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.

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.

AI/ML Overview

The provided text contains information about a 510(k) submission for the QuickVue® Influenza test. However, it does not contain acceptance criteria or detailed study results that would allow for a complete description as requested. The document primarily focuses on establishing substantial equivalence to a predicate device and includes a brief analytical study for H7N9 detection.

Here's an analysis based on the available information, noting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given text. A typical 510(k) summary for a diagnostic test would include sensitivity, specificity, and potentially positive and negative predictive values, along with their acceptance criteria. The document only mentions a "minimum detectable level" for H7N9.

Acceptance Criteria (e.g., Sensitivity, Specificity, LoD)	Reported Device Performance
Not specified in document	Not specified in document
Minimum detectable level for Influenza A (H7N9)	1.98 x 10^7 EID50/mL

2. Sample Size Used for the Test Set and Data Provenance

The document describes an "analytical study" to assess the ability to detect H7N9 and establish the Limit of Detection (LoD). It does not specify a sample size for this analytical study.

Sample Size for Test Set: Not explicitly stated for the analytical study mentioned.
Data Provenance: Not specified, but given it's an "analytical study" focused on LoD, it typically involves prepared samples (e.g., spiked samples or known concentrations of virus) rather than patient specimens. The document doesn't mention a clinical study with patient samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For an analytical study establishing Limit of Detection, ground truth is typically established by the known concentration of the analyte in the prepared samples, not by expert review of test results. If a clinical study were performed (which is not described in detail here), expert-adjudicated ground truth might be relevant.

4. Adjudication Method for the Test Set

This information is not provided. Given that the described study is analytical to determine LoD, an adjudication method for test interpretation by multiple readers is not relevant. The result (presence/absence of a test line) is read directly from the test strip.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable and not mentioned. The QuickVue® Influenza test is a visual, qualitative immunoassay designed for direct interpretation, not an AI-assisted diagnostic device where human readers interact with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The QuickVue® Influenza test is a lateral flow immunoassay that requires human interpretation of visual lines for a positive or negative result. It does not involve an algorithm working independently.

7. The Type of Ground Truth Used

For the analytical study mentioned (LoD for H7N9), the ground truth would be based on the known concentration of the H7N9 virus in the prepared samples used to determine the detection limit.

Type of Ground Truth: Known viral concentration (for the LoD study).

8. The Sample Size for the Training Set

This information is not provided. For a rapid immunoassay like the QuickVue® Influenza test, there isn't typically a "training set" in the machine learning sense. Assay parameters are optimized through biochemical development and analytical testing.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no mention of a "training set" in the context of an AI/machine learning algorithm for this device. For the development and optimization of such an immunoassay, the "ground truth" during development would be established through careful analytical studies using known positive and negative samples, and samples with known concentrations of the target analyte.

Summary

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K13/599

510(k) SUMMARY

JUL 0 5 2013

Submitted By:	Quidel Corporation10165 McKellar CourtSan Diego, California 92121
	Telephone: 858-552-7908Fax: 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.

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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.

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Device Comparison:

ltem	Proposed Device	Predicate Device
Features	QuickVue Influenza test	QuickVue Influenza test
Intended Use	The QuickVue Influenza Testallows for the rapid, qualitativedetection of influenza type A andtype B antigens directly from nasalswab, nasal aspirate, and nasalwash specimens. The test isintended for use as an aid in therapid diagnosis of acute influenzavirus infection. The test is notintended to detect influenza Cantigens. Negative test resultsshould be confirmed by cellculture; they do not precludeinfluenza virus infection and shouldnot be used as the sole basis fortreatment or other managementdecisions. The test is intended forprofessional and laboratory use.	The QuickVue Influenza Testallows for the rapid, qualitativedetection of influenza type A andtype B antigens directly from nasalswab, nasal aspirate, and nasalwash specimens. The test isintended for use as an aid in therapid diagnosis of acute influenzavirus infection. The test is notintended to detect influenza Cantigens. Negative test resultsshould be confirmed by cellculture; they do not precludeinfluenza virus infection and shouldnot be used as the sole basis fortreatment or other managementdecisions. The test is intended forprofessional and laboratory use.
Read Results	Visual	Visual
SpecimenTypes	Nasal swab, nasal aspirate, andnasal wash	Nasal swab, nasal aspirate, andnasal wash
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 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.

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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,

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

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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)

Regulation Number and Section

§ 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.