(18 days)
The CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel (CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel) is intended for use in real-time RT-PCR assays on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument in conjunction with clinical and epidemiological information:
- For the qualitative detection of influenza virus type A viral RNA from nasopharyngeal swabs (NPS), nasal swabs (NS), nasal aspirates (NA), nasal washes (NW), dual nasopharyngeal / throat swabs (NPS/TS), broncheoalveolar lavage (BAL), tracheal aspirate (TA), and bronchial wash (BW), collected from the respiratory tract of human patients with signs and symptoms of respiratory infection and/or from viral culture.
- For differentiation of 2009 H1N1 influenza virus RNA from nasopharyngeal swabs (NPS), nasal swabs (NS), nasal aspirates (NA), nasal washes (NW) dual nasopharyngeal / throat swabs (NPS/TS), broncheoalveolar lavage (BAL), tracheal aspirate (TA), and bronchial wash (BW) collected from the respiratory tract of human patients with signs and symptoms of respiratory infection and/or from viral culture.
- To provide epidemiologic information for surveillance of the 2009 H1N1 influenza virus.
The CDC Influenza 2009 A(H1N1)pdm Real-time RT-PCR Panel (CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel) is a panel of oligonucleotide primers and dual-labeled hydrolysis (TaqMan®) probes which may be used in real-time RT-PCR (rRT-PCR) assays for the in vitro qualitative detection and characterization of human influenza viruses (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 epidemiologic information on influenza and aids in the presumptive laboratory identification of specific novel influenza A viruses. The influenza A primer and probe sets are designed for universal detection of type A influenza viruses, Influenza A subtyping primer and probe sets are designed to specifically detect 2009 A (H1N1) influenza virus. The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel is an updated version of the assay distributed by CDC. during the 2009 A(H1N1) pandemic strain to qualified laboratories (CDC rRT-PCR Swine Flu Panel G090072) under Emergency Use Authorization (EUA) from the FDA in that it has different sequences of primers and probes that are more specific to the currently circulating 2009 A(H1N1) influenza virus. The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel includes the following primer and probe sets and positive control: InfA detects all influenza A strains, but does not detect influenza B strains. pdm InfA is specific for 2009 influenza A. pdm H1 is specific for 2009 influenza A, subtype H1. RNase P (RP) detects human RNase P and is used with human clinical specimens to indicate that adequate isolation of nucleic acid resulted from the extraction of the clinical specimen. Inactivated Influenza Typing Panel Real-Time RT-PCR Positive Control is a positive control designed to react with all the primer and probe sets including RNase P.
Device Acceptance Criteria and Study Details: CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Specific Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Analytical Performance | |||
| Limit of Detection (LoD) | Lowest detectable concentration (EID50/mL) | 95.0% or greater positivity for each primer and probe set. | - A/California/07/2009: InfA (10^1.6), pdm InfA (10^1.6), pdm H1 (10^1.6). Final LoD = 10^1.6 (EID50/mL).- A/New York/18/2009: InfA (10^1.3), pdm InfA (10^0.6), pdm H1 (10^1.3). Final LoD = 10^1.3 (EID50/mL). |
| Inclusivity | Concordance with diverse 2009 A(H1N1) influenza viruses | Not explicitly stated as a numerical threshold, implied to be high for specific detection. | 100% concordance with all primer and probe sets when testing ten diverse 2009 A(H1N1) influenza viruses at low concentrations. |
| Exclusivity (Seasonal) | Non-detection of seasonal influenza viruses by pdm InfA and pdm H1 | Complete non-reactivity (negative results) of pdm InfA and pdm H1 with seasonal Inf A and Inf B strains, while Inf A should detect seasonal A. | - Seasonal H1N1: InfA detected all 16 tested strains; pdm InfA and pdm H1 were negative for all.- Seasonal H3N2: InfA detected all 7 tested strains; pdm InfA and pdm H1 were negative for all.- Influenza B: InfA, pdm InfA, and pdm H1 were negative for all 12 tested strains. |
| Exclusivity (H5N1) | Non-detection of H5N1 by pdm InfA and pdm H1, while InfA should detect H5N1 | Complete non-reactivity (negative results) of pdm InfA and pdm H1 with H5N1 strains, while Inf A should detect H5N1. | InfA detected all 10 tested H5N1 strains; pdm InfA and pdm H1 were negative for all, except for one H5N1 strain (A/Chicken/Vietnam/NCVD-016/2008) where pdm H1 result was not provided. |
| Non-Influenza Pathogens | Non-cross reactivity with common respiratory pathogens and flora | 100% agreement with expected negative results. | 100% concordance with expected results for all primer and probe sets (InfA, pdm InfA, pdm H1) when tested against 34 non-influenza organisms (commensal bacteria, yeast, and non-influenza respiratory viruses). This means all markers were negative. |
