(22 days)
Not Found
No
The device description focuses on standard real-time RT-PCR technology and does not mention any AI or ML components for data analysis or interpretation.
No.
This device is an in vitro diagnostic (IVD) test intended for the qualitative detection and characterization of human influenza viruses, not for therapeutic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For the presumptive identification of virus in patients who may be infected with influenza A subtype A/H5(Asian Lineage) from viral RNA in human respiratory specimens..." and "The Influenza A/H5 Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays..." These statements indicate that the device is used to identify a condition (influenza A/H5 virus) in patients, which is the primary function of a diagnostic device.
No
The device is a kit containing reagents and controls for a real-time RT-PCR assay, which are physical components, not software. While it is used with a PCR instrument, the device itself is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "presumptive identification of virus in patients" and "to provide epidemiologic information for surveillance of circulating influenza viruses" using human respiratory specimens and viral culture. This clearly indicates it's used to test samples taken from the human body to provide information about a person's health status.
- Device Description: The description details the components (reagents, primers, probes) and the technology (real-time RT-PCR) used for the "in vitro qualitative detection and characterization of human influenza viruses from viral RNA in respiratory specimens from patients." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Regulatory Context: The mention of the "CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel" as a predicate device (K132508) further confirms its classification as a diagnostic device intended for in vitro use.
Therefore, based on the provided information, the Influenza A/H5 Subtyping Kit meets the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Influenza A/H5 Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an Applied Biosystems (ABI) 7500 Fast Dx Real Time PCR Instrument in conjunction with clinical and epidemiological information:
· For the presumptive identification of virus in patients who may be infected with influenza A subtype A/H5(Asian Lineage) from viral RNA in human respiratory specimens and viral culture in conjunction with clinical and epidemiological risk factors;
· To provide epidemiologic information for surveillance of circulating influenza viruses.
Performance characteristics for influenza were established during a season when seasonal influenza viruses A/H1 and A/H3 were the predominant influenza A viruses in circulation and during a season when the A/ H1 pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.
Testing with the influenza H5a and H5b primer and probe sets should not be performed unless the most current U.S. Department of Health and Human Services (DHHS) clinical and epidemiological criteria for testing suspect A/H5 specimens. The definitive identification of influenza A/H5 (Asian lineage) either directly from patient specimens or from virus cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection with other viruses. The agent detected may not be the definite cause of disease.
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 unless a BSL 3+ facility is available to receive and culture specimens.
All users, and any person reporting results from use of this device should be trained to perform and interpret the results from this procedure by a competent instructor prior to use. CDC Influenza Division will limit the distribution of this device to only those users who have successfully completed a training course provided by CDC instructors or designees.
Product codes
OZE, NSU, NXD
Device Description
The Influenza A/H5 Subtyping Kit contains components of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel that is used in real-time RT-PCR (rRT-PCR) assays on the ABI 7500 Fast Dx Real-Time PCR Instrument. The Influenza A/H5 Subtyping Kit consists of oligonucleotide primers and dual-labeled hydrolysis (TaqMan®) probes to be used in rRT-PCR for the in vitro qualitative detection and characterization of human influenza viruses from viral RNA in respiratory specimens from patients presenting with influenza-like illness (ILI).
The Influenza A/H5 Subtyping Kit is based on technology which is used in many molecular diagnostic assays. rRT-PCR assays are one-tube assays that first reverse-transcribe specific regions of RNA into cDNA copies. The cDNA then serves as a template for a polymerase chain reaction that utilizes a thermocyclic heating and cooling of the reaction to logarithmically amplify a specific region of DNA. The probe anneals to a specific internal target sequence located between the target loci of the forward and reverse primers. During the extension phase of the PCR cycle, the 5' nuclease activity of Tag polymerase degrades any probe molecules hybridized to amplified target sequence, causing the reporter dye to separate from the quencher dye, and generating a fluorescent signal. With each cycle, additional reporter dye molecules are cleaved from their respective probes, increasing the fluorescence intensity. Fluorescence intensity is monitored at each PCR cycle. Amplification of targets is reflected by logarithmic increase in fluorescence over time in comparison to the background signal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human respiratory specimens (including nasopharyngeal swabs, nasal swabs, throat swabs, nasal aspirates, nasal washes and dual nasopharyngeal/throat swabs), and lower respiratory tract specimens (including bronchoalveolar lavages, bronchial washes, tracheal aspirates, sputum, and lung tissue)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
All users, analysts, and any person reporting results from use of this device should be trained to perform and interpret the results from this procedure by a competent instructor prior to use. CDC Influenza Division will limit the distribution of this device to only those users who have successfully completed a training course provided by CDC instructors or designees.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2014
Centers for Disease Control and Prevention Yon Yu, Pharm.D. Associate Director for Regulatory Affairs 1600 Clifton Road NE, MS C-18 Atlanta, GA 30333
Re: K141859
Trade/Device Name: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OZE, NSU, NXD Dated: July 09, 2014 Received: July 10, 2014
Dear Dr. Yu:
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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
Tamara V. Feldblyum -S for
Sally A. Hojvat M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141859
Device Name
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Kit
Indications for Use (Describe)
The Influenza A/H5 Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an Applied Biosystems (ABI) 7500 Fast Dx Real Time PCR Instrument in conjunction with clinical and epidemiological information:
· For the presumptive identification of virus in patients who may be infected with influenza A subtype A/H5(Asian Lineage) from viral RNA in human respiratory specimens and viral culture in conjunction with clinical and epidemiological risk factors;
· To provide epidemiologic information for surveillance of circulating influenza viruses.
