(78 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 2011 and 2013 influenza seasons 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 assay can be performed using either the Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx, or the Cepheid SmartCycler® II.
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 Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx, or the Cepheid SmartCycler® II 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-fabeled probes that will hybridize to a conserved influenza B sequence within the neuraminidase gene.
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 device is intended to be used 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.
Here's an analysis of the acceptance criteria and study as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the clinical performance study aiming to demonstrate substantial equivalence to an FDA-cleared RT-PCR influenza detection device. The agreement metrics (Positive Percent Agreement, Negative Percent Agreement) are the key performance indicators. The document does not explicitly state pre-defined acceptance thresholds (e.g., "PPA must be > 90%"). However, the reported performance is presented in comparison to a predicate device.
| Metric | Target/Acceptance Criteria (Implied by comparison to FDA-cleared RT-PCR) | Reported Device Performance (Quidel Molecular Influenza A + B Assay) |
|---|---|---|
| Influenza A | ||
| Positive Percent Agreement (PPA) | High agreement with predicate device | 100% (204/204) |
| Negative Percent Agreement (NPA) | High agreement with predicate device | 92.0% (382/415) |
| Influenza B | ||
| Positive Percent Agreement (PPA) | High agreement with predicate device | 99.1% (106/107) |
| Negative Percent Agreement (NPA) | High agreement with predicate device | 98.0% (502/512) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size:
- Initial specimens: 631 fresh swab specimens
- Specimens remaining after exclusions for invalid results: 619
- Data Provenance: Prospective study conducted during the 2013 respiratory virus season (January to March 2013) at three sites across the United States.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state that experts were used to establish the ground truth for the clinical test set. Instead, a "high performance FDA-cleared Influenza A and B molecular test" was used as the comparator (reference standard) to determine agreement.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for reconciling discordant results between the subject device and the comparator device. It simply reports the raw agreement percentages and notes the number of discordant dual infections.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This study focuses on a standalone diagnostic device performance.
6. Standalone Performance
Yes, a standalone performance study was conducted. The "Clinical Performance" section evaluates the Quidel Molecular Influenza A + B Assay's performance (algorithm only, as it's an in vitro diagnostic test) against an FDA-cleared comparator device without human intervention in the result interpretation from the device itself.
7. Type of Ground Truth Used
The ground truth for the clinical test set was established by a "high performance FDA-cleared Influenza A and B molecular test" (a comparator device). This is a type of reference standard comparison, where the performance of the new device is measured against an established, cleared diagnostic method.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size for the clinical performance evaluation. The clinical study described appears to be a validation/test set. For analytical performance (e.g., Limit of Detection, Analytical reactivity), quantified cultures of various influenza strains were used, but these are for analytical validation, not for training a machine learning model. This is a molecular diagnostic assay, not an AI/ML-based device in the sense of requiring a "training set" of patient data for model development.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" for an AI/ML model with associated ground truth from patient data is not applicable here because this is a molecular diagnostic assay. For the analytical studies (e.g., Limit of Detection, Inclusivity), the "ground truth" was established by using quantified cultures of known influenza A and B strains at specified concentrations (TCID50/mL). These cultures serve as the known positive and negative controls at defined viral loads.
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Quidel Molecular Influenza A + B Assay 8/26/2013 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 Regulatory 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
AUG 2 9 2013
Date of preparation of 510(k) summary:
June 11, 2013
Device Name:
Trade name - Quidel Molecular Influenza A + B Assav Classification name - Respiratory viral panel multiplex nucleic acid assay Product Code - OZE Subsequent Product Code - OOI Regulation - 21 CFR 866.3980 Classification - Class II
Device Description:
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 Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx, or the Cepheid SmartCycler® II 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-fabeled probes that will hybridize to a conserved influenza B sequence within the neuraminidase gene.
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Ouidel Molecular Influenza A + B Assay
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.
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 tube or plate well. 5 uL of extracted nucleic acids (specimen with PRC) is then added to the reaction tube or plate well. Place the tube into the Cepheid SmartCycler® II instrument, or place the plate into either the Applied Biosystems® 7500 Fast Dx instrument or Life Technologies QuantStudioTM Dx.