| Reproducibility | Agreement with expected results and %CV for Ct values across sites and operators | Demonstrated reproducibility across six sites, two operators, and five days. Percentage of agreement for moderate, low, "high negative", and negative samples. Low %CV for average Ct values, particularly for moderate and low viral RNA concentrations. | - No Template Control, RP, HSC, Positive Control: 100% agreement (60/60) across all sites.- Sample 1 (moderate viral RNA): 100% agreement (60/60) for InfA, pdm InfA, pdm H1, and RP. Low %CV for all markers (e.g., InfA 2.59-4.23%, pdm InfA 2.10-3.10%, pdm H1 1.48-3.17%, RP 1.33-2.65%).- Sample 2 (low viral RNA): High agreement (54/60 to 60/60 total). Some sites showed lower agreement (e.g., 7/10 for pdm H1 at Roche MagNA Pure LC and Compact NA). %CV generally higher than moderate samples (e.g., InfA 1.04-35.61%, pdm InfA 2.48-35.27%, pdm H1 1.27-52.94%, RP 1.34-5.11%).- Sample 3 ("high negative"): Agreement ranged from 54/60 to 58/60, with some individual site variations. All samples were expected to be negative for InfA, pdm InfA, and pdm H1. |
| Clinical Performance | |||
| Clinical Sensitivity | Greater than a specified percentage | >96% for all markers (upper respiratory specimens).>83% for all markers (lower respiratory specimens). | - Upper Respiratory (NPS/NS): InfA (96.8%), 2009 H1N1 (100%).- Upper Respiratory (NA/NW): InfA (100%), 2009 H1N1 (100%).- Upper Respiratory (NPS/TS): InfA (100%), 2009 H1N1 (100%).- Lower Respiratory (BAL, TA, BW): InfA (83.3%), 2009 H1N1 (100%). Results meet or exceed criteria. |
| Clinical Specificity | Greater than a specified percentage | >96% for all markers (upper respiratory specimens).>83% for all markers (lower respiratory specimens). | - Upper Respiratory (NPS/NS): InfA (96.2%), 2009 H1N1 (96.7%).- Upper Respiratory (NA/NW): InfA (99.3%), 2009 H1N1 (98.6%).- Upper Respiratory (NPS/TS): InfA (100%), 2009 H1N1 (98.3%).- Lower Respiratory (BAL, TA, BW): InfA (83.3%), 2009 H1N1 (84.0%). Results meet or exceed criteria. |
| Positive Percent Agreement | Greater than a specified percentage | >96% for all markers (upper respiratory specimens).100% for all markers (lower respiratory specimens). | - Upper Respiratory (NPS/NS): InfA (99.4%), 2009 H1N1 (99.7%).- Upper Respiratory (NA/NW): InfA (97.7%), 2009 H1N1 (99.0%).- Upper Respiratory (NPS/TS): InfA (100%), 2009 H1N1 (100%).- Lower Respiratory (BAL, TA, BW): InfA (100%), 2009 H1N1 (100%). Results meet or exceed criteria. |
| Overall Performance Call Rate | (Clinical Evaluation) | >99% | >99% |
2. Sample Size and Data Provenance (Clinical Performance Test Set)
- Sample Size for Test Set: 1901 total patient specimens.
- 1191 nasopharyngeal swabs (NPS) and nasal swabs (NS)
- 50 throat swabs (TS)
- 519 nasal washes (NW) and nasal aspirates (NA)
- 99 dual nasopharyngeal / throat swabs (NPS/TS)
- 42 lower respiratory specimens (broncheoalveolar lavage (BAL), tracheal aspirate (TA), and bronchial wash (BW))
- Data Provenance: Prospective study, supplemented with retrospective specimens. Data collected during the 2009-2010 respiratory virus season (February-April) from 8 U.S. public health laboratories and a Department of Defense (DoD) laboratory. Samples were from individuals symptomatic with influenza-like illness (ILI). Retrospective specimens were used to supplement due to low prevalence of influenza.
3. Number of Experts and Qualifications for Test Set Ground Truth
The document does not explicitly state the "number of experts" used to establish the ground truth in the same way one would delineate expert radiologists for image annotation.
Instead, the ground truth for the clinical performance study was established by standard laboratory methods:
- For InfA (Influenza A detection): Virus culture with Immunofluorescent Antibody (IFA) or Direct Fluorescent Antibody (DFA) was used for screening and identification of influenza type.
- For 2009 H1N1 (subtype detection): Bi-directional sequencing was used for confirmation of 2009 influenza A (H1N1) subtype. (Sequencing was performed only on specimens already identified as positive for influenza A by virus culture).
These methods represent established diagnostic procedures typically performed by trained laboratory personnel, rather than interpretation by "experts" in the context of a consensus reading.
4. Adjudication Method for the Test Set
The document does not describe an explicit "adjudication method" in the context of multiple human readers reconciling differences. The ground truth was established by laboratory methods as described above. If there were discrepancies between initial screening (IFA/DFA) and confirmatory sequencing, the sequencing result would have been the definitive ground truth for subtyping.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study evaluates the standalone performance of the RT-PCR panel against laboratory reference methods, not improvement in human reader performance with AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The entire document focuses on evaluating the analytical and clinical performance of the CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel (an algorithm/assay) independent of human interpretation or assistance, against established laboratory reference methods. The results presented for sensitivity, specificity, and agreement are for the device's performance directly.
7. Type of Ground Truth Used
- Clinical Performance Ground Truth:
- Virus Culture (with IFA/DFA): For the detection of influenza type A (against which the InfA analyte of the device was compared).
- Bi-directional Sequencing: For the confirmation of 2009 influenza A (H1N1) subtype (against which the pdm InfA and pdm H1 analytes of the device were compared).
- Analytical Performance Ground Truth:
- Known viral concentrations (EID50/mL, TCID50/mL): For Limit of Detection, Inclusivity, and Exclusivity studies.
- Known identity of specific influenza and non-influenza organisms: For Inclusivity, Exclusivity, and Reactivity of Non-Influenza Respiratory Viral and Bacterial Pathogens studies.
8. Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. This type of device (RT-PCR panel) is a diagnostic kit where the primers and probes are designed based on known viral sequences, rather than an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The "development" and "optimization" of such a panel would involve bioinformatic design and iterative testing, not "training" on a sample set like an AI model.
9. How the Ground Truth for the Training Set (if applicable) was Established
As mentioned above, the concept of a "training set" and "ground truth establishment for a training set" as it applies to AI/ML devices is not applicable here. The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel is a molecular diagnostic assay where the "design" is based on established scientific principles of molecular biology and virology, including viral genome sequencing and primer/probe design. The specificity and sensitivity are intrinsically built into the primer and probe sequences themselves, which are designed to target specific genetic regions of the influenza virus.
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7. 510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Assigned 510(k) number: K101564
Submitted by:
Centers for Disease Control and Prevention 1600 Clifton Road NE Atlanta, GA 30333
Contact Person:
Hve-Joo Kim, Pharm.D. Associate Director, Regulatory Affairs Office of the Director National Center for Emerging and Zoonotic Infectious Diseases (proposed) Centers for Disease Control and Prevention 1600 Clifton Road, NE, MS C-12 Atlanta, GA 30333 (404) 639-4643 (office) (404) 639-1275 (fax) (404) 729-7015 (cell) hek6@cdc.gov
Date prepared
June 22, 2010
Device Name
CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel
Common or Usual Name
CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel
Classification Name
Reagents for detection of specific novel influenza A viruses (21 CFR 866.3332, Product Code NXD)
Predicate devices
No predicate devices have been determined
Device Description
The CDC Influenza 2009 A(H1N1)pdm Real-time RT-PCR Panel (CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel) is a panel of oligonucleotide primers and dual-labeled hydrolysis (TaqMan®) probes which may be used in real-time RT-PCR (rRT-PCR) assays for the in vitro qualitative detection and characterization of human influenza
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viruses (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 epidemiologic information on influenza and aids in the presumptive laboratory identification of specific novel influenza A viruses.
The influenza A primer and probe sets are designed for universal detection of type A influenza viruses, Influenza A subtyping primer and probe sets are designed to specifically detect 2009 A (H1N1) influenza virus.
The CDC rRT-PCR 2009 A(H1N1)ødm Flu Panel is an updated version of the assay distributed by CDC. during the 2009 A(H1N1) pandemic strain to qualified laboratories (CDC rRT-PCR Swine Flu Panel G090072) under Emergency Use Authorization (EUA) from the FDA in that it has different sequences of primers and probes that are more specific to the currently circulating 2009 A(H1N1) influenza virus.
The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel includes the following primer and probe sets and positive control:
- InfA detects all influenza A strains, but does not detect influenza B strains .
- pdm InfA is specific for 2009 influenza A .
- pdm H1 is specific for 2009 influenza A, subtype H1 .
- RNase P (RP) detects human RNase P and is used with human clinical . specimens to indicate that adequate isolation of nucleic acid resulted from the extraction of the clinical specimen
- Inactivated Influenza Typing Panel Real-Time RT-PCR Positive Control is a . positive control designed to react with all the primer and probe sets including RNase P
Assay principle
The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel assay is based on real-time RT-PCR technology which is used in many molecular diagnostic assays to date. The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel influenza A primer and probe sets are designed for universal detection of type A influenza viruses. The panel also contains influenza A type and subtyping primer and probe sets designed to specifically detect human 2009 A(H1N1) influenza viruses.
One-step real-time RT-PCR assays are one-tube assays that first reverse-transcribe specific RNA templates into complementary deoxyribonucleic acid (cDNA) copies. The cDNA then serves as 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 target sequence located between the forward and reverse primers. During the extension phase of the PCR cycle, the 5' nuclease activity of Tag polymerase degrades the probe, causing the reporter dye to separate from the quencher dye, generating a fluorescent signal. With each cycle,
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additional reporter dye molecules are cleaved from their respective probes, increasing the fluorescence intensity. Fluorescence intensity is monitored at each PCR cycle.
The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel includes internal positive control materials. The human RNase P (RP) primer and probe set detects human RNase P and is used with human clinical specimens to indicate that adequate isolation of nucleic acid resulted from the extraction process of the clinical specimen. A positive result in the RP assay indicates adequate specimen was present, ensures that common reagents and equipment are functioning properly, and demonstrates the absence of inhibitory substances. A Human Specimen Control (HSC) is a noninfectious cultured human cell material that demonstrates successful recovery of RNA as well as extraction reagent integrity. The Influenza 2009 A(H1N1)pdm Positive Control (pdm PC) consists of influenza viruses representing 2009 A(H1N1) influenza virus and cultured human cells. The pdm PC serves as a rRT-PCR reaction control and demonstrates that the master mix and primer and probe sets for InfA, pdm InfA, pdm H1, and RP are functioning properly. All controls (HSC and pdm PC) are inactivated using beta propiolactone and are noninfectious.
The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel components used for testing are similar to the components provided in the CDC rRT-PCR Flu Panel ([IVD] [K080570]}, following the same instructions for use on the ABI 7500 Fast Dx Real-Time PCR system.
Intended use
The CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel (CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel) is intended for use in real-time RT-PCR assays on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument in conjunction with clinical and epidemiological information:
- For the qualitative detection of influenza virus type A viral RNA from . nasopharyngeal swabs (NPS), nasal swabs (NS), nasal aspirates (NA), nasal washes (NW), dual nasopharyngeal / throat swabs (NPS/TS), broncheoalveolar. lavage (BAL), tracheal aspirate (TA), and bronchial wash (BW), collected from the respiratory tract of human patients with signs and symptoms of respiratory infection and/or from viral culture.
