(12 days)
Not Found
No
The device description details a chromatographic immunoassay that relies on antigen-antibody binding and visual interpretation of lines, with no mention of AI or ML technologies.
No
This device is an in vitro diagnostic assay used to detect influenza A and B viral antigens, aiding in diagnosis. It does not provide treatment or modify a disease state, which are characteristics of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is "to be used as an aid in the diagnosis of influenza A and B viral infections."
No
The device is a rapid chromatographic immunoassay, which is a physical test kit that uses chemical reactions and visual indicators to detect antigens. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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 further confirms the in vitro nature of the test.
- Aid in Diagnosis: The intended use also states the test is to be used "as an aid in the diagnosis of influenza A and B viral infections." This is a key characteristic of IVD devices.
The definition of an IVD device is a medical device that is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The BD Directigen™ EZ Flu A+B assay 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 Directigen™ EZ Flu A+B assay 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.
Product codes
GNX
Device Description
The 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 Directigen EZ 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 Directigen EZ 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 and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Hazard Analysis did not identify any changes that raised new issues of safety and effectiveness. The parameters listed below were evaluated in studies performed according to appropriate Design Control procedures. The modified BD Directigen™ EZ Flu A+ B assay met all current product claims for performance.
- Dry swabs controls must be comparable in stability to current liquid controls: Data to date from accelerated stability studies have indicated 30 months at 2-30C. Confirmatory real time stabilities have indicated 5 months at 2-30C. Real time stabilities will continue.
- Dry swabs controls must perform in the assay comparable to the current liquid controls: Dry swabs perform comparably in the assay to the current liquid controls.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Kl01529
Confidential
JUN 1 6 2010 PAGE 1 OF 3
510(K) SUMMARY
BECTON, DICKINSON AND COMPANY SUBMITTED BY: 11085 NORTH TORREY PINES ROAD SUITE 210 LA JOLLA, CA 92037 Tel: (858) 795 7890 Fax: (858 795 7885
Gregory P. Payne, RAC, Director CONTACT NAME: Regulatory Affairs
May 28, 2010 DATE PREPARED:
BD Directigen™ EZ Flu A+B assay DEVICE TRADE NAME:
Influenza virus serological reagents DEVICE COMMON NAME:
21 CFR 866.3330 DEVICE CLASSIFICATION:
BD Directigen™ EZ Flu A+B assay PREDICATE DEVICES :
INTENDED USE :
The BD Directigen™ EZ Flu A+B assay 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 Directigen™ EZ Flu A+B assay 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.
1
DEVICE DESCRIPTION :
The 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 Directigen EZ 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 Directigen EZ Flu B read window.
DEVICE COMPARISON:
The modified kit differs from the currently marketed BD Directigen™ EZ Flu A+ B kit in the following way:
The controls have been changed from liquid to dry swabs.
SUBSTANTIAL EQUIVALENCE:
The modified device BD Directigen™ EZ Flu A+ B is substantially equivalent to the current legally marketed device, BD Directigen™ EZ Flu A+B assay.
Modifications are as follows:
| Modification | Potential Impact of Modification |
|---|---|
| Change of control from Liquid to dry swab. | Dry controls are more stable than liquid controls. |
| Use of dry control swabs allows for optimal | |
| inventory management during viral outbreaks | |
| are also supplied by most competitors. | |
| Additionally, rare customer complaints regarding | |
| control failures have been attributed to improper | |
| processing (protocol not followed, processing | |
| agent not added to liquid control). This possibility | |
| Dry swabs controls are also supplied by most | |
| competitors. |
Dry swabs may not perform like liquid controls or
be as stable. Stabililty and swab performance
studies will define stability and performance
characteristics of the swabs. |
BD Diagnostics
2
PAGE 3 of 3
Included in the Special 510(k) are the Hazard Analysis and the associated validations and verifications conducted to address individual hazards/risks identified for this modification. The Hazard Analysis did not identify any changes that raised new issues of safety and effectiveness. The parameters listed below were evaluated in studies performed according to appropriate Design Control procedures. The modified BD Directigen™ EZ Flu A+ B assay met all current product claims for performance.
| Parameter | Result |
|---|---|
| Dry swabs controls must be | |
| comparable in stability to current | |
| liquid controls | Data to date from accelerated stability |
| studies have indicated 30 months at 2-30*C. | |
| Confirmatory real time stabilities have | |
| indicated 5 months at 2-30*C. Real time | |
| stabilities will continue. | |
| Dry swabs controls must perform in | |
| the assay comparable to the | |
| current liquid controls | Dry swabs perform comparably in the assay |
| to the current liquid controls. |
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
JUN 1 4 2010
Becton Dickinson and Company Gregory P. Payne Director, Regulatory Affairs and Quality Systems 11085 North Torrey Pines Rd, Suite 210 La Jolla, CA 92037
Re: K101529
Trade/Device Name: BD Directigen EZ Flu A + B Assay Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: May 28, 2010 Received: June 2, 2010
Dear Mr. Payne:
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.
Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into class II (Special Controls), 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
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing vour 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Vály attm
Sally A. Hojvat, Ph.D. Director. Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
INDICATION FOR USE
510(K) Number (if known)
101529
BD Directigen™ EZ Flu A+B assay Device Name:
Indication for Use:
The BD Directigen™ EZ Flu A+B assay 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 Directigen™ EZ Flu A+B assay 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.
Prescription Use X 21 CFR 801 Subpart D) And/or
Over the Counter Use (21 CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Une Schf
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101529
BD Diagnostics