(147 days)
The Quidel Molecular Influenza A+B assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay does not detect the presence of influenza C virus.
Negative results do not preclude Influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Performance characteristics for influenza A were established during the 2010-2011 influenza season when influenza A/H3 and 2009 H1N1 influenza were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
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.
The Quidel Molecular Influenza A+B Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® automated extraction platform. A multiplex real-time RT-PCR reaction is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing the Applied Biosystems® 7500 Fast Dx platform. Identification of influenza A occurs by the use of target specific primers and a fluorescentlabeled probe that hybridizes to a conserved influenza A sequence within the matrix protein gene. Identification of influenza B occurs by the use of target specific primers and fluorescent-labeled probes that will hybridize to a conserved influenza B sequence within the neuraminidase gene.
The following is a summary of the procedure:
- Sample Collection: Obtain nasal swab and nasopharyngeal swab specimens using standard techniques from symptomatic patients. These specimens are transported, stored, and processed according to established laboratory procedures.
- Nucleic Acid Extraction: Extract Nucleic Acids from the specimens with the NucliSENS easyMAG System following the manufacturer's instructions using the appropriate reagents. Use of other extraction systems with the Quidel Molecular Influenza A+B kit has not been validated. Validation of these systems is the responsibility of the end-user. Prior to the extraction procedure add 20 uL of the Process Control (PRC) to each 180 uL aliquot of specimen. The PRC serves to monitor inhibitors in the extracted specimen, assures that adequate amplification has taken place and that nucleic acid extraction was sufficient.
- Rehydration of Master Mix: Rehydrate the lyophilized Master Mix using 135uL of Rehydration Solution. The Master Mix contains oligonucleotide primers, fluorophore and quencher-labeled probes targeting highly conserved regions of the influenza A and influenza B viruses as well as the process control sequence. The primers are complementary to highly specific and conserved regions in the genome of these viruses. The probes are dual labeled with a reporter dye attached to the 5-end and a quencher attached to the 3'-end. The rehydrated Master Mix is sufficient for eight reactions.
- Nucleic Acid Amplification and Detection: Add 15 uL of the rehydrated Master Mix to each reaction plate well. 5uL of extracted nucleic acids (specimen with PRC) is then added to the plate well. Then place the plate into the ABI 7500 FastDx.
Once the plate is added to the instrument, the assay protocol is initiated. This protocol initiates reverse transcription of the RNA targets generating complementary DNA, and the subsequent amplification of the target amplicons occur. The Quidel Molecular Influenza A+B assay is based on TaqMan® chemistry, and uses an enzyme with reverse transcriptase, DNA polymerase, and 5'-3' exonuclease activities. During DNA amplification, this enzyme cleaves the probe bound to the complementary DNA sequence, separating the quencher dye from the reporter dye. This step generates an increase in fluorescent signal upon excitation by a light source of the appropriate wavelength. With each cycle, additional dye molecules are separated from their quenchers resulting in additional signal. If sufficient fluorescence is achieved by 35 cycles during the data collection stage of amplification, the sample is reported as positive for the detected nucleic acid.
This document describes the Quidel Molecular Influenza A+B Assay, a real-time RT-PCR assay for the qualitative detection and differentiation of influenza A and influenza B viral RNA.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in a single table, but rather are implied by the results presented in the analytical and clinical performance sections when compared to a legally marketed predicate device (Gen-Probe Prodesse ProFlu+).
Here’s a table summarizing the reported device performance, which implicitly suggests the acceptance criteria were met by demonstrating adequate performance comparable to the predicate regarding various analytical and clinical characteristics.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Reproducibility | Consistent results across sites, operators, and days. | Influenza A:- High Negative (1.44E+01 TCID50/mL): 12/90 positive results across 3 sites, with AVE Ct ~34 and %CV ~2.0.- Low Positive (9.6E+01 TCID50/mL): 90/90 positive across 3 sites, with AVE Ct ~27-29 and %CV ~3.5-7.0.- Med Positive (2.4E+02 TCID50/mL): 90/90 positive across 3 sites, with AVE Ct ~25-27 and %CV ~2.9-5.5.- Negative: 0/90 positive.Influenza B:- High Negative (1.3E+01 TCID50/mL): 3/90 positive results across 3 sites, with AVE Ct 34.2 and %CV 1.2.- Low Positive (8.6E+01 TCID50/mL): 90/90 positive across 3 sites, with AVE Ct ~24-25 and %CV ~2.6-5.1.- Med Positive (2.2E+02 TCID50/mL): 90/90 positive across 3 sites, with AVE Ct ~22-23 and %CV ~2.0-2.9.- Negative: 0/90 positive.Positive Controls for both A & B were 90/90 positive with low %CV (1.1-3.1). Conclusion: "generates reproducible results". |
| Limit of Detection (LoD) | 95% of replicates test positive at the lowest concentration. | LoD for Influenza A strains ranged from 1.60E+01 to 9.20E+01 TCID50/mL.LoD for Influenza B strains ranged from 5.70E+00 to 4.30E+01 TCID50/mL.These values are within a similar range or better than the predicate device's LoD of 10² to 10⁻¹ TCID₅₀/mL. |
| Analytical Reactivity (Inclusivity) | Detection of various influenza A and B strains at specified concentrations. | Detected 100% (38/38) of influenza A strains (including H1N1, 2009H1N1, H3N2, H5N1) and 100% (15/15) of influenza B strains at 10² to 10³ TCID50 levels. This included novel, pandemic, and avian influenza A strains and recent circulating influenza B strains. |
| Analytical Specificity (Cross-reactivity) | No false positives with common respiratory pathogens or flora. | 100% analytical specificity. No cross-reactivity observed with 26 viral, 24 bacterial, and 1 yeast strain (all tested negative for Influenza A and B). |
| Clinical Performance | High positive and negative percent agreement compared to a 510(k) cleared molecular device. | Prospective Study (N=668 fresh specimens):- Influenza A: PPA 100% (139/139), NPA 98.5% (521/529)- Influenza B: PPA 95.5% (105/110), NPA 97.8% (546/558)Retrospective Study (N=372 frozen specimens):- Influenza A: PPA 100% (37/37), NPA 100% (335/335)- Influenza B: PPA 97.4% (37/38), NPA 99.4% (332/334)Conclusion: "yielded good positive and negative percent agreement". |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Analytical Reproducibility: 90 replicates per level for each virus tested across 3 sites (30 per site).