Once the reaction tube or 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 sequences occurs. 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
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| 510(k) Summary | Quidel Molecular Influenza A + B Assay |
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| Page 3 of 16 |
fluorescence is achieved the sample is reported as positive for the detected target sequence
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 2011 and 2013 influenza seasons 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 assay can be performed using the Life Technologies OuantStudio™ Dx. the Applied Biosystems® 7500 Fast Dx, or the Cepheid SmartCycler® II.
Conditions for Use:
For prescription use only.
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 the two predicates. Quidel Molecular Influenza A+B Assay (previously cleared for use with two other instruments) and the Prodesse ProFlu+ are described in the table below:
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| Device Comparison | ||||
|---|---|---|---|---|
| Item | Subject DeviceQuidel MolecularInfluenza A+B Assay | Comparator DeviceQuidel MolecularInfluenza A+B Assay(K112172, K113777) | Comparator DeviceProdesse ProFlu+(K092500) | |
| Intended Use | The Quidel MolecularInfluenza A+B Assayis a multiplex RealTime RT-PCR assayfor the in vitroqualitative detectionand differentiation ofinfluenza A andinfluenza B viral RNAin nasal andnasopharyngeal swabsfrom patients withsigns and symptomsof respiratoryinfection. This test isintended for use as anaid in the differentialdiagnosis of influenzaA and influenza Bviral infections inhumans inconjunction withclinical andepidemiological riskfactors. The assaydoes not detect thepresence of influenzaC virus.Negative results donot preclude influenzavirus infection andshould not be used asthe sole basis fordiagnosis, treatmentor other patient | The Quidel MolecularInfluenza A+B Assayis a multiplex RealTime RT-PCR assayfor the in vitroqualitative detectionand differentiation ofinfluenza A andinfluenza B viral RNAin nasal andnasopharyngeal swabsfrom patients withsigns and symptomsof respiratoryinfection. This test isintended for use as anaid in the differentialdiagnosis of influenzaA and influenza Bviral infections inhumans inconjunction withclinical andepidemiological riskfactors. The assaydoes not detect thepresence of influenzaC virus.Negative results donot preclude Influenzavirus infection andshould not be used asthe sole basis fordiagnosis, treatmentor other patient | The ProFluTM+ Assayis a multiplex Real-Time PCR (RT-PCR)in vitro diagnostictest for the rapid andqualitative detectionand discrimination ofInfluenza A Virus,Influenza B Virus,and RespiratorySyncytial Virus(RSV) nucleic acidsisolated and purifiedfrom nasopharyngeal(NP) swab specimensobtained fromsymptomatic patients.This test is intendedfor use to aid in thedifferential diagnosisof Influenza A,Influenza B and RSVviral infections inhumans and is notintended to detectInfluenza C.Negative results donot precludeinfluenza or RSVvirus infection andshould not be used asthe sole basis fortreatment or othermanagementdecisions. It is | |
| Device Comparison | ||||
| Item | Subject DeviceQuidel MolecularInfluenza A+B Assay | Comparator DeviceQuidel MolecularInfluenza A+B Assay(K112172, K113777) | Comparator DeviceProdesse ProFiu+(K092500) | |
| decisions. | decisions. | negative RSV results | ||
| Performance | Performance | be confirmed by | ||
| characteristics for | characteristics for | culture. | ||
| influenza A were | influenza A were | Performance | ||
| established during the | established during the | characteristics for | ||
| 2011 and 2013 | 2011 influenza season | Influenza A Virus | ||
| influenza seasons | when influenza A/H3 | were established | ||
| when influenza A/H3 | and 2009 H1N1 | when Influenza A/H3 | ||
| and 2009 H1N1 | influenza were the | and A/H1 were the | ||
| influenza were the | predominant influenza | predominant | ||
| predominant influenza | A viruses in | Influenza A viruses | ||
| A viruses in | circulation. When | in circulation. When | ||
| circulation. When | other influenza A | other Influenza A | ||
| other influenza A | viruses are emerging, | viruses are emerging, | ||
| viruses are emerging, | performance | performance | ||
| performance | characteristics may | characteristics may | ||
| characteristics may | vary. | vary. | ||
| vary. | If infection with a | If infection with a | ||
| If infection with a | novel influenza A | novel Influenza A | ||
| novel influenza A | virus is suspected | virus is suspected | ||
| virus is suspected | based on current | based on current | ||
| based on current | clinical and | clinical and | ||
| clinical and | epidemiological | epidemiological | ||
