(25 days)
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 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.
Here's a breakdown of the acceptance criteria and the study information derived from the provided text for the QuickVue® Influenza A+B test:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Limit of Detection (LoD) for Influenza A H7N9 | To be established for H7N9 for substantial equivalence. | 7.90 x 10^6 Egg Infective Dose (EID)50/mL |
Note: The document primarily focuses on demonstrating substantial equivalence to a predicate device and includes only one specific analytical study result for a new influenza strain (H7N9). There are no explicitly stated acceptance criteria with numerical targets for clinical performance metrics (e.g., sensitivity, specificity) within this summary. Instead, the "Conclusion" states "The QuickVue Influenza A+B test is substantially equivalent with the current QuickVue Influenza A+B test," implying that its performance should be comparable to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The provided text only details one analytical study for H7N9 detection. It does not specify a separate "test set" in the context of clinical samples, nor does it provide details on the sample size for this analytical study beyond the reported Limit of Detection. The data provenance (country of origin, retrospective/prospective) is also not mentioned for this analytical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The provided text describes an analytical study for Limit of Detection (LoD), which typically involves laboratory measurements and does not require expert ground truth establishment in the same way clinical studies do.
4. Adjudication Method for the Test Set
Not applicable as there is no described clinical "test set" and no method for adjudicating results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with AI vs. Without AI Assistance
Not applicable. The QuickVue® Influenza A+B test is a rapid, qualitative immunological test, not an AI-assisted diagnostic device that would involve human readers and requiring an MRMC study to assess AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (the test strip and reagents) without human interpretation beyond reading the result. The QuickVue® Influenza A+B test is inherently a standalone device in this sense, as it produces visual results that are interpreted directly. The "Summary of Performance Data" details an analytical study of the device's ability to detect the H7N9 virus independently.
7. The Type of Ground Truth Used
For the analytical study concerning H7N9, the "ground truth" would be established by the known concentration of the H7N9 virus (7.90 x 10^6 EID50/mL) in the prepared samples, which is a laboratory standard rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. The QuickVue® Influenza A+B test is a lateral flow immunoassay, not a machine learning or AI-based device that would require a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reasons as point 8.
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510(k) SUMMARY
Submitted By:
Quidel Corporation 10165 McKellar Court San Diego, California 92121 Telephone: 858-552-7908 858-646-8045 Fax:
QuickVue® Influenza A+B test
Quick/ue Influenza A+B test
Influenza A+B immunological test
John D. Tamerius, Ph.D.
May 31, 2013
Submission Contact:
Date Prepared:
Device Trade Name:
Common Name:
Predicate Devices:
Device Classification/Name:
Intended Use:
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 -
The QuickVue Influenza A+B test allows for the rapid, qualitative detection of influenza type A and B antigens directly from nasal swab, type 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.
JUN 2 8 2013
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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.
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.
Device Description:
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Device Comparison:
| Froposed Device | Proposed Device | |
|---|---|---|
| Features | QuickVue Influenza A+B test | QuickVue Influenza A+B test |
| Intended Use | The QuickVue Influenza A+B testallows for the rapid, qualitativedetection of influenza type A andtype B antigens directly from nasalswab, nasopharyngeal swab, nasalaspirate, and nasal washspecimens. The test is intended foruse as an aid in the rapiddifferential diagnosis of acuteinfluenza type A and type B viralinfections. The test is not intendedto detect influenza C antigens.Negative results should beconfirmed by cell culture; they donot preclude influenza virusinfection and should not be usedas the sole basis for treatment orother management decisions. Thetest is intended for professionaland laboratory use. | The QuickVue Influenza A+B testallows for the rapid, qualitativedetection of influenza type A andtype B antigens directly from nasalswab, nasopharyngeal swab, nasalaspirate, and nasal washspecimens. The test is intended foruse as an aid in the rapiddifferential diagnosis of acuteinfluenza type A and type B viralinfections. The test is not intendedto detect influenza C antigens.Negative results should beconfirmed by cell culture; they donot preclude influenza virusinfection and should not be usedas the sole basis for treatment orother management decisions. Thetest is intended for professionaland laboratory use. |
| Read Results | Visual | Visual |
| SpecimenTypes | Nasal swab, nasopharyngealswab, nasal aspirate, and nasalwash | Nasal swab, nasopharyngealswab, nasal aspirate, and nasalwash |
| Read ResultTime | 10 minutes | 10 minutes |
| ExternalControls | Test kit contains Positive andNegative Control swabs | Test kit contains Positive andNegative Control swabs |
Summary of Performance Data:
An analytical study was performed to assess the ability of the QuickVue Influenza A+B 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 A+B test detects H7N9 with a minimum detectable level of 7.90 x 10° Egg Infective Dose (EID)56/mL. The QuickVue Influenza A+B test is substantially equivalent with the current QuickVue Influenza A+B test.
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Image /page/3/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JOHN D. TAMERIUS SENIOR VICE PRESIDENT, CLINICAL AND REGULATORY AFFAIRS QUIDEL CORPORATION June 28, 2013 10165 MCKELLAR COURT SAN DIEGO CA 92121
Re: K131619
Trade/Device Name: QuickVue® Influenza A + B Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: I Product Code: GNX Dated: May 31, 2013 Received: June 03, 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 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 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. 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,
Uwe Scherf -S for
Sally Hojvat, Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131619
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, 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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 -A
Division Sian-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K131619
Page 1 of 1
§ 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.