- Limit of Detection: Replicates of 20 per concentration of virus for each strain.
- Analytical Reactivity: Triplicate testing for each of the 38 Influenza A strains and 15 Influenza B strains.
- Analytical Specificity: Triplicate testing for each of the 26 viral, 24 bacterial, and 1 yeast strain.
- Clinical Performance (Prospective): 668 fresh clinical specimens (373 nasal swabs, 313 nasopharyngeal swabs) after removing invalid results.
- Clinical Performance (Retrospective): 372 frozen nasopharyngeal swabs after removing invalid results.
- Data Provenance: The document does not explicitly state the country of origin for the clinical samples. The study involved three laboratory sites for reproducibility, which might imply multi-site data collection, potentially from different locations. The clinical studies (prospective and retrospective) are referenced as "clinical studies," implying patient samples. The analytical studies use cultured viral strains and negative matrix.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "experts" in this context refers to the methods and outcomes used to establish the true presence or absence of influenza in clinical samples.
- Clinical Studies Ground Truth: The ground truth for the clinical test set was established by comparing the Quidel Molecular Influenza A+B Assay to a "Comparator: FDA Cleared RT-PCR device" (specifically identified as the Gen-Probe Prodesse ProFlu+ in the device comparison). For discordant results in the prospective study, sequence analysis was used to resolve discrepancies for Influenza A (7 cases) and Influenza B (12 cases). This suggests that a more definitive molecular testing method was considered the "expert" or "gold standard" for resolving these cases, rather than a human expert diagnosis.
- No explicit mention of human experts' qualifications for establishing ground truth, as the ground truth was primarily based on a predicate molecular test and confirmatory sequencing.
4. Adjudication Method for the Test Set
- For the clinical performance studies, the primary comparison was between the Quidel Molecular Influenza A+B Assay and the FDA Cleared RT-PCR device (predicate).
- Discordant results in the prospective clinical study were subjected to sequence analysis for adjudication:
- For Influenza A: 7 specimens negative by the predicate but positive by the subject device were confirmed positive by sequence analysis. 1 specimen negative by both was also negative by sequence analysis.
- For Influenza B: 12 specimens negative by the predicate but positive by the subject device were confirmed positive by sequence analysis.
- This is a form of resolution by a higher-tier method rather than a traditional expert consensus method (e.g., 2+1 or 3+1 review).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was NOT done. This device is a molecular diagnostic assay, not an imaging or interpretive AI-based diagnostic tool that would involve human "readers" or "interpreters." The performance is evaluated based on the analytical and clinical accuracy of the assay itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the studies evaluate the standalone performance of the assay. The Quidel Molecular Influenza A+B Assay is a laboratory-based real-time RT-PCR test. Its "performance" refers to the accuracy of the assay in detecting viral RNA in a sample. The results presented (reproducibility, LoD, inclusivity, specificity, clinical agreement) are all measures of the device's inherent performance. Human involvement is in sample collection, processing, and executing the assay protocol, but the "performance" itself is the output of the automated assay.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Clinical Ground Truth: Primarily established by comparison to a legally marketed, FDA-cleared molecular diagnostic device (Gen-Probe Prodesse ProFlu+). For discordant results, molecular sequence analysis was used as the confirmatory "gold standard" to establish true positivity/negativity.
- Analytical Ground Truth: For LoD, inclusivity, and specificity studies, the ground truth was based on quantified viral cultures (TCID50/mL) or bacterial/yeast cultures (CFU/mL), which are established analytical standards for concentration and identity.
8. The Sample Size for the Training Set
- The document does not specify a separate "training set" as would be typical for machine learning algorithms. This is a traditional molecular diagnostic assay where performance is characterized through analytical and clinical validation studies. The "development" of the assay involves optimization of primers, probes, and reaction conditions, but not typically a labeled training data set in the sense of AI.
9. How the Ground Truth for the Training Set Was Established
- Since there isn't a "training set" explicitly mentioned or evaluated in the context of this traditional diagnostic device, the question of how its ground truth was established is not applicable. The assay's components and parameters would have been developed and optimized using well-characterized viral strains and clinical samples based on established laboratory methods.
