(110 days)
Not Found
No
The device description and performance studies focus on immunochromatographic assay technology and visual interpretation of results, with no mention of AI or ML.
No
The device is an in vitro diagnostic (IVD) test intended to aid in the rapid diagnosis of influenza A and B viral infections, not to treat or prevent a disease.
Yes
The device is an "in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens" and is "intended to aid in the rapid differential diagnosis of influenza A and B viral infections." This clearly indicates its purpose is to diagnose.
No
The device description clearly outlines a physical immunochromatographic assay with a test strip and a cardboard housing, indicating it is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
The term "in vitro" directly indicates that the test is performed outside of the living body, which is the defining characteristic of an In Vitro Diagnostic device. The description further clarifies that it analyzes biological specimens (nasopharyngeal swab and nasal wash/aspirate specimens) to aid in the diagnosis of a disease (influenza A and B viral infections).
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 (comma separated list FDA assigned to the subject device)
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, book-shaped 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 oreparation. 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 or absence 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, nasal wash/aspirate
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical and Clinical Comparison to Predicates:
Analytical and Clinical Comparisons of the individual NOW® Flu A and NOW® Flu B Tests vs. their diluted performance were originally established in a multi-center prospective study of national conventional culture during the 2002 flu season at physician offices and clinics located in the United States. The analytical sensitivity and specificity of the BinaxNOW® Influenza A & B Test are equivalent to that of the individual NOW® Flu A and Flu B Tests due to the identical libar low, inner and antibody composition. The performance was confirmed in clinical specimens and inactivated viral standards.
Clinical Sample Comparison:
A total of 191 nasal wash and 182 nasopharyngeal (NP) swab specimens were evaluated as part of a 2002 multi-site prospective clinical study comparing the original Binax NOW® Flu A and Flu B Tests to viral culture.
Sensitivity to influenza A was 82% (95% Cl of 69-90%) for nasal washes and 78% (95% Cl of 62-88%) for NP swabs.
Sensitivity to influenza B was 71% (95% CI of 56-83%) for nasal washes and 58% for NP swabs (95% CI of 42-73%).
Specificity for washes and swabs ranged from 92% to 97% with 95% CI of 86% to 99%.
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 (
§ 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
AUG 1 0 2004
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in This Summary of or or or or or or of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
SUBMITTER
Binax, Inc. 217 Read Street Portland, Maine 04103 (207) 772-3988 (Office) (207) 871-5751 (FAX)
CONTACT PERSON
Pamela S. Angell pangell@binax.com (email)
DATE PREPARED
April 21, 2004
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® Flu A Test, K021649 Binax NOW® Flu B Test; K021646 FLU OIA A/B Test Kit; K023556
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, book-shaped 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 oreparation. 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 or absence 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 BinaxNOVP "Influenza A and B nucleoprotein antigens in nasopharyngeal
the qualitative detection of influenza A and B nucleoprotein antigens in nasophary the qualitative delection of influenza A and B hasto provid in the rapid differential Swab and flashfaspirate opedination will infections. Negative test results should be confirmed by culture.
TECHNOLOGICAL CHARACTERISTICS
The BinaxNOW® Influenza A & B Test and the two predicate Binax NOW® Flu Tests rne DinaxNOW - Innlaoize Annochromatographic technology while the Thermo Biostar tuse identival librar low minner. All tests are rapid immunoassays that employ specific test is an option infridhodoud). All this phase to capture and visualize influenza nucleoprotein antigens.
PERFORMANCE SUMMARY
Analytical and Clinical Comparison to Predicates
Allarytoar and Olinkour Companies of the individual NOW® Flu A and NOW® Flu B Tests vs. rne oiltion performance were originally established in a multi-center prospective conventional ouring the 2002 flu season at physician offices and clinics located in stady of national auring and States. The analytical sensitivity and specificity of the BinaxNOW® Influenza A & B Test are equivalent to that of the individual NOW® Flu the Binaxive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . clinical specimens and inactivated viral standards.
Clinical Sample Comparison:
A total of 191 nasal wash and 182 nasopharyngeal (NP) swab specimens were evaluated as part of a 2002 multi-site prospective clinical study comparing the original Binax NOW® Flu A and Flu B Tests to viral culture. In this study, sensitivity to influenza A was 82% (95% Cl of 69-90%) for nasal washes and 78% (95% Cl of 62-88%) for NP swabs. Sensitivity to influenza B was 71% (95% CI of 56-83%) for nasal washes and 58% for NP swabs (95% CI of 42-73%). Specificity for washes and swabs ranged from 92% to 97% with 95% CI of 86% to 99%.
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 (Wav and nasar wasn't wasn't level infections. Negative test results should be confirmed by culture.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
ාස්ථි Device Evaluation and Safety
Page 1 of 1
*10(k) Ko4104 9