(22 days)
The Verigene® Respiratory Virus Nucleic Acid Test on the Verigene SP System (RVNATsp) 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 SP 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. As Influenza A viruses emerge, 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.
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This document is a 510(k) clearance letter for the "Verigene® Respiratory Virus Nucleic Acid Test on the Verigene SP System (RVNATSP)." It describes the device's intended use and substantial equivalence to a predicate device. However, it does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive 510(k) submission summary.
Therefore, many of the requested fields cannot be directly answered from this document.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted: This document does not provide acceptance criteria or detailed performance data (e.g., sensitivity, specificity, accuracy). It only mentions that performance characteristics for Influenza A Virus were established for specific subtypes.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted: The document does not specify the sample size, data provenance, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be extracted: The document does not mention experts, their number, or qualifications related to establishing ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted: The document does not describe any adjudication method.
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
- N/A: This device is a diagnostic nucleic acid test, not an AI-assisted imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Applicable, but details not provided: As an in vitro diagnostic test, the "algorithm only" performance (i.e., the diagnostic test itself) is what is assessed. However, the performance metrics (sensitivity, specificity) are not provided in this letter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implicitly standard of care/reference method, but not explicitly stated: For a nucleic acid test, the ground truth would typically be established by a highly sensitive and specific reference method, such as culture or another validated molecular test. The document mentions "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," which suggests culture might be part of the ground truth or a confirmatory method. However, the specific method for establishing ground truth for the primary study is not explicitly detailed.
8. The sample size for the training set
- Cannot be extracted: This document does not provide details about a training set since it's a 510(k) clearance letter, not a full study report for an AI/machine learning device.
9. How the ground truth for the training set was established
- Cannot be extracted: As above, details about a training set or its ground truth establishment are not present.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces left and is enclosed within a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Gregory W. Shipp, M.D. Vice President, Medical and Regulatory Affairs Nanosphere, Inc. 4088 Commercial Avenue Northbrook, IL 60062
NOV 1 7 2009
Re: K093337
Trade/Device Name: Verigene® Respiratory Virus Nucleic Acid Test on the Verigene SP System Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Regulatory Class: Class II Product Code: OCC, NSU Dated: October 23, 2009 Received: October 24, 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.
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
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medical device-related adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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) 796-5680 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hall, attyns
Sally A. Hojvat, M.Sc. 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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Indication for Use
510(k) Number (if known): K093337
Device Name: Verigene® Respiratory Virus Nucleic Acid Test on the Verigene® SP System (RVNATSP)
Indication for Use:
The Verigene® Respiratory Virus Nucleic Acid Test on the Verigene SP System (RVNATsp) 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 SP 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. As Influenza A viruses emerge, 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.
X 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 (OVD)
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 6093337
§ 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.