(32 days)
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No
The description details a lateral flow immunoassay that relies on chemical reactions and visual interpretation of lines, with no mention of computational analysis, algorithms, or learning processes.
No
The device is a diagnostic test for influenza antigens, intended to aid in diagnosis, not to treat or directly manage a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The QuickVue Influenza 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 diagnosis of acute influenza virus infection." This indicates its purpose is to diagnose a condition.
No
The device description clearly outlines a physical test strip and chemical reagents used for antigen detection, indicating it is a hardware-based diagnostic test, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal aspirate, and nasal wash specimens." This involves testing a biological sample (specimen) outside of the body to provide information about a person's health status (presence of influenza antigens).
- Device Description: The description details how the test works by reacting with viral antigens in the specimen to produce a visual result on a test strip. This is a typical mechanism for an in vitro diagnostic test.
- Specimen Type: The test uses biological specimens (nasal swab, nasal aspirate, nasal wash).
- Purpose: The purpose is to aid in the rapid diagnosis of acute influenza virus infection, which is a diagnostic purpose.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QuickVue Influenza Test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid diagnosis of acute influenza virus infection. The test is not intended to detect influenza C antigens. Negative test 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.
Product codes
GNX
Device Description
The QuickVue Influenza 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 antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. If influenza type A or type B antigens are not present, or are present at very low levels, only a blue procedural Control Line will appear.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Respiratory tract (specimens: nasal swab, nasal aspirate, nasal wash)
Indicated Patient Age Range
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Intended User / Care Setting
professional and laboratory use.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
An analytical study was performed to assess the ability of the QuickVue Influenza test to detect the influenza A virus H7N9 (A/Anhui/1/2013) and establish the Limit of Detection. The results of this study show that QuickVue Influenza test detects H7N9 with a minimum detectable level of 1.98 x 10^7 Egg Infective Dose (EID)50/mL.
Key Metrics
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Predicate Device(s)
QuickVue Influenza test
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3330 Influenza virus serological reagents.
(a)
Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
K13/599
510(k) SUMMARY
JUL 0 5 2013
| Submitted By: | Quidel Corporation
10165 McKellar Court
San Diego, California 92121 |
|---------------------|---------------------------------------------------------------------------|
| | Telephone: 858-552-7908
Fax: 858-646-8045 |
| Submission Contact: | John D. Tamerius, Ph.D. |
Date Prepared: May 31, 2013
QuickVue® Influenza test Device Trade Name:
Common Name: Influenza immunological test
Predicate Devices: QuickVue Influenza test
Device Classification/Name: 21 CFR 866.3330 / Influenza virus serological reagents
These tests are used to aid in the diagnosis of influenza and provide epidemiological information on influenza (21 CFR 866.3330). The Food and Drug Administration has classified serological test systems for the detection of influenza virus as Class 1.
The QuickVue Influenza Test allows for the rapid, Intended Use: qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid diagnosis of acute influenza virus infection. The test is not intended to detect influenza C antigens. Negative test 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.
1
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 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
If the extracted specimen contains influenza antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. If influenza type A or type B antigens are not present, or are present at very low levels, only a blue procedural Control Line will appear.
nucleoproteins in the specimen will react with the
reagents in the Test Strip.
2
Device Comparison:
| ltem | Proposed Device | Predicate Device |
|---|---|---|
| Features | QuickVue Influenza test | QuickVue Influenza test |
| Intended Use | The QuickVue Influenza Test | |
| allows for the rapid, qualitative | ||
| detection of influenza type A and | ||
| type B antigens directly from nasal | ||
| swab, nasal aspirate, and nasal | ||
| wash specimens. The test is | ||
| intended for use as an aid in the | ||
| rapid diagnosis of acute influenza | ||
| virus infection. The test is not | ||
| intended to detect influenza C | ||
| antigens. Negative test 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 QuickVue Influenza Test | |
| allows for the rapid, qualitative | ||
| detection of influenza type A and | ||
| type B antigens directly from nasal | ||
| swab, nasal aspirate, and nasal | ||
| wash specimens. The test is | ||
| intended for use as an aid in the | ||
| rapid diagnosis of acute influenza | ||
| virus infection. The test is not | ||
| intended to detect influenza C | ||
| antigens. Negative test 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. | ||
| Read Results | Visual | Visual |
| Specimen | ||
| Types | Nasal swab, nasal aspirate, and | |
| nasal wash | Nasal swab, nasal aspirate, and | |
| nasal wash | ||
| Read Result | ||
| Time | 10 minutes | 10 minutes |
| External | ||
| Controls | Test kit contains Positive and | |
| Negative Control swabs | Test kit contains Positive and | |
| Negative Control swabs |
Summary of Performance Data:
An analytical study was performed to assess the ability of the QuickVue Influenza test to detect the influenza A virus H7N9 (A/Anhui/1/2013) and establish the Limit of Detection.
Conclusion:
The results of this study show that QuickVue Influenza test detects H7N9 with a minimum detectable level of 1.98 x 107 Egg Infective Dose (EID)50/mL. The QuickVue Influenza test is substantially equivalent with the current QuickVue Influenza test.
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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 depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JOHN D. TAMERIUS SENIOR VICE PRESIDENT OF CLINICAL AND REGULATORY AFFAIRS QUIDEL CORPORATION July 5,2013 10165 MCKELLAR COURT SAN DIEGO CA 92121
Re: K131599
Trade/Device Name: QuickVue® Influenza test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: I Product Code: GNX Dated: May 30, 2013 Received: June 05, 2013
Dear Dr. Tamerius:
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 conninered processified 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 r ou may a 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 it may of subject to additions, 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 that I Dr the Intellites and regulations administered by other Federal agencies. You must Or any I coolar statution and 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.
4
Page 2-Dr. Tamerius
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,
Sally A. Hojvat -S
Sally A. Hojvat Ph. D. M. Sc Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Intended Use
510(k) Number (if known): K131599
Device Name: QuickVue® Influenza test
Intended Use: The QuickVue Influenza Test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid diagnosis of acute influenza virus infection. The test is not intended to detect influenza C antigens. Negative test 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.
× 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 Diagnostics and Radiological Health (OIR)
Tamara V. Feldblyum -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)