(122 days)
Not Found
No
The device description details a standard immunochromatographic assay with no mention of AI or ML components. The performance studies are based on traditional clinical trial metrics, not AI/ML model evaluation.
No.
The device is an in vitro diagnostic test for the qualitative detection of influenza A nucleoprotein antigen, intended to aid in the rapid diagnosis of influenza A infections, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended to aid in the rapid diagnosis of influenza A infections."
No
The device description clearly outlines a physical immunochromatographic assay with a test strip, cardboard device, and sample preparation steps, indicating it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is an "in vitro rapid immunochromatographic assay for the qualitative detection of influenza A nucleoprotein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients." The term "in vitro" is a key indicator of an IVD, meaning it is used to test samples outside of the body.
- Device Description: The description details how the device works by analyzing a biological sample (nasal wash and nasopharyngeal swab specimens) to detect a specific analyte (influenza A nucleoprotein antigen). This is the core function of an IVD.
- Anatomical Site: The device uses specimens from specific anatomical sites (nasal wash and nasopharyngeal swab specimens), which are biological samples collected from the body for analysis.
- Performance Studies: The document describes clinical studies where the device was tested on patient specimens to evaluate its performance (sensitivity, specificity, accuracy) in diagnosing influenza A infections. This type of testing is characteristic of IVD validation.
- Predicate Device: The mention of a predicate device (Quidel QuickVue® Influenza Test) with a K number (K991633) indicates that this device is being compared to a previously cleared IVD, which is a standard process for regulatory submission of new IVDs.
All of these factors strongly indicate that the Binax NOW® Flu A Test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Binax NOW® Flu A Test is an in vitro rapid immunochromatographic assay for the qualitative detection of influenza A nucleoprotein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients. It is intended to aid in the rapid diagnosis of influenza A infections. Negative test results should be confirmed by cell culture.
Product codes (comma separated list FDA assigned to the subject device)
GNX
Device Description
The Binax NOW® Flu A Test is an immunochromatographic membrane assay used to detect influenza A nucleoprotein antigen in nasal wash and nasopharyngeal swab specimens. A test strip, containing goldconjugated and immobilized anti-influenza A antibodies, is mounted on the right side of a cardboard, book-shaped hinged test device. Swab specimens require a sample preparation step, in which the sample is eluted off the swab into a saline solution. The nasal wash sample does not require any preparation. The sample to be tested is added to a pad at the top of the test strip, and the test device is closed. Influenza A antigen present in the sample reacts to bind anti-influenza A conjugated antibody. The resulting antigenconjugate complexes are captured by immobilized anti-influenza A antibody, forming the Sample Line. Immobilized Control Line antibody, which appears as a blue line in an untested device, captures a visualizing conjugate, forming a pink Control Line. The sample is contained, and results are available within 15 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal wash and nasopharyngeal swab specimens
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytic Reactivity: Six (6) ATCC traceable influenza A strains were assayed in the Binax NOW® test at concentrations ranging from 10^3 to 10^6 TCID36/ml. One hundred percent (100%) were positive, indicating that the Binax NOW test detects all influenza A strains.
Analytic Specificity (Cross-Reactivity): 42 potential cross-reactants were tested. Bacteria tested at concentrations greater than 1 x 10^8 organisms/ml and viruses tested at concentrations greater than 1 x 10^6 TCID50/ml did not cross-react.
Clinical Sensitivity and Specificity: Multi-site prospective study, 191 nasal wash specimens and 182 nasopharyngeal swab specimens from symptomatic patients.
Nasal wash specimens: 82% sensitivity, 94% specificity, 91% overall accuracy.
Nasopharyngeal swab specimens: 78% sensitivity, 92% specificity, 89% overall accuracy.
Interfering Substances: Tested with 19 substances. All negative (no virus) and positive (spiked with LOD virus) samples generated expected results.
Reproducibility: Blind study at 3 separate sites using a panel of coded specimens (negative, low positive, moderate positive controls). 234 samples tested. One hundred percent (100%) were correctly interpreted.