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Quidel Corporation
Quidel Molecular Influenza A + B Assay
10/26/11 Page 1 of 16
510(k) Summary
Applicant:
Quidel Corporation 10165 McKellar Court San Diego, California 92121 Telephone: 858-552-7910 Fax: 858-646-8045
Contact Information:
Ronald H. Lollar, Senior Director Clinical and Quality Affairs 1055 East State Street Suite 100 Athens, Ohio 45701 740-589-3300 - Corporate number 740-589-3373 - Desk phone 740-593-8437 - Fax lollar@dhiusa.com
Date of preparation of 510(k) summary:
December 20, 2011
Device Name:
Trade name - Quidel Molecular Influenza A + B Assay Classification name - Respiratory viral panel multiplex nucleic acid assay Product Code - OCC Regulation - 21 CFR 866.3980
Legally marketed devices to which equivalence is claimed:
Gen-Probe Prodesse ProFlu+ (K092500)
The ProFluTM+ Assay is a multiplex Real-Time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from symptomatic patients. This test is intended for use to aid in the differential diagnosis of Influenza A. Influenza B and RSV viral infections in humans and is not intended to detect Influenza C.
Negative results do not preclude influenza or RSV virus infection and should not be used as the sole basis for treatment or other management
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decisions. It is recommended that negative RSV results be confirmed by culture.
Performance characteristics for Influenza A Virus were established when Influenza A/H3 and A/H1 were the predominant Influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. 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.
Intended Use:
The Quidel Molecular Influenza A+B assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay does not detect the presence of influenza C virus.
Negative results do not preclude Influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Performance characteristics for influenza A were established during the 2010-2011 influenza season when influenza A/H3 and 2009 H1N1 influenza were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
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.
Device Description:
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The Quidel Molecular Influenza A+B Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® automated extraction platform. A multiplex real-time RT-PCR reaction is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing the Applied Biosystems® 7500 Fast Dx platform. Identification of influenza A occurs by the use of target specific primers and a fluorescentlabeled probe that hybridizes to a conserved influenza A sequence within the matrix protein gene. Identification of influenza B occurs by the use of target specific primers and fluorescent-labeled probes that will hybridize to a conserved influenza B sequence within the neuraminidase gene.
The following is a summary of the procedure:
-
- Sample Collection: Obtain nasal swab and nasopharyngeal swab specimens using standard techniques from symptomatic patients. These specimens are transported, stored, and processed according to established laboratory procedures.
-
- Nucleic Acid Extraction: Extract Nucleic Acids from the specimens with the NucliSENS easyMAG System following the manufacturer's instructions using the appropriate reagents. Use of other extraction systems with the Quidel Molecular Influenza A+B kit has not been validated. Validation of these systems is the responsibility of the end-user. Prior to the extraction procedure add 20 uL of the Process Control (PRC) to each 180 uL aliquot of specimen. The PRC serves to monitor inhibitors in the extracted specimen, assures that adequate amplification has taken place and that nucleic acid extraction was sufficient.
-
- Rehydration of Master Mix: Rehydrate the lyophilized Master Mix using 135uL of Rehydration Solution. The Master Mix contains oligonucleotide primers, fluorophore and quencher-labeled probes targeting highly conserved regions of the influenza A and influenza B viruses as well as the process control sequence. The primers are complementary to highly specific and conserved regions in the genome of these viruses. The probes are dual labeled with a reporter dye attached to the 5-end and a quencher attached to the 3'-end. The rehydrated Master Mix is sufficient for eight reactions.
-
- Nucleic Acid Amplification and Detection: Add 15 uL of the rehydrated Master Mix to each reaction plate well. 5uL of extracted nucleic acids (specimen with PRC) is then added to the plate well. Then place the plate into the ABI 7500 FastDx.
Once the plate is added to the instrument, the assay protocol is initiated. This protocol initiates reverse transcription of the RNA targets generating
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complementary DNA, and the subsequent amplification of the target amplicons occur. The Quidel Molecular Influenza A+B assay is based on TaqMan® chemistry, and uses an enzyme with reverse transcriptase, DNA polymerase, and 5'-3' exonuclease activities. During DNA amplification, this enzyme cleaves the probe bound to the complementary DNA sequence, separating the quencher dye from the reporter dye. This step generates an increase in fluorescent signal upon excitation by a light source of the appropriate wavelength. With each cycle, additional dye molecules are separated from their quenchers resulting in additional signal. If sufficient fluorescence is achieved by 35 cycles during the data collection stage of amplification, the sample is reported as positive for the detected nucleic acid.
