(22 days)
No
The document describes a real-time RT-PCR kit for genotyping influenza B viruses. It focuses on the reagents, instrumentation, and intended use for diagnostic and surveillance purposes. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an in vitro diagnostic (IVD) device used for the genetic lineage determination of human influenza B viruses, providing epidemiologic information for surveillance. It does not exert a therapeutic effect on the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the kit is for "determination of the genetic lineage of human influenza B viruses" and mentions it is part of a "Diagnostic Panel." The "Device Description" also refers to it as being used for "in vitro qualitative detection and characterization of human influenza viruses."
No
The device is a kit containing reagents and controls for a real-time RT-PCR assay, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "in real-time RT-PCR (rRT-PCR) assays... for determination of the genetic lineage of human influenza B viruses... from viral RNA in upper respiratory tract clinical specimens... from human patients with signs and symptoms of respiratory infection and/or from viral culture." This describes a test performed on biological samples taken from the human body to provide information about a disease state.
- Device Description: The device description states it contains components "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 term "in vitro" is a key indicator of an IVD, meaning the test is performed outside of the living organism.
- Clinical Specimens: The device is intended for use with "upper respiratory tract clinical specimens," which are biological samples collected from patients.
- Diagnostic Purpose: While it also provides "epidemiologic information for surveillance," the primary intended use is for "determination of the genetic lineage" from clinical specimens, which is a diagnostic purpose.
Therefore, based on the provided information, the Influenza B Lineage Genotyping Kit clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Influenza B Lineage Genotyping 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 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 nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW], and dual nasopharyngeal/throat swabs [NPS/TS]) from human patients with signs and symptoms of respiratory infection and/or from viral culture;
- To provide epidemiologic information for surveillance of circulating influenza viruses.
Performance characteristics for influenza B lineage genotyping were established during a season when influenza B/Victoria and B/Yamagata lineages were found in approximately equal proportion.
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.
Product codes
OZE, NSU
Device Description
The Influenza B Lineage Genotyping 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 B Lineage Genotyping 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 B Lineage Genotyping 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
upper respiratory tract clinical specimens (including nasopharyngeal swabs, nasal swabs, throat swabs, nasal aspirates, nasal washes and dual nasopharyngeal/throat swabs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
All users, analysts, and any person reporting results from 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
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
New Special 510(k) CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza B Lineage Genotyping Kit
8. 510(k) Summary
APR 2 5 2014
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. Acting 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 B Lineage Genotyping Kit
Common or Usual Name
Influenza B Lineage Genotyping Kit
Regulatory Information
Classification Regulation Section: 866.3980- Respiratory viral panel multiplex nucleic acid assay Classification: Class II Classification Product Code: OZE Subsequent Product Codes: NSU Panel: Microbiology
Predicate Device
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (K132508)
Device Description
The Influenza B Lineage Genotyping 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 B Lineage Genotyping 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 B Lineage Genotyping Kit is based on technology which is used in many molecular diagnostic assays.
1
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 B Lineage Genotyping 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 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 nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW], and dual nasopharyngeal/throat swabs [NPS/TS]) from human patients with signs and symptoms of respiratory infection and/or from viral culture;
- . To provide epidemiologic information for surveillance of circulating influenza viruses.
Performance characteristics for influenza B lineage genotyping were established during a season when influenza B/Victoria and B/Yamagata lineages were found in approximately equal proportion.
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.
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.
2
New Special 510(k)
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza B Lincage Genotyping Kit
| Table 1: Device Comparison | Influenza B Lineage Genotyping Kit | ||||
|---|---|---|---|---|---|
| CDC Human Influenza Virus Real-time PCR Diagnostic Panel (K132508) | |||||
| 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: | The Influenza B Lineage Genotyping 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 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: | 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 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 determination of the subtype of seasonal human influenza A virus as seasonal | |||||
| A/H1. A/113, 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: | To provide epidemiologic information for surveillance of the | ||||
| circulating influenza viruses. | To provide epidemiologic information for surveillance of the | ||||
| circulating influenza viruses. | |||||
| 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: | Performance characteristics for influenza B lineage genotyping were | ||||
| established during a season when influenza B/Victoria and | |||||
| B/Yamagata lineages were found in approximately equal proportion. | Performance characteristics for influenza B lineage genotyping were | ||||
| established during a season when influenza B/Victoria and | |||||
| B/Yamagata lineages were found in approximately equal proportion. | |||||
| Intended Use | |||||
| 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/115 specimens. The definitive identification of influenza A/15 (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. |
Table 1: Device Compariso
8-3
.
3
New Special 510(k)
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza B Lineage Genotyping Kit
8-4
.
4
New Special 510(k)
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza B Lineage Genotyping Kit
Risk Analysis
The Influenza B Lineage Genotyping 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 B Lineage Genotyping 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 B Lineage Genotyping Kit made available to users retains all required label information, and is determined to be substantially equivalent to the predicate.
5
Image /page/5/Picture/0 description: The image shows a circular logo. The logo contains a symbol of a bird-like figure with three curved lines representing its body and wings. The symbol is surrounded by text that reads 'U.S. Department of Health & Human Services' in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20903-0002
CENTERS FOR DISEASE CONTROL AND PREVENTION April 25. 2014 CDR YON YU, Pharm. D. ACTING ASSOCIATE DIRECTOR FOR REGULATORY AFFAIRS OFFICE OF THE DIRECTOR NATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASE 1600 CLIFTON ROAD, MS-C18 ATLANTA GA 30333
Re: K140857
Trade/Device Name: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza B Lineage Genotyping Kit Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OZE. NSU Dated: April 02, 2014 Received: April 03, 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 i 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 or any I 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 medical device relation (QS) regulation (21 CFR Part 820): and if applicable, the
6
Page 2-Dr. Yu
electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for vour 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.lda.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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/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.
Uwe Scherf -S tor
Sally 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
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known): K140857
Device Name: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panci. Influenza B Lincage Genotyping Kit
Indications For Use:
The Influenza B Lineage Genotyping Kit contains reagents and controls of the CDC Human Intluenza Virus Real-Time RT-PCR Diagnostic Panch 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 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 nasopharvngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) from human patients with signs and symptoms of respiratory infection and/or from viral culture:
- To provide epidemiologic information for surveillance of circulating influenza . viruses.
Performance characteristics for influenza B lineage genotyping were established during a season when influenza B/Victoria and B/Yamagata lineages were found in approximately equal proportion.
Negative results do not prechide 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.
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.
8
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
|-------------------------------------------------|--------|------------------------------------------------|
| X | | |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)