Quality Control: Evaluated procedural control. 3 operators each ran 20 kit controls in a panel of 20 devices, 9 of which had been rendered inoperative. One hundred percent (100%) of the 60 devices were correctly interpreted as positive, negative, or invalid.
Preliminary Stability: Ongoing. Test results consistent with other Binax 510(k) cleared ICT products. Minimum shelf life of one year anticipated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Nasal wash specimens:
Sensitivity = 82% (69% - 90%)
Specificity = 94% (89% - 97%)
Accuracy = 91% (86% - 94%)
Nasopharyngeal Swab Specimens:
Sensitivity = 78% (62% - 88%)
Specificity = 92% (86% - 95%)
Accuracy = 89% (84% - 93%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 1 9 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Binax NOW® FLU A Test
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter: Binax, Inc. 217 Read Street Portland, Maine 04103
Attention: Anne Jepson (207) 772-3988 (Office) (207) 871-5751 (FAX) ajepson@binax.com (email)
Binax NOW® Flu A Test Trade Name:
Flu A ICT, NOW® Flu A test, NOW® Influenza A, Common Name: Influenza A ICT
- Antigens, CF (Including Classification Name: CF Control), Influenza virus A, B, C (per 21 CFR 866.3330)
- QuickVue® Predicate Device: Quidel Influenza Test, 510 (k) number K991633
- NOW® NOW® Device Description: The Binax Flu A Test is an immunochromatographic membrane assay used to detect influenza A nucleoprotein antigen in nasal wash and nasopharyngeal swab specimens. A test strip, containing goldconjugated and immobilized anti-influenza A antibodies, is mounted on the right side of a cardboard, book-shaped hinged test device. Swab specimens require a sample preparation step, in which the sample is eluted off the swab into a saline solution. The nasal wash sample does not require any preparation. The sample to be tested is added to a pad at the top of the test strip, and the test device is closed. Influenza A antigen present in the sample reacts to bind anti-influenza A conjugated antibody. The resulting antigenconjugate complexes are captured by immobilized anti-influenza A antibody, forming the Sample Line. Immobilized
1
Control Line antibody, which appears as a blue line in an untested device, captures a visualizing conjugate, forming a pink Control Line. The sample is contained, and results are available within 15 minutes.
The Binax NOW Flu A Test is an in vitro Intended Use: rapid immunochromatographic assay for the qualitative detection of influenza A nucleoprotein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients. It is intended to aid in the rapid diagnosis of influenza A infections. Negative test results should be confirmed by cell culture.
Technological Characteristics:
Both the Binax NOW® Flu A Test and the Quidel QuickVue® Influenza Test are simple rapid immunochromatographic tests with a visual result interpretation. Both employ antibodies conjugated to visualizing particles and an antibody striped membrane to capture and visualize influenza A antigen. The Quidel QuickVue® Test also detects influenza B antigen.
The Binax NOW® Flu A Test is substantially Performance Summary: equivalent to the predicate device, the Quidel QuickVue® Influenza Test (K991633), for the detection of influenza A antigen. The performance of the Binax NOW® Flu A Test was verified using freshly collected and characterized nasal wash and nasopharyngeal swab specimens. Refer to attached PERFORMANCE CHARACTERISTICS.
Signed
Date _________________________________________________________________________________________________________________________________________________________________________
Karen Hickey Vice President, Regulatory Affairs
2
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)
PERFORMANCE CHARACTERISTICS BINAX NOW® FLU A TEST
Analytic Reactivity:
Although the specific influenza A strains causing infection in humans can vary year to year, all contain the conserved nucleoprotein targeted by the Binax NOW® test. Six (6) ATCC traceable influenza A strains were assayed in the Binax NOW® test at concentrations ranging from 103 to 10° TCID36/ml. One hundred percent (100%) were positive, indicating that the Binax NOW test detects all influenza A strains.
Analytic Specificity (Cross-Reactivity):
To demonstrate the immunologic specificity of the Binax NOW® test, 42 potential cross-reactants were tested in the Binax NOW® test. The cross-reactant panel included bacteria and viruses that may be present in respiratory specimens. Bacteria tested at concentrations greater than l x 10* organisms/ml and viruses tested at concentrations greater than 1 x 10° TCIDs;/ml did not cross-react in the Binax NOW® Test.
