(227 days)
No
The summary describes a standard RT-PCR assay for detecting viral RNA, which is a well-established molecular diagnostic technique that does not inherently involve AI or ML. There are no mentions of AI, ML, or related concepts in the document.
No
This device is an in vitro diagnostic test intended to detect and identify viral RNA, aiding in the diagnosis of infections, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that this is an "in vitro qualitative detection and identification" assay and is "intended to aid in the differential diagnosis of respiratory syncytial virus and human metapneumovirus infections." This clearly defines it as a diagnostic device.
No
The device description explicitly states that the assay is performed utilizing either the Cepheid SmartCycler® II or the Applied Biosystems 7500 Fast DX, which are hardware instruments. The device is a diagnostic kit that relies on these instruments for its function, not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic test is intended to aid in the differential diagnosis of respiratory syncytial virus and human metapneumovirus infections." This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Quidel Molecular RSV + hMPV assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and identification of respiratory syncytial virus and human metapneumovirus viral RNA extracted from nasal and nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of respiratory syncytial virus and human metapneumovirus infections. This test is not intended to differentiate the four genetic sub-lineages of hMPV.
Negative results do not preclude RSV or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Product codes
OEM, OCC
Device Description
The Quidel Molecular RSV + 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 either the Cepheid SmartCycler® II or the Applied Biosystems 7500 Fast DX. Identification of RSV and hMPV and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of RSV and hMPV and the PRC.
The following is a summary of the procedure:
- I. Sample Collection: Obtain nasal or nasopharyngeal swabs specimens using standard techniques from symptomatic patients. Transport, store, and process these specimens according to established laboratory procedures.'
-
- Nucleic Acid Extraction: Extract Nucleic Acids from the specimens with the NucliSENS® easyMAG® System following the manufacturer's instructions and using the appropriate reagents (See Materials Required but Not Provided).
Prior to the extraction procedure, add 20 uL of the Process Control (PRC) to each 180 µL aliquot of specimen. The PRC serves to monitor inhibitors in the extracted specimen, assures that adequate amplification has taken place, and confirms that the nucleic acid extraction was sufficient.
-
- Rehydration of Master Mix: Rehydrate the lyophilized Master Mix using the Rehydration Solution. The Master Mix contains oligonucleotide primers, fluorophore and quencher-labeled probes targeting conserved regions of RSV and hMPV, as well as the process control sequence.
-
- Nucleic Acid Amplification and Detection: Add 15 µL of the rehydrated Master Mix to each reaction tube or plate well. Then add 5 uL of extracted nucleic acids (specimen with PRC) to the plate well or appropriately labeled reaction tube. Place the tube or plate into either the SmartCycler® II or 7500 Fast Dx instruments, respectively.
Once the reaction tube or plate is added to the instrument, initiate the assay protocol. This protocol initiates reverse transcription of the RNA targets generating complementary DNA, and the subsequent amplification of the target amplicons occurs. The Quidel Molecular RSV + hMPV assay is based on TagMan® 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 50 cycles on the SmartCycler® II or 35 cycles on the ABI 7500 Fast Dx, 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 swabs 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
Performance characteristics of the Ouidel Molecular RSV + hMPV assay using the Cepheid SmartCycler® II instrument and the Applied Biosystems® 7500 Fast Dx platform were established during a prospective study during the 2012 respiratory virus season (January to March 2012). Samples used for this study were fresh (414) and frozen (600) swab specimens that were collected for routine respiratory virus testing four sites across the United States. A single specimen was collected per patient and tested (direct specimen DFA and culture with DFA) for RSV immediately after collection. The specimens were extracted with the bioMériuex easyMAG and tested with Ouidel Molecular RSV + hMPV assay. Aliquots of each specimen were sent to a central location for testing with a FDA Cleared hMPV molecular test.
Cepheid SmartCycler® II
One thousand and fourteen (1014) specimens were tested by both the subject and comparative methods for RSV. Five specimens were contaminated in cell culture (0.5%). Results for the remaining 1009 specimens are detailed in the table below.
Nine hundred and sixty (960) specimens were tested by both the subject and comparative devices for hMPV (the comparator device was unavailable to complete comparison testing). Nine specimens were invalid in the comparative device (0.9%). Results for the remaining 951 specimens are detailed in the table below.
Applied Biosystems 7500 Fast Dx
One thousand and fourteen (1014) specimens were tested by both the subject and comparative methods for RSV. Five specimens were contaminated in cell culture (0.5%). Two specimens were invalid in the subject methods (0.2%). Results for the remaining 1,007 specimens are detailed in the table below.
