(108 days)
The Quidel Molecular hMPV assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection of human metapneumovirus RNA in nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of human metapneumovirus infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the four genetic sub-lineages of hMPV.
Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
The Quidel Molecular hMPV Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® automated extraction platform. A multiplex 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 hMPV occurs by the use of target specific primers and a fluorescent- labeled probe that hybridizes to conserved regions in the RNA dependent RNA polymerase gene of hMPV.
Here's a summary of the acceptance criteria and study details for the Quidel Molecular hMPV Assay, based on the provided text:
Acceptance Criteria and Reported Device Performance
For the clinical study, performance was compared against an FDA-cleared RT-PCR comparator device. While explicit acceptance criteria ("Pass/Fail") are not stated in terms of specific percentages, the reported percentages (Positive Percent Agreement and Negative Percent Agreement) implicitly serve as the achieved performance against which the device's efficacy is judged.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Positive Percent Agreement | High agreement with comparator | 95.2% (95% CI: 86.7% to 99.0%) |
| Negative Percent Agreement | High agreement with comparator | 99.8% (95% CI: 99.3% to 100%) |
| Reproducibility (Low Positive) | Consistent detection | 89/90 positive results (98.9%) |
| Reproducibility (Medium Positive) | Consistent detection | 90/90 positive results (100%) |
| Limit of Detection (LoD) | 95% of replicates test positive | Achieved for various strains (e.g., hMPV A1: 5.29E+01 TCID50/mL, hMPV B1: 3.15E+00 TCID50/mL) |
| Analytical Reactivity | 100% detection of hMPV strains | 100% detection (12 strains) |
| Analytical Specificity (Cross-reactivity) | No cross-reactivity | 100% specificity (51 organisms tested) |
Study Details
-
Sample sizes used for the test set and the data provenance:
- Clinical Performance Test Set: N=1072 specimens (after excluding invalid results).
- 742 fresh specimens: Collected for routine respiratory virus testing at thirteen sites across the United States.
- 374 frozen specimens: Collected and tested at two geographically distinct locations.
- Data Provenance: United States (multiple sites).
- Retrospective/Prospective: The clinical study was prospective, conducted during the 2010-2011 respiratory virus season (January to March 2011).
- Clinical Performance Test Set: N=1072 specimens (after excluding invalid results).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for the clinical performance test set was established by an "FDA Cleared RT-PCR" device (the comparator device, Gen-Probe Prodesse Pro hMPV+ (K082688)).
- For 2 discrepant specimens that were positive by the Quidel Molecular hMPV assay but negative by the comparator, "sequence analysis" was used to resolve the discrepancy. The number and qualifications of experts for this sequence analysis are not specified in the provided text.
-
Adjudication method for the test set:
- For the clinical performance study, direct comparison was made against the "FDA Cleared RT-PCR" device.
- For the two discrepant cases where the Quidel assay was positive and the comparator was negative, "sequence analysis" was used as an adjudication method to determine the true state.
-
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission describes an in vitro diagnostic (IVD) assay where the "reader" is an automated instrument, not a human clinician interpreting images or data for diagnosis. Therefore, improvement of human readers with/without AI assistance is not applicable.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics described (analytical and clinical performance) represent the standalone performance of the Quidel Molecular hMPV Assay. It is an automated RT-PCR assay that provides a qualitative result (positive/negative) without human intervention in the interpretation of the primary result from the instrument.
-
The type of ground truth used:
- Clinical Performance: "FDA Cleared RT-PCR" device (the predicate device) and, for discrepant cases, sequence analysis.
- Analytical Performance (LoD, Inclusivity, Specificity): Quantified cultures of hMPV strains (TCID50/mL) for LoD and inclusivity, and specified concentrations of viral, bacterial, and yeast strains for specificity.
-
The sample size for the training set:
- The provided document does not specify a separate training set size for the development of the Quidel Molecular hMPV Assay. This is common for molecular diagnostic kits, where the "training" involves optimizing primer/probe design and assay conditions, rather than training a machine learning algorithm on a specific data set.
-
How the ground truth for the training set was established:
- As no specific "training set" in the machine learning sense is mentioned, information on how its ground truth was established is not provided. The development of this molecular assay would have involved standard molecular biology techniques, using characterized viral isolates and nucleic acid samples to optimize primer/probe sequences and reaction conditions, rather than a "ground truth" derived from patient data for an algorithm.