| epidemiological | screening criteria | screening criteria | ||
| screening criteria | recommended by | recommended by | ||
| recommended by | public health | public health | ||
| public health | authorities, specimens | authorities, | ||
| authorities, specimens | should be collected | specimens should be | ||
| should be collected | with appropriate | collected with | ||
| with appropriate | infection control | appropriate infection | ||
| infection control | precautions for novel | control precautions | ||
| precautions for novel | virulent Influenza | for novel virulent | ||
| virulent Influenza | viruses and sent to | Influenza viruses and | ||
| viruses and sent to | state or local health | sent to state or local | ||
| state or local health | department for testing. | health department for | ||
| department for testing. | Viral culture should | testing. Viral culture | ||
| Viral culture should | not be attempted in | should not be | ||
| Device Comparison | ||||
| Item | Subject DeviceQuidel MolecularInfluenza A+B Assay | Comparator DeviceQuidel MolecularInfluenza A+B Assay(K112172, K113777) | Comparator DeviceProdesse ProFlu+(K092500) | |
| not be attempted inthese cases unless aBSL 3+ facility isavailable to receiveand culturespecimens. | these cases unless aBSL 3+ facility isavailable to receiveand culturespecimens. | attempted in thesecases unless a BSL3+ facility isavailable to receiveand culturespecimens. | ||
| The assay can beperformed usingeither the LifeTechnologiesQuantStudio™ Dx;the AppliedBiosystems® 7500Fast Dx, or theCepheidSmartCycler® II. | ||||
| Assay Target | Influenza A virus,influenza B virus | Influenza A virus,influenza B virus | Influenza A virus,influenza B virus,respiratory syncytialvirus | |
| SampleTypes | nasal swab andnasopharyngeal swab | nasal swab andnasopharyngeal swab | nasopharyngeal swab | |
| ExtractionMethods | bioMérieuxeasyMAG®Automated MagneticExtraction Reagents | bioMérieux easyMAGAutomated MagneticExtraction Reagents | Roche MagNA PureLC Total NucleicAcid Isolation Kit orthe bioMérieuxeasyMAG AutomatedMagnetic ExtractionReagents | |
| AssayMethodology | PCR-based system fordetecting the presenceor absence of viralRNA in clinicalspecimens | PCR-based system fordetecting the presenceor absence of viralRNA in clinicalspecimens | PCR-based systemfor detecting thepresence or absenceof viral RNA inclinical specimens | |
| Detection | Multiplex assay using | Multiplex assay using | Multiplex assay using | |
| Item | Subject DeviceQuidel MolecularInfluenza A+B Assay | Comparator DeviceQuidel MolecularInfluenza A+B Assay(K112172, K113777) | Comparator DeviceProdesse ProFlu+(K092500) | |
| Techniques | different reporter dyesfor each target | different reporter dyesfor each target | different reporterdyes for each target | |
| Viral Targets | Influenza A: MatrixGene;Influenza B:conserved influenza Bsequence within theneuraminidase gene | Influenza A: MatrixGene;Influenza B:conserved influenza Bsequence within theneuraminidase gene | Influenza A: MatrixGene;Influenza B: Non-structural NS1 andNS2 | |
| LoD | The analyticalsensitivity (limit ofdetection or LoD) ofthe Quidel MolecularInfluenza A+B assaywas determined usingquantified(TCID50/mL) culturesof five (5) influenza Astrains, three (3)influenza B strains,serially diluted innegativenasopharyngealmatrix. Each dilutionwas extracted usingthe NucliSENSeasyMAG System andtested in replicates of20 per concentrationof virus on the LifeTechnologiesQuantStudio™ Dx;the AppliedBiosystems® 7500Fast Dx, or theCepheidSmartCycler® II. | The analyticalsensitivity (limit ofdetection or LoD) ofthe Quidel MolecularInfluenza A+B assaywas determined usingquantified(TCID50/mL) culturesof 3 influenza Astrains (1 H1N1, 12009H1N1 and 1H3N2), 3 influenza Bstrains, serially dilutedin negativenasopharyngealmatrix. Each dilutionwas extracted usingthe NucliSENSeasyMAG System andtested in replicates of20 per concentrationof virus on theApplied Biosystems®7500 Fast Dx platformand the CepheidSmartCycler II.Analytical sensitivity(LoD), as defined as | The analyticalsensitivity (limit ofdetection or LoD) ofthe ProFlu+ Assaywas determined usingquantified(TCID50/mL) culturesof 4 Influenza A (2H1N1 and 2 H3N2),2 Influenza B, 2Respiratory SyncytialVirus Type A, and 2Respiratory SyncytialVirus Type B strainsserially diluted innasopharyngealclinical matrix. Eachviral strain wasextracted using theRoche MagNA PureLC instrument andtested in replicates of20 per concentrationof virus.Analytical sensitivity(LoD), as defined asthe lowestconcentration at |
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Page 5 of 16
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8/26/2013 Page 6 of 16
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Quidel Molecular Influenza A + B Assay
510(k) Summary
. .
