(12 days)
Not Found
No
The device description and intended use focus on a rapid, qualitative immunoassay using a test strip and chemical reactions to detect antigens. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
This device is a diagnostic test intended to aid in the rapid differential diagnosis of influenza, not to treat or alleviate a disease or condition.
Yes
The product description explicitly states, "The QuickVue Influenza A+B Test allows for the rapid, qualitative detection of influenza type A and type B antigens... The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type B viral infections." This indicates its purpose is to aid in diagnosing a medical condition.
No
The device description clearly outlines a physical test strip and extraction reagents, indicating it is a hardware-based diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients." This describes a test performed on a biological specimen taken from the human body to provide information about a disease state (influenza).
- Device Description: The description details how the test works by reacting with viral antigens in the patient specimen. This is a characteristic of an in vitro diagnostic test.
- Specimen Type: The test uses "nasal swab and nasopharyngeal swab specimens," which are biological samples.
- Regulatory Context: The "Summary of Performance Studies" mentions meeting performance characteristics detailed in "21 CFR 866.3328 for Class II influenza virus antigen detection test systems." This CFR section specifically pertains to in vitro diagnostic devices for detecting influenza virus antigens.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K162438 Sofia Influenza A+B FIA) is a strong indicator that this device is being compared to another legally marketed IVD.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QuickVue Influenza A+B Test allows for the rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections 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 A were established during the 2017/2018 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel influenza A 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
PSZ
Device Description
The QuickVue Influenza A+B Test involves the extraction of influenza A and B viral antigens. The patient specimen is placed in the Extraction Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After extraction, the Test Strip is placed in the Extraction Reagent Tube where nucleoproteins in the specimen will react with the reagents in the Test Strip.
If the extracted specimen contains influenza A or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. The Test Line for influenza A or B will develop at separate specified locations on the same Test Strip. If influenza A or B antigens are not present, or are present at very low levels, only the blue procedural Control Line will appear.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal swab, nasopharyngeal swab
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)
Additional Clinical Studies were performed using the QuickVue Influenza A+B Test to confirm the device meets the performance characteristics detailed in 21 CFR 866.3328 for Class II influenza virus antigen detection test systems.
The results of this study demonstrate that the QuickVue Influenza A+B Test meets the performance requirements according to FDA's reclassification of rapid Influenza assays.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3328 Influenza virus antigen detection test system.
(a)
Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized emblem. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text. The logos are positioned side by side, indicating a connection between the two organizations.
Quidel Corporation Jennifer Rial Director, Regulatory Affairs 10165 McKellar Court San Diego, California 92121
February 13, 2018
Re: K180288
Trade/Device Name: OuickVue Influenza A+B Regulation Number: 21 CFR 866.3328 Regulation Name: Influenza virus antigen detection test systems Regulatory Class: Class II Product Code: PSZ Dated: January 31, 2018 Received: February 2, 2018
Dear Jennifer Rial:
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 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 Part 801 and Part 809); medical device 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.
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Uwe Scherf -S
Uwe Scherf, MSc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180288
Device Name QuickVue Influenza A+B Test
Indications for Use (Describe)
The QuickVue Influenza A+B Test allows for the rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections 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 A were established during the 2017/2018 influenza A/ H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel influenza A 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.
Type of Use (Select one or both, as applicable)
| ✑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image features the logo for Quidel. The logo consists of a square with rounded corners, divided into two sections. The larger section is a gradient of colors, including yellow, green, red, and purple. The smaller section is blue. Below the square is the word "QUIDEL" in a sans-serif font.
7. SPECIAL 510(K) SUMMARY
| Submitted By: | Quidel Corporation
10165 McKellar Court
San Diego, California 92121 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Telephone: 858-552-7910 |
| | Fax: 858-646-8045 |
| Submission Contact: | Jennifer S. Rial, Director, Regulatory Affairs |
| Date Prepared: | January 25, 2018 |
| Device Trade Name: | QuickVue® Influenza A+B Test |
| Common Name: | Influenza A+B immunological test |
| Predicate Devices: | Sofia Influenza A+B FIA, K162438 |
| Device Classification/Name: | 21 CFR 866.3328 / Class II / Influenza virus antigen
detection system |
| | 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. |
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Image /page/4/Picture/0 description: The image features the logo for Quidel. The logo consists of a square shape with rounded corners, divided into four quadrants. The top-left quadrant displays a gradient of colors, including yellow, orange, red, and pink. The bottom-right quadrant is colored in shades of blue and purple. Below the square is the word "QUIDEL" in a simple, sans-serif font.