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DEC 1 5 2011 K112490
Quidel Corporation
Quidel Molecular hMPV Assay 11/30/2011 Page 1 of 10
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:
November 30, 2011
Device Name:
Trade name - Quidel Molecular hMPV Assay Classification name - Respiratory viral panel multiplex nucleic acid assay Product Code - OEM Regulation - 21 CFR 866.3980
Legally marketed devices to which equivalence is claimed:
Gen-Probe Prodesse Pro hMPV+ (K082688)
The Pro hMPV+ Assay is a Real Time RT-PCR in vitro diagnostic test for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid isolated and purified from nasopharyngeal swab (NP) specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This assay targets a highly conserved region of the Nucleocapsid gene of hMPV. The detection of hMPV nucleic acid from symptomatic patients aids in the diagnosis of human respiratory hMPV infection if used in conjunction with other clinical and laboratory findings. This test is not intended to differentiate the four genetic sub-lineages of hMPV.
Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.
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Intended Use:
The Quidel Molecular hMPV assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection of human metapneumovirus RNA in nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of human metapneumovirus infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the four genetic sub-lineages of hMPV.
Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Device Description:
The Quidel Molecular hMPV Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® automated extraction platform. A multiplex 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 hMPV occurs by the use of target specific primers and a fluorescent- labeled probe that hybridizes to conserved regions in the RNA dependent RNA polymerase gene of hMPV.
The following is a summary of the procedure:
-
- Sample Collection: Obtain nasal or 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 hMPV as well as the process control sequence. The primers are
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complementary to highly specific and conserved regions in the genome of the virus. 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 Applied Biosystems 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 occurs. The Quidel Molecular hMPV 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.
- 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 Applied Biosystems 7500 FastDx.
Device Comparison
The Quidel Molecular hMPV assay was compared to legally marketed RT-PCR assay. The characteristics of Quidel Molecular hMPV assay ("Subject Device") and the Prodesse Pro hMPV+ ("Predicate Device") are described in Table 5.1, below:
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.
| Table 5.1:Subject Device and Comparator Device Comparison | ||
|---|---|---|
| Item | Subject DeviceQuidel Molecular hMPV Assay | Predicate DeviceProdesse ProFlu+ |
| Intended Use | The Quidel Molecular hMPVassay is a multiplex Real TimeRT-PCR assay for the in vitroqualitative detection of humanmetapneumovirus RNA in nasaland nasopharyngeal swabspecimens from patients withsigns and symptoms of respiratoryinfection. This test is intended foruse as an aid in the differentialdiagnosis of humanmetapneumovirus infections inhumans in conjunction withclinical and epidemiological riskfactors. This test is not intended todifferentiate the four genetic sub-lineages of hMPV.Negative results do not precludehMPV infection and should not beused as the sole basis fordiagnosis, treatment or otherpatient management decisions. | The Pro hMPV+ Assay is a RealTime RT-PCR in vitro diagnostictest for the qualitative detection ofhuman Metapneumovirus (hMPV)nucleic acid isolated and purifiedfrom nasopharyngeal swab (NP)specimens obtained fromindividuals exhibiting signs andsymptoms of acute respiratoryinfection. This assay targets ahighly conserved region of theNucleocapsid gene of hMPV. Thedetection of hMPV nucleic acidfrom symptomatic patients aids inthe diagnosis of human respiratoryhMPV infection if used inconjunction with other clinical andlaboratory findings. This test is notintended to differentiate the fourgenetic sub-lineages of hMPV.Negative results do not precludehMPV infection and should not beused as the sole basis for diagnosis,treatment or other managementdecisions. |
| Assay Target | hMPV | hMPV |
| SampleTypes | nasal and nasopharyngeal swabspecimens | nasopharyngeal swab |