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Quidel Molecular Influenza A + B Assay
| 510(k) Summary | ||
|---|---|---|
8/26/2013 Page 8 of 16
| Device Comparison | |||
|---|---|---|---|
| Item | Subject DeviceQuidel MolecularInfluenza A+B Assay | Comparator DeviceQuidel MolecularInfluenza A+B Assay(K112172, K113777) | Comparator DeviceProdesse ProFlu+(K092500) |
| Analytical sensitivity(LoD), as defined asthe lowestconcentration atwhich 95% of allreplicates testedpositive, ranged from$10^1$ to $10^0$TCID₅₀/mL. | the lowestconcentration atwhich 95% of allreplicates testedpositive, ranged from$10^1$ to $10^0$TCID₅₀/mL. | which 95% of allreplicates testedpositive, ranged from$10^2$ to $10^{-1}$TCID₅₀/mL. |
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. The panels consisted of 2 positive samples (above LoD), a high negative (0.3x LoD) sample and a negative sample for each virus, influenza A (A/Mexico/4108/2009) and influenza B (B/Florida/04/2006). 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 Life Technologies QuantStudio™ Dx.
| Reproducibility Results - Life Technologies QuantStudio™ Dx | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PanelMemberID | Site 1 | Site 2 | Site 3 | Combined Site Data | ||||||||
| Rate ofDetection | AVECt | %CV | Rate ofDetection | AVECt | %CV | Rate ofDetection | AVECt | %CV | Rate ofDetection | AVE Ct | %CV | |
| InfluenzaA HighNegative(0.3 xLoD) | 25/30 | 37.4* | 3.8 | 13/30 | 38.2* | 2.6 | 4/28** | 37.5* | 4.2 | 42/88** | 37.2 | 3.6 |
| InfluenzaA Positive1 | 30/30 | 27.5 | 2.5 | 30/30 | 27.7 | 2.1 | 29/29** | 27.9 | 4.3 | 89/89** | 27.7 | 3.1 |
| InfluenzaA Positive2 | 30/30 | 26.4 | 1.7 | 30/30 | 26.4 | 1.8 | 30/30 | 27.0 | 6.1 | 90/90 | 26.6 | 3.9 |
| Influenza | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 | N/A | N/A |
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| Reproducibility Results - Life Technologies QuantStudio™ Dx | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PanelMember ID | Site 1 | Site 2 | Site 3 | Combined Site Data | ||||||||
| Rate of Detection | AVE Ct | %CV | Rate of Detection | AVE Ct | %CV | Rate of Detection | AVE Ct | %CV | Rate of Detection | AVE Ct | %CV | |
| A Negative | ||||||||||||
| InfluenzaB HighNegative(0.3 x LoD) | 28/30 | 37.7* | 3.1 | 23/30 | 37.8* | 3.6 | 14/28** | 37.7* | 2.7 | 65/88** | 37.7 | 3.2 |
| InfluenzaB Positive1 | 30/30 | 25.8 | 1.8 | 30/30 | 25.4 | 1.5 | 29/29 | 25.9 | 8.7 | 89/89** | 25.7 | 5.2 |
| InfluenzaB Positive2 | 30/30 | 24.4 | 1.8 | 30/30 | 24.0 | 1.7 | 30/30 | 24.9 | 8.8 | 90/90 | 24.4 | 5.5 |
| InfluenzaB Negative | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 | N/A | N/A |
| InfluenzaA PositiveControl | 30/30 | 28.7 | 2.7 | 30/30 | 30.7 | 2.1 | 30/30 | 31.7 | 9.2 | 90/90 | 30.4 | 7.1 |
| InfluenzaB PositiveControl | 30/30 | 27.9 | 1.2 | 30/30 | 27.5 | 1.8 | 30/30 | 29.9 | 6.9 | 90/90 | 28.7 | 6.6 |
| NegativeControl | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 | N/A | N/A |
- Average Ct of positive results only
** One or more of the replicates was invalid due to non-detection of the PRC
Upon review of the Life Technologies QuantStudio™ Dx reproducibility data it was determined that the concentration of the positive samples was higher than expected. A supplemental study was conducted internally using a near-LoD specimen. In this study, a sample with a low positive concentration (2x LoD) for influenza A and for influenza B and a negative sample were each extracted on three bioMérieux easyMAG® systems and then tested on three Life Technologies QuantStudio™ Dx platforms. The two samples and controls were tested by two operators per instrument for five days, each sample tested in 3 replicates, for a total of 90 results per sample for each virus for each instrument (2 operators x 5 days x 3 instruments x 3 replicates). This data is presented separately as a supplemental study.