Performance characteristics for influenza were established during a season when seasonal influenza viruses A/H1 and A/H3 were the predominant influenza A viruses in circulation and during a season when the A/ H1 pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.
Testing with the influenza H5a and H5b primer and probe sets should not be performed unless the most current U.S. Department of Health and Human Services (DHHS) clinical and epidemiological criteria for testing suspect A/H5 specimens. The definitive identification of influenza A/H5 (Asian lineage) either directly from patient specimens or from virus cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection with other viruses. The agent detected may not be the definite cause of disease.
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 unless a BSL 3+ facility is available to receive and culture specimens.
All users, and any person reporting results from use of this device should be trained to perform and interpret the results from this procedure by a competent instructor prior to use. CDC Influenza Division will limit the distribution of this device to only those users who have successfully completed a training course provided by CDC instructors or designees.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
3
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Tamara V. Feldblyum -S 2014.07.31 16:25:13 -04I00
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
8. 510(k) Summary
CDC hereby submits this Special 510(k) in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter
Centers for Disease Control and Prevention 1600 Clifton Road NE Atlanta, GA 30333 Establishment Registration: 1050190
Contact Person
CDR Yon Yu, Pharm.D. Associate Director for Regulatory Affairs Office of the Director National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention 1600 Clifton Road, NE, MS C-18 Atlanta, GA 30333 (404) 639-3046 (office) (404) 639-1275 (fax) fkb8@cdc.gov
Proprietary Name
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Kit
Common or Usual Name
Influenza A/H5 Subtyping Kit
Regulatory Information
Classification Regulation Section: 866.3980 - Respiratory viral panel multiplex nucleic acid assay Subsequent Regulation Sections: 862.2570 - Instrumentation for clinical multiplex test systems 866.3332 - Reagents for detection of specific novel influenza A viruses Classification: Class II
Classification Product Code: OZE Subsequent Product Codes: NSU, NXD Panel: Microbiology
Predicate Device
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (K132508)
Device Description
The Influenza A/H5 Subtyping Kit contains components of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel that is used in real-time RT-PCR (rRT-PCR) assays on the ABI 7500 Fast Dx Real-Time PCR Instrument. The Influenza A/H5 Subtyping Kit consists of oligonucleotide primers and dual-labeled hydrolysis (TaqMan®) probes to be used in rRT-PCR for the in vitro qualitative
5
detection and characterization of human influenza viruses from viral RNA in respiratory specimens from patients presenting with influenza-like illness (ILI).
The Influenza A/H5 Subtyping Kit is based on technology which is used in many molecular diagnostic assays. rRT-PCR assays are one-tube assays that first reverse-transcribe specific regions of RNA into cDNA copies. The cDNA then serves as a template for a polymerase chain reaction that utilizes a thermocyclic heating and cooling of the reaction to logarithmically amplify a specific region of DNA. The probe anneals to a specific internal target sequence located between the target loci of the forward and reverse primers. During the extension phase of the PCR cycle, the 5' nuclease activity of Tag polymerase degrades any probe molecules hybridized to amplified target sequence, causing the reporter dye to separate from the quencher dye, and generating a fluorescent signal. With each cycle, additional reporter dye molecules are cleaved from their respective probes, increasing the fluorescence intensity. Fluorescence intensity is monitored at each PCR cycle. Amplification of targets is reflected by logarithmic increase in fluorescence over time in comparison to the background signal.