| ExtractionMethods | bioMérieux easyMAG AutomatedMagnetic Extraction Reagents | Roche MagNA Pure LC Total NucleicAcid Isolation Kit or the bioMérieuxeasyMAG Automated MagneticExtraction Reagents |
| AssayMethodology | PCR-based system for detecting thepresence or absence of viral RNA inclinical specimens | PCR-based system for detecting thepresence or absence of viral RNA inclinical specimens |
| DetectionTechniques | Multiplex assay using differentreporter dyes for each target | Multiplex assay using differentreporter dyes for each target |
| Table 5.1: Subject Device and Comparator Device Comparison | ||
| Item | Subject DeviceQuidel Molecular hMPV Assay | Predicate DeviceProdesse ProFlu+ |
| Viral Targets | RNA polymerase gene | Nucleocapsid |
| LoD | The analytical sensitivity (limit ofdetection or LoD) of the QuidelMolecular hMPV assay wasdetermined using quantified(TCID50/mL) cultures of 4 hMPVstrains (A1, A2, B1, B2) seriallydiluted in negativenasopharyngeal matrix. Eachdilution was extracted using theNucliSENS easyMAG Systemand tested in replicates of 20 perconcentration of virus on both theApplied Biosystems® 7500 FastDx platform. Analyticalsensitivity (LoD) is defined as thelowest concentration at which95% of all replicates testedpositive, ranged from 10¹ to 10⁰TCID50/mL. | The analytical sensitivity (limit ofdetection or LoD) of the ProhMPV+ Assay was determinedusing quantified (TCID50/mL)cultures of 2 hMPV (subtype A2and subtype B2) strains seriallydiluted in nasopharyngeal clinicalmatrix. Each viral strain wasextracted using the Roche MagNAPure LC instrument and tested inreplicates of 20 per concentrationof virus.Analytical sensitivity (LoD) asdefined as the lowest concentrationat which ≥ 95% of all replicatestested positive, ranged from 10² –10¹ TCID50/mL. |
。
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Analytical Performance:
Reproducibility:
The reproducibility of the Quidel Molecular hMPV assay was evaluated at 3 laboratory sites. Reproducibility was assessed using a panel of 4 simulated samples that included a medium positive hMPV sample (2.65E+02 TCIDsy/mL), a low positive hMPV sample (1.06E+02 TCID50/mL), a high negative hMPV sample (1.59E+01 TCID50/mL) and a negative. Panels and controls were tested at each site by 2 operators for 5 days in triplicate (2 operators X 5 days X triplicate testing X 3 sites = 90 results per sample). The panels and controls were extracted using the bioMérieux easyMAG system and tested on the ABI 7500Fast Dx.
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| Table 5.2: Reproducibility | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PanelMember ID | Site 1 | Site 2 | Site 3 | TotalResults | ||||||
| Results | AVECt | %CV | Results | AVECt | %CV | Results | AVECt | %CV | ||
| hMPV HighNegative(1.59E+01TCID50/mL) | 10/30 | 33.36* | 5.08 | 10/30 | 32.76* | 3.38 | 0/30 | N/A | N/A | 20/90 |
| hMPV LowPositive(1.06E+02TCID50/mL) | 30/30 | 28.73 | 5.28 | 30/30 | 28.18 | 8.42 | 29/30 | 30.18 | 4.89 | 89/90 |
| hMPV MediumPositive .(2.65E+02TCID50/mL) | 30/30 | 25.09 | 6.65 | 30/30 | 25.18 | 7.63 | 30/30 | 26.58 | 5.68 | 90/90 |
| Negative Sample | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 |
| hMPV PositiveControl | 30/30 | 18.37 | 3.88 | 30/30 | 18.48 | 4.35 | 30/30 | 18.60 | 3.08 | 90/90 |
| Negative Control | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 |
- CV of positive results
The data from the combined sites indicates that the Quidel Molecular hMPV assay generates reproducible results for hMPV when tested with the ABI 7500 Fast Dx.
Limit of Detection
The analytical sensitivity (limit of detection or LoD) of the Quidel Molecular hMPV assay was determined using quantified (TCID50/mL) cultures of 4 hMPV strains (A1, A2, B1, B2) serially diluted in negative nasopharyngeal matrix. Each dilution was extracted using the NucliSENS easyMAG System and tested in replicates of 20 per concentration of virus on both the Applied Biosystems® 7500 Fast Dx platform. Analytical sensitivity (LoD) is defined as the lowest concentration at which 95% of all replicates tested positive.
| Table 5.3: Level of Detection | |
|---|---|
| Strain | FinalTCID50/mL LoD7500 Fast Dx |
| hMPV A1 | 5.29E+01 |
| hMPV A2 | 1.39E+01 |
| hMPV B1 | 3.15E+00 |
| hMPV B2 | 1.07E+01 |
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Analytical reactivity (inclusivity)
The reactivity of the Quidel Molecular hMPV assay was evaluated against multiple strains of hMPV. The clinical panel consisted of 12 hMPV strains (3 A-1, 2 A-2, 3 B-1, and 4 B-2). Each panel member was extracted using the NucliSens easyMAG instrument and tested in triplicate.