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| Reproducibility Results - Life Technologies QuantStudio™ Dx - Supplemental Study | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PanelMember ID(TCID50/mL) | QuantStudio™ #1Rate ofDetection | QuantStudio™ #1AVECt | QuantStudio™ #1%CV | QuantStudio™ #2Rate ofDetection | QuantStudio™ #2AVECt | QuantStudio™ #2%CV | QuantStudio™ #3Rate ofDetection | QuantStudio™ #3AVECt | QuantStudio™ #3%CV | Combined Instrument DataRate ofDetection | Combined Instrument DataAVECt | Combined Instrument Data%CV |
| Influenza ALowPositive(3.90E+01) | 30/30 | 35.1 | 3.5 | 30/30 | 33.7 | 4.6 | 30/30 | 35.7 | 3.1 | 90/90 | 34.8 | 4.4 |
| Influenza ANegative | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 | N/A | N/A |
| Influenza BLowPositive(2.01E+02) | 30/30 | 35.2 | 3.1 | 30/30 | 34.5 | 3.2 | 30/30 | 35.6 | 2.7 | 90/90 | 35.1 | 3.2 |
| Influenza BNegative | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 | N/A | N/A |
| Influenza APositiveControl | 30/30 | 31.0 | 4.6 | 30/30 | 30.9 | 6.1 | 30/30 | 31.3 | 4.0 | 90/90 | 31.1 | 5.0 |
| Influenza BPositiveControl | 30/30 | 27.7 | 1.5 | 30/30 | 27.7 | 3.2 | 30/30 | 28.1 | 1.3 | 90/90 | 27.8 | 2.3 |
| NegativeControl | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 | N/A | N/A |
The data from the combined sites indicates that the Quidel Molecular Influenza A + B Assay generates reproducible results for both influenza A and influenza B viruses when tested with the Life Technologies QuantStudioTM 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 five influenza A strains and three influenza B strains, serially diluted in negative nasopharyngeal matrix. Each dilution was extracted using the NucliSENS® easyMAG® System in replicates of 20 per concentration of virus and tested on both the Cepheid SmartCycler® II, the Applied Biosystems® 7500 Fast Dx, and the Life Technologies QuantStudio™ Dx platforms. Analytical sensitivity (LoD) is defined as the lowest concentration at which at least 95% of all replicates tested positive. The demonstrated LoD for each of the three instruments is shown below.
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Quidel Molecular Influenza A + B Assay
510(k) Summary
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| Strain | Final LOD(TCID50/mL)CepheidSmartCycler® II(K113777) | Final LOD(TCID50/mL)AppliedBiosystems®7500 Fast Dx(K112172) | Final LOD(TCID50/mL)LifeTechnologiesQuantStudio™Dx(K131728) |
|---|---|---|---|
| A/Mexico/4108/2009(H1N1) | 2.40E+01 | 4.80E+01 | 2.0E+01 |
| A1/Mal/302/54(H1N1) | 7.00E+00 | 1.60E+01 | N/A |
| A/Victoria/3/75(H3N2) | 3.10E+01 | 9.20E+01 | N/A |
| A/Brisbane/59/2007(H1N1) | N/A | 3.33E+01 | 1.00E+02 |
| A/Brisbane (H3N2) | N/A | 1.00E+01 | 5.00E+01 |
| B/RCHIN 8/05 | 1.80E+00 | 1.20E+01 | N/A |
| B/Brisbane '09-'10Vaccine Strain | N/A | 1.50E+02 | 1.00E+02 |
| B/Florida/04/2006 | 6.00E+00 | 4.30E+01 | 1.00E+02 |
| B/Malaysia/25/06/04 | 1.30E+00 | 5.70E+00 | 1.00E+00 |
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 influenza panel consisted of ten Influenza A subtype H1N1, two Influenza A subtype 2009H1N1, eight Influenza A subtype H3N2, two Influenza A subtype H5N1, and 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 on both the Cepheid SmartCycler® II and Applied Biosystems® 7500 Fast Dx platforms.
