospitals located in the Southern, Northeastern and Midwestern regions of the United States and from one hospital in Sweden. Nasal wash/aspirate specimens comprised approximately 57% of the samples tested, while NP swabs represented 42%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CLINICAL STUDIES
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture / DFA - Prospective Study
Study Type: Prospective Study
Sample Size: 114 samples (113 NP swab, 1 wash/aspirate)
Key Results: When compared to culture/DFA, the BinaxNOW® Test was 75% (3/4) sensitive and 100% (110/110) specific for detection of influenza A and 50% (1/2) sensitive and 100% (112/112) specific for detection of influenza B. There was 100% agreement between the BinaxNOW® Influenza A & B Test and the individual Flu A and Flu B Tests.
BinaxNOW® Influenza A & B Test Performance vs. Binax NOW® Flu A and Flu B Tests:
Study Type: Retrospective Study
Sample Size: 306 samples (for Flu A comparison), 303 samples (for Flu B comparison)
Key Results: The BinaxNOW® Influenza A & B Test was 100% sensitive and 96% specific for detection of influenza A vs. the NOW® Flu A Test and 93% sensitive and 97% specific for detection of influenza B vs. the NOW® Flu B Test.
Binax NOW® Flu A and Flu B Test Performance vs. Cell Culture
Study Type: Multi-center study
Sample Size: 373 prospective clinical samples
Key Results: The Binax NOW® Flu A Test was 80% sensitive and 93% specific while the Binax NOW® Flu B Test was 65% sensitive and 97% specific when compared to cell culture.
ANALYTICAL STUDIES
Analytical Sensitivity
Key Results: The BinaxNOW® test limit of detection (LOD) for Flu A/Beijing was identified as 1.03 x 10^2 ng/ml (96% detected) and for Flu B/Harbin as 6.05 x 10^1 ng/ml (96% detected). The analytical sensitivity of the BinaxNOW® Influenza A & B Test is equivalent or better than that of the individual NOW® Flu A and B Tests.
Avian Influenza (H5N1) Analytical Reactivity Testing
Key Results: Two live avian influenza (H5N1) strains tested positive in the BinaxNOW Influenza A & B Test at concentrations ranging from 10^-1 to 10^-1 TCID50/ml.
Reactivity Testing
Key Results: Seven live influenza A strains and five live influenza B strains tested positive in the BinaxNOW® Influenza A & B Test at concentrations ranging from 10^1-10^3 CEID50/ml.
Analytic Specificity (Cross-Reactivity)
Key Results: 36 commensal and pathogenic microorganisms (27 bacteria, 8 viruses and 1 yeast) were tested and found negative, demonstrating analytical specificity.
Interfering Substances
Key Results: Substances like OTC mouthwash, nasal sprays, throat drops, throat sprays, and various medications did not affect test performance. Whole blood (1%) interfered with the interpretation of Flu A LOD positive samples but not negative results.
Transport Media
Key Results: Amies Media, Hank's Balanced Salt Solution, M4 Media, M4-RT Media, M5 Media, Stuart's Media, and Saline did not impact BinaxNOW test performance for negative or LOD inoculated samples.
Reproducibility
Study Type: Blind study
Sample Size: Panels of blind coded specimens (number not explicitly stated but tested multiple times on 3 different days at 3 sites)
Key Results: There was 97% (242/250) agreement with expected test results, with no significant differences within run, between run, or between sites.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture / DFA - Prospective Study
Influenza A:
- Sensitivity: 75% (3/4)
- Specificity: 100% (110/110)
- NP Swab Specificity: 100% (95% CI: 97-100%)
- Wash/Aspirate Specificity: 100% (95% CI: 16-99%)
- Overall Specificity: 100% (95% CI: 97-100%)
Influenza B:
- Sensitivity: 50% (1/2)
- Specificity: 100% (112/112)
- NP Swab Specificity: 100% (95% CI: 97-100%)
- Wash/Aspirate Specificity: 100% (95% CI: 16-99%)
- Overall Specificity: 100% (95% CI: 97-100%)
BinaxNOW® Influenza A & B Test Performance vs. Binax NOW® Flu A and Flu B Tests:
Influenza A:
- Sensitivity: 100%
- NP Swab Sensitivity: 100% (95% CI: 89-100%)
- Wash/Aspirate Sensitivity: 100% (95% CI: 93-100%)
- Overall Sensitivity: 100% (95% CI: 95-100%)
- Specificity: 96%
- NP Swab Specificity: 99% (95% CI: 94-100%)
- Wash/Aspirate Specificity: 93% (95% CI: 88-96%)
- Overall Specificity: 96% (95% CI: 88-96%)
Influenza B:
- Sensitivity: 93%
- NP Swab Sensitivity: 100% (95% CI: 29-99%)
- Wash/Aspirate Sensitivity: 92% (95% CI: 66-98%)
- Overall Sensitivity: 93% (95% CI: 70-98%)
- Specificity: 97%
- NP Swab Specificity: 99% (95% CI: 96-100%)
- Wash/Aspirate Specificity: 94% (95% CI: 90-97%)
- Overall Specificity: 97% (95% CI: 94-98%)
Binax NOW® Flu A and Flu B Test Performance vs. Cell Culture
Binax NOW® Flu A Test vs. Cell Culture
- Sensitivity: 80%
- NP Swab Sensitivity: 78% (95% CI: 62-88%)
- Wash/Aspirate Sensitivity: 82% (95% CI: 69-90%)
- Overall Sensitivity: 80% (95% CI: 71-87%)
- Specificity: 93%
- NP Swab Specificity: 92%
- Wash/Aspirate Specificity: 94%
- Overall Specificity: 93%
Binax NOW® Flu B Test vs. Cell Culture
- Sensitivity: 65%
- NP Swab Sensitivity: 58% (95% CI: 42-73%)
- Wash/Aspirate Sensitivity: 71% (95% CI: 56-83%)
- Overall Sensitivity: 65% (95% CI: 54-75%)
- Specificity: 97%
- NP Swab Specificity: 97% (95% CI: 93-99%)
- Wash/Aspirate Specificity: 97% (95% CI: 93-99%)
- Overall Specificity: 97% (95% CI: 95-99%)
Predicate Device(s)
Binax NOW® Influenza A & B Test; K041049, Binax NOW® Flu A Test; K021649, Binax NOW® Flu B Test: K021646
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3328 Influenza virus antigen detection test system.