The Quidel Molecular hMPV assay detected 100% of the hMPV at 10° to 10° TCID50mL levels on both the Applied Biosystems® 7500 Fast Dx platform.
| Table 5.4: hMPV Inclusivity Panel | |||
|---|---|---|---|
| Subtype | Strain | TCID50/mL | (7500 Dx) |
| A1 | Italy | 1.11E+2 | Positive |
| B1 | Italy | 2.20E+0 | Positive |
| B2 | Italy | 4.50E+1 | Positive |
| B1 | Peru2-2002 G Gene | 4.17E+2 | Positive |
| B2 | Peru1-2002 G Gene | 1.26E+2 | Positive |
| B1 | Peru3-2003 G Gene | 1.26E+2 | Positive |
| B2 | Peru6-2003 | 5.01E+2 | Positive |
| A1 | IA3-2002 G Gene | 1.51E+2 | Positive |
| A1 | IA10-2003 | 3.80E+2 | Positive |
| B2 | IA18-2003 G Gene | 6.61E+2 | Positive |
| A2 | IA14-2003 G Gene | 1.95E+2 | Positive |
| A2 | Clinical Isolate | 1.05E+2 | Positive |
Analytical specificity (cross-reactivity)
The analytical specificity of the Quidel Molecular hMPV 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 105 to 1010 CFU/mL. Viruses were tested at concentrations of 103 to 108 TCIDso/mL. Samples were extracted using the NucliSENS easyMAG instrument and tested in triplicate. Analytical specificity of the Quidel Molecular hMPV assay was 100%.
| Table 5.5: Cross-reactivity | ||
|---|---|---|
| Organism ID | TCID50/mLor CFU/mL | hMPVResult |
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| Table 5.5: Cross-reactivity | ||
|---|---|---|
| Organism ID | TCID50/mLor CFU/mL | hMPVResult |
| RSV Long | 4.40E+04 | Negative |
| RSV Washington | 1.75E+04 | Negative |
| A/Mexico/4108/2009 | 1.40E+07 | Negative |
| B/Florida/04/2006 | 5.25E+05 | Negative |
| Adenovirus 1/Adenoid 71 | 5.67E+04 | Negative |
| Coronavirus 229E | 1.70E+06 | Negative |
| Coronavirus OC43 | 1.67E+06 | Negative |
| Coxsackievirus B4 | 2.43E+06 | Negative |
| Coxsackievirus B5/10/2006 | 2.28E+06 | Negative |
| Cytomegalovirus | 8.76E+05 | Negative |
| Echovirus 7 | 5.38E+08 | Negative |
| Echovirus 9 | 1.50E+06 | Negative |
| Echovirus 6 | 1.05E+08 | Negative |
| Echovirus 11 | 1.50E+05 | Negative |
| Enterovirus 71 | 2.68E+03 | Negative |
| Enterovirus 70 | 1.66E+05 | Negative |
| Epstein Barr Virus | 5,000cp/mL | Negative |
| HSV Type 1 Maclnytre strain | 1.95E+06 | Negative |
| HSV Type 2 G strain | 3.67E+06 | Negative |
| Rubeola | 3.78E+05 | Negative |
| Mumps virus | 8.43E+04 | Negative |
| Parainfluenza Type 1 | 2.50E+05 | Negative |
| Parainfluenza Type 2 | 2.20E+04 | Negative |
| Parainfluenza Type 3 | 9.10E+05 | Negative |
| Parainfluenza Type 4 | 9.57E+06 | Negative |
| Varicella Zoster Virus | 7.50E+02 | Negative |
| Bordetella pertussis | 1.04E+07 | Negative |
| Bordetella bronchiseptica | 2.55E+07 | Negative |
| Chlamydia trachomatis | 2.10E+05 | Negative |
| Legionella pneumophila | 2.05E+08 | Negative |
| Mycobacterium intracellulare | 6.90E+08 | Negative |
| Mycobacterium tuberculosis | 6.60E+07 | Negative |
| Mycobacterium avium | 1.36E+10 | Negative |
| Haemophilus influenzae | 5.90E+07 | Negative |
| Pseudomonas aeruginosa | 5.15E+07 | Negative |
| Table 5.5: Cross-reactivity | ||
| Organism ID | TCID50/mLor CFU/mL | hMPVResult |
| Proteus vulgaris | 2.65E+08 | Negative |
| Proteus mirabilis | 2.75E+07 | Negative |
| Neisseria gonorrhoeae | 2.15E+07 | Negative |
| Neisseria menigitidis | 1.85E+08 | Negative |
| Neisseria mucosa | 1.85E+08 | Negative |
| Klebsiella pneumoniae | 3.30E+07 | Negative |
| Escherichia coli | 6.80E+07 | Negative |
| Moraxella catarrhalis | 5.85E+07 | Negative |
| Corynebacterium diptheriae | 6.0E+05 | Negative |
| Lactobacillus plantarum | 1.03E+08 | Negative |
| Streptococcus pneumoniae | 4.5E+07 | Negative |
| Streptococcus pyogenes | 2.05E+08 | Negative |