In 2013 additional studies were performed using two new and unique strains of influenza A virus (H3N2v and H7N9). Six (6) isolates of the H3N2v strain were extracted using the NucliSENS® easyMAG® instrument and tested in triplicate on both the Life Technologies QuantStudio™ Dx and the Applied Biosystems® 7500 Fast Dx platforms. An inactivated isolate of H7N9 was extracted using the NucliSENS® easyMAG® instrument and tested in triplicate on both the Life Technologies QuantStudio™ Dx and Applied Biosystems® 7500 Fast Dx platforms.
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8/26/2013 Page 12 of 16
The Quidel Molecular Influenza A+B Assay detected 100% of the influenza A (45/45) and influenza B strains (15/15) at 2 to 3x LoD levels including pandemic and avian influenza A strains and recent circulating influenza A variant strains.
| Influenza A Viruses | ||||
|---|---|---|---|---|
| Subtype | Strain | TCID50/mL | A | B |
| 2009 H1N1 | H1N1 A/California/07/2009 | 1.45E+02 | Positive | Negative |
| H1N1 | A/New Caledonia/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 |
| 2009 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/Solomon Islands/3/06 | 1.41E+01 | 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 |
| 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 |
| 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 |
| H3N2v | A/Indiana/10/11 | 5.90E+01 | Positive | Negative |
| H3N2v | A/Kansas/13/9 | 4.90E+01 | Positive | Negative |
| H3N2v | A/Pennsylvania/14/10 | 4.80E+01 | Positive | Negative |
| H3N2v | A/Victoria/361/11 | 5.20E+01 | Positive | Negative |
| H3N2v | A/Minnesota/11/10 | 4.60E+01 | Positive | Negative |
| H3N2v | A/West Virginia/6/11 | 5.00E+01 | Positive | Negative |
| H7N9* | A/ANHUI/1/2013 | 3.95E+03* | Positive | Negative |
- Inactivated virus - relative EID50 Titer/mL
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8/26/2013 Page 13 of 16
| Influenza B Viruses | |||
|---|---|---|---|
| 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 |
The following avian strains were tested as cultured isolates in a BS-3 facility.
| Non-clinical Restricted Influenza A Viruses | ||||
|---|---|---|---|---|
| Subtype | Strain | TCID50/mL | A | B |
| 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 Winged Teal/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 |
۰۷ ، ۱۰ ، ۱۳۹۶ ،
• • .
・バン・
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Carryover and Cross-contamination Studies
An internal study was completed with the Cepheid SmartCycler® II, the Applied Biosystems® 7500 Fast Dx, and Life Technologies QuantStudio™ Dx platform where a number of PCR reactions were performed in five separate extractions and PCR runs. Each extraction run had alternating high positive and high negative samples within the same disposable. Each PCR run had alternating high positive and negative samples. All the high positive samples were positive for influenza A and influenza B (100%). All of the high negative samples were negative for influenza A and influenza B. The data demonstrates that no carry-over or cross contamination was observed with the bioMérieux NucliSENS® easyMAG® automated nucleic acid extraction instrument and the Cepheid SmartCycler® II instrument, the Applied Biosystems® 7500 Fast Dx, or Life Technologies QuantStudio™ Dx platform.
Analytical Specificity (Cross-reactivity)
Please see K113777 for Analytical Specificity (Cross-Reactivity) studies.
Analytical Specificity - Interfering Substances
Please see K113777 for Analytical Specificity (Interfering Substances) studies.