Nine hundred and fifty seven (957) specimens were tested by both the subject and comparative devices for hMPV (the comparator device was unavailable to complete comparison testing). Nine (9) specimens were invalid in the comparative device (0.9%). Two (2) specimens were invalid in the subject methods (0.2%). Results for the remaining 946 specimens are detailed in the table below.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance:
Reproducibility:
The reproducibility of the Quidel Molecular Influenza RSV + hMPV assay was evaluated at 3 laboratory sites. Reproducibility was assessed using a panel of 4 simulated samples that include medium (5x LoD) and low (2x LoD), high negative (0.3x LoD) RSV, hMPV and negative samples. Panels and controls were tested at each site by 2 operators for 5 days (triplicate testing x 2 operators x 5 days x 3 sites = 90 results per level for each virus). The LoD values are based on the values obtained in the LoD study. The panels and controls were extracted using the bioMérieux easyMAG system and tested on the Cepheid SmartCycler® II and the Applied Biosystems® 7500 Fast Dx.
Limit of Detection
The analytical sensitivity (limit of detection or LoD) of the Quidel Molecular RSV + hMPV assay was determined using quantified (TCID50/mL) cultures of 2 RSV strains and 4 hMPV strains (1 A1, 1 A2, 1 B1, 1B2) serially diluted in negative nasopharyngeal matrix. Each dilution was extracted in replicates of 20 per concentration of virus using the NucliSENS easyMAG System and tested on both the 7500 Fast Dx or Cepheid SmartCycler® II platforms. Analytical sensitivity (LoD) is defined as the lowest concentration at which 95% of all replicates tested positive.
Analytical reactivity (inclusivity)
The reactivity of the Quidel Molecular RSV + hMPV assay was evaluated against multiple strains of RSV and hMPV. The clinical panel consisted of 13 RSV strains and 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.
Analytical specificity (cross-reactivity)
The analytical specificity of the Quidel Molecular RSV + hMPV assay was evaluated by testing a panel consisting of 27 viruses, 24 bacteria and 1 yeast strain representing common respiratory pathogens or flora commonly present in nasopharynx. Samples were extracted using the NucliSENS easyMAG instrument and tested in triplicate. Analytical specificity of the Quidel Molecular RSV + hMPV assay was 100%.
Clinical Performance:
Cepheid SmartCycler® II
- RSV: 1009 specimens. Sensitivity 97.9%, Specificity 97.6%.
- hMPV: 951 specimens. Positive percent agreement 96.7%, Negative percent agreement 99.6%.
Applied Biosystems 7500 Fast Dx
- RSV: 1007 specimens. Sensitivity 98.6%, Specificity 96.8%.
- hMPV: 946 specimens. Positive percent agreement 98.0%, Negative percent agreement 99.3%.
Key results:
Quidel Molecular RSV + hMPV Assay yielded good sensitivity and specificity for RSV. with nasal and nasopharyngeal swabs when compared to a direct specimen DFA and cell culture with DFA.
Quidel Molecular RSV + hMPV Assay yielded good positive and negative percent agreement with nasal and nasopharyngeal swabs compared to a 510(k) cleared molecular device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cepheid SmartCycler® II
RSV:
Sensitivity: 97.9% (95% CI: 93.9% - 99.3%)
Specificity: 97.6% (95% CI: 96.3% - 98.4%)
Prevalence: 13.9%
hMPV:
Positive percent agreement: 96.7% (95% CI: 92.4% - 98.6%)
Negative percent agreement: 99.6% (95% CI: 98.9% - 99.9%)
Prevalence: 15.8%
Applied Biosystems 7500 Fast Dx
RSV:
Sensitivity: 98.6% (95% CI: 94.9% - 99.6%)
Specificity: 96.8% (95% CI: 95.4% - 97.8%)
Prevalence: 13.9%
hMPV:
Positive percent agreement: 98.0% (95% CI: 94.3% - 99.3%)
Negative percent agreement: 99.3% (95% CI: 98.4% - 99.7%)
Prevalence: 15.9%
Predicate Device(s)
Gen-Probe Prodesse ProFlu+ (K092500), Gen-Probe Prodesse Pro hMPV+ (K082688)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K 122189
MAR
1
Quidel Corporation
Quidel Molecular RSV + hMPV Assay 7/20/2012 Page 1 of 15
Section 05, 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:
July 20, 2012
Device Name:
Trade name - Quidel Molecular RSV + hMPV Assay Classification name - Respiratory viral panel multiplex nucleic acid assay Product Code - OEM. OCC Regulation - 21 CFR 866.3980
Legally marketed devices to which equivalence is claimed:
Gen-Probe Prodesse ProFlu+ (K092500)
The ProFluTM+ Assay is a multiplex Real-Time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from symptomatic patients. This test is intended for use to aid in the differential diagnosis of Influenza A, Influenza B and RSV viral infections in humans and is not intended to detect Influenza C.
