(300 days)
No
The device description and performance studies describe a traditional chromatographic immunoassay, which relies on chemical reactions and visual interpretation of lines, not AI/ML algorithms. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No
This device is a diagnostic test for influenza A and B viral antigens and is used as an aid in diagnosis, not for treatment.
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 outlines a physical chromatographic immunoassay test device 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 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
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 and throat swabs of symptomatic patients. The BD Directigen™ EZ Flu A+B test is a differentiated test, and therefore 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.
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 and/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 is visualized as a reddish purple line at the Test "T" position in the Flu A or Flu B read window in combination with a reddish purple line at the Control "C".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal washes/aspirates 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)
ANALYTICAL STUDIES
Comparison studies were conducted to determine analytical sensitivity and specificity as well as evaluate the BD Directigen™ EZ Flu A+B test for potential cross reactivity or interfering substances.
Analytical Sensitivity
The limit of detection (LoD) for the BD Directigen™ EZ Flu A+B test was established for a total of nine influenza A and six influenza B strains. The LoD for the strains tested ranged from 2.78 X 102 to 6.95 X 105 CEIDs/mL.
Analytical Specificity
A panel of 37 influenza A and influenza B strains were tested in triplicate with the BD Directigen™ EZ Flu A+B test. All influenza A strains resulted in positive Flu A results and negative Flu B results. Likewise, all influenza B strains resulted in positive Flu B results and negative Flu A results.
Cross Reactivity
A panel of 98 microorganisms (including bacteria, yeasts and viruses) was cultured and tested in triplicate with the BD Directigen™ EZ Flu A+B test. None of the microorganisms tested in the panel were shown to cross react with the BD Directigen™ EZ Flu A+B test.
Interfering Substances
A variety of substances were tested with the BD Directigen™ EZ Flu A+B test in A variety of substantes were cores warable to or greater than levels that may be present in patient respiratory samples. Substances tested included blood and various medications. in patient respiratory sumptos. "Bassassed with the performance of the BD Directigen™ EZ Flu A+B test.
CLINICAL STUDIES
Performance characteristics of the Directigen™ EZ Flu A+B test were established over I croninance characterior of the secondically diverse multi-center study.
Reproducibility
The reproducibility of the BD Directigen™ EZ Flu A+B test was evaluated at four sites. The overall reproducibility for the BD Directigen™ EZ Flu A+B test was 99.6%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Performance
Clinical Performance characteristics of the BD Directigen EZ Flu A+B test were determined by I crolmance characterior on afficity for this assay compared to cell culture. The overall calculating sellshirrity and specificity of the BD Directigen EZ Flu A+B test compared to culture for sensitivity and spectively collected nasopharyngeal wash/aspirate and throat specimens in both an the prospectively continuenza A was 83.2% and 94.3%, respectively. For influenza B, the overall sensitivity and specificity was 75.4% and 99.3%, respectively.
Predicate Device(s)
Cell Culture, Direct Fluorescent Antibody (DFA), K001364, K031565
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
JUL 7 - 2005
510(k) SUMMARY
| SUBMITTED BY: | BECTON, DICKINSON AND COMPANY
7 LOVETON CIRCLE
SPARKS, MD 21152
Phone: 410-316-4000
Fax: 410-316-4499 |
|------------------------|-------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Michelle Bytheway Bandy |
| DATE PREPARED: | May 31, 2005 |
| DEVICE TRADE NAME: | BD Directigen™ EZ Flu A+B |
| DEVICE COMMON NAME: | Influenza virus serological reagents |
| DEVICE CLASSIFICATION: | 21 CFR§866.3330 |
| PREDICATE DEVICES: | Cell Culture
Direct Fluorescent Antibody (DFA) |
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 and throat swabs of symptomatic patients. The BD Directigen™ EZ Flu A+B test is a differentiated test, and therefore 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.
BD Directigen™ Flu A+B Remel Xpect™ FLU A/B
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 and/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 is visualized as a reddish purple line at the Test "T" position in the Flu A or Flu B read window in combination with a reddish purple line at the Control "C".
1
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 Remel Xpect FLU A/B test (K031565). Although there are some differences between the BD Directigen™ EZ Flu A+B test and the predicate devices, these differences do not present new issues of safety and effectiveness. The impact of these differences on the safety and effectiveness of the BD Directigen™ EZ Flu A+B test was assessed using accepted scientific methods.
SUMMARY OF PERFORMANCE DATA:
ANALYTICAL STUDIES
Comparison studies were conducted to determine analytical sensitivity and specificity as well as evaluate the BD Directigen™ EZ Flu A+B test for potential cross reactivity or interfering substances.
Analytical Sensitivity
The limit of detection (LoD) for the BD Directigen™ EZ Flu A+B test was established for a total of nine influenza A and six influenza B strains. The LoD for the strains tested ranged from 2.78 X 102 to 6.95 X 105 CEIDs/mL.
Analytical Specificity
A panel of 37 influenza A and influenza B strains were tested in triplicate with the BD Directigen™ EZ Flu A+B test. All influenza A strains resulted in positive Flu A results and negative Flu B results. Likewise, all influenza B strains resulted in positive Flu B results and negative Flu A results.
Cross Reactivity
A panel of 98 microorganisms (including bacteria, yeasts and viruses) was cultured and tested in triplicate with the BD Directigen™ EZ Flu A+B test. None of the microorganisms tested in the panel were shown to cross react with the BD Directigen™ EZ Flu A+B test.
2
Interfering Substances
A variety of substances were tested with the BD Directigen™ EZ Flu A+B test in A variety of substantes were cores warable to or greater than levels that may be present in patient respiratory samples. Substances tested included blood and various medications. in patient respiratory sumptos. "Bassassed with the performance of the BD Directigen™ EZ Flu A+B test.
CLINICAL STUDIES
Performance characteristics of the Directigen™ EZ Flu A+B test were established over I croninance characterior of the secondically diverse multi-center study.
Reproducibility
The reproducibility of the BD Directigen™ EZ Flu A+B test was evaluated at four sites. The overall reproducibility for the BD Directigen™ EZ Flu A+B test was 99.6%.
Clinical Performance
Performance characteristics of the BD Directigen EZ Flu A+B test were determined by I crolmance characterior on afficity for this assay compared to cell culture. The overall calculating sellshirrity and specificity of the BD Directigen EZ Flu A+B test compared to culture for sensitivity and spectively collected nasopharyngeal wash/aspirate and throat specimens in both an the prospectively continuenza A was 83.2% and 94.3%, respectively. For influenza B, the overall sensitivity and specificity was 75.4% and 99.3%, respectively.
Overall performance of the BD Directigen™ EZ Flu A+B test is substantially equivalent' to viral cell culture and DFA tests that were in use prior to May 28, 1976 and to the BD Directigen™ Flu A+B and Remel Xpect™ FLU A/B tests.
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 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 ally ocaring whatsover on the recolution of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three wavy lines representing the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 7 - 2005
Ms. Michelle B. Bandy Regulatory Affairs Specialist BD Diagnostics Systems Becton Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Re: K042472
Trade/Device Name: BD Directigen™ EZ-Flu A+B Kit Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: Class I Product Code: GNX Dated: May 31, 2005 Received: June 1, 2005
Dear Ms. Bandy:
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).
4
Page 2 -
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)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sale, a Hoy
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
Page 1_of 1
510(k) Number: K042472
Device Name: BD Directigen™ EZ Flu A+B
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 and throat swabs of symptomatic patients. The BD Directigen EZ Flu A+B test is a differentiated test, and therefore 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k\varphi2472