(99 days)
No
The device description details a lateral flow immunoassay that relies on chemical reactions and visual interpretation of color changes, with no mention of computational analysis, algorithms, or learning processes.
No.
The device is a diagnostic test that detects antigens to aid in the diagnosis of influenza, rather than providing therapy or treatment.
Yes
The device is described as "an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections," which directly indicates its use for diagnostic purposes.
No
The device description clearly outlines a physical test strip and 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 from nasal swab, nasal wash and nasal aspirate specimens." This involves testing a specimen taken from the human body in vitro (outside the body) to provide information about a person's health status (presence of influenza).
- Device Description: The description details how the test works by reacting the patient specimen with reagents on a test strip to detect viral antigens. This is a classic description of an in vitro diagnostic assay.
- Specimen Type: The test uses nasal swab, nasal wash, and nasal aspirate specimens, which are biological samples taken from a patient.
- Performance Studies: The document describes clinical and analytical studies conducted to evaluate the performance of the test using clinical specimens. This is a requirement for IVD devices to demonstrate their accuracy and reliability.
- Predicate Devices: The listed predicate devices (Quidel QuickVue® Influenza test, BD Directigen™ Flu A+B test, BioStar® AB Flu OIA® test) are all known IVD devices for influenza detection. This further supports the classification of this device as an IVD.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that definition.
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 from nasal swab, nasal wash and nasal aspirate 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.
Product codes
GNX
Device Description
The QuickVue Influenza A + B test, the successor product to the QuickVue Influenza test, has two Test Line indicators - one for type A and one for type B. The two Test Line indicators allow for the separate identification of type A and type B viral antigens from the same specimen. If either Test Line turns pinkto-red, the test is positive for influenza. Nasal swabs, nasal wash and/or nasal aspirates serve as specimens for this test. The patient specimen is placed in a tube containing Extraction Reagent, during which time the virus particles in the specimen are disrupted, exposing internal viral antigens. After extraction, the Test Strip is placed in the Extraction Tube for 10 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, respiratory tract
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)
Substantial equivalence has been demonstrated between the QuickVue test and viral culture for the qualitative detection of influenza Type A and B antigens. Using clinical specimens obtained from patients symptomatic for upper respiratory infection, a retrospective comparison of the QuickVue Influenza A + B test to viral culture was conducted in a multi-clinical field study. Analytical testing, including analytical sensitivity, specificity, cross-reactivity and interference were conducted. These studies further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
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
SEP 1 1 2003
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
l
| Assigned 510(k) Number: | K031899 |
|---|---|
| Submitted By: | Quidel Corporation |
| 10165 McKellar Court | |
| San Diego, California 92121 | |
| Telephone: 858-552-7908 | |
| Telefax: 858-646-8045 | |
| Submission Contact: | Robin Weiner |
| Date Prepared: | June 27, 2003 |
| Device Trade Name: | QuickVue® Influenza A + B test |
| Predicate Devices: | Quidel QuickVue® Influenza test (K991633) |
| BD Directigen™ Flu A+B test (K001364) | |
| BioStar® AB Flu OIA® test (K023556) | |
| Device Classification: | 21 CFR 866.3330 |
| The device, the QuickVue Influenza A + B test, | |
| is similar to other FDA-cleared devices used | |
| for the qualitative detection of influenza type A | |
| and B directly from clinical specimens. These | |
| tests are used to aid in the diagnosis of | |
| disease cause by influenza viruses A and B | |
| and provide epidemiological information on | |
| these diseases (21CFR 866.3330). | |
| The Food and Drug Administration has | |
| proposed that serological test systems for the | |
| detection of influenza virus be classified as | |
| Class I. | |
| Intended 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, nasal wash and nasal aspirate | |
| 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. The test is intended for professional | |
| and laboratory use. |
1
-
Physiologic Basis of the Test: Influenza is a highly contagious, acute, viral infection of the respiratory tract. The causative agents of the disease are immunologically diverse, single-strand RNA viruses known as Influenza Viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with the most serious epidemics. Type B produces a disease that is generally milder than that caused by Type A. Type C has never been connected 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.