Negative results do not preclude influenza or RSV virus infection and should not be used as the sole basis for treatment or other management decisions. It is recommended that negative RSV results be confirmed by culture.
1
Performance characteristics for Influenza A Virus were established when Influenza A/H3 and A/H1 were the predominant Influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
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.
Intended Use:
The Ouidel Molecular RSV + hMPV assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and identification of respiratory syncytial virus and human metapneumovirus viral RNA extracted from nasal and nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of respiratory syncytial virus and human metapneumovirus infections. This test is not intended to differentiate the four genetic sub-lineages of hMPV.
Negative results do not preclude RSV or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Device Description:
The Quidel Molecular RSV + 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
2
viruses present in the sample. This reaction is performed utilizing either the Cepheid SmartCycler® II or the Applied Biosystems 7500 Fast DX. Identification of RSV and hMPV and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of RSV and hMPV and the PRC.
The following is a summary of the procedure:
- I. Sample Collection: Obtain nasal or nasopharyngeal swabs specimens using standard techniques from symptomatic patients. Transport, store, and process these specimens according to established laboratory procedures.'
-
- Nucleic Acid Extraction: Extract Nucleic Acids from the specimens with the NucliSENS® easyMAG® System following the manufacturer's instructions and using the appropriate reagents (See Materials Required but Not Provided).
Prior to the extraction procedure, add 20 uL of the Process Control (PRC) to each 180 µL aliquot of specimen. The PRC serves to monitor inhibitors in the extracted specimen, assures that adequate amplification has taken place, and confirms that the nucleic acid extraction was sufficient.
-
- Rehydration of Master Mix: Rehydrate the lyophilized Master Mix using the Rehydration Solution. The Master Mix contains oligonucleotide primers, fluorophore and quencher-labeled probes targeting conserved regions of RSV and hMPV, as well as the process control sequence.
-
- Nucleic Acid Amplification and Detection: Add 15 µL of the rehydrated Master Mix to each reaction tube or plate well. Then add 5 uL of extracted nucleic acids (specimen with PRC) to the plate well or appropriately labeled reaction tube. Place the tube or plate into either the SmartCycler® II or 7500 Fast Dx instruments, respectively.
Once the reaction tube or plate is added to the instrument, initiate the assay protocol. This protocol initiates reverse transcription of the RNA targets generating complementary DNA, and the subsequent amplification of the target amplicons occurs. The Quidel Molecular RSV + hMPV assay is based on TagMan® 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
3
.
fluorescence is achieved by 50 cycles on the SmartCycler® II or 35 cycles on the ABI 7500 Fast Dx, the sample is reported as positive for the detected nucleic acid.
Device Comparison
.
The Quidel Molecular RSV + hMPV assay will be compared to legally marketed RT-PCR assays. The characteristics of Quidel Molecular RSV + hMPV assay ("Subject Device") and the Prodesse ProFlu + and Pro hMPV+ ("Predicate Devices") are described in the table below:
| Subject Device and Comparator Device Comparison | |||
|---|---|---|---|
| Item | Subject Device | ||
| Quidel Molecular | |||
| RSV + hMPV Assay | Predicate Device | ||
| Prodesse ProFlu+ | Predicate Device | ||
| Prodesse ProhMPV+ | |||
| Intended Use | The Quidel Molecular | ||
| RSV + hMPV assay is | |||
| a multiplex Real Time | |||
| RT-PCR assay for the | |||
| in vitro qualitative | |||
| detection and | |||
| identification of | |||
| respiratory syncytial | |||
| virus and human | |||
| metapneumovirus | |||
| viral RNA extracted | |||
| from nasal and | |||
| nasopharyngeal swabs | |||
| specimens with signs | |||
| and symptoms of | |||
| respiratory infection. | |||
| This in vitro | |||
| diagnostic test is | |||
| intended to aid in the | |||
| differential diagnosis | |||
| of respiratory | |||
| syncytial virus and | |||
| human | |||
| metapneumovirus | |||
| infections. This test is | |||
| not intended to | The ProFlu™+ Assay | ||
| is a multiplex Real- | |||
| Time PCR (RT-PCR) | |||
| in vitro diagnostic test | |||
| for the rapid and | |||
| qualitative detection | |||
| and discrimination of | |||
| Influenza A Virus, | |||
| Influenza B Virus, and | |||
| Respiratory Syncytial | |||
| Virus (RSV) nucleic | |||
| acids isolated and | |||
| purified from | |||
| nasopharyngeal (NP) | |||
| swab specimens | |||
| obtained from | |||
| symptomatic patients. | |||
| This test is intended | |||
| for use to aid in the | |||
| differential diagnosis | |||
| of Influenza A, | |||
| Influenza B and RSV | |||
| viral infections in | |||
| humans and is not | |||
| intended to detect | |||
| Influenza C | 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 |
4
| Item | Subject Device
Quidel Molecular | Predicate Device
Prodesse ProFlu+ | Predicate Device
Prodesse ProhMPV+ | | |
|------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | RSV + hMPV Assay | | | | |
| | differentiate the four
genetic sub-lineages
of hMPV.
