(28 days)
Not Found
No
The device description and intended use focus on a rapid qualitative test detecting antigens, with no mention of AI or ML technologies. The modification is limited to adding specific influenza strains to the analytical inclusivity section.
No
The device is an in vitro diagnostic test for detecting influenza antigens, intended to aid in diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states: "It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections." This clearly indicates its role in diagnosis.
No
The device is an in vitro diagnostic test that detects antigens from biological specimens. The modification described is an update to the package insert regarding analytical sensitivity for specific influenza strains. This indicates a physical test kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the BioSign Flu A+B test is an "in vitro rapid qualitative test."
- Specimen Type: It analyzes specimens obtained from the human body (nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens).
- Purpose: It is intended to "aid in the rapid differential diagnosis of influenza A and B viral infections," which is a diagnostic purpose.
- Setting: It is intended for "professional and laboratory use," which is a typical setting for IVDs.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of a transplant organ with a potential recipient, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The BioSign Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. The test is intended for professional and laboratory use. Performance characteristics for influenza were established during the 2007-2009 influenza seasons when influenza A viruses A/New Caledonia/20/99 (H1N1), A/Solomon Islands/3/2006 (H1N1), A/Brisbane/59/2007 (H1N1), A/California/07/2009 (H1N1), A/Wisconsin/67/2005 (H3N2), A/Brisbane/10/2007 (H3N2), and influenza B viruses B/Ohio/01/2005, B/Florida/4/2006, B/Brisbane/60/2008 were the predominant influenza viruses in circulation according to the Flu Activity & Surveillance report by CDC. Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL+3 facility is available to receive and culture specimens.
Product codes
GNX
Device Description
The modification presented in this 510(k) is the addition of influenza A/Vietnam/1194/2004 (H5N1) and influenza A/Anhui/01/2005 (H5N1) along with their respective analytical sensitivity concentrations, to the Analytical Inclusivity section of the package insert. The avian influenza A (H5N1) viruses, A/Vietnam/1194/2004 (H5N1) and A/Anhui/01/2005 (H5N1) were obtained from CDC as a non-infectious form with known titer. Analytical sensitivity is reported as the lowest dilution/concentration of the virus that the BioSign Flu A+B Test is able to detect.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and laboratory use.
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)
Not Found
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
K133474 DEC 1 0 2013
510(k) Summary
1. Name and 510k number of the previously cleared device
510k Number: K132465 Trade Name: BioSign® Flu A+B, Status Flu A&B Common or Usual Name: Influenza test Classification Name: Influenza virus serological reagents (21CFR 866.3330)
2. Regulatory Class: 1
3. Product Code: GNX
4. Description of the device modification(s):
The modification presented in this 510(k) is the addition of influenza A/Vietnam/1194/2004 (H5N1) and influenza A/Anhui/01/2005 (H5N1) along with their respective analytical sensitivity concentrations, to the Analytical Inclusivity section of the package insert. The avian influenza A (H5N1) viruses, A/Vietnam/1194/2004 (H5N1) and A/Anhui/01/2005 (H5N1) were obtained from CDC as a non-infectious form with known titer. Analytical sensitivity is reported as the lowest dilution/concentration of the virus that the BioSign Flu A+B Test is able to detect.
5. Comparison to the cleared device
Below are the similarities and differences between the modified device and the cleared device.