Device Comparison
The Quidel Molecular Influenza A+B assay was compared to Prodesse ProFlu+ ("Comparator Device"). The characteristics of Quidel Molecular Influenza A+B assay ("Subject Device") and Prodesse ProFlu+ ("Predicate Device") are described in the table below:
| Device Comparison | ||
|---|---|---|
| Item | Subject DeviceQuidel Molecular InfluenzaA+B Assay | Comparator DeviceProdesse ProFlu+ |
| Intended Use | The Quidel MolecularInfluenza A+B assay is amultiplex Real Time RT-PCRassay for the in vitroqualitative detection anddifferentiation of influenza Aand influenza B viral RNA innasal and nasopharyngealswabs from patients with signsand symptoms of respiratoryinfection. This test is intendedfor use as an aid in thedifferential diagnosis ofinfluenza A and influenza Bviral infections in humans inconjunction with clinical andepidemiological risk factors.The assay does not detect thepresence of influenza C virus. | The ProFlu™+ Assay is amultiplex Real-Time PCR(RT-PCR) in vitro diagnostictest for the rapid andqualitative detection anddiscrimination of Influenza AVirus, Influenza B Virus, andRespiratory Syncytial Virus(RSV) nucleic acids isolatedand purified fromnasopharyngeal (NP) swabspecimens obtained fromsymptomatic patients. Thistest is intended for use to aidin the differential diagnosis ofInfluenza A, Influenza B andRSV viral infections inhumans and is not intended todetect Influenza C. |
| Device Comparison | ||
| Item | Subject DeviceQuidel Molecular InfluenzaA+B Assay | Comparator DeviceProdesse ProFlu+ |
| Negative results do notpreclude Influenza virusinfection and should not beused as the sole basis fordiagnosis, treatment or otherpatient management decisions.Performance characteristics forinfluenza A were establishedduring the 2010-2011influenza season when | Negative results do notpreclude influenza or RSVvirus infection and should nobe used as the sole basis fortreatment or othermanagement decisions. It isrecommended that negativeRSV results be confirmed byculture.Performance characteristics | |
| influenza A/H3 and 2009H1N1 influenza were thepredominant influenza Aviruses in circulation. Whenother influenza A viruses areemerging, performancecharacteristics may vary. | for Influenza A Virus wereestablished when InfluenzaA/H3 and A/H1 were thepredominant Influenza Aviruses in circulation. Whenother Influenza A viruses areemerging, performancecharacteristics may vary. | |
| If infection with a novelinfluenza A virus is suspectedbased on current clinical andepidemiological screeningcriteria recommended bypublic health authorities,specimens should be collectedwith appropriate infectioncontrol precautions for novelvirulent Influenza viruses andsent to state or local healthdepartment for testing. Viralculture should not beattempted in these cases unlessa BSL 3+ facility is availableto receive and culture | If infection with a novelInfluenza A virus is suspectedbased on current clinical andepidemiological screeningcriteria recommended bypublic health authorities,specimens should be collectedwith appropriate infectioncontrol precautions for novelvirulent Influenza viruses andsent to state or local healthdepartment for testing. Viralculture should not beattempted in these casesunless a BSL 3+ facility isavailable to receive and | |
| Device Comparison | ||
| Item | Subject DeviceQuidel Molecular InfluenzaA+B Assay | Comparator DeviceProdesse ProFlu+ |
| Assay Target | Influenza A virus, influenza Bvirus | Influenza A virus, influenza Bvirus; respiratory syncytialvirus |
| Sample Types | nasal swab andnasopharyngeal swab | nasopharyngeal swab |
| ExtractionMethods | bioMérieux easyMAGAutomated MagneticExtraction Reagents | Roche MagNA Pure LC TotalNucleic Acid Isolation Kit orthe bioMérieux easyMAGAutomated MagneticExtraction Reagents |
| AssayMethodology | PCR-based system fordetecting the presence orabsence of viral RNA inclinical specimens | PCR-based system fordetecting the presence orabsence of viral RNA inclinical specimens |
| DetectionTechniques | Multiplex assay using differentreporter dyes for each target | Multiplex assay usingdifferent reporter dyes foreach target |
| Viral Targets | Influenza A: Matrix Gene;Influenza B: conservedinfluenza B sequence withinthe neuraminidase gene | Influenza A: Matrix Gene;Influenza B: Non-structuralNS1 and NS2 |
| LoD | The analytical sensitivity (limitof detection or LoD) of theQuidel Molecular InfluenzaA+B assay was determinedusing quantified (TCID50/mL)cultures of 3 influenza Astrains (1 H1N1, 1 2009H1N1and 1 H3N2), 3 influenza Bstrains, serially diluted innegative nasopharyngealmatrix. Each dilution wasextracted using the NucliSENSeasyMAG System and testedin replicates of 20 per | The analytical sensitivity(limit of detection or LoD) ofthe ProFlu+ Assay wasdetermined using quantified(TCID50/mL) cultures of 4Influenza A (2 H1N1 and 2H3N2), 2 Influenza B, 2Respiratory Syncytial VirusType A, and 2 RespiratorySyncytial Virus Type Bstrains serially diluted innasopharyngeal clinicalmatrix. Each viral strain wasextracted using the Roche |
| Item | Subject DeviceQuidel Molecular InfluenzaA+B Assay | Comparator DeviceProdesse ProFlu+ |
| concentration of virus on theApplied Biosystems® 7500Fast Dx platform. | MagNA Pure LC instrumentand tested in replicates of 20per concentration of virus. | |
| Analytical sensitivity (LoD),as defined as the lowestconcentration at which 95% ofall replicates tested positive,ranged from 10¹ to 10⁰TCID₅₀/mL. | Analytical sensitivity (LoD),as defined as the lowestconcentration at which 95%of all replicates testedpositive, ranged from 10² to10⁻¹ TCID₅₀/mL. |
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Quidel Molecular Influenza A + B Assay
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Analytical Performance:
Precision/Reproducibility:
The reproducibility of the Quidel Molecular Influenza A and B assay was evaluated at 3 laboratory sites. Reproducibility was assessed using a panel of 4 simulated samples that included medium (5x LoD), low (2x LoD), high negative (.3x LoD) levels of influenza A virus, influenza B virus, and negative samples. Panels and controls were tested at each site by 2 operators for 5 days (triplicate testing x 2 operators x 5 days x 3 sites = 90 results per level for each virus). The panels and controls were extracted using the bioMérieux easyMAG system and tested on the ABI 7500Fast Dx.
