The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel 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 qualitative detection of influenza virus type A or B 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]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) 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/H3, and/or A/H1pdm09 from viral RNA in upper respiratory tract clinical specimens (including NPS, NS, TS, NA, NW and NPS/TS) and lower respiratory tract specimens (including BAL, BW, TA, sputum, and lung tissue) 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 circulating influenza viruses.

Device Description

The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel is used in real-time RT-PCR assays (rRT-PCR) on the ABI 7500 Fast Dx Real-Time PCR Instrument. The CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel is a panel 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). Detection of viral RNA not only aids in the diagnosis of illness caused by seasonal and novel influenza viruses in patients with ILI, but also provides epidemiological information on influenza and aids in the presumptive laboratory identification of specific novel influenza A viruses. The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel 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 background signal.

AI/ML Overview

The provided text does not contain specific acceptance criteria with numerical thresholds that the device must meet, nor does it detail a dedicated pivotal study with a defined sample size and ground truth establishment methodology for this specific device (K111507) to demonstrate its performance against those criteria.

Instead, the submission for K111507 relies on the "substantial equivalence comparison" to two previously FDA-cleared predicate devices (K080570 and K101564). The performance data cited for K111507 directs the reader to the performance characteristics established for these predicate devices. The document also includes additional performance data collected during the 2010-2011 influenza season to show that recent circulating strains can be detected.

Therefore, the following information is extracted and presented based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

As specific, quantified acceptance criteria for K111507 are not explicitly stated in the provided text, a direct comparison table cannot be created in the traditional sense. The submission for K111507 primarily relies on the equivalency to predicate devices and additional data showing detection of recent circulating strains.

Reported Device Performance (for K111507, based on additional data for recent circulating strains):

Performance Aspect	Reported Device Performance (K111507)
Detection of recent seasonal influenza A/H3 and Influenza B strains	The device demonstrated detection of recent circulating seasonal influenza virus strains.
	- Influenza A/H3: Detected in 24 of 49 (49%) original specimens received from US public health laboratories.
	- Influenza B: Detected in 25 of 49 (51%) original specimens received from US public health laboratories.
Detection in Lower Respiratory Tract Specimens	The device detected influenza A/H3, A/H1pdm09, and influenza B in various lower respiratory tract specimens (bronchoalveolar lavage, bronchial washes, tracheal aspirates, sputum, and lung tissue) from 18 original lower respiratory specimens received from US public health laboratories.

2. Sample Size and Data Provenance for Test Set

Sample Size for Test Set:
- For detection of recent seasonal influenza A/H3 and B: 49 original specimens.
- For detection in lower respiratory tract specimens: 18 original specimens.
Data Provenance: Retrospective, from US public health laboratories (identified as "original specimens received from US public health laboratories").

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. Given the nature of a PCR diagnostic panel, the ground truth would typically be established through a reference method, often a combination of viral culture and/or additional molecular testing performed by qualified laboratory personnel, rather than expert interpretation of images or clinical assessments.

4. Adjudication Method for Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This device is a real-time RT-PCR diagnostic panel, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with AI vs. without AI assistance is not applicable.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone study was implicitly done. The performance data presented (detection of influenza A/H3 and B in specimens) represents the algorithm's (the PCR panel's) performance independent of human-in-the-loop diagnostic interpretation beyond standard laboratory procedures. The detection is based on the fluorescent signal generated by the rRT-PCR assay.

7. Type of Ground Truth Used

The ground truth type is implied to be a reference method for influenza detection and characterization, likely viral culture and/or a validated molecular method accepted as the standard for influenza diagnosis. The text states "Performance characteristics for influenza were established...as demonstrated by analytical testing of the 49 original specimens...". For the lower respiratory specimens, it states the panel "detected influenza A/H3, A/H1pdm09, and influenza B," implying comparison to an established truth.

8. Sample Size for Training Set

The document does not explicitly mention a "training set" in the context of this diagnostic panel. As a PCR diagnostic kit, its development involves designing primers and probes that target specific viral genetic sequences. This process typically involves bioinformatics analysis and wet-lab analytical validation using known positive and negative controls, rather than a machine learning "training set" in the conventional sense. The "performance characteristics" data mentioned (from predicate devices and the additional 2010-2011 season data) serve as validation or evaluation data.

