INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

K140857 · Centers for Disease Control and Prevention · OZE · Apr 25, 2014 · Microbiology

Device Facts

• Record ID: K140857
• Device Name: INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
• Applicant: Centers for Disease Control and Prevention
• Product Code: OZE · Microbiology
• Decision Date: Apr 25, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

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 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 NPS, NS, TS, NA, NW, and NPS/TS) 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. 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.

Device Story

The Influenza B Lineage Genotyping Kit is a component of the CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel. It utilizes real-time RT-PCR technology to detect and differentiate influenza B virus lineages (B/Victoria and B/Yamagata) from viral RNA extracted from upper respiratory tract specimens. The device is intended for use on the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument. It is operated by laboratory personnel in clinical or public health settings to provide epidemiological surveillance data. The output is a genetic lineage determination, which assists healthcare providers in monitoring circulating influenza strains. The modification allows for flexible ordering of specific panel components to manage reagent supply and minimize waste.

Clinical Evidence

No clinical data; bench testing only. Performance characteristics established during a season with approximately equal proportions of B/Victoria and B/Yamagata lineages.

Technological Characteristics

Real-time RT-PCR assay; utilizes Applied Biosystems 7500 Fast Dx Real-Time PCR instrument with SDS software version 1.4; requires nucleic acid extraction; detects influenza B/Yamagata and B/Victoria lineages.

Indications for Use

Indicated for human patients with signs/symptoms of respiratory infection or viral culture to determine genetic lineage of influenza B (B/Victoria or B/Yamagata) from upper respiratory tract specimens.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (K132508)

Submission Summary (Full Text)

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K140857

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 [phone] (office) [phone] (fax) [e-mail]

# 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.

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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.

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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<br>in Real-time RT-PCR assays on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time<br>PCR Instrument in conjunction with clinical and epidemiological information: | | The Influenza B Lineage Genotyping Kit contains reagents and controls of<br>the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel<br>and is intended for use in Real-time RT-PCR assays on an Applied<br>Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument in<br>conjunction with clinical and epidemiological information: | | | |
| For qualitative detection of influenza virus type A or B from viral RNA in upper<br>respiratory tract clinical specimens (including nasopharyngeal swabs, nasal swabs,<br>throat swabs, nasal aspirates, nasal washes and dual nasopharyngeal throat swabs),<br>and lower respiratory tract specimens (including bronchoalveolar lavages,<br>bronchial washes, tracheal aspirates, sputum, and lung tissue) from human patients<br>with signs and symptoms of respiratory infection and/or from viral culture: | For the determination of the genetic lineage of human influenza B<br>viruses as B/Victoria or B/Yamagata lineage from viral RNA in upper<br>respiratory tract clinical specimens (including NPS, NS, TS, NA,<br>NW, and NPS/TS) from human patients with signs and symptoms of<br>respiratory infection and/or from viral culture; | For the determination of the genetic lineage of human influenza B<br>viruses as B/Victoria or B/Yamagata lineage from viral RNA in upper<br>respiratory tract clinical specimens (including NPS, NS, TS, NA,<br>NW, and NPS/TS) from human patients with signs and symptoms of<br>respiratory infection and/or from viral culture; | | | |
| For determination of the subtype of seasonal human influenza A virus as seasonal<br>A/H1. A/113, and/or A/H1pdm09 from viral RNA in upper respiratory tract<br>clinical specimens (including nasopharyngeal swabs, nasal swabs, throat swabs,<br>nasal aspirates, nasal washes and dual nasopharyngeal/throat swabs), and lower<br>respiratory tract specimens (including bronchoalveolar lavages, bronchial washes,<br>tracheal aspirates, sputum, and lung tissue) from human patients with signs and<br>symptoms of respiratory infection and/or from viral culture: | To provide epidemiologic information for surveillance of the<br>circulating influenza viruses. | To provide epidemiologic information for surveillance of the<br>circulating influenza viruses. | | | |
| For the determination of the genetic lineage of human influenza B viruses as<br>B/Victoria or B/Yamagata lineage from viral RNA in upper respiratory tract<br>clinical specimens (including NPS. NS. TS. NA. NW. and NPS/TS) from human<br>patients with signs and symptoms of respiratory infection and/or from viral culture: | Performance characteristics for influenza B lineage genotyping were<br>established during a season when influenza B/Victoria and<br>B/Yamagata lineages were found in approximately equal proportion. | Performance characteristics for influenza B lineage genotyping were<br>established during a season when influenza B/Victoria and<br>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<br>performed unless the patient meets the most current U.S. Department of Health and<br>Human Services (DHHS) clinical and epidemiological criteria for testing suspect<br>A/115 specimens. The definitive identification of influenza A/15 (Asian lineage)<br>either directly from patient specimens or from virus cultures requires additional<br>laboratory testing, along with clinical and epidemiological assessment in<br>consultation with national influenza surveillance experts | | Negative results do not preclude influenza virus infection and should<br>not be used as the sole basis for treatment or other patient management<br>decisions. Conversely. positive results do not rule out bacterial<br>infection or co-infection with other viruses. The agent detected may not<br>be the definite cause of disease. |

# Table 1: Device Compariso

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New Special 510(k)
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza B Lineage Genotyping Kit

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### 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.

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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.

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| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(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)

# Li Li -S 2014.04.24 14:44:30 -04'00'