Negative results do
not preclude RSV or
hMPV infection and
should not be used as
the sole basis for
diagnosis, treatment
or other patient
management
decisions. | Negative results do not
preclude influenza or
RSV virus infection
and should not be used
as the sole basis for
treatment or other
management decisions.
It is recommended that
negative RSV results
be confirmed by
culture.
Performance
characteristics for
Influenza A Virus
were established when
Influenza A/H3 and
A/H1 were the
predominant Influenza
A viruses in
circulation. When
other Influenza A
viruses are emerging,
performance
characteristics may
vary.
If infection with a
novel Influenza A
virus is suspected
based on current
clinical and
epidemiological
screening criteria
recommended by | 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. | | |
5
| Subject Device and Comparator Device Comparison | |||
|---|---|---|---|
| Item | Subject Device | ||
| Quidel Molecular | |||
| RSV + hMPV Assay | Predicate Device | ||
| Prodesse ProFlu+ | Predicate Device | ||
| Prodesse ProhMPV+ | |||
| 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. | |||
| Assay Target | respiratory syncytial | ||
| virus, hMPV | Influenza A virus, | ||
| influenza B virus, | |||
| respiratory syncytial | |||
| virus | hMPV | ||
| Sample | |||
| Types | nasal swab, | ||
| nasopharyngeal swab | nasopharyngeal swab | 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 | 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 | 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 | Multiplex assay using | ||
| different reporter dyes | |||
| for each target | |||
| Viral Targets | RSV: L viral | ||
| polymerase and NS2 | |||
| genes | Influenza A: Matrix | ||
| Gene; | |||
| Influenza B: Non- | Nucleocapsid | ||
| Subject Device and Comparator Device Comparison | |||
| Item | Subject Device | ||
| Quidel Molecular | |||
| RSV + hMPV Assay | Predicate Device | ||
| Prodesse ProFlu+ | Predicate Device | ||
| Prodesse ProhMPV+ | |||
| hMPV: RNA | |||
| polymerase gene | structural NS1 and | ||
| NS2 | |||
| LoD | The analytical | ||
| sensitivity (limit of | |||
| detection or LoD) of | |||
| the Quidel Molecular | |||
| hMPV assay was | |||
| determined using | |||
| quantified | |||
| (TCID50/mL) cultures | |||
| of 2 RSV strains and | |||
| 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 | |||
| 10 -1 to 101 | |||
| TCID50/mL. | The analytical | ||
| sensitivity (limit of | |||
| detection or LoD) of | |||
| the ProFlu+ Assay was | |||
| determined using | |||
| quantified | |||
| (TCID50/mL) cultures | |||
| of 4 Influenza A (2 | |||
| H1N1 and 2 H3N2), 2 | |||
| Influenza B, 2 | |||
| Respiratory Syncytial | |||
| Virus Type A, and 2 | |||
| Respiratory Syncytial | |||
| Virus Type B 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 to 101 | |||
| 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. |
·
6
Quidel Molecular RSV + hMPV Assay 7/20/2012
Section 05, Page 7 of 15
7
Analytical Performance:
Reproducibility:
The reproducibility of the Quidel Molecular Influenza RSV + hMPV assay was evaluated at 3 laboratory sites. Reproducibility was assessed using a panel of 4 simulated samples that include medium (5x LoD) and low (2x LoD), high negative (0.3x LoD) RSV, hMPV and negative samples. Panels and controls were tested at each site by 2 operators for 5 days (triplicate testing x 2 operators x 5 days x 3 sites = 90 results per level for each virus). The LoD values are based on the values obtained in the LoD study. The panels and controls were extracted using the bioMérieux easyMAG system and tested on the Cepheid SmartCycler® II and the Applied Biosystems® 7500 Fast DX.