Intended Use
The Influenza A/H5 Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument in conjunction with clinical and epidemiological information:
- . For the presumptive identification of virus in patients who may be infected with influenza A subtype A/H5(Asian Lineage) from viral RNA in human respiratory specimens and viral culture in conjunction with clinical and epidemiological risk factors;
- To provide epidemiologic information for surveillance of circulating influenza viruses. •
Performance characteristics for influenza were established during a season when seasonal influenza viruses A/H1 and A/H3 were the predominant influenza A viruses in circulation and during a season when the A/H1pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.
Testing with the influenza H5a and H5b primer and probe sets should not be performed unless the patient meets the most current U.S. Department of Health and Human Services (DHHS) clinical and epidemiological criteria for testing suspect A/H5 specimens. The definitive identification of influenza A/H5 (Asian lineage) either directly from patient specimens or from virus cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
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
6
health department for testing. Viral culture should not be attempted unless a BSL 3+ facility is available to receive and culture specimens.
All users, analysts, and any person reporting results from use of this device should be trained to perform and interpret the results from this procedure by a competent instructor prior to use. CDC Influenza Division will limit the distribution of this device to only those users who have successfully completed a training course provided by CDC instructors or designees.
Technological Characteristics
The changes proposed to the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel subject to this special 510(k) are for labeling purposes only and will not alter the technological attributes of the device.
Substantial Equivalence Comparison
The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (K132508) will serve as the predicate for the intended change. Please see Table 1 for a detailed comparison.
7
| Table 1. Device Comparison | ||
|---|---|---|
| CDC Human Influenza Virus Real-time PCR Diagnostic Panel (K132508) | Influenza A/H5 Subtyping Kit | |
| The CDC Human Influenza Virus Real-Time PCR Diagnostic Panel is intended for use | ||
| in Real-time RT- PCR assays on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time | ||
| PCR Instrument in conjunction with clinical and epidemiological information: | ||
| For qualitative detection of influenza virus type A or B from viral RNA in upper | ||
| respiratory tract clinical specimens (including nasopharyngeal swabs, nasal swabs, | ||
| throat swabs, nasal aspirates, nasal washes and dual nasopharyngeal/throat swabs), | ||
| and lower respiratory tract specimens (including bronchoalveolar lavages, | ||
| bronchial washes, tracheal aspirates, sputum, and lung tissue) from human patients | ||
| with signs and symptoms of respiratory infection and/or from viral culture; | The Influenza A/H5 Subtyping Kit contains reagents and controls of the | |
| CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is | ||
| intended for use in Real-time RT-PCR assays on an Applied Biosystems | ||
| (ABI) 7500 Fast Dx Real-Time PCR Instrument in conjunction with | ||
| clinical and epidemiological information: | ||
| For the presumptive identification of virus in patients who may be | ||
| infected with influenza A subtype A/H5(Asian Lineage) from viral | ||
| RNA in human respiratory specimens and viral culture in | ||
| Intended Use | For determination of the subtype of seasonal human influenza A virus as seasonal | |
| A/H1, A/H3, and/or A/H1pdm09 from viral RNA in upper respiratory tract | ||
| clinical specimens (including nasopharyngeal swabs, nasal swabs, throat swabs, | ||
| nasal aspirates, nasal washes and dual nasopharyngeal/throat swabs), and lower | ||
| respiratory tract specimens (including bronchoalveolar lavages, bronchial washes, | ||
| tracheal aspirates, sputum, and lung tissue) from human patients with signs and | ||
| symptoms of respiratory infection and/or from viral culture; For the determination of the genetic lineage of human influenza B viruses as | ||
| B/Victoria or B/Yamagata lineage from viral RNA in upper respiratory tract | ||
| clinical specimens (including NPS, NS, TS, NA, NW, and NPS/TS) from human | ||
| patients with signs and symptoms of respiratory infection and/or from viral culture; For the presumptive identification of virus in patients who may be infected with | ||
| influenza A subtype A/H5(Asian Lineage) from viral RNA in human respiratory | ||
| specimens and viral culture in conjunction with clinical and epidemiological risk | ||
| factors; To provide epidemiologic information for surveillance of the circulating | ||
| influenza viruses. Performance characteristics for influenza were established during a season when | ||
| seasonal influenza viruses A/H1 and A/H3 were the predominant influenza A | ||
| viruses in circulation and during a season when the A/H1pdm09 influenza virus | ||