- For differentiation of 2009 H1N1 influenza virus RNA from nasopharyngeal . swabs (NPS), nasal swabs (NS), nasal aspirates (NA), nasal washes (NW) .dual nasopharyngeal / throat swabs (NPS/TS), broncheoalveolar lavage (BAL), tracheal aspirate (TA), and bronchial wash (BW) collected from the respiratory tract of human patients with signs and symptoms of respiratory infection and/or from viral culture.
- To provide epidemiologic information for surveillance of the 2009 H1N1 influenza virus.
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Performance characteristics for influenza A were established during the 2009-2010 influenza season when 2009 H1N1 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary against other emerging influenza A viruses.
A negative test result for the broncheoalveolar lavage (BAL), tracheal aspirate (TA), and bronchial wash (BW) is presumptive and it is recommended these results be confirmed by viral culture.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
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+ 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
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Substantial Equivalence Comparison:
-
Predicate device name(s): Focus Simplexa™ Influenza A H1N1 (2009) assay and CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel
-
Predicate 510(k) number(s):_ K0100148 and K080570 respectively
-
Comparison with predicate:
| DeviceCharacteristics | CDC rRT-PCR 2009A(H1N1)pdm Flu Panel(New Device) | Simplexa™ InfluenzaA H1N1 (2009)(K100148) | CDC Human Influenza VirusReal-Time RT-PCR Detectionand Characterization Panel(K080570) |
|---|---|---|---|
| Intended Use | The CDC rRT-PCR 2009A(H1N1)pdm 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 nasopharyngealswabs (NPS), nasal swabs(NS), throat swabs (TS),nasal aspirates (NA), nasalwashes (NW), dualnasopharyngeal / throatswabs (NPS/TS) and lowerrespiratory tract specimens(LRTS) from humanpatients with signs andsymptoms of respiratoryinfection and/or from viralculture, in conjunction withclinical and epidemiologicalrisk factors. | The Focus DiagnosticsSimplexa™ Influenza AH1N1 (2009) assay isintended for use on the3M Integrated Cycler aspart of the MicrofluidicMolecular System forthe in vitro qualitativedetection anddifferentiation ofinfluenza A and 2009H1N1 influenza viralRNA in nasopharyngealswabs (NPS), nasalswabs (NS), andnasopharyngealaspirates (NPA) fromhuman patients withsigns and symptoms ofrespiratory infection inconjunction with clinicaland epidemiological riskfactors. | The Human Influenza Virus Real-time RT-PCR Detection andCharacterization Panel (rRT-PCRFlu Panel) is intended for use inReal-time RT-PCR assays on anABI 7500 Fast Dx Real-time PCRinstrument in conjunction withclinical and epidemiologicalinformation: for qualitativedetection of influenza virus type Aor B in symptomatic patients fromviral RNA in nasopharyngealand/or nasal swab specimens, fordetermination of the subtype ofseasonal human influenza A virus,as seasonal A/HI or A/H3, ifpresent, from viral RNA innasopharyngeal and/or nasal swabspecimens, for presumptiveidentification of virus in patientswho may be infected with influenzaA subtype A/H5 (Asian lineage)from viral RNA in humanrespiratory specimens and viralculture in conjunction with clinicaland epidemiological risk factors toprovide epidemiologic informationfor surveillance for influenzaviruses. |
| Identification ofInf A | Yes (Universal A) | Yes | Yes |
| Assay Results | Qualitative | Qualitative | Qualitative |
| Nucleic AcidExtraction | Yes | Yes | Yes |
| DeviceCharacteristics | CDC rRT-PCR 2009A(H1N1)pdm FluPanel (New Device) | Simplexa™ Influenza AH1N1 (2009) (NewDevice) | CDC Human Influenza VirusReal-Time RT- PCR Detectionand Characterization Panel(Predicate Device #2) |
| Sample types | NPS, NS, NPS/TS,NA, NW, BAL, BW,TA, and/or virusculture | NPS, NS, NPA | NPS, NS |
| Extraction Methods | • QIAamp® Viral RNAMini Kit, Qiagen Inc.• MagNA PureCompact -TotalNucleic Acid Kit.Roche AppliedScience• MagNA PureCompact - RNAIsolation Kit, RocheApplied Science• MagNA Pure LC -RNA Isolation Kit II,Roche AppliedScience• Qiagen QIAcubewith QIAamp® ViralRNA Mini Kit,Qiagen Inc.• NucliSENS®easyMAG®,bioMerieux | • QIAamp® Viral RNAMini Kit, Qiagen Inc.• MagNA Pure TotalNucleic Acid IsolationKit (Roche)• MagNA Pure LCInstrument (Roche) | • QIAamp® Viral RNA Mini Kit,Qiagen Inc.• RNeasy® Mini Kit, Qiagen, Inc.• MagNA Pure LC RNA IsolationKit II, Roche Applied Science• MagNA Pure Total Nucleic AcidKit, Roche Applied Science |
| Assay Type | Real-time RT-PCR | Real-time RT-PCR | Real-Time RT-PCR |
| ldentification of2009 H1N1 Subtype | Yes | Yes | No |
| RequiredInstrumentation | Applied Biosystems7500 Fast Dx Real-Time PCR Instrument | Integrated cycler withIntegrated Cycler Studiosoftware v. 2.0 | Applied Biosystems 7500 Fast DxReal- Time PCR Instrument withSDS software version 1.4 |
| Multiplex Capability | No(Modular Use withCDC rRT-PCR FluPanel (K08570) | Yes | No |
Similarities
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Differences
Analytical Performance
1. Limit of Detection
Analytical sensitivity was demonstrated by determining the limit of detection (LoD) of each primer and probe set in the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel. Each primer and probe set was tested with two different 2009 A(H1N1) influenza virus
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strains. The limit of detection for each primer and probe set was calculated to indicate the range of lowest detectable concentration of influenza virus (EID50/mL) with a 95.0 percent or greater positivity. The lowest concentration of influenza virus detected was determined to be the end-point concentration where the type and subtype primer and probe sets had uniform detection. If the two end-points differ in concentration the higher (or limiting) concentration was used.
| Limit of Detection (EID50/mL) | ||||
|---|---|---|---|---|
| 2009 H1N1 Virus | InfA | pdm InfA | pdm H1 | Final LoD |
| A/California/07/2009 | 10 1.6 | 10 1.6 | 10 1.6 | 10 1.6 |
| A/New York/18/2009 | 10 1.3 | 10 0.6 | 10 1.3 | 10 1.3 |
2. Inclusivity of 2009 A(H1N1) Influenza Viruses
The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel analytical specificity was demonstrated by inclusivity testing. To demonstrate the specificity of the primer and probe sets to detect a diverse population of 2009 A(H1N1) influenza viruses, ten 2009 A(H1N1) influenza viruses were tested at low concentrations using the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel. The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel analytical specificity inclusivity data indicated 100% concordance with all primer and probe sets included in the device. These data indicate that the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel is highly specific for detecting 2009 A(H1N1) influenza viruses.
| 2009 A/H1N1 Virus | ID50/mLTested | AverageInfA CtValue(N=3) | Averagepdm InfACt Value(N=3) | Averagepdm H1Ct Value(N=3) |
|---|---|---|---|---|
| A/MEXICO/4108/2009 | 102.5 | 33.46 | 36.20 | 32.86 |
| A/CALIFORNIA/8/2009 | 102.2 | 29.75 | 31.57 | 28.80 |
| A/CALIFORNIA/7/2009 | 102.4 | 34.16 | 35.28 | 33.78 |
| A/CALIFORNIA/04/2009 | 101.9 | 32.26 | 33.54 | 32.13 |
| A/TEXAS/48/2009 | 102.0 | 32.20 | 33.14 | 32.06 |
| A/WASHINGTON/29/2009 | 102.5 | 30.58 | 32.35 | 30.10 |
| A/SOUTH CAROLINA/18/2009 | 102.6 | 25.44 | 24.55 | 26.90 |
| A/NEW YORK/18/2009 | 102.7 | 27.95 | 26.42 | 28.23 |
| A/ENGLAND/195/2009 | 102.0 | 26.92 | 27.03 | 29.36 |
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| A/NORTH CAROLINA/39/2009 | $10^{2.7}$ | 27.23 | 26.47 | 27.96 |
|---|---|---|---|---|
| -------------------------- | ------------ | ------- | ------- | ------- |
3. Exclusivity of Seasonal Influenza Viruses and Influenza Viruses with Pandemic Potential
Characterized seasonal influenza viruses representing various geographical locations (A/H1, A/H3, Influenza B) were tested with the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel to demonstrate the specificity of the primer and probe sets. To demonstrate the ability of the influenza A primer and probe sets to detect influenza A/H5 viruses with pandemic potential, the reactivity of the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel was tested with ten avian A/H5 influenza viruses that have been shown to infect humans. The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel demonstrates the ability to detect influenza type A viruses other than 2009 A(H1N1) viruses without a subtype as expected.
| Type | Virus | Titer(logTCID50/mL) | InfA | pdmInfA | pdm H1 |
|---|---|---|---|---|---|
| H1N1 | A/JIANGXI/160/2005 | 5.6 | + | - | - |
| A/SOLOMON ISLANDS/03/2006 | 6.2 | + | - | - | |
| A/TAIWAN/42/2006 | 4.7 | + | - | - | |
| A/FUKUSHIMA/141/2006 | 5.7 | + | - | - | |
| A/MEXICO/1744/2007 | 5.3 | + | - | - | |
| A/MEXICO/1729/2007 | 4.8 | + | - | - | |
| A/MEXICO/1677/2007 | 5.7 | + | - | - | |
| A/MEXICO/949/2007 | 5.1 | + | - | - | |
| A/BANGLADESH/7286/2007 | 6.1 | + | - | - | |
| A/MEXICO/2010/2007 | 5.1 | + | - | - | |
| A/BRISBANE/59/2007 | 8.4 (EID50/mL) | + | - | - | |
| A/PARAGUAY/61/2009 | 7.2 | + | - | - | |
| A/HAWAII/08/2006 | 7.8 | + | - | - | |
| A/WISCONSIN/03/2007 | 8.2 | + | - | - | |
| A/HENAN/JINSHUI/147/2007 | 8.1 | + | - | - | |
| A/BRISBANE/10/2007 | 6.8 | + | - | - | |
| A/MEXICO/922/2007 | 7.8 | + | - | - | |
| H3N2 | A/AFGHANISTAN/2903/2008 | 5.0 | + | - | - |
| A/MEXICO/1938/2007 | 5.1 | + | - | - | |
| A/MEXICO/1995/2007 | 4.3 | + | - | - | |
| A/ANHUI/1239/2005 | 8.1 | + | - | - | |