| Reproducibility Results | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PanelMember ID(TCID50/mL) | Site 1 | Site 2 | Site 3 | TotalResults | ||||||
| Results | AVECt | %CV | Results | AVECt | %CV | Results | AVECt | %CV | ||
| Influenza AHighNegative(1.44E+01) | 4/30 | 34.03*(4 positiveresults) | 2.0 | 8/30(8 positiveresults) | 34.07 | 1.9 | 0/30 | N/A | N/A | 12/90 |
| Influenza ALow Positive(9.6E+01) | 30/30 | 27.3 | 3.5 | 30/30 | 27.3 | 6.3 | 30/30 | 29.2 | 7.0 | 90/90 |
| Influenza AMed Positive(2.4E+02) | 30/30 | 25.3 | 2.9 | 30/30 | 25.2 | 5.1 | 30/30 | 26.8 | 5.5 | 90/90 |
| Influenza ANegative | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
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| Reproducibility Results | Site 1 | Site 2 | Site 3 | Total Results | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PanelMember ID(TCID50/mL) | Results | AVE Ct | %CV | Results | AVE Ct | %CV | Results | AVE Ct | %CV | |
| Influenza BHighNegative(1.3E+01) | 0/30 | N/A | N/A | 3/30(3 positiveresults) | 34.2 | 1.2 | 0/30 | N/A | N/A | 3/90 |
| Influenza BLow Positive(8.6E+01) | 30/30 | 24.7 | 2.6 | 30/30 | 24.6 | 4.8 | 30/30 | 25.7 | 5.1 | 90/90 |
| Influenza BMed Positive(2.2E+02) | 30/30 | 22.9 | 2.0 | 30/30 | 22.7 | 2.6 | 30/30 | 23.5 | 2.9 | 90/90 |
| Influenza BNegative | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
| Influenza APositiveControl | 30/30 | 12.4 | 1.6 | 30/30 | 11.8 | 2.2 | 30/30 | 12.1 | 1.1 | 90/90 |
| Influenza BPositiveControl | 30/30 | 15.2 | 2.6 | 30/30 | 14.9 | 3.1 | 30/30 | 15.1 | 1.4 | 90/90 |
| NegativeControl | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
- Ct values for positive tests
The data from the combined sites indicates that the Quidel Molecular assay generates reproducible results for both influenza A and influenza B viruses when tested with the ABI 7500 Fast Dx.
Limit of Detection
The analytical sensitivity (limit of detection or LoD) of the Quidel Molecular Influenza A+B assay was determined using quantified (TCID50/mL) cultures of 3 influenza A strains (1 HIN1, 1 2009H1N1 and 1 H3N2), and 3 influenza B strains, serially diluted in negative nasopharyngeal matrix. Each dilution was extracted in replicates of 20 per concentration of virus using the NucliSENS easyMAG System and tested on the Applied Biosystems® 7500 Fast Dx platform. Analytical sensitivity (LoD) is defined as the lowest concentration at which 95% of all replicates tested positive.
| Final TCID50/mL LoD | |
|---|---|
| Strain | 7500 Dx |
| A1/Mal/302/54 | 1.60E+01 |
| A/Mexico/4108/2009 | 4.80E+01 |
| A/Victoria/3/75 | 9.20E+01 |
| B/Florida/04/2006 | 4.30E+01 |
| B/RCHIN 8/05 | 1.20E+01 |
| B/Malaysia/25/06/04 | 5.70E+00 |
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Analytical reactivity (inclusivity)
The reactivity of the Quidel Molecular Influenza A+B assay was evaluated against multiple strains of influenza A and influenza B viruses. The clinical panel consisted of 10 Influenza A subtype H1N1, 2 Influenza A subtype 2009H1N1, 8 Influenza A subtype H3N2, 2 Influenza A subtype H5N1, 13 Influenza B, strains. An additional panel of non-clinical restricted isolates was also tested. Each panel member was extracted using the NucliSens easyMAG instrument and tested in triplicate.
The Quidel Molecular Influenza A+B assay detected 100% of the influenza A (38/38) and influenza B strains (15/15) at 102 to 103 TCID50 levels including novel, pandemic and avian influenza A strains and recent circulating influenza B strains.
