Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard real-time RT-PCR assay, which is a molecular diagnostic technique that does not inherently involve AI or ML. The summary does not mention any AI/ML components or algorithms.

Therapeutic

Yes
This device is a diagnostic tool used to detect and characterize influenza viruses, which aids in the diagnosis and epidemiological surveillance of the illness. It does not directly provide therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the panel is "intended for use in real-time RT-PCR (rRT-PCR) assays... For qualitative detection of influenza virus type A or B viral RNA..." and "aids in the diagnosis of illness." This function clearly identifies it as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "panel of oligonucleotide primers and dual-labeled hydrolysis (TaqMan®) probes," which are physical reagents, not software. It also describes a process involving "thermocyclic heating and cooling" and "fluorescence intensity monitoring," which are hardware-dependent functions of the ABI 7500 Fast Dx Real-Time PCR Instrument.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it is for "qualitative detection of influenza virus type A or B viral RNA in upper respiratory tract clinical specimens... and lower respiratory tract specimens... from human patients with signs and symptoms of respiratory infection and/or from viral culture." This involves testing samples taken from the human body in vitro (outside the body) to diagnose a condition.
Device Description: The description further clarifies that the panel is used in "real-time RT-PCR assays... 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 phrase "in vitro" is a key indicator of an IVD.
Regulatory Context: The mention of FDA-cleared 510(k) Premarket Notifications (K080570 and K101564) for previous versions of this panel strongly suggests that this device falls under the regulatory framework for medical devices, specifically IVDs, which require such clearance.
Purpose: The device is used to aid in the diagnosis of illness caused by influenza viruses and provides epidemiological information. This is a typical function of an IVD.

Therefore, based on the provided information, the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel is clearly an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

OQW, NXD, OEP, NSU

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper respiratory tract (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 (bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], 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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K080570, K101564

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K082562

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

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.

Summary

0

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)

1

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

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

2

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.

3

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 Virus
Real-time PCR Diagnostic
Panel | 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) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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: 1)
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, 2) 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 | The Human Influenza Virus
Real-time RT-PCR
Detection and
Characterization Panel is
intended for use in Real-
time RT-PCR assays on an
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 in symptomatic
patients from viral RNA in
nasopharyngeal and/or nasal
swab specimens, for
determination of the
subtype of seasonal human
influenza A virus, as
seasonal A/HI or A/H3, if
present, from viral RNA in
nasopharyngeal and/or nasal
swab specimens, for
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 | The CDC rRT-PCR
A(H1N1)pdm09 Flu Panel is
intended for use in real-time
RT-PCR assays on the
Applied Biosystems (ABI)
7500 Fast Dx Real-Time
PCR Instrument for the in
vitro qualitative detection of
influenza virus type A and
2009 A/H1N1 viral RNA
from nasopharyngeal swabs,
nasal swabs, throat swabs,
nasal aspirates, nasal
washes, dual
nasopharyngeal / throat
swabs and lower respiratory
tract specimens from human
patients with signs and
symptoms of respiratory
infection and/or from viral
culture, in conjunction with
clinical and epidemiological
risk factors. |
| | | | |
| | 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, 3) 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, and 4) to provide
epidemiologic information for
surveillance of the circulating
influenza viruses. | factors to provide
epidemiologic information
for surveillance for
influenza viruses. | |
| Specimen Types | Nasopharyngeal swabs, nasal
swabs, throat swabs, nasal
aspirates, nasal washes and dual
nasopharyngeal/throat swabs,
bronchoalveolar lavages,
bronchial washes, tracheal
aspirates, sputum, and lung tissue
and virus culture | Nasopharyngeal swabs,
nasal swabs, and virus
culture | Nasopharyngeal swabs,
nasal swabs, nasal aspirates,
nasal washes, dual collected
nasopharyngeal and throat
swabs, bronchoalveolar
lavages, bronchial washes,
and tracheal aspirates, and
virus culture. |
| Technology | Real-time RT-PCR | Real-time RT-PCR | Real-time RT-PCR |
| Required
Instrumentation | Applied Biosystems 7500 Fast
Dx Real-Time PCR Instrument | Applied Biosystems 7500
Fast Dx Real- Time PCR
Instrument | Applied Biosystems 7500
Fast Dx Real- Time PCR
Instrument |
| Organism
Detected | Universal influenza A viruses,
Swine-origin influenza A
viruses, Influenza B viruses, and
Influenza A subtypes: seasonal
A/H1, A/H3, A/H1pdm09, and
A/H5 (Asian Lineage) | Universal influenza A virus,
subtypes A/H1 and A/H3;
Influenza B virus;
Influenza A virus, subtype
A/H5 (Asian lineage) | Universal influenza A,
Swine-Origin Influenza A,
and A/H1pdm09 subtype |
| Nucleic Acid
Extraction | Yes | Yes | Yes |
| Extraction
Method | • QIAamp® DSP Viral RNA
Mini Kit, Qiagen Inc.
• MagNA Pure Compact -Total
Nucleic Acid Kit, Roche
Applied Science
• MagNA Pure Compact - RNA
Isolation Kit, Roche Applied
Science
• MagNA Pure LC - RNA
Isolation Kit II, Roche Applied
Science
• Qiagen QIAcube with
QIAamp® DSP Viral RNA
Mini Kit, Qiagen Inc.
• NucliSENS® easyMAG®,
bioMerieux | • QIAamp® Viral RNA
Mini Kit, Qiagen Inc.
• RNeasy® Mini Kit,
Qiagen, Inc.
• MagNA Pure LC RNA
Isolation Kit II, Roche
Applied Science
• MagNA Pure Total
Nucleic Acid Kit, Roche
Applied Science | • QIAamp® Viral RNA
Mini Kit, Qiagen Inc.
• MagNA Pure Compact -
Total Nucleic Acid Kit,
Roche Applied Science
• MagNA Pure Compact -
RNA Isolation Kit, Roche
Applied Science
• MagNA Pure LC - RNA
Isolation Kit II, Roche
Applied Science
• Qiagen QIAcube with
QIAamp® Viral RNA
Mini Kit, Qiagen Inc.
• NucliSENS® easyMAG®,
bioMerieux |
| Enzyme Master
Mix | Invitrogen SuperScript™ III
Platinum® One-Step | Invitrogen SuperScript™ III
Platinum® One-Step | Invitrogen SuperScript™ III
Platinum® One-Step |
| | | | |

4

100 - 100 -

and the comments of the comments of the country

,

5

| Quantitative RT-PCR Kits (with
or 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.

6

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-Time
RT-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

7

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

8

Indications for Use Statement

510(k) Number (if known): K111507

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

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 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. .

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.

9

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.

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.

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