Influenza antigens may be detected in clinical specimens by immunoassay. The QuickVue Influenza A + B test is a lateral-flow immunoassay using highly sensitive monoclonal antibodies that are specific for influenza antigens. The test is specific to influenza Types A and B antigen with no know cross-reactivity to normal flora or other known respiratory pathogens. -
Device Description: The QuickVue Influenza A + B test, the successor product to the QuickVue Influenza test, has two Test Line indicators - one for type A and one for type B. The two Test Line indicators allow for the separate identification of type A and type B viral antigens from the same specimen. If either Test Line turns pinkto-red, the test is positive for influenza.
Nasal swabs, nasal wash and/or nasal aspirates serve as specimens for this test. The patient specimen is placed in a tube containing Extraction Reagent, during which time the virus particles in the specimen are disrupted, exposing internal viral antigens. After extraction, the Test Strip is placed in the Extraction Tube for 10 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip.
2
If the extracted specimen contains influenza Type A and/or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip. If influenza Type A and B viral antigens are not present, or present at very low levels, only a blue procedural Control Line will appear. If no blue procedural Control Line develops, the result is considered invalid.
Device Comparison:
| Features | QuickVue®
Influenza A+B
test | QuickVue®
Influenza test | BD
Directigen™
Flu A+B | BioStar®
AB Flu OIA®
test |
|------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended
Use | Differential
detection of
influenza A and B
viral antigen | Detection of
influenza A and
B viral antigen | Direct and
qualitative
detection of
influenza A and
B viral antigen | Qualitative,
rapid detection
of influenza A
and B viral
antigen
(nucleoprotein) |
| Specimen
Types | Nasal Swab
Nasal Wash
Nasal Aspirate | Nasal Swab
Nasal Wash
Nasal Aspirate | Nasopharyngeal
Washes
Nasopharyngeal
Swabs
Nasopharyngeal
Aspirates
Throat Swabs
Lower Nasal
Swabs
Bronchoalveolar
Lavages | Nasal Aspirates
Nasopharyngeal
Swabs
Throat Swabs
Sputum |
| Technology | Lateral-flow
immunoassay | Lateral-flow
immunoassay | Enzyme
immunoassay | Optical
sandwich
immunoassay |
| Detection of
Influenza
Virus | Detection of
Influenza type A
and type B | Differentiated
detection of
Influenza type
A and type B | Differentiated
detection of
Influenza type A
and type B | Differentiated
detection of
Influenza type A
and type B |
| Extraction | 1 step; buffer and
detergent | 1 step; buffer
and detergent | 1 step;
detergent | 2 steps;
detergent and
reducing agent |
3
Summary of Performance Data:
Clinical Studies
Substantial equivalence has been demonstrated between the QuickVue test and viral culture for the qualitative detection of influenza Type A and B antigens. Using clinical specimens obtained from patients symptomatic for upper respiratory infection, a retrospective comparison of the QuickVue Influenza A + B test to viral culture was conducted in a multi-clinical field study.
Analytical Studies
Analytical testing, including analytical sensitivity, specificity, cross-reactivity and interference were conducted. These studies further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
4
Public Health Service
Image /page/4/Picture/2 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged around the circumference. Inside the circle is a stylized symbol resembling an abstract bird in flight, composed of four curved lines. The logo is presented in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 1 2003
Ms. Robin Weiner Vice President, Clinical and Regulatory Affairs Quidel Corporation 10165 McKellar Court San Diego, CA 92121
K031899 Re:
Trade/Device Name: QuickVue® Influenza A+B Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: June 3. 2003 Received: June 25, 2003
Dear Ms. Weiner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
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510(k) Number (if known):
Device Name:
QuickVue® Influenza A+B test
Indications for 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, nasal wash and nasal aspirate 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | 9/11/03 |
|---|---|
| ------------------- | -------------------------------------------- |
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K031899 |
|---|---|
| -------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |