(108 days)
No
The device description details a traditional immunochromatographic assay with visual interpretation of colored lines. There is no mention of AI, ML, image processing, or any computational analysis of the results. The performance studies describe standard clinical validation methods, not training or testing of AI/ML models.
No
This device is an in vitro diagnostic test for detecting influenza antigens, not for treating or preventing disease.
Yes
The intended use of the device is for the "qualitative detection of influenza A and B nucleoprotein antigens" and "to aid in the rapid differential diagnosis of influenza A and B viral infections." These phrases directly indicate its role in diagnosis.
No
The device description clearly outlines a physical immunochromatographic assay with a test strip and a cardboard housing. It involves adding a sample to the device and interpreting results based on visible color changes on the membrane. This is a hardware-based diagnostic test, not a software-only 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 for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens." The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Specimen Type: The test analyzes biological specimens (nasopharyngeal swabs, nasal swabs, and nasal wash/aspirate specimens) collected from the human body.
- Purpose: The test is intended to "aid in the rapid differential diagnosis of influenza A and B viral infections," which is a diagnostic purpose.
These characteristics clearly align with the definition of an In Vitro Diagnostic device.
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, 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 results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decision.
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 respiratory 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, saline, 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 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 (NP) swab, nasal swab, and nasal wash/aspirate specimens
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
A total of 846 prospective specimens collected from children (less than 18 years of age) and adults (18 years or older) were evaluated in the BinaxNOW® Influenza A & B Test and compared to culture/DFA. Evaluated specimens include nasopharyngeal swabs and nasal swabs collected from patients presenting with influenza-like symptoms. Fortyfour percent (44%) of the population tested was male, 54% female, 54% 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
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: K062109
The purpose of this 510(k) submission is to expand the Indications for Use claim to add nasal swab specimens, modify the caution statement related to the determination of sensitivity by testing of archived specimens, expand the Analytical Reactivity claim to include two additional influenza A strains, provide data supporting the use of additional transport media, and to update the labeling in compliance with FDA Guidance: In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Requlatory Path, as well as minor modifications consistent with competitor claims of the currently 510(k) cleared BinaxNOW® Influenza A & B Test (510(k) #K053126, originally cleared as 510(k) #K041049).
To establish substantial equivalence to the predicate, the BinaxNOW® Influenza A & B Test was compared to the BD Directigen™ Flu A+B Test (510(k) # K001364),
SUBMITTER
Binax, Inc., d/b/a Inverness Medical Professional Diagnostics 10 Southgate Road Scarborough, Maine 04074 (207) 730-5739 (Office) (207) 730-5710 (FAX) Establishment Registration Number: 1221359
CONTACT PERSON
Angela Drvsdale angela.drysdale@binax.com (email)
ALTERNATE CONTACT PERSON
Pamela Angell pam.angell@binax.com (email)
DATE PREPARED July 17, 2006
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 DEVICE
BD Directigen™ Flu A+B Test: K001364
1
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 respiratory 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, saline, 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 or absence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.
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 (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 results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decision.
TECHNOLOGICAL CHARACTERISTICS
The BinaxNOW® Influenza A & B Test uses lateral flow immunochromatographic technology while the BD Directigen™ Flu A+B test is an enzyme immunoassay (EIA) membrane test. 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
The clinical performance of the BinaxNOW® Influenza A & B Test was established in multi-center, prospective, clinical studies conducted at a central testing laboratory outside the US during the 2004 respiratory season and at three US trial sites during the 2005-2006 respiratory season. Additional performance testing was conducted on retrospective frozen clinical samples 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.
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture / DFA - Prospective Study
2
A total of 846 prospective specimens collected from children (less than 18 years of age) and adults (18 years or older) were evaluated in the BinaxNOW® Influenza A & B Test and compared to culture/DFA. Evaluated specimens include nasopharyngeal swabs and nasal swabs collected from patients presenting with influenza-like symptoms. Fortyfour percent (44%) of the population tested was male, 54% female, 54% pediatric ( Amies Media Brain Heart Infusion Broth Dulbecco Medium Hank's Balanced Salt Solution M4 Media M4-RT Media M5 Media Phosphate Buffer Solution Saline Stuart's Media Tryptose Phosphate Broth UTM-RT Media Veal Infusion Broth
It has been determined that Sucrose-Phosphate Buffer may not be suitable for use with this test.
REPRODUCIBILITY
A blind study of the BinaxNOW® Influenza A & B Test was conducted at 3 separate sites using panels of blind coded specimens containing negative, low positive, and moderate positive samples. Participants tested each sample multiple times on 3 different days. There was 97% (242/250) agreement with expected test results, with no significant differences within run (replicates tested by one operator), between run (3 different days), between sites (3 sites), or between operators (6 operators).
| Signed | |
|---|---|
| Pamela Angell | |
| Director, Worldwide Clinical Affairs, IMPD Scarborough | |
| Binax, Inc., d/b/a Inverness Medical Professional Diagnostics | |
| Date |
- Dowdle, W.R, Kendal, A.P., and Noble, G.R. 1980. Influenza Virus, p 836-884. Manual of Clinical Microbiology, 3rd edition, In Lennette, et. Al (ed.). American Society for Microbiology, Washington, D.C
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Image /page/7/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, surrounded by a circular border. The text "U.S. Department of Health & Human Services" is written along the border of the circle. The eagle is drawn with thick, flowing lines, giving it a modern and abstract appearance.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Angela Drysdale Clinical Affairs Specialist Binax, Inc. 10 Southgate Road Scarborough, ME 04074
NOV - 9 2006
Re: K062109 Trade/Device Name: BinaxNOW® Influenza A & B Tcst Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: October 28, 2006 Received: October 30, 2006
Dear Ms. Drysdale:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally, autry
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known):
BinaxNOW® Influenza A & B Test Device Name:
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, 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 results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decision.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - (CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| [Signature] |
| Division Sign-Off |
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)________________________________________________________________________________________________________________________________________________________________________