VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST by NANOSPHERE, INC

The Verigene® Respiratory Virus Nucleic Acid Test is a qualitative multiplex in vitro diagnostic test for the detection and identification of Influenza A Virus. Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids purified from nasopharyngeal swab specimens obtained from patients symptomatic for viral upper respiratory infection. The test is intended to be used on the Verigene® System as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV infections. The test is not intended to detect Influenza C virus.

Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other management decisions. It is recommended that negative test results be confirmed by culture.

Performance characteristics for Influenza A Virus were established when Influenza A/H3 and A/H1 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.

Device Description

Not Found

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria or a comprehensive study report that proves the device meets those criteria. It is a 510(k) clearance letter from the FDA for a device called "Verigene® Respiratory Virus Nucleic Acid Test," along with its indications for use.

While it mentions that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, it does not provide the specific performance metrics, sample sizes, ground truth establishment methods, or expert qualifications that would be expected in a detailed study report.

Here's what can be extracted and what is missing:

Information Present in the Document:

Device Name: Verigene® Respiratory Virus Nucleic Acid Test
Target Pathogens: Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV)
Specimen Type: Nasopharyngeal swab
Intended Use: Qualitative multiplex in vitro diagnostic test as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV infections.
Limitations:
- Not intended to detect Influenza C virus.
- Negative results do not preclude infection and should not be used as the sole basis for treatment or management.
- Negative results recommended to be confirmed by culture.
- Performance characteristics for Influenza A Virus were established when A/H3 and A/H1 were predominant; performance may vary with other emerging strains.
- If a novel Influenza A virus is suspected, specimens should be sent to public health authorities for testing (with appropriate precautions).

Missing Information (Required for the question):

A table of acceptance criteria and the reported device performance: This document does not contain this information. It only states that the device is "substantially equivalent."
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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: Not applicable as this is an in-vitro diagnostic (IVD) test, not an AI-assisted imaging device with human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As an IVD test, its performance is inherently standalone (the instrument provides the result). However, the specific metrics (sensitivity, specificity, etc.) are not provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): While it mentions confirmation by culture for negative results, the primary ground truth for the study (if one was conducted for the 510(k)) is not explicitly detailed. Often for such tests, ground truth would be established by culture or a highly sensitive and specific PCR method.
The sample size for the training set: Not mentioned (and likely not applicable in the same way as an AI model, as this is a traditional IVD).
How the ground truth for the training set was established: Not mentioned.

Conclusion:

The provided document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not detail the specific performance study, acceptance criteria, and results in the format requested. To obtain this information, one would typically need to review the full 510(k) submission summary or a peer-reviewed publication of the clinical validation study for the device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tails, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

OCT 2 1 2009

Gregory W. Shipp, M.D. Vice President, Medical and Regulatory Affairs Nanosphere, Inc. 4088 Commercial Avenue Northbrook, IL 60062

Re: K092957

Trade/Device Name: Verigene® Respiratory Virus Nucleic Acid Test Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Regulatory Class: Class II Product Code: OCC, NSU Dated: September 24, 2009 Received: September 25, 2009

Dear Dr. Shipp:

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 class II (Special Controls), 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.

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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). 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,

Jalvartyna

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K092957

Device Name: Verigene® Respiratory Virus Nucleic Acid Test

Indications for 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 Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

Uve Schef
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K092957

Regulation Number and Section

§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.

(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.