(a)
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.(b)
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.
0
NOV 3 0 2005
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K025312 |
|---|---|
| -------------------------------- | --------- |
The purpose of this 510(k) submission is to expand the Analytical Reactivity claims of the currently 510(k) cleared BinaxNOW® Influenza A & B Test (510(k) #K041049).
SUBMITTER
Binax, Inc. 10 Southgate Road Scarborough, Maine 04074 (207) 730-5700 (Office) (207) 730-5710 (FAX)
CONTACT PERSON
Angela Drysdale angela.drysdale@binax.com {email)
DATE PREPARED
November 04, 2005
TRADE NAME
BinaxNOW® Influenza A & B Test
COMMON NAME
NOW® Flu A/B Test, NOW® Influenza A/B, NOW® Influenza A & B, Binax NOW® Influenza A & B, Binax NOW® Influenza A/B
CLASSIFICATION NAME
Antigen, CF (including CF Controls), Influenza Virus A, B, C (per 21 CFR 866.3330)
PREDICATE DEVICES
Binax NOW® Influenza A & B Test; K041049 Binax NOW® Flu A Test; K021649 Binax NOW® Flu B Test: K021646
DEVICE DESCRIPTION:
The BinaxNOW® Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A & B nucleoprotein antigens in nasopharyngeal specimens. These antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. This test strip is mounted inside a cardboard, bookshaped hinged test device.
Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test device is closed. Test results are interpreted at 15 minutes based on the presence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.
1
INTENDED USE
The BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal 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 should be confirmed by culture.
TECHNOLOGICAL CHARACTERISTICS
The Expanded Claim BinaxNOW® Influenza A & B Test is exactly the same as the currently 510/k) cleared BinaxNOW® Influenza A & B Test. Both tests use identical lateral flow immunochromatographic technology. Both tests are rapid immunoassays that employ specific antibodies immobilized onto a solid phase to capture and visualize influenza nucleoprotein antigens.
PERFORMANCE SUMMARY
CLINICAL STUDIES
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture / DFA - Prospective Study
The performance of the BinaxNQW® Influenza A & B Test was compared to cell culture and/or DFA, and to the Binax NOW® Flu A Test and the Binax NOW® Flu B Test, in a prospective study conducted in 2004 outside the US. Nasopharyngeal (NP) swab and nasal wash / aspirate specimens, collected at multiple sites from children (less than 18 years of age) and adults (18 years or older) presenting with influenza-like symptoms, were evaluated in the Binax test at a central testing lab.
Forty-seven percent (47%) of the population tested was male, 53% female, 40% pediatric ( 18 years). No differences in test performance were observed based on patient age or gender. There were no invalid tests reported.
One hundred and thirteen (113) NP swab specimens and 1 wash/aspirate specimen were tested. One hundred and eight (108) of the 114 samples tested were influenza negative by culture/DFA, and 6 samples were influenza positive. When compared to culture/DFA, the BinaxNOW® Test was 75% (3/4) sensitive and 100% (110/110) specific for detection of influenza A and 50% (1/2) sensitive and 100% (112/112) specific for detection of influenza B. There was 100% agreement between the BinaxNOW® Influenza A & B Test and the individual Flu A and Flu B Tests.
BinaxNOW® A & B Test specificity by sample type versus cell culture / DFA, including 95% confidence intervals, is listed below.
BinaxNOW® Influenza A & B Test Specificity vs. Cell Culture/DFA
| FLU A SPECIFICITY | ||||
|---|---|---|---|---|
| Sample | -/+ | +/- | % Spec | 95% CI |
| NP Swab | 109 | 0 | 100% | 97-100% |
| Wash/Aspirate | 1 | 0 | 100% | 16-99% |
| Overall | 110 | 0 | 100% | 97-100% |
| FLU B SPECIFICITY | |||
|---|---|---|---|
| -/- | +/- | % Spec | 95% CI |
| 111 | 0 | 100% | 97-100% |
| 1 | 0 | 100% | 16-99% |
| 112 | 0 | 100% | 97-100% |
2
BinaxNOW® Influenza A & B Test Performance vs. Binax NOW® Flu A and Flu B Tests:
Performance of the BinaxNOW® Influenza A & B Test was compared to the current NOW® Flu A Test on 306 retrospective frozen clinical samples and to the NOW® Flu B Test on 303 retrospective frozen clinical samples. All clinical samples were collected from symptomatic patients at multiple physician offices, clinics and hospitals located in the Southern, Northeastern and Midwestern regions of the United States and from one hospital in Sweden. Fifty-three percent (53%) of the population tested was male, 47% female, 64% pediatric (