| A/MEXICO/1842/2007 | 6.1 | + | - | - | |
| A/PERTH/16/2009 | 8.2 (EID50/mL) | + | - | - | |
| A/WISCONSIN/15/2009 | 8.1 (EID50/mL) | + | - | - | |
| Inf B | B/FLORIDA/04/2006 | 5.7 | - | - | |
| B/CHONGQING/YONGCHUAN18/2007 | 7.7 | - | - | - | |
| B/FLORIDA/02/2006 | 6.0 | - | - | - | |
| B/PENNSYLVANIA/05/2007 | 6.6 | - | - | - | |
| B/BANGLADESH/5972/2007 | 4.7 | - | - | - | |
| B/BANGLADESH/3461/2007 | 3.7 | - | - | - |
{8}------------------------------------------------
| B/BANGLADESH/7110/2007 | 4.2 | - | - |
|---|---|---|---|
| A/MEXICO/1819/2007 | 5.1 | - | - |
| B/TEXAS/17/2007 | 5.7 | - | - |
| B/TEXAS/03/2007 | 5.6 | - | - |
| B/BRISBANE/60/2008 | 8.5 (EID50/mL) | - | - |
| B/TEXAS/26/2008 | 8.2 (EID50/mL) | - | - |
| Type | Virus | Clade | Titer(logEID50/mL) | InfA | pdmInfA | pdmH1 |
|---|---|---|---|---|---|---|
| H5N1 | A/Japanese white eye/Hong Kong/1038/2006 | 2.3.4 | 9.2 | +(3/3) | - | - |
| A/Duck/Hunan/795/2002 | 2.1 | 9.9 | +(3/3) | - | - | |
| A/Chicken/Yunnan/1251/2003 | 1 | 9.3 | +(3/3) | - | - | |
| A/Common magpie/Hong Kong/645/2006 | 2.3.2 | 9.2 | +(3/3) | - | - | |
| A/Vietnam/1194/2004 | 1 | 9.3 | +(3/3) | - | - | |
| A/Egypt/321/2007 | 2.2 | 9.2 | +(3/3) | - | - | |
| A/Anhui/1/2005 | 2.3.4 | 9.3 | +(3/3) | - | - | |
| A/Chicken/India/NIV3487/2006 | 2.2 | 9.3 | +(3/3) | - | - | |
| A/Chicken/Vietnam/NCVD-016/2008 | 7 | 9.1 | +(3/3) | - | ||
| A/Cambodia/R040505/2007 | 1 | 8.5 | +(3/3) | - | - |
To demonstrate the ability of the influenza A primer and probe sets to detect potential pandemic influenza A viruses, the reactivity of the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel was also tested with 15 non-human influenza viruses that have been shown to infect humans. These data demonstrate 100% concordance with expected results and strongly supports the intended use claims of the device and demonstrates the performance specificity of the device.
- Reactivity of Non-Influenza Respiratory Viral and Bacterial Pathogens
The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel analytical specificity was further demonstrated by testing 34 non-influenza organisms (respiratory pathogens or flora) commonly present in the nasopharynx region of the human respiratory tract. The CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel analytical specificity reactivity study showed 100% concordance with the expected results for all primer and probe sets included in the device. These data indicate that the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel primer and probe sets do not cross react with biological organisms that may be present in the human nasopharynx.
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| MarkersTested | CommensalBacteria andYeastDetection | Non-InfluenzaRespiratoryVirus Detection | DetectionExpected | Concordance |
|---|---|---|---|---|
| Inf A | 0/19 | 0/15 | No | 100 % |
| pdm InfA | 0/19 | 0/15 | No | 100 % |
| pdm H1 | 0/19 | 0/15 | No | 100 % |
5. Reproducibility
The reproducibility and precision of the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel were evaluated at six separate laboratory sites. Each testing site assessed a panel of four simulated samples at relative moderate, low (near the assay lower limit of detection range), and "high negative" viral RNA concentration, and a negative sample. The panels and assay controls were tested at each site by two operators on 5 different days within a 10-day period. Each site tested one of the six extraction methods associated with this device. Simulated samples in the qualification panel used in the reproducibility evaluation were:
Sample #1 Influenza 2009 A/H1N1 moderate viral RNA titer range Sample #2 Influenza 2009 A/H1N1 low viral RNA titer range