| Clinical Panel Influenza A viruses | ||||
|---|---|---|---|---|
| (7500 Dx) | ||||
| Subtype | Strain | TCID50/mL | A | B |
| H1N1 | H1N1A/California/07/2009 | 1.45E+02 | Positive | Negative |
| H1N1 | A/NewCaledonia/20/1999 | 1.12E+02 | Positive | Negative |
| H1N1 | A/New Jersey/8/76 | 3.80E+02 | Positive | Negative |
| H1N1 | A/PR/8/34 | 5.89E+02 | Positive | Negative |
| H1N1 | A/NWS/33 | NA | Positive | Negative |
| H1N1 | A/Denver/1/57 | 1.26E+02 | Positive | Negative |
| H1N1 | A/FM/1/47 | 3.80E+02 | Positive | Negative |
| H1N1 | A/Mexico/4108/2009 | 1.40E+02 | Positive | Negative |
| H1N1 | A1/Mal/302/54 | 4.19E+02 | Positive | Negative |
| H1N1 | A/Taiwan/42/06 | 3.39E+02 | Positive | Negative |
| H1N1 | A/Brisbane/59/07 | 7.24E+01 | Positive | Negative |
| H1N1 | A/SolomonIslands/3/06 | 1.41E+01 | Positive | Negative |
| H3N2 | A/Hong Kong/8/68 | 1.15E+02 | Positive | Negative |
| H3N2 | A/Wisconsin/67/2005 | 7.24E+02 | Positive | Negative |
| H3N2 | A/Aichi/2/68 | 4.17E+02 | Positive | Negative |
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| Clinical Panel Influenza A viruses | ||||
|---|---|---|---|---|
| Subtype | Strain | TCID50/mL | (7500 Dx) | |
| A | B | |||
| H3N2 | A/Port Chalmers/1/73 | 4.57E+02 | Positive | Negative |
| H3N2 | A/Perth/16/2009 | 9.83E+02 | Positive | Negative |
| H3N2 | A/Uruguay/7/16/2007 | 1.03E+02 | Positive | Negative |
| H3N2 | A/Victoria/3/75 | 2.19E+02 | Positive | Negative |
| H3N2 | A/Brisbane/10/07 | 4.17E+02 | Positive | Negative |
| Clinical Panel Influenza B viruses | ||||
|---|---|---|---|---|
| (7500 Dx) | ||||
| Strain | TCID50/mL | A | B | |
| B/HongKong/5/72 | 6.67E+02 | Negative | Positive | |
| B/Panama/45/90 | 1.02E+02 | Negative | Positive | |
| B/Florida/02/2006 | 3.16E+02 | Negative | Positive | |
| B/Florida/04/2006 | 3.80E+02 | Negative | Positive | |
| B/Florida/07/2004 | 1.26E+02 | Negative | Positive | |
| B/Malaysia/25/06/04 | 3.41E+02 | Negative | Positive | |
| B/Maryland/1/59 | 1.15E+02 | Negative | Positive | |
| B/Allen/45 | 4.17E+02 | Negative | Positive | |
| B/Taiwan/2/62 | 1.51E+02 | Negative | Positive | |
| B/Russia/69 | 2.19E+02 | Negative | Positive | |
| B/Mass/3/66 | 1.38E+02 | Negative | Positive | |
| B/Lee/40 | 1.95E+02 | Negative | Positive | |
| B/GL/1739/54 | 6.30E+02 | Negative | Positive |
| Non-clinical Restricted viruses | ||||
|---|---|---|---|---|
| Subtype | Strain | TCID50/mL | (7500 Dx) | |
| A | B |
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| A/WI/629-9/2008 | 2.00E+02 | Positive | Negative | |
|---|---|---|---|---|
| H3N2 | A/WI/629-2/2008(H3N2) | 2.00E+02 | Positive | Negative |
| H1N1 | A/WI/629-S7(D02473)/2009(H1N1pdm) | 2.00E+02 | Positive | Negative |
| H1N1 | A/WI/629-S5(D02312)/2009(H1N1pdm) | 2.00E+02 | Positive | Negative |
| H2N2 | A/Mallard/NY/6750/78 (H2N2) | 2.00E+02 | Positive | Negative |
| H7N3 | A/Chicken/NJ/15086-3/94 (H7N3) | 2.00E+02 | Positive | Negative |
| H9N2 | A/Chicken/NJ/12220/97 (H9N2) | 2.00E+02 | Positive | Negative |
| H4N8 | A/Mallard/OH/338/86(H4N8) | 2.00E+02 | Positive | Negative |
| H6N2 | A/Chicken/CA/431/00(H6N2) | 2.00E+02 | Positive | Negative |
| H8N4 | A/Blue WingedTeal/LA/B174/86(H8N4) | 2.00E+02 | Positive | Negative |
| H5N1 | A/Anhui/01/2005(H5N1)-PR8-IBCDC-RG5 | 2.00E+02 | Positive | Negative |
| H10N7 | A/GWT/LA/169GW/88 (H10N7) | 2.00E+02 | Positive | Negative |
| H11N9 | A/Chicken/NJ/15906-9/96 (H11N9) | 2.00E+02 | Positive | Negative |
| H12N5 | A/Duck/LA/188D/87(H12N5) | 2.00E+02 | Positive | Negative |
| H13N6 | A/Gull/MD/704/77(H13N6) | 2.00E+02 | Positive | Negative |
| H14N5 | A/Mallard/GurjevRussia/262/82 (H14N5) | 2.00E+02 | Positive | Negative |
| H15N9 | A/Shearwater/Australia/2576/79 (H15N9) | 2.00E+02 | Positive | Negative |
| H16N3 | A/Shorebird/DE/172/2006(H16N3) | 2.00E+02 | Positive | Negative |
Analytical specificity (cross-reactivity)