9. How Ground Truth for Training Set Was Established

Not applicable, as a discrete "training set" with established ground truth in the context of machine learning is not described or relevant for this type of PCR diagnostic device. The design and analytical validation of PCR primers and probes rely on known viral sequences and synthetic or cultured viral samples with confirmed identities, not a "ground truth" derived from human experts interpreting a diagnostic outcome.

Summary

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6. 510(k) Summary

Assigned 510(k) number: K111507

Submitted by:

Centers for Disease Control and Prevention 1600 Clifton Road NE Atlanta, GA 30333

Contact Person:

Hye-Joo Kim, 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-12 Atlanta, GA 30333 (404) 639-4643 (office) (404) 639-1275 (fax) hek6@cdc.gov

Date prepared: August 19, 2011

Device Name: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel

Common or Usual Name: CDC Flu rRT-PCR Dx Panel

Regulatory Information:

Regulation Section: Reagents for detection of specific novel influenza A viruses (21 CFR 866.3332) Classification: Class II Product Codes: OQW, NXD, OEP, NSU Panel: Microbiology

Predicate Devices:

CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (K080570)
CDC Influenza 2009 A (H1N1)pdm Real-time RT-PCR Panel (K101564)

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Device Description

The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel is used in real-time RT-PCR assays (rRT-PCR) on the ABI 7500 Fast Dx Real-Time PCR Instrument.

The CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel is a panel 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). Detection of viral RNA not only aids in the diagnosis of illness caused by seasonal and novel influenza viruses in patients with ILI, but also provides epidemiological information on influenza and aids in the presumptive laboratory identification of specific novel influenza A viruses.

The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel 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 background signal.

Intended Use

For qualitative detection of influenza virus type A or B 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]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) 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/H3. and/or A/H1pdm09 from viral RNA in upper respiratory tract clinical

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specimens (including NPS, NS, NA, NW and NPS/TS) and lower respiratory tract specimens (including BAL, BW, TA, sputum, and lung tissue) 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 coniunction 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 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 epidemiologic 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 health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facilable 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.

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Substantial Equivalence Comparison

The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel merges two previously FDA-cleared CDC devices and is equivalent to the CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (K080570) and the CDC Influenza 2009 A (H1N1)pdm Real-time RT-PCR Panel (K101564). These devices were developed to the same specifications and utilize the same real-time RT-PCR technology to detect influenza A and influenza B in human respiratory specimens. The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel further detects and differentiates influenza A and B viruses and characterizes influenza A viruses as A/H1, A/H3 subtypes, A/H1pdm09, and A/H5 using real-time RT-PCR. All three devices utilize the same instrumentation, the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument. which has been granted marketing clearance by FDA (K082562). The CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (K080570) and the CDC Influenza 2009 A (H1N1)pdm Real-time RT-PCR Panel (K101564) were granted marketing clearance by the FDA on September 30, 2008, and June 22, 2010, respectively.

	CDC Human Influenza VirusReal-time PCR DiagnosticPanel	CDC Human InfluenzaVirus Real-time RT-PCRDetection andCharacterization Panel(K080570)	CDC Influenza 2009 A(H1N1)pdm Real-time RT-PCR Panel (K101564)
Intended Use	The CDC Human Influenza VirusReal-Time PCR Diagnostic Panelis intended for use in Real-timeRT-PCR assays on an AppliedBiosystems (ABI) 7500 Fast DxReal-Time PCR Instrument inconjunction with clinical andepidemiological information: 1)for qualitative detection ofinfluenza virus type A or B fromviral RNA in upper respiratorytract clinical specimens (includingnasopharyngeal swabs, nasalswabs, throat swabs nasalaspirates, nasal washes and dualnasopharyngeal/throat swabs), andlower respiratory tract specimens(including bronchoalveolarlavages, bronchial washes,tracheal aspirates, sputum, andlung tissue) from human patientswith signs and symptoms ofrespiratory infection and/or fromviral culture, 2) for determinationof the subtype of seasonal humaninfluenza A virus as seasonalA/H1, A/H3, and/or A/H1pdm09from viral RNA in upperrespiratory tract clinicalspecimens (includingnasopharyngeal swabs, nasalswabs, throat swabs nasal	The Human Influenza VirusReal-time RT-PCRDetection andCharacterization Panel isintended for use in Real-time RT-PCR assays on anABI 7500 Fast Dx Real-Time PCR Instrument inconjunction with clinicaland epidemiologicalinformation: for qualitativedetection of influenza virustype A or B in symptomaticpatients from viral RNA innasopharyngeal and/or nasalswab specimens, fordetermination of thesubtype of seasonal humaninfluenza A virus, asseasonal A/HI or A/H3, ifpresent, from viral RNA innasopharyngeal and/or nasalswab specimens, forpresumptive identificationof virus in patients who maybe infected with influenza Asubtype A/H5 (Asianlineage) from viral RNA inhuman respiratoryspecimens and viral culturein conjunction with clinicaland epidemiological risk	The CDC rRT-PCRA(H1N1)pdm09 Flu Panel isintended for use in real-timeRT-PCR assays on theApplied Biosystems (ABI)7500 Fast Dx Real-TimePCR Instrument for the invitro qualitative detection ofinfluenza virus type A and2009 A/H1N1 viral RNAfrom nasopharyngeal swabs,nasal swabs, throat swabs,nasal aspirates, nasalwashes, dualnasopharyngeal / throatswabs and lower respiratorytract specimens from humanpatients with signs andsymptoms of respiratoryinfection and/or from viralculture, in conjunction withclinical and epidemiologicalrisk factors.