Intended Use:
The QuickVue Influenza A+B Test allows for the rapid. qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections 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 A were established during the 2017/2018 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel influenza A 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.
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Image /page/5/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape with rounded corners, filled with a gradient of colors including green, yellow, orange, red, and blue. A smaller blue square is positioned in the lower right corner of the larger square. Below the square is the word "QUIDEL" in a sans-serif font.
| Physiologic Basis of the Test: | Influenza viruses are causative agents of highly
contagious, acute, viral infections of the respiratory tract.
Influenza viruses are immunologically diverse, single-
stranded RNA viruses. There are three types of influenza
viruses: A, B, and C. Type A viruses are the most prevalent
and are associated with most serious epidemics. Type B
viruses produce a disease that is generally milder than that
caused by type A. Type C viruses have never been
associated with a large epidemic of human disease. Both
Type A and B viruses can circulate simultaneously, but
usually one type is dominant during a given season. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Every year in the United States, on average 5% to 20% of
the population contract influenza; more than 200,000
people are hospitalized from influenza complications; and
about 36,000 people die from influenza-related causes.
Some people, such as older people, young children, and
people with certain health conditions, are at high risk for
serious influenza complications. |
| Device Description: | The QuickVue Influenza A+B Test involves the extraction
of influenza A and B viral antigens. The patient specimen
is placed in the Extraction Reagent Tube, during which
time the virus particles in the specimen are disrupted,
exposing internal viral nucleoproteins. After extraction, the
Test Strip is placed in the Extraction Reagent Tube where
nucleoproteins in the specimen will react with the reagents
in the Test Strip. |
| | If the extracted specimen contains influenza A or B
antigens, a pink-to-red Test Line along with a blue
procedural Control Line will appear on the Test Strip
indicating a positive result. The Test Line for influenza A
or B will develop at separate specified locations on the
same Test Strip. If influenza A or B antigens are not
present, or are present at very low levels, only the blue
procedural Control Line will appear. |
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Image /page/6/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape with rounded corners, divided into two sections. The top section is a gradient of colors, including yellow, orange, red, and green. The bottom section is a gradient of blue and purple. The word "QUIDEL" is written in black, sans-serif font below the square shape.
Device Comparison
| Item | Proposed Device | Previously Cleared Device | Predicate Device |
|---|---|---|---|
| Features | QuickVue Influenza A+B Test | QuickVue Influenza A+B Test | Sofia Influenza A+B FIA |
| Intended Use | The QuickVue Influenza A+B Test allows for | ||
| the rapid, qualitative detection of influenza | |||
| type A and type B antigens directly in nasal | |||
| swab and nasopharyngeal swab specimens | |||
| from symptomatic patients. The test is | |||
| intended for use as an aid in the rapid | |||
| differential diagnosis of acute influenza type | |||
| A and type B viral infections. The test is not | |||
| intended to detect influenza C antigens. A | |||
| negative test is presumptive, and it is | |||
| recommended these results be confirmed by | |||
| viral culture or an FDA-cleared influenza A | |||
| and B molecular assay. Negative results do not | |||
| preclude influenza virus infections 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. | The QuickVue Influenza A+B Test allows for | ||
| the rapid, qualitative detection of influenza type | |||
| A and type B antigens directly from nasal swab, | |||
| nasopharyngeal swab, nasal aspirate, and nasal | |||
| wash specimens. The test is intended for use as | |||
| an aid in the rapid differential diagnosis of acute | |||
| influenza type A and type B viral infections. The | |||
| test is not intended to detect influenza C | |||
| antigens. Negative results should be confirmed | |||
| by cell culture; they do not preclude influenza | |||