Clinical Sensitivity and Specificity:
The Binax NOW® Flu A Test was evaluated in prospective clinical studies.
In a multi-site prospective study, 191 nasal wash specimens and 182 nasopharyngeal swab specimens collected from patients presenting with influenza-like symptoms were tested in the NOW® test and in culture. NOW® test performance versus viral cell culture, calculated using standard methods, was as follows:
| Nasal wash specimens: | 82% sensitivity
94% specificity
91% overall accuracy |
|--------------------------------|------------------------------------------------------------|
| Nasopharyngeal swab specimens: | 78% sensitivity
92% specificity
89% overall accuracy |
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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)
PERFORMANCE CHARACTERISTICS BINAX NOW® FLU A TEST
Ninety-five percent (95%) confidence intervals are listed below.
Nasal Wash Specimens:
| Viral Culture | |||
|---|---|---|---|
| + | - | ||
| NOW® | |||
| Result | + | 40 | 9 |
| - | 9 | 133 | |
| Sensitivity = 82% (69% - 90%) | |||
| Specificity = 94% (89% - 97%) | |||
| Accuracy = 91% (86% - 94%) |
Nasopharyngeal Swab Specimens:
| Viral Culture | |||
|---|---|---|---|
| + | - | ||
| NOW® | + | 29 | 12 |
| Result | - | 8 | 133 |
| Sensitivity | = | 78% | (62% - 88%) |
| Specificity | = | 92% | (86% - 95%) |
| Accuracy | = | 89% | (84% - 93%) |
Interfering Substances:
The Binax NOW test was found not to cross-react with 19 substances that may be artificially introduced into the nasal cavity or nasopharynx or that are naturally present in respiratory specimens. These 19 potentially interfering substances were diluted to appropriate concentrations in a saline/BSA solution and tested in the Binax NOW Test. A portion of each of these solutions was also spiked with the limit of detection (LOD) level of a viable influenza A strain (See LOD Testing, Section 9) before testing in the Binax NOW® Test. All negative (no virus) and positive (spiked with LOD virus) samples generated expected results in the Binax NOW® Test.
Reproducibility:
A blind study of the Binax NOW® test was conducted at 3 separate sites using a panel of coded specimens containing negative, low positive, and moderate positive controls. Participants performed
4
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)
PERFORMANCE CHARACTERISTICS BINAX NOW® FLU A TEST
testing on 3 different days. One hundred percent (100%) of the 234 samples tested were correctly interpreted.
Quality Control:
The ability of the Binax NOW® Test procedural control to indicate test failure was evaluated when 3 operators each ran 20 kit controls in a panel of 20 devices, 9 of which had been rendered inoperative. The number of defective devices and the defect itself were not apparent to the operator. One hundred percent (100%)of the 60 devices were correctly interpreted as positive, negative, or invalid.
Preliminary Stability:
Preliminary stability studies of the Binax NOW® Flu A Test and kit controls are ongoing. Test results are consistent with other Binax 510(k) cleared ICT products. A minimum shelf life of one year is anticipated.
References:
- Dowdle, W.R, Kendal, A.P., and Noble, G.R. 1980. Influenza Virus, p 1 836-884. Manual of Clinical Microbiology, 3rd edition, In Lennette, et. Al (ed.). American Society for Microbiology, Washington, D.C
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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three stylized profiles forming the eagle's head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Anne Jepson Manager, Technical Support and Services Binax, Inc. 217 Read Street Portland, ME 04103
SEP 1 9 2002
Re: K021649
Trade/Device Name: Binax Now® Flu A Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: July 31, 2002 Received: August 1, 2002
Dear Ms. Jepson:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
APPENDIX B
INDICATIONS FOR USE FORM
510(k) Number (if known):
Device Name:
Binax NOW® Flu A Test
Indications For Use:
Binax NOW® Flu A Test is an in vitro rapid The The immunochromatographic assay for the qualitative detection of influenza A nucleoprotein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients. It is intended to aid in the rapid diagnosis of influenza A infections. Negative test results should be confirmed by cell culture.
Woody Dubois
510(k) Number