(85 days)
Viral Cell Culture
No
The device description details a chromatographic immunoassay that relies on chemical reactions and visual interpretation of lines, with no mention of computational analysis, algorithms, or learning processes.
No
The device is described as a rapid chromatographic immunoassay that aids in the diagnosis of influenza A and B by detecting viral antigens, not directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The test is to be used as an aid in the diagnosis of influenza A and B viral infections."
No
The device description clearly states it is a "chromatographic assay" and a "test device" that uses "test strips" and "membranes" to visualize results, indicating it is a physical, hardware-based diagnostic test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states the test is for the "direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal washes/aspirates, nasopharyngeal swabs and throat swabs of symptomatic patients." This involves testing samples taken from the human body in vitro (outside the body) to provide information for diagnosis.
- Device Description: The description details a "chromatographic assay to qualitatively detect influenza A and B viral antigens in samples processed from respiratory specimens." This describes a laboratory test performed on biological samples.
- Performance Studies: The document describes studies comparing the device's performance to "viral cell culture," which is a standard laboratory method for identifying viruses in biological samples. This further confirms its use in a diagnostic setting.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
The BD Directigen™ EZ Flu A+B test is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal washes/aspirates, nasopharyngeal swabs and throat swabs of symptomatic patients. The BD Directigen EZ Flu A+B test is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. All negative test results should be confirmed by cell culture because negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
Performance characteristics for Influenza B using nasopharyngeal swabs (NPS) were established primarily with retrospective, frozen specimens. Users may wish to establish the sensitivity of this test for Influenza B using fresh nasopharyngeal swab specimens.
Product codes
GNX
Device Description
The BD Directigen EZ Flu A+B test is a chromatographic assay to qualitatively detect influenza A and B viral antigens in samples processed from respiratory specimens. When specimens are processed and added to the test device, influenza A or B viral antigens bind to anti-influenza antibodies conjugated to visualizing particles in the corresponding A and B test strips. The antigen-conjugate complex migrates across the test strip to the reaction area and is captured by the line of antibody on the membrane. A positive result for influenza A is visualized as a reddish-purple line at the Test "T" position and the Control "C" position in the BD Directigen EZ device Flu A read window. A positive result for influenza B is visualized as a reddish-purple line at the Test "T" position and the Control "C" position in the BD Directigen EZ device Flu B read window.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal washes/aspirates, nasopharyngeal swabs, throat swabs
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
CLINICAL STUDIES
New performance characteristics of the BD Directigen EZ Flu A+B test were established in a geographically diverse multi-center study to support the addition of the nasopharyngeal swab specimen type to the intended use of this device.
Clinical Performance
The performance characteristics of the BD Directigen EZ Flu A+B test as compared to viral cell culture were determined using 456 prospective nasopharyngeal swab specimens. The sensitivity and specificity of the BD Directigen EZ A+B test for influenza A were 90.7% (146/161) and 93.2% (275/295), respectively. For influenza B, the sensitivity and specificity were 100.0% (1/1) and 100.0% (455/455), respectively. To augment the study with an adequate number of positive samples for influenza B, 59 retrospective nasopharyngeal swab specimens were tested with the BD Directigen EZ Flu A+B test and compared to viral cell culture. The positive and negative agreement of the BD Directigen EZ A+B test for influenza A with the retrospective nasopharyngeal swab specimens were 85.7% (6/7) and 96.2% (50/52). The positive and negative agreement for influenza B with the retrospective nasopharyngeal swab specimens were 74.4% (32/43) and 100.0% (16/16), respectively.
Overall performance of the BD Directigen EZ Flu A+B test is substantially equivalent to viral cell culture that was in use prior to May 28, 1976.