| virus infection and should not be used as the sole | |||
| basis for treatment or other management | |||
| decisions. The test is intended for professional | |||
| and laboratory use. | The Sofia Influenza A+B FIA employs | ||
| immunofluorescence to detect influenza A | |||
| and influenza B viral nucleoprotein antigens | |||
| in direct nasal swab, nasopharyngeal swab, | |||
| and nasopharyngeal aspirate/wash | |||
| specimens and nasopharyngeal swab and | |||
| nasopharyngeal aspirate/wash specimens in | |||
| transport media from symptomatic patients. | |||
| This qualitative test is intended for use as an | |||
| aid in the rapid differential diagnosis of | |||
| acute influenza A and influenza B viral | |||
| infections. The test is not intended to detect | |||
| influenza C antigens. A negative test is | |||
| presumptive and it is recommended these | |||
| results be confirmed by viral culture or an | |||
| FDA-cleared influenza A and B molecular | |||
| assay. Negative results do not preclude | |||
| influenza virus infections and should not be | |||
| used as the sole basis for treatment or other | |||
| patient management decisions. This test is | |||
| intended for professional and laboratory use. | |||
| Item | Proposed Device | Previously Cleared Device | Predicate Device |
| Features | QuickVue Influenza A+B Test | QuickVue Influenza A+B Test | Sofia Influenza A+B FIA |
| Intended Use (cont.) | Performance characteristics for influenza A | ||
| were established during the 2017/2018 | |||
| influenza seasons when influenza A/H3N2 | |||
| and A/H1N1 pandemic were the predominant | |||
| influenza A viruses in circulation. When other | |||
| influenza A viruses are | |||
| emerging, | |||
| performance characteristics may vary. |
If infection with a novel influenza A 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. | -- | The Sofia Influenza A+B FIA may be used
with Sofia or Sofia 2.
Performance characteristics for influenza A
and B were established during February
through March 2011 when influenza viruses
A/California/7/2009 (2009 H1N1),
A/Perth/16/2009 (H3N2), and
B/Brisbane/60/2008 (Victoria-Like) were
the predominant influenza viruses in
circulation according to the Morbidity and
Mortality Weekly Report from the CDC
entitled "Update: Influenza Activity---
United States, 2010-2011 Season, and
Composition of the 2011-2012 Influenza
Vaccine." 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,
samples 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 samples. |
| Item | Proposed Device | Previously Cleared Device | Predicate Device |
| Features | QuickVue Influenza A+B Test | QuickVue Influenza A+B Test | Sofia Influenza A+B FIA |
| Read Results | Visual | Visual | Reader |
| Specimen Types | Nasal swab, nasopharyngeal swab | Nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash | Direct nasal swab, nasopharyngeal swab and nasopharyngeal aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media |
| Read Result Time | 10 minutes | 10 minutes | 15 minutes |
| External Controls | Test kit contains Positive and Negative Control swabs | Test kit contains Positive and Negative Control swabs | Test kit contains Positive and Negative Control swabs |
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Image /page/7/Picture/0 description: The image shows the logo for Quidel. The logo features a square with rounded corners that is divided into four quadrants. The top left quadrant is filled with a gradient of colors, including yellow, green, blue, and red. The bottom right quadrant is filled with a dark blue color. The bottom of the image shows the word "QUIDEL" in a sans-serif font.
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Image /page/8/Picture/0 description: The image shows the logo for Quidel. The logo features a square with rounded corners, divided into four quadrants. The top left quadrant is a gradient of colors, including yellow, green, and red. The bottom right quadrant is blue. Below the square is the word "QUIDEL" in a sans-serif font.
7.1. Summary of Performance Data
Additional Clinical Studies were performed using the QuickVue Influenza A+B Test to confirm the device meets the performance characteristics detailed in 21 CFR 866.3328 for Class II influenza virus antigen detection test systems.
7.2. Conclusion
The results of this study demonstrate that the QuickVue Influenza A+B Test meets the performance requirements according to FDA's reclassification of rapid Influenza assays. The QuickVue Influenza A+B test is substantially equivalent with the predicate device, Sofia Influenza A+B FIA.