	aspirates, nasal washes and dualnasopharyngeal/throat swabs), andlower respiratory tract specimens(including bronchoalveolarlavages, bronchial washes,tracheal aspirates, sputum, andlung tissue) from human patientswith signs and symptoms ofrespiratory infection and/or fromviral culture, 3) for thepresumptive identification of virusin patients who may be infectedwith influenza A subtype A/H5(Asian Lineage) from viral RNAin human respiratory specimensand viral culture in conjunctionwith clinical and epidemiologicalrisk factors, and 4) to provideepidemiologic information forsurveillance of the circulatinginfluenza viruses.	factors to provideepidemiologic informationfor surveillance forinfluenza viruses.
Specimen Types	Nasopharyngeal swabs, nasalswabs, throat swabs, nasalaspirates, nasal washes and dualnasopharyngeal/throat swabs,bronchoalveolar lavages,bronchial washes, trachealaspirates, sputum, and lung tissueand virus culture	Nasopharyngeal swabs,nasal swabs, and virusculture	Nasopharyngeal swabs,nasal swabs, nasal aspirates,nasal washes, dual collectednasopharyngeal and throatswabs, bronchoalveolarlavages, bronchial washes,and tracheal aspirates, andvirus culture.
Technology	Real-time RT-PCR	Real-time RT-PCR	Real-time RT-PCR
RequiredInstrumentation	Applied Biosystems 7500 FastDx Real-Time PCR Instrument	Applied Biosystems 7500Fast Dx Real- Time PCRInstrument	Applied Biosystems 7500Fast Dx Real- Time PCRInstrument
OrganismDetected	Universal influenza A viruses,Swine-origin influenza Aviruses, Influenza B viruses, andInfluenza A subtypes: seasonalA/H1, A/H3, A/H1pdm09, andA/H5 (Asian Lineage)	Universal influenza A virus,subtypes A/H1 and A/H3;Influenza B virus;Influenza A virus, subtypeA/H5 (Asian lineage)	Universal influenza A,Swine-Origin Influenza A,and A/H1pdm09 subtype
Nucleic AcidExtraction	Yes	Yes	Yes
ExtractionMethod	• QIAamp® DSP Viral RNAMini Kit, Qiagen Inc.• MagNA Pure Compact -TotalNucleic Acid Kit, RocheApplied Science• MagNA Pure Compact - RNAIsolation Kit, Roche AppliedScience• MagNA Pure LC - RNAIsolation Kit II, Roche AppliedScience• Qiagen QIAcube withQIAamp® DSP Viral RNAMini Kit, Qiagen Inc.• NucliSENS® easyMAG®,bioMerieux	• QIAamp® Viral RNAMini Kit, Qiagen Inc.• RNeasy® Mini Kit,Qiagen, Inc.• MagNA Pure LC RNAIsolation Kit II, RocheApplied Science• MagNA Pure TotalNucleic Acid Kit, RocheApplied Science	• QIAamp® Viral RNAMini Kit, Qiagen Inc.• MagNA Pure Compact -Total Nucleic Acid Kit,Roche Applied Science• MagNA Pure Compact -RNA Isolation Kit, RocheApplied Science• MagNA Pure LC - RNAIsolation Kit II, RocheApplied Science• Qiagen QIAcube withQIAamp® Viral RNAMini Kit, Qiagen Inc.• NucliSENS® easyMAG®,bioMerieux
Enzyme MasterMix	Invitrogen SuperScript™ IIIPlatinum® One-Step	Invitrogen SuperScript™ IIIPlatinum® One-Step	Invitrogen SuperScript™ IIIPlatinum® One-Step