Key Metrics
For influenza A from 456 prospective nasopharyngeal swab specimens:
Sensitivity: 90.7% (146/161)
Specificity: 93.2% (275/295)
For influenza B from 456 prospective nasopharyngeal swab specimens:
Sensitivity: 100.0% (1/1)
Specificity: 100.0% (455/455)
For influenza A from 59 retrospective nasopharyngeal swab specimens:
Positive agreement: 85.7% (6/7)
Negative agreement: 96.2% (50/52)
For influenza B from 59 retrospective nasopharyngeal swab specimens:
Positive agreement: 74.4% (32/43)
Negative agreement: 100.0% (16/16)
Predicate Device(s)
Viral Cell Culture, Direct fluorescent antibody (DFA), BD Directigen™ Flu A+B Test K001364, Binax NOW® Influenza A&B Test K053126
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
K063689
CONFIDENTIAL AND PROPRIETARY
510(k) SUMMARY
MAR 0 7 2007
| SUBMITTED BY: | BECTON, DICKINSON AND COMPANY
7 LOVETON CIRCLE
SPARKS, MD 21152
Phone: 410-316-4905
Fax: 410-316-4499 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Dainelle N. Clark |
| DATE PREPARED: | March 6, 2007 |
| DEVICE TRADE NAME: | BD Directigen™ EZ Flu A+B Test |
| DEVICE COMMON NAME: | Influenza virus serological reagents |
| DEVICE CLASSIFICATION: | 21 CFR§866.3330 |
| PREDICATE DEVICES: | Viral Cell Culture
Direct fluorescent antibody (DFA)
BD Directigen™ Flu A+B Test
Binax NOW® Influenza A&B Test |
INTENDED USE:
The BD Directigen™ EZ Flu A+B test is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal washes/aspirates, nasopharyngeal swabs and throat swabs of symptomatic patients. The BD Directigen EZ Flu A+B test is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. All negative test results should be confirmed by cell culture because negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
Performance characteristics for Influenza B using nasopharyngeal swabs (NPS) were established primarily with retrospective, frozen specimens. Users may wish to establish the sensitivity of this test for Influenza B using fresh nasopharyngeal swab specimens,
DEVICE DESCRIPTION:
The BD Directigen EZ Flu A+B test is a chromatographic assay to qualitatively detect influenza A and B viral antigens in samples processed from respiratory specimens. When specimens are processed and added to the test device, influenza A or B viral antigens bind to anti-influenza antibodies conjugated to visualizing particles in the corresponding
1
A and B test strips. The antigen-conjugate complex migrates across the test strip to the reaction area and is captured by the line of antibody on the membrane. A positive result for influenza A is visualized as a reddish-purple line at the Test "T" position and the Control "C" position in the BD Directigen EZ device Flu A read window. A positive result for influenza B is visualized as a reddish-purple line at the Test "T" position and the Control "C" position in the BD Directigen EZ device Flu B read window.
DEVICE COMPARISON:
The BD Directigen EZ Flu A+B test was compared to viral cell culture, direct fluorescent antibody (DFA) tests, the BD Directigen Flu A+B test (K001364) and the Binax NOW Influenza A&B test (K053126). Comparison testing of the BD Directigen EZ A+B test and viral cell culture did not exhibit any new issues associated with the safety and effectiveness of the product when using nasopharyngeal swab specimens. The studies demonstrate that the BD Directigen EZ A+B test is substantially equivalent to the predicate device, viral cell culture.
SUMMARY OF PERFORMANCE DATA:
CLINICAL STUDIES
New performance characteristics of the BD Directigen EZ Flu A+B test were established in a geographically diverse multi-center study to support the addition of the nasopharyngeal swab specimen type to the intended use of this device.
Clinical Performance
The performance characteristics of the BD Directigen EZ Flu A+B test as compared to viral cell culture were determined using 456 prospective nasopharyngeal swab specimens. The sensitivity and specificity of the BD Directigen EZ A+B test for influenza A were 90.7% (146/161) and 93.2% (275/295), respectively. For influenza B, the sensitivity and specificity were 100.0% (1/1) and 100.0% (455/455), respectively. To augment the study with an adequate number of positive samples for influenza B, 59 retrospective nasopharyngeal swab specimens were tested with the BD Directigen EZ Flu A+B test and compared to viral cell culture. The positive and negative agreement of the BD Directigen EZ A+B test for influenza A with the retrospective nasopharyngeal swab specimens were 85.7% (6/7) and 96.2% (50/52). The positive and negative agreement for influenza B with the retrospective nasopharyngeal swab specimens were 74.4% (32/43) and 100.0% (16/16), respectively.
Overall performance of the BD Directigen EZ Flu A+B test is substantially equivalent to viral cell culture that was in use prior to May 28, 1976.
1 The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or
2
reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Dainelle N. Clark Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
MAR 0 7 2007
Re: K063689
Trade/Device Name: BD Directigen™ EZ Flu A+B Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class II Product Code: GNX Dated: December 11, 2006 Received: December 12, 2006
Dear Ms. Clark:
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, artym
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
5
510(k) Number:
Device Name: BD Directigen™ EZ Flu A+B Test
Indications for Use:
The BD Directigen™ EZ Flu A+B test is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal washes/aspirates, nasopharyngeal swabs and throat swabs of symptomatic patients. The BD Directigen EZ Flu A+B test is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. All negative test results should be confirmed by cell culture because negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
Performance characteristics for Influenza B using nasopharyngeal swabs (NPS) were established primarily with retrospective, frozen specimens. Users may wish to establish the sensitivity of this test for Influenza B using fresh nasopharyngeal swab specimens.
Prescription Use V (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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Uve Schif
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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