| was the predominant influenza A virus in circulation. Performance characteristics | ||
| may vary with other emerging influenza A viruses. | ||
| Testing with the influenza H5a and H5b primer and probe sets should not be | ||
| performed unless the patient meets the most current U.S. Department of Health and | conjunction with clinical and epidemiological risk factors; | |
| To provide epidemiologic information for surveillance of the | ||
| circulating influenza viruses. Performance characteristics for influenza were established during a | ||
| season when seasonal influenza viruses A/H1 and A/H3 were the | ||
| predominant influenza A viruses in circulation and during a season | ||
| when the A/H1pdm09 influenza virus was the predominant influenza | ||
| A virus in circulation. Performance characteristics may vary with | ||
| other emerging influenza A viruses. | ||
| Testing with the influenza H5a and H5b primer and probe sets should | ||
| not be performed unless the patient meets the most current U.S. | ||
| Department of Health and Human Services (DHHS) clinical and | ||
| epidemiological criteria for testing suspect A/H5 specimens. The | ||
| definitive identification of influenza A/H5 (Asian lineage) either directly | ||
| from patient specimens or from virus cultures requires additional | ||
| laboratory testing, along with clinical and epidemiological assessment in | ||
| consultation with national influenza surveillance experts. | ||
| Negative results do not preclude influenza virus infection and should not | ||
| be used as the sole basis for treatment or other patient management | ||
| decisions. Conversely, positive results do not rule out bacterial infection | ||
| or co-infection with other viruses. The agent detected may not be the | ||
| definite cause of disease. | ||
| If infection with a novel influenza A virus is suspected based on current | ||
| clinical and epidemiological screening criteria recommended by public | ||
| Human Services (DHHS) clinical and epidemiological criteria for testing suspect | ||
| A/H5 specimens. The definitive identification of influenza A/H5 (Asian lineage) | ||
| either directly from patient specimens or from virus cultures requires additional | ||
| laboratory testing, along with clinical and epidemiological assessment in | ||
| consultation with national influenza surveillance experts. | 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 unless a BSL 3+ facility is available to receive and culture | ||
| specimens. | ||
| CDC Human Influenza Virus Real-time PCR Diagnostic Panel (K132508) | Influenza A/H5 Subtyping Kit | |
| Intended Use | ||
| (Cont'd) | Negative results do not preclude influenza virus infection and should not be used as the | |
| sole basis for treatment or other patient management decisions. Conversely, positive | ||
| results do not rule out bacterial infection or co-infection with other viruses. The agent | ||
| detected may not be the definite cause of disease. | ||
| 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 unless a BSL 3+ facility is available to receive and culture | ||
| specimens. | ||
| Specimen Types | Nasopharyngeal swabs, nasal swabs, throat swabs, nasal aspirates, nasal washes and | |
| dual nasopharyngeal/throat swabs, bronchoalveolar lavages, bronchial aspirates, | ||
| bronchial washes, tracheal aspirates, sputum, and lung tissue. Only upper respiratory | ||
| specimens for influenza B genetic lineage determination | Nasopharyngeal swabs, nasal swabs, throat swabs, nasal aspirates, nasal | |
| washes and dual nasopharyngeal/throat swabs, bronchoalveolar lavages, | ||
| bronchial aspirates, bronchial washes, tracheal aspirates, sputum, and lung | ||
| tissue. | ||
| Technology | Real-time RT-PCR | Same |
| Required | ||
| Instrumentation | Applied Biosystems 7500 Fast Dx Real- Time PCR | |
| Instrument with SDS software version 1.4 | Same | |
| Organism | ||
| Detected | Universal influenza A viruses (animal and human), Swine-origin influenza A viruses, | |
| Influenza B viruses, Influenza A subtypes: seasonal A/H1, A/H3, A/H1pdm09, and | ||
| A/H5, Influenza B/Yamagata and B/Victoria lineages | Universal influenza A viruses (animal and human), Influenza A/H5 (Asian | |
| lineage) subtypes | ||
| Nucleic Acid | ||
| Extraction | Yes | Same |
Table 1: Device Comparison
8
9
Risk Analysis
The Influenza A/H5 Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel. A risk analysis of the labeling modification to create a separate Package Insert for the Influenza A/H5 Subtyping Kit was performed to verify that the change in the package insert did not present increased or new risks to the user. No new significant risks were identified as a result of the proposed modification.
Substantial Equivalence Conclusion
The changes proposed to the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel do not alter the device's design or technological attributes. In addition, the indications for use and intended use of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel will remain the same. The modification to the package insert included with the Influenza A/H5 Subtyping Kit made available to users retains all required label information, and is determined to be substantially equivalent to the predicate.