Sample #3 Influenza 2009 A/H1N1 "high negative" RNA titer range
Sample #4 Influenza Negative (uninfected A549 cells)
{10}------------------------------------------------
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| N=10 tests | bioMerieux NucliSENSeasyMAG | Roche MagNA Pure LCTNA | Roche MagNA PureCompact NA | Qiagen QIAcube ViralRNA | Qiagen Manual ViralRNA | Roche MagNA PureCompact RNA | TotalAgreement | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Agreement withexpectedresult | Avg. Ct | % CV | Agreement withexpectedresult | Avg. Ct | % CV | Agreement withexpectedresult | Avg. Ct | % CV | Agreement withexpectedresult | Avg. Ct | % CV | Agreement withexpectedresult | Avg. Ct | % CV | Agreement withexpectedresult | Avg. Ct | % CV | |||
| No TemplateControl | 10/10 | NA | NA | 10/10 | NA | NA | 10/10 | NA | NA | 10/10 | NA | NA | 10/10 | NA | NA | 10/10 | NA | NA | 60/60 | |
| Sample 1moderate | InfA | 10/10 | 28.52 | 2.59 | 10/10 | 30.53 | 2.55 | 10/10 | 31.99 | 4.23 | 10/10 | 27.92 | 2.06 | 10/10 | 28.85 | 2.00 | 10/10 | 30.54 | 2.12 | 60/60 |
| pdmInfA | 10/10 | 27.49 | 2.10 | 10/10 | 29.98 | 2.69 | 10/10 | 30.63 | 3.10 | 10/10 | 27.68 | 2.25 | 10/10 | 28.72 | 1.59 | 10/10 | 29.81 | 2.57 | 60/60 | |
| pdmH1 | 10/10 | 30.21 | 2.12 | 10/10 | 32.23 | 3.17 | 10/10 | 32.98 | 2.31 | 10/10 | 30.63 | 1.48 | 10/10 | 31.09 | 1.69 | 10/10 | 32.38 | 2.57 | 60/60 | |
| RP | 10/10 | 28.78 | 1.33 | 10/10 | 30.79 | 2.65 | 10/10 | 32.27 | 2.51 | 10/10 | 27.55 | 2.43 | 10/10 | 27.82 | 2.45 | 10/10 | 29.43 | 1.77 | 60/60 | |
| Sample 2low | InfA | 10/10 | 33.10 | 3.26 | 8/10 | 31.75 | 35.61 | 8/10 | 36.12 | 4.11 | 10/10 | 32.95 | 1.04 | 10/10 | 33.49 | 3.14 | 10/10 | 34.48 | 2.88 | 58/60 |
| pdmInfA | 10/10 | 32.50 | 2.48 | 9/10 | 30.42 | 35.27 | 9/10 | 31.50 | 35.27 | 10/10 | 32.91 | 3.32 | 10/10 | 33.89 | 3.27 | 10/10 | 34.48 | 2.92 | 58/60 | |
| pdmH1 | 10/10 | 35.19 | 3.10 | 7/10 | 28.85 | 52.94 | 7/10 | 29.34 | 52.77 | 10/10 | 34.66 | 1.27 | 10/10 | 36.12 | 2.18 | 10/10 | 36.57 | 3.70 | 54/60 | |
| RP | 10/10 | 28.44 | 1.34 | 10/10 | 30.33 | 2.78 | 10/10 | 31.44 | 3.27 | 10/10 | 27.41 | 1.95 | 10/10 | 28.34 | 1.55 | 10/10 | 28.57 | 5.11 | 60/60 | |
| Sample 3"highnegative" | InfA | 8/10 | NA | NA | 10/10 | NA | NA | 9/10 | NA | NA | 10/10 | NA | NA | 7/10 | NA | NA | 10/10 | NA | NA | 54/60 |
| pdmInfA | 10/10 | NA | NA | 10/10 | NA | NA | 10/10 | NA | NA | 9/10 | NA | NA | 8/10 | NA | NA | 10/10 | NA | NA | 57/60 | |
| pdmH1 | 10/10 | NA | NA | 9/10 | NA | NA | 10/10 | NA | NA | 9/10 | NA | NA | 10/10 | NA | NA | 10/10 | NA | NA | 58/60 | |
| RP | 10/10 | 28.04 | 2.13 | 10/10 | 30.08 | 4.92 | 10/10 | 31.12 | 2.60 | 10/10 | 26.89 | 2.09 | 10/10 | 28.33 | 1.41 | 10/10 | 28.45 | 3.31 | 60/60 | |
| Sample 4A549cells | RP | 10/10 | 28.68 | 2.75 | 10/10 | 30.20 | 5.68 | 10/10 | 32.10 | 1.74 | 10/10 | 27.06 | 2.65 | 10/10 | 28.60 | 2.29 | 10/10 | 29.33 | 4.00 | 60/60 |
| HSC | RP | 10/10 | 28.51 | 2.30 | 10/10 | 29.80 | 4.48 | 10/10 | 29.55 | 3.11 | 10/10 | 25.89 | 2.04 | 10/10 | 27.30 | 1.61 | 10/10 | 27.35 | 4.98 | 60/60 |
| Influenza2009A(H1N1)PositiveControl | InfA | 10/10 | 23.71 | 2.10 | 10/10 | 21.95 | 2.97 | 10/10 | 23.54 | 4.10 | 10/10 | 21.62 | 1.39 | 10/10 | 23.66 | 2.63 | 10/10 | 24.95 | 2.21 | 60/60 |
| pdmInfA | 10/10 | 22.81 | 2.68 | 10/10 | 22.27 | 1.91 | 10/10 | 23.79 | 2.78 | 10/10 | 21.82 | 2.62 | 10/10 | 23.63 | 1.57 | 10/10 | 24.93 | 2.03 | 60/60 | |
| pdmH1 | 10/10 | 25.76 | 1.55 | 10/10 | 24.35 | 4.78 | 10/10 | 26.36 | 2.42 | 10/10 | 25.31 | 1.19 | 10/10 | 25.89 | 2.13 | 10/10 | 27.52 | 2.53 | 60/60 | |
| RP | 10/10 | 28.84 | 1.66 | 10/10 | 27.44 | 3.23 | 10/10 | 29.03 | 4.03 | 10/10 | 27.35 | 1.84 | 10/10 | 28.59 | 2.35 | 10/10 | 28.82 | 3.26 | 60/60 |
.
