(108 days)
Not Found
No
The summary describes a standard RT-PCR assay and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
Explanation: The device is an in vitro diagnostic (IVD) test that qualitatively detects human metapneumovirus RNA, intended as an aid in diagnosis. It does not provide treatment or directly affect the body to restore health.
Yes
The device is intended for the in vitro qualitative detection of human metapneumovirus RNA and is used as an aid in the differential diagnosis of human metapneumovirus infections.
No
The device description explicitly mentions the use of hardware components like the NucliSENS® easyMAG® automated extraction platform and the Applied Biosystems 7500 Fast Dx platform for sample processing and analysis. This indicates it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "in vitro qualitative detection of human metapneumovirus RNA". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device analyzes "nasal and nasopharyngeal swab specimens," which are biological samples taken from a patient.
- Purpose: The test is intended as an "aid in the differential diagnosis of human metapneumovirus infections in humans," which is a diagnostic purpose.
- Device Description: The description details how the device detects viral nucleic acids extracted from a patient sample, further confirming its role in analyzing biological material outside the body for diagnostic purposes.
N/A
Intended Use / Indications 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OEM
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and nasopharyngeal swab specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance:
Reproducibility:
Study type: Reproducibility
Sample size: 90 results per sample (2 operators X 5 days X triplicate testing X 3 sites = 90 results per sample) for each of 4 simulated samples and 2 controls.
Key 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.
| Panel Member ID | Site 1 Results | AVE Ct | %CV | Site 2 Results | AVE Ct | %CV | Site 3 Results | AVE Ct | %CV | Total Results |
|---|---|---|---|---|---|---|---|---|---|---|
| hMPV High Negative (1.59E+01 TCID50/mL) | 10/30 | 33.36* | 5.08 | 10/30 | 32.76* | 3.38 | 0/30 | N/A | N/A | 20/90 |
| hMPV Low Positive (1.06E+02 TCID50/mL) | 30/30 | 28.73 | 5.28 | 30/30 | 28.18 | 8.42 | 29/30 | 30.18 | 4.89 | 89/90 |
| hMPV Medium Positive (2.65E+02 TCID50/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 Positive Control | 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 |
Limit of Detection (LoD):
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.
| Strain | Final TCID50/mL LoD 7500 Fast Dx |
|---|---|
| hMPV A1 | 5.29E+01 |
| hMPV A2 | 1.39E+01 |
| hMPV B1 | 3.15E+00 |
| hMPV B2 | 1.07E+01 |
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.
Key result: 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.
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.
Key result: Analytical specificity of the Quidel Molecular hMPV assay was 100%.
Clinical Performance:
Study type: Prospective study
Sample size: 1072 specimens (after removing invalid results)
Key results: 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.
| Nasal/nasopharyngeal swab (N=1072) | FDA Cleared RT-PCR Positive | FDA Cleared RT-PCR Negative | Total |
|---|---|---|---|
| Quidel Molecular Positive | 60 | 2* | 62 |
| Quidel Molecular Negative | 3 | 1007 | 1010 |
| Total | 63 | 1009 | 1072 |
- Specimens negative for hMPV by sequence analysis
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement: 95.2% (95% CI: 86.7 to 99.0%)
Negative Percent Agreement: 99.8% (95% CI: 99.3% to 100%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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:
3
.
| Table 5.1:
| Subject Device and Comparator Device Comparison | ||
|---|---|---|
| Item | Subject Device | |
| Quidel Molecular hMPV Assay | Predicate Device | |
| Prodesse ProFlu+ | ||
| 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 differentialdiagnosis 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 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. |
| Assay Target | hMPV | hMPV |
| Sample
Types | nasal and nasopharyngeal swab
specimens | nasopharyngeal swab |
| Extraction
Methods | bioMérieux easyMAG Automated
Magnetic Extraction Reagents | Roche MagNA Pure LC Total Nucleic
Acid Isolation Kit or the bioMérieux
easyMAG Automated Magnetic
Extraction Reagents |
| Assay
Methodology | PCR-based system for detecting the
presence or absence of viral RNA in
clinical specimens | PCR-based system for detecting the
presence or absence of viral RNA in
clinical specimens |
| Detection
Techniques | Multiplex assay using different
reporter dyes for each target | Multiplex assay using different
reporter dyes for each target |
| Table 5.1: Subject Device and Comparator Device Comparison | | |
| Item | Subject Device
Quidel Molecular hMPV Assay | Predicate Device
Prodesse ProFlu+ |
| Viral Targets | RNA polymerase gene | Nucleocapsid |
| LoD | 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, ranged from 10¹ to 10⁰
TCID50/mL. | The analytical sensitivity (limit of
detection or LoD) of the Pro
hMPV+ Assay was determined
using quantified (TCID50/mL)
cultures of 2 hMPV (subtype A2
and subtype B2) strains serially
diluted in nasopharyngeal clinical
matrix. Each viral strain was
extracted using the Roche MagNA
Pure LC instrument and tested in
replicates of 20 per concentration
of virus.
Analytical sensitivity (LoD) as
defined as the lowest concentration
at which ≥ 95% of all replicates
tested positive, ranged from 10² –
10¹ TCID50/mL. |
。
4
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.
5
| Table 5.2: Reproducibility | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Panel | ||||||||||
| Member ID | Site 1 | Site 2 | Site 3 | Total | ||||||
| Results | ||||||||||
| Results | AVE | |||||||||
| Ct | %CV | Results | AVE | |||||||
| Ct | %CV | Results | AVE | |||||||
| Ct | %CV | |||||||||
| hMPV High | ||||||||||
| Negative | ||||||||||
| (1.59E+01 | ||||||||||
| TCID50/mL) | 10/30 | 33.36* | 5.08 | 10/30 | 32.76* | 3.38 | 0/30 | N/A | N/A | 20/90 |
| hMPV Low | ||||||||||
| Positive | ||||||||||
| (1.06E+02 | ||||||||||
| TCID50/mL) | 30/30 | 28.73 | 5.28 | 30/30 | 28.18 | 8.42 | 29/30 | 30.18 | 4.89 | 89/90 |
| hMPV Medium | ||||||||||
| Positive . | ||||||||||
| (2.65E+02 | ||||||||||
| TCID50/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 Positive | ||||||||||
| Control | 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 | Final |
| TCID50/mL LoD | |
| 7500 Fast Dx | |
| hMPV A1 | 5.29E+01 |
| hMPV A2 | 1.39E+01 |
| hMPV B1 | 3.15E+00 |
| hMPV B2 | 1.07E+01 |
6
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/mL | |
| or CFU/mL | hMPV | |
| Result |
7
| Table 5.5: Cross-reactivity | ||
|---|---|---|
| Organism ID | TCID50/mL | |
| or CFU/mL | hMPV | |
| Result | ||
| 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/mL | |
| or CFU/mL | hMPV | |
| Result | ||
| 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.
9
、
| Table 5.6: Clinical Performance Data | |||
|---|---|---|---|
| Nasal/nasopharyngeal | |||
| swab (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 Percent | |||
| Agreement | 60/63 | 95.2% | 86.7 to |
| 99.0% | |||
| Negative Percent | |||
| Agreement | 1007/1009 | 99.8% | 99.3% to |
| 100% |
· * 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.
10
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
11
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