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100 - 100 -

and the comments of the comments of the country

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Quantitative RT-PCR Kits (withor without ROX)	Quantitative RT-PCR Kits(with or without ROX)	Quantitative RT-PCR Kits(with or without ROX)
---------------------------------------------------	---------------------------------------------------	---------------------------------------------------

Performance Characteristics

For analytical and clinical performance characteristics, please refer to previously FDAcleared CDC 510(k) Premarket Notifications:

1. K080570 Cleared on September 30, 2008: CDC Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel
1. · K 101564 Cleared on June 22, 2010: CDC Influenza 2009 A (H N N )pdm Real-Time RT-PCR Panel

Additional performance data were collected during the 2010-2011 influenza season. Recent circulating seasonal influenza virus strains can be detected by the CDC Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel and the CDC Influenza 2009 A (H1N1)pdm Real-Time RT-PCR Panel as demonstrated by analytical testing of the 49 original specimens received from US public health laboratories that contained 24 Influenza A/H3 (49%) and 25 Influenza B (51%).

Eighteen original lower respiratory specimens were received from US public health laboratories during the 2010-2011 influenza season from hospitalized patients or fatal cases. The CDC Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel and the CDC Influenza 2009 A (H1N1)pdm Real-Time RT-PCR Panel detected influenza A/H3, A/H1pdm09, and influenza B in bronchoalveolar lavage, bronchial washes, tracheal aspirates, sputum, and lung tissue specimens, verifying detection of recent circulating influenza viruses in the lower respiratory tract.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

Public Health Service

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

National Center for Emerging and Zoonotic Infectious Diseases Center for Disease Control and Prevention c/o CAPT, Hve-Joo Kim, Pharm.D. Associate Director for Regulatory Affairs Office of the Director 1600 Clifton Road, N.E. MS-C12 Atlanta, GA 30333

AUG 23 2011

Re:	K111507
Trade/Device Name:	CDC Human Influenza Virus Real-TimeRT-PCR Diagnostic Panel
Regulation Number:	21CFR §866.3332
Regulation Name:	Reagents for detection of specific novel influenza A viruses.
Regulatory Class:	Class II
Product Code:	OQW, NXD, OEP, NSU
Dated:	May 31, 2011
Received:	June 1, 2011

Dear Ms. Kim:

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 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

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Page 2 - CAPT. Hye-Joo Kim

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 Part 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Taqdtyra

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K111507

Device Name: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel

For qualitative detection of influenza virus type A or B viral RNA in upper respiratory t 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]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) 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/H3, and/or A/H1pdm09 from viral RNA in upper respiratory tract clinical specimens (including NPS, NS, TS, NA, NW and NPS/TS) and lower respiratory tract specimens (including BAL, BW, TA, sputum, and lung tissue) 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 circulating influenza viruses. .

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If infection with a novel influenza A virus is suspected based on current clinical and evidemiological 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.

Prescription Use x (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k)

Tawarah Feldboly
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111507

Regulation Number and Section

§ 866.3332 Reagents for detection of specific novel influenza A viruses.

(a)
Identification. Reagents for detection of specific novel influenza A viruses are devices that are intended for use in a nucleic acid amplification test to directly detect specific virus RNA in human respiratory specimens or viral cultures. Detection of specific virus RNA aids in the diagnosis of influenza caused by specific novel influenza A viruses in patients with clinical risk of infection with these viruses, and also aids in the presumptive laboratory identification of specific novel influenza A viruses to provide epidemiological information on influenza. These reagents include primers, probes, and specific influenza A virus controls.(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses.” See § 866.1(e) for information on obtaining this document.
(2) The distribution of these devices is limited to laboratories with experienced personnel who have training in standardized molecular testing procedures and expertise in viral diagnosis, and appropriate biosafety equipment and containment.