Clinical Performance:
Performance characteristics of the Quidel Molecular Influenza A + B Assay using the Life Technologies QuantStudio™ Dx were established during a prospective study during the 2013 respiratory virus season (January to March 2013). Six hundred and thirty-one (631) fresh swab specimens that were collected for routine respiratory virus testing were used for this study at three sites across the United States. A single specimen was collected per patient. The specimens were extracted with the bioMérieux easyMAG® and tested with Quidel Molecular Influenza A + B Assay using the Life Technologies QuantStudio™ Dx. The specimens were also tested with a high performance FDA-cleared Influenza A and B molecular test.
| Age and Gender Distribution | ||
|---|---|---|
| Sex | F | M |
| Total | 339 | 292 |
| < 5 years | 124 (36.6%) | 103 (35.3%) |
| 6 - 21 years | 90 (26.5%) | 103 (35.3%) |
| 22 - 59 years | 67 (19.8%) | 47 (16.1%) |
| > 60 years | 58 (17.1%) | 39 (13.4%) |
| Total | 339 | 292 |
The gender and age demographics
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Quidel Molecular Influenza A + B Assay
510(k) Summary
Six hundred and thirty-one (631) fresh swab specimens were tested by both the subject and comparator device for influenza A and influenza B viral RNA. Four (4) of these specimens were invalid on initial testing with the subject device (0.6%, 95% Cl: 0.2% to 1.6%). Re-testing of the specimens according to the Interpretation algorithm described above also yielded invalid results. Eight (8) specimens were invalid on initial and repeat testing (as per the device's PI) on the comparator device (1.3%, 95% CI: 0.6% to 2.5%). A total of twelve (12) invalid specimens have been removed from additional analysis. The table below details the performance of the Quidel Influenza A + B Assay on the QuantStudio™ Dx with the remaining 619 specimens when compared to a commercially available FDA-cleared RT-PCR influenza detection device.
| Influenza A | |||
|---|---|---|---|
| Comparator: FDA-cleared RT-PCRdevice | |||
| QuidelMolecular | Positive | Negative | Total |
| Positive | 204 | 33 | 237 |
| Negative | 0 | 382 | 382 |
| Total | 204 | 415 | 619 |
| 95% CI | |||
| Positive PercentAgreement | 204/204 | 100% | 98.2% to100% |
| Negative PercentAgreement | 382/415 | 92.0% | 89.0% to94.3% |
| Influenza B | |||
|---|---|---|---|
| Comparator: FDA-cleared RT-PCR device | |||
| Quidel Molecular | Positive | Negative | Total |
| Positive | 106 | 10 | 116 |
| Negative | 1 | 502 | 503 |
| Total | 107 | 512 | 619 |
| 95% CI | |||
| Positive PercentAgreement | 106/107 | 99.1% | 94.9% to99.8% |
| Negative PercentAgreement | 502/512 | 98.0% | 96.4% to98.9% |
The prospective clinical study had a dual infection rate for Influenza A and Influenza B of 1.8% (11/631, 95% CI: 1.0% to 3.1%) using the Quidel Molecular Influenza A + B Assay. Three (3) of these dual infections were concordant with the FDA-cleared RT-PCR device comparator assay. Six (6) of
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these dual infections were discordant with the influenza A results from the FDA-cleared RT-PCR device comparator assay. Two (2) of these dual infections were discordant with the influenza B results from the FDA-cleared RT-PCR device comparator assay.
Conclusion
When performed on the Life Technologies QuantStudio™ Dx, the Quidel Molecular Influenza A + B Assay yielded good positive and negative percent agreement when compared to a 510(k) cleared molecular device.
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Image /page/16/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2013
Ronald H. Lollar Senior Director, Clinical and Regulatory Affairs Quidel Corporation 1055 East State Street, Suite 100 Athens, OH 45701
Re: K131728
Trade/Device Name: Quidel Molecular Influenza A + B Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic assay Regulatory Class: Class II Product Code: OZE, OOI Dated: June 11, 2013 Received: June 12, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must 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
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Page 2 - Ronald H. Lollar
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sally A. Hojvat -S
Sally A. Hojvat, M. Sc., Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health (OIR) Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131728
Device Name: Quidel Molecular Influenza A+B Assay
Indications 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 2011 and 2013 influenza seasons 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 assay can be performed using either the Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx, or the Cepheid SmartCycler® II.
| Prescription Use x |
|---|
| (Part 21 CFR 801 Subpart D) |
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of Center for Devices and Radiological Health (CDRH)
Tamara V. Feldblyum -S 2013.08.29 12:46:08 -04'00'
Page 1 of 1
§ 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.