Similarities
| Device
| Characteristics | Modified Device | Cleared Device K132465 |
|---|---|---|
| Intended Use | Same as Cleared device | The BioSign Flu A+B test is an in vitro |
| rapid qualitative test that detects | ||
| influenza type A and type B | ||
| nucleoprotein antigens directly from | ||
| nasal swab, nasopharyngeal swab, and | ||
| nasopharyngeal aspirate/wash | ||
| specimens obtained from patients with | ||
| signs and symptoms of respiratory | ||
| infection. It is intended to aid in the | ||
| rapid differential diagnosis of influenza | ||
| A and B viral infections. Negative test | ||
| results are presumptive and it is | ||
| recommended these results be | ||
| confirmed by viral culture. Negative | ||
| results do not preclude influenza virus | ||
| infection and should not be used as the | ||
| sole basis for treatment or other patient | ||
| management decisions. The test is | ||
| intended for professional and laboratory | ||
| use. Performance characteristics for | ||
| influenza were established during the | ||
| 2007-2009 influenza seasons when | ||
| influenza A viruses A/New | ||
| Caledonia/20/99 (H1N1), A/Solomon | ||
| Islands/3/2006 (H1N1), | ||
| A/Brisbane/59/2007 (H1N1), | ||
| A/California/07/2009 (H1N1), | ||
| A/Wisconsin/67/2005 (H3N2), | ||
| A/Brisbane/10/2007 (H3N2), and | ||
| influenza B viruses B/Ohio/01/2005, | ||
| B/Florida/4/2006, B/Brisbane/60/2008 | ||
| were the predominant influenza viruses | ||
| in circulation according to the Flu | ||
| Activity & Surveillance report by CDC. | ||
| Performance characteristics may vary | ||
| against other emerging influenza | ||
| viruses. If infection with a novel | ||
| influenza virus is suspected based on | ||
| current clinical and epidemiological | ||
| screening criteria recommended by | ||
| public health authorities, specimens | ||
| should be collected with appropriate | ||
| infection control precautions for novel | ||
| virulent Influenza viruses and sent to | ||
| state or local health department for | ||
| testing. Viral culture should not be | ||
| attempted in these cases unless a BSL+3 | ||
| facility is available to receive and | ||
| culture specimens. | ||
| Sample Type | Same as Cleared device | Nasal swab |
| Nasopharyngeal swab Nasopharyngeal | ||
| aspirate/wash specimens | ||
| Analytical | ||
| Principle | Same as Cleared device | Solid phase chromatographic |
| immunoassay | ||
| Extraction | Same as Cleared device | Incubated for 1 min in the extraction |
| reagent | ||
| Result Read time | Same as Cleared device | 10 minutes |
| Test Line | Same as Cleared device | Colloidal gold |
| Internal Control | Same as Cleared device | Reddish-purple line |
| Control Samples | ||
| (supplied as | ||
| prepared | ||
| swabs) | Same as Cleared device | Positive Control Swab: Influenza A and |
| B antigens (non-infective recombinant | ||
| nucleoprotein) | ||
| Negative Control Swab: Inactivated | ||
| Group B Streptococcus antigen (non- | ||
| infective) |
1
2
Differences
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
The package insert has been updated to include detection of Influenza A/Vietnam/1194/2004 (H5N1) and Influenza A/Anhui/01/2005 (H5N1) in the analytical reactivity table.
3
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 consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the text "U.S. Department of Health & Human Services - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Comrol Center - WO66-G609 Silver Spring, MD 20993-0002
Kyung-ah Kim. Ph.D. Director Operations/Quality Systems Princeton BioMeditech Corporation 4242 US Highway 1 Monmouth Junction, NJ 08852
December 10, 2013
Re: K133474
Trade/Device Names: BioSign® Flu A+B Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: I Product Code: GNX Dated: November 7, 2013 Received: November 12, 2013
Dear Dr. Kim:
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 the legally marketed predicate device marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the device that has been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that does 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 either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Dr. Kim
・・
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Uwe Scherf -S ®r
Sally Hoivat, M.Sc., Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number: K133474
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
BioSign®Flu A+B Device Name: --
Intended Use: The BioSign Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to sid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. The test is intended for professional and laboratory use. Performance characteristics for influenza were established during the 2007-2009 influenza seasons when influenza A viruses A/New Caledonia/20/99 (H1N1), A/Solomon Islands/3/2006 (H1N1), A/Brisbane/59/2007 (H1N1), A/California/07/2009 (H1N1), A/Wisconsin/67/2005 (H3N2), A/Brisbane/10/2007 (H3N2), and influenza B viruses B/Ohio/01/2005, B/Florida/4/2006, B/Brisbane/60/2008 were the predominant influenza viruses in circulation according to the Flu Activity & Surveillance report by CDC. Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL+3 facility is available to receive and culture specimens.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Tamara V. Feldblyum -S 2013.12.10 11:51:35 -05'00'
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