| Streptococcus salivarius | 2.50E+06 | Negative |
| Staphylococcus epidermidis | 2.6E+07 | Negative |
| Staphylococcus aureus | 5.15E+08 | Negative |
| Candida albicans | 1.07E+06 | Negative |
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Clinical Performance:
Performance characteristics of the Quidel Molecular hMPV assay were established during a prospective study during the 2010-2011 respiratory virus season (January to March 2011). A total of 1116 specimens were evaluated in this study (742-fresh, 374frozen). Of the fresh specimens, 399 specimens were nasal swabs, and 343 were nasopharyngeal swabs. The fresh specimens were collected for routine respiratory virus testing at thirteen sites across the United States. The frozen specimens were collected and tested at two geographically distinct locations and were comprised of 374 nasopharyngeal swabs.
The 1116 specimens were tested by both the subject and a comparator device for human metapneumovirus RNA. Sixteen of these specimens were invalid on initial testing with the subject device (1.4%). Re-testing of the specimens according to the Interpretation algorithm described above also yielded invalid results. Thirty-six specimens were invalid on initial and repeat testing (as per the device's package insert) on the comparator device (3.2%). The invalid specimens have been removed from the additional analysis. The Table 5.6 below details the results for the remaining 1072 specimens.
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、
| Table 5.6: Clinical Performance Data | |||
|---|---|---|---|
| Nasal/nasopharyngealswab (N=1072) | FDA Cleared RT-PCR | ||
| Quidel Molecular | Positive | Negative | Total |
| Positive | 60 | 2* | 62 |
| Negative | 3 | 1007 | 1010 |
| Total | 63 | 1009 | 1072 |
| 95% CI | |||
| Positive PercentAgreement | 60/63 | 95.2% | 86.7 to99.0% |
| Negative PercentAgreement | 1007/1009 | 99.8% | 99.3% to100% |
· * Specimens negative for hMPV by sequence analysis
Conclusions
Quidel Molecular hMPV Assay yielded good positive and negative percent agreement for nasal and nasopharyngeal swabs when compared to a 510(k) cleared molecular device.
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Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. To the right of the text is an abstract symbol that resembles a stylized human figure or bird in flight.
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 1 5 2011
Re: K112490
Trade/Device Name: Quidel Molecular hMPV Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: Class II Product Code: OEM Dated: November 18, 2011 Received: November 21, 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
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Page 2 - Ronald H. Lollar
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 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Vouy attorn
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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Ouidel Corporation
Indication for Use Statement
510(k) Number (if known): K112490
Device Name: Ouidel Molecular hMPV Assay
Indication for Use:
The Quidel Molecular hMPV assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection of human metapneumovirus RNA in nasopharyngcal swab specimens from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of human metapneumovirus infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the four genetic sub-lineages of hMPV,
Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Tamare Feldberg
Division Sign-Off
tt1. Diagram
്ffice of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112490
§ 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.