The analytical specificity of the Quidel Molecular Influenza A+B assay was evaluated by testing a panel consisting of 26 viral, 24 bacterial, and 1 yeast strain representing common respiratory pathogens or flora commonly present in nasopharynx. Bacteria and yeast were tested at concentrations of 10° to 1010 CFU/mL. Viruses were tested at concentrations of 103 to 106 TCIDs0/mL. Samples were extracted using the NucliSens easyMAG instrument and tested in
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| Quidel Molecular influenza A+B assay Cross-reactivity Data | |||
|---|---|---|---|
| Organism ID | CFU/mLorTCID50/mL | Influenza AResult | Influenza BResult |
| hMPV A1 | 3.70E+04 | Negative | Negative |
| hMPV BI | 2.37E+04 | Negative | Negative |
| RSV Long | 4.40E+04 | Negative | Negative |
| RSV Washington | 1.75E+03 | Negative | Negative |
| Adenovirus 1/Adenoid 71 | 5.67E+04 | Negative | Negative |
| Coronavirus 229E | 1.70E+06 | Negative | Negative |
| Coronavirus OC43 | 1.67E+06 | Negative | Negative |
| Coxsackievirus B4 | 2.43E+06 | Negative | Negative |
| Coxsackievirus B5/10/2006 | 2.28E+06 | Negative | Negative |
| Cytomegalovirus | 8.76E+05 | Negative | Negative |
| Echovirus 7 | 5.38E+08 | Negative | Negative |
| Echovirus 9 | 1.50E+06 | Negative | Negative |
| Echovirus 6 | 1.05E+08 | Negative | Negative |
| Echovirus 11 | 1.50E+05 | Negative | Negative |
| Enterovirus 71 | 2.68E+03 | Negative | Negative |
| Enterovirus 70 | 1.66E+05 | Negative | Negative |
| Epstein Barr Virus | 5,000cp/mL | Negative | Negative |
| HSV Type 1 MacIntyre strain | 1.95E+06 | Negative | Negative |
| HSV Type 2 G strain | 3.67E+06 | Negative | Negative |
| Rubeola | 3.78E+05 | Negative | Negative |
| Mumps virus | 8.43E+04 | Negative | Negative |
| Parainfluenza Type 1 | 2.50E+05 | Negative | Negative |
| Parainfluenza Type 2 | 2.20E+04 | Negative | Negative |
| Parainfluenza Type 3 | 9.10E+05 | Negative | Negative |
| Parainfluenza Type 4 | 9.57E+06 | Negative | Negative |
| Varicella Zoster Virus | 7.50E+02 | Negative | Negative |
| Bordetella pertussis | 1.04E+07 | Negative | Negative |
| Bordetella bronchiseptica | 2.55E+07 | Negative | Negative |
| Chlamydia trachomatis | 2.10E+05 | Negative | Negative |
| Legionella pneumophila | 2.05E+08 | Negative | Negative |
| Mycobacterium intracellulare | 6.90E+08 | Negative | Negative |
| Mycobacterium tuberculosis | 6.60E+07 | Negative | Negative |
| Quidel Molecular influenza A+B assay Cross-reactivity Data | |||
| Organism ID | CFU/mLorTCID50/mL | Influenza AResult | Influenza BResult |
| Mycobacterium avium | 1.36E+10 | Negative | Negative |
| Haemophilus influenzae | 5.90E+07 | Negative | Negative |
| Pseudomonas aeruginosa | 5.15E+07 | Negative | Negative |
| Proteus vulgaris | 2.65E+08 | Negative | Negative |
| Proteus mirabilis | 2.75E+07 | Negative | Negative |
| Neisseria gonorrhoeae | 2.15E+07 | Negative | Negative |
| Neisseria meningitidis | 1.85E+08 | Negative | Negative |
| Neisseria mucosa | 1.85E+08 | Negative | Negative |
| Klebsiella pneumoniae | 3.30E+07 | Negative | Negative |
| Escherichia coli | 6.80E+07 | Negative | Negative |
| Moraxella catarrhalis | 5.85E+07 | Negative | Negative |
| Corynebacterium diphtheriae | 6.0E+05 | Negative | Negative |
| Lactobacillus plantarum | 1.03E+08 | Negative | Negative |
| Streptococcus pneumoniae | 4.5E+07 | Negative | Negative |
| Streptococcus pyogenes | 2.05E+08 | Negative | Negative |
| Streptococcus salivarius | 2.50E+06 | Negative | Negative |
| Staphylococcus epidermidis | 2.6E+07 | Negative | Negative |
| Staphylococcus aureus | 5.15E+08 | Negative | Negative |
| Candida albicans | 1.07E+06 | Negative | Negative |
triplicate. Analytical specificity of the Quidel Molecular influenza A+B assay was 100%.
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8/26/11 Page 13 of 16
Clinical Performance:
A total of 1062 specimens were evaluated in this study (686-fresh, 376-frozen). Of the fresh specimens 373 specimens were nasal swabs, and 313 were nasopharyngeal swabs. The frozen specimens were comprised of 376 nasopharyngeal swabs.