11
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Clinical Performance
Performance characteristics of the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel were established during a prospective study at 8 U.S. public health laboratories and a Department of Defense (DoD) laboratory during the 2009-2010 respiratory virus season (February-April). Samples used for this study were collected for routine influenza testing at each site from individuals who were symptomatic with influenzalike illness (ILI) and included both upper and lower respiratory specimen types. Because of the low prevalence of influenza, retrospective specimens were used to supplement prospectively collected specimens.
The reference methods utilized in this study were virus culture with Immunofluorescent Antibody (IFA) or Direct Fluorescent Antibody (DFA) for screening and identification of influenza type and bi-directional sequencing for confirmation of 2009 influenza A (H1N1) subtype. InfA analyte results from the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel were compared to virus culture results in the analysis. Sequencing was performed only with specimens that were first identified as positive for influenza A by virus culture. Pdm InfA and pdm H1 analyte results from the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel were compared to bidirectional sequencing results in the analysis.
There were 1901 total patient specimens evaluated at the nine clinical testing sites: 1191 nasopharyngeal swabs (NPS) and nasal swabs (NS), 50 throat swabs, 519 nasal washes and nasal aspirates, 99 dual NPS/TS, and 42 lower respiratory specimens.
The overall performance call rate for the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel in the clinical evaluation at nine different sites was greater than 99%.
The clinical sensitivity of the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel for all markers tested using upper respiratory specimens was greater than 96% and the clinical specificity for all markers was greater than 96%. The positive percent agreement was greater than 96% for all markers tested.
The clinical sensitivity and specificity of the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel was also evaluated with lower respiratory specimens. The clinical sensitivity and specificity for all markers in the panel were greater than 83% when compared to culture. The positive percent agreement of the CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel was 100%.
The clinical performance of the CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel supports the intended use of this device, demonstrates a clinical utility, and meets labeling claims.
The CDC 2009 A(H1N1)pdm rRT-PCR Panel Clinical Sensitivity, Specificity, and Percent Agreement Summary
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| SpecimenType | InfA | 2009 H1N1 | ||||
|---|---|---|---|---|---|---|
| Sensitivity% (95% CI) | Specificity% (95% CI) | PositivePercentAgreementRetrospective | Sensitivity% (95% CI) | Specificity% (95% CI) | PositivePercentAgreementRetrospective | |
| NPS/NS | 96.8(89.1-99.1) | 96.2(94.6-97.3) | 99.4(97.7-99.8) | 100(93.7-100) | 96.7(95.3-97.7) | 99.7(98.1-99.9) |
| NA/NW | 100(83.2-100) | 99.3(97.5-99.8) | 97.7(94.6-99.0) | 100(80.6-100) | 98.6(96.5-99.5) | 99.0(96.5-99.7) |
| NPS/TS | 100(61.0-100) | 100(93.9-100) | 100(89.0-100) | 100(56.6-100) | 98.3(91.1-99.7) | 100(88.3-100) |
| BAL, TA,BW | 83.3(43.6-97.0) | 83.3(64.1-93.3) | 100(72.3-100) | 100(56.6-100) | 84.0(65.3-93.6) | 100(72.3-100) |
and the comments of the comments of the comments of the comments of
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{13}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Dr. Hye-Joo Kim Associate Director, Regulatory Affairs Centers for Disease Control and Prevention 1600 Clifton Rd, N.E., Mail Stop C-12 Atlanta, Georgia 30333
UUN 2 2 2010
Re: K101564
| Trade/Device Name: | CDC Influenza 2009 A (H1N1)pdm Real-time RT-PCR Panel |
|---|---|
| Regulation Number: | 21 CFR §866.3332 |
| Regulation Name: | Reagents for detection of specific novel influenza A viruses |
| Regulatory Class: | Class II |
| Product Code: | OQW |
| Dated: | June 02, 2010 |
| Received: | June 04, 2010 |
Dear Dr. 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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{14}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutlFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Uhe Schlf for
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
{15}------------------------------------------------
3. Indications for Use Statement
510(k) Number: K101564
Device Name: CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel
Intended use
The CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel (CDC rRT-PCR 2009 A(H1N1)pdm Flu Panel) is intended for use in real-time RT-PCR assays on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument in conjunction with clinical and epidemiological information:
- For the qualitative detection of influenza virus type A viral RNA from . nasopharyngeal swabs (NPS), nasal swabs (NS), nasal aspirates (NA), nasal washes (NW), dual nasopharyngeal / throat swabs (NPS/TS), broncheoalveolar lavage (BAL), tracheal aspirate (TA), and bronchial wash (BW), collected from the respiratory tract of human patients with signs and symptoms of respiratory infection and/or from viral culture.
- For differentiation of 2009 H1N1 influenza virus RNA from nasopharyngeal . swabs (NPS), nasal swabs (NS), nasal aspirates (NA), nasal washes (NW) .dual nasopharyngeal / throat swabs (NPS/TS), broncheoalveolar lavage (BAL), tracheal aspirate (TA), and bronchial wash (BW) collected from the respiratory tract of human patients with signs and symptoms of respiratory infection and/or from viral culture.
- To provide epidemiologic information for surveillance of the 2009 H1N1 . influenza virus.
Performance characteristics for influenza A were established during the 2009-2010 influenza season when 2009 H1N1 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary against other emerging influenza A viruses.
A neqative test result for the broncheoalveolar lavage (BAL), tracheal aspirate (TA), and bronchial wash (BW) is presumptive and it is recommended these results be confirmed by viral culture.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
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+ facility is available to receive and culture specimens.
{16}------------------------------------------------
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
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety
Uive Sch
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_ < 101564
§ 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.