Prospective Clinical Study
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Quidel Corporation
Ouidel Molecular Influenza A + B Assay
Six hundred and eighty six (686) fresh specimens (373 nasal swabs and 313 nasopharyngeal swabs) were tested by both the subject and comparator device for influenza A and influenza B virus viral RNA. Four of these specimens were invalid on initial testing with the subject device (0.6%). Re-testing of the specimens according to the Interpretation algorithm described above also yielded invalid results. Seventeen specimens were invalid on initial and repeat testing (as per the device's PI) on the comparator device (2.5%). Three specimens were invalid in both devices; therefore, a total 18 specimens were removed from additional analysis. The table below details the results for the remaining 668 specimens.
| Influenza A | |||
|---|---|---|---|
| Fresh nasal andnasopharyngeal swabs(N=668) | Comparator: FDA Cleared RT-PCRdevice | ||
| Quidel Molecular | Positive | Negative | Total |
| Positive | 139 | 8* | 147 |
| Negative | 0 | 521 | 521 |
| Total | 139 | 529 | 668 |
| 95% CI | |||
| Positive PercentAgreement | 139/139 | 100% | 97.4% to100% |
| Negative PercentAgreement | 521/529 | 98.5% | 97.0% to99.3% |
*Seven specimens were negative by FDA Cleared RT-PCR device but positive for influenza A by sequence analysis. One specimen was negative by FDA Cleared RT-PCR device and negative for influenza A by sequence analysis.
| Influenza B | |||
|---|---|---|---|
| Fresh nasal andnasopharyngeal swabs(N=668) | Comparator: FDA Cleared RT-PCR device | ||
| Quidel Molecular | Positive | Negative | Total |
| Positive | 105 | 12* | 117 |
| Negative | 5 | 546 | 551 |
| Total | 110 | 558 | 668 |
| 95% CI | |||
| Positive PercentAgreement | 105/110 | 95.5% | 89.7% to98.5% |
| Negative PercentAgreement | 546/558 | 97.8% | 96.3% to98.9% |
*Twelve specimens were negative by FDA Cleared RT-PCR device but positive for influenza B by sequence analysis.
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The prospective clinical study had a dual infection rate for Influenza A and Influenza B of 1.8% (12/668) using the Quidel Molecular Influenza A + B Assay. Three of these dual infections were concordant with the FDA Cleared RT-PCR device comparator assay. Five of these dual infections were discordant with the Influenza A results from the FDA Cleared RT-PCR device comparator assay. Four of these dual infections were discordant with the Influenza B results from the FDA Cleared RT-PCR device comparator assay.
Retrospective Study
Three hundred and seventy six (376) frozen nasopharyngeal swabs were tested by both the subject and comparator devices for influenza A and influenza B virus viral RNA. Two of these specimens were invalid on initial testing with the subject device (0.5%). Re-testing of the specimens according to the Interpretation algorithm described above also yielded invalid results. Two specimens were invalid on initial and repeat testing (as per the device's PI) on the comparator device (0.5%). The invalid specimens were removed from performance analyses. The table below details the results for the remaining 372 specimens.
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| Influenza A | |||
|---|---|---|---|
| Frozen nasopharyngealswab (N=372) | Comparator: FDA Cleared RT-PCRDevice | ||
| Quidel Molecular | Positive | Negative | Total |
| Positive | 37 | 0 | 37 |
| Negative | 0 | 335 | 335 |
| Total | 37 | 335 | 372 |
| 95% CI | |||
| Positive PercentAgreement | 37/37 | 100% | 90.5% to100% |
| Negative PercentAgreement | 335/335 | 100% | 98.9% to100% |
| Influenza B | |||
|---|---|---|---|
| Frozen nasopharyngealswab (N=372) | Comparator: FDA Cleared RT-PCRDevice | ||
| Quidel Molecular | Positive | Negative | Total |
| Positive | 37 | 2* | 39 |
| Negative | 1 | 332 | 333 |
| Total | 38 | 334 | 372 |
| 95% CI | |||
| Positive PercentAgreement | 37/38 | 97.4% | 86.2% to99.9% |
| Negative PercentAgreement | 332/334 | 99.4% | 97.9% to99.9% |
*Two specimens were negative by FDA Cleared RT-PCR device but positive for influenza B by sequence analysis.
CONCLUSIONS
Quidel Molecular Influenza A + B Assay yielded good positive and negative percent agreement when compared to a 510(k) cleared molecular device.
Quidel Molecular Influenza A + B Assay yielded good positive and negative percent agreement for frozen nasopharyngeal swabs compared to a 510(k) cleared molecular device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/16/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 bird-like figure with flowing lines, representing the department's mission related to health and human well-being.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Quidel Corporation c/o Ronald H. Lollar Senior Director Clinical and Quality Affairs 1055 East State Street, Suite 100 Athens, Ohio 45701
DEC 2 2 2011
Re: K112172
Trade/Device Name: Quidel Molecular Influenza A + B Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: Class II Product Code: OCC, OOI Dated: November 29, 2011 Received: November 30, 2011
Dear Mr. Lollar:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
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Page 2 - Ronald H. Lollar
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 Parts 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,
Val, artomo
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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510(k) Number (if known): K112172
Device Name: Quidel Molecular Influenza A+B Assay
Indication for Use:
The Quidel Molecular Influenza A+B assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay does not detect the presence of influenza C virus.
Negative results do not preclude Influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Performance characteristics for influenza A were established during the 2010-2011 influenza season when influenza A/H3 and 2009 H1N1 influenza were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging. performance characteristics may vary.
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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 (OIVD)
Taurus Fields
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112172
§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.
(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.