| Reproducibility Results - Cepheid SmartCycler | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Panel Member | ||||||||||
| ID | Site 1 | Site 2 | Site 3 | Total | ||||||
| Results | ||||||||||
| Results | AVE | |||||||||
| Ct | %CV | Results | AVE | |||||||
| Ct | %CV | Results | AVE | |||||||
| Ct | %CV | |||||||||
| RSV High | ||||||||||
| Negative 0.06x | ||||||||||
| LoD | 18/30 | 43.15 | 9.84 | 18/30 | 41.9 | 11.0 | 7/30 | 45.3 | 11.8 | 43/90 |
| RSV Low | ||||||||||
| Positive | ||||||||||
| 2x LoD | 29/29 | 31.79 | 6.32 | 30/30 | 31.2 | 4.1 | 30/30 | 31.9 | 4.4 | 89/89 |
| RSV Med | ||||||||||
| Positive 5x | ||||||||||
| LoD | 30/30 | 30.35 | 9.57 | 30/30 | 29.7 | 2.5 | 30/30 | 29.2 | 9.1 | 90/90 |
| RSV Negative | 1/30 | 48.50 | N/A | 0/30 | N/A | N/A | 1/30 | 43.0 | N/A | 2/90 |
| RSV Negative | ||||||||||
| Control | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
| RSV Positive | ||||||||||
| Control | 30/30 | 28.25 | 5.31 | 30/30 | 27.5 | 2.9 | 30/30 | 26.8 | 9.7 | 90/90 |
| hMPV High | ||||||||||
| Negative 0.06x | ||||||||||
| LoD | 25/30 | 37.27 | 10.75 | 20/30 | 40.43 | 7.75 | 11/30 | 42.3 | 5.4 | 56/90 |
| hMPV Low | ||||||||||
| Positive | ||||||||||
| 2x LoD | 30/30 | 32.35 | 7.68 | 30/30 | 31.55 | 3.19 | 30/30 | 32.2 | 3.5 | 90/90 |
| hMPV Med | ||||||||||
| Positive 5x | ||||||||||
| LoD | 30/30 | 30.19 | 4.01 | 30/30 | 29.95 | 2.02 | 30/30 | 30.4 | 1.7 | 90/90 |
| hMPV | ||||||||||
| Negative | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
| hMPVNegative | ||||||||||
| Control | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
| hMPV Positive | ||||||||||
| Control | 30/30 | 27.51 | 2.53 | 30/30 | 26.83 | 2.37 | 30/30 | 27.0 | 1.1 | 90/90 |
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| Reproducibility Results - Applied Biosystems 7500 Fast Dx | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Panel Member | ||||||||||
| ID | Site 1 | Site 2 | Site 3 | Total | ||||||
| Results | ||||||||||
| Results | AVE Ct | %CV | Results | AVE Ct | %CV | Results | AVE Ct | %CV | ||
| RSV High | ||||||||||
| Negative 0.06x | ||||||||||
| LoD | 4/30 | 26.4 | 18.2 | 5/30 | 34.6 | 1.0 | 7/30 | 31.7 | 9.1 | 16/90 |
| RSV Low | ||||||||||
| Positive | ||||||||||
| 2x LoD | 30/30 | 24.5 | 6.64 | 30/30 | 22.8 | 7.3 | 30/30 | 24.5 | 8.8 | 90/90 |
| RSV Med | ||||||||||
| Positive 5x | ||||||||||
| LoD | 30/30 | 21.02 | 5.57 | 30/30 | 20.8 | 6.2 | 30/30 | 21.5 | 8.4 | 90/90 |
| RSV Negative | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
| RSV Negative | ||||||||||
| Control | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
| RSV Positive | ||||||||||
| Control | 30/30 | 19.2 | 3.75 | 30/30 | 7.21 | 2.8 | 30/30 | 7.8 | 8.0 | 90/90 |
| hMPV High | ||||||||||
| Negative 0.06x | ||||||||||
| LoD | 6/30 | 28.5 | 20.9 | 2/30 | 31.6 | 0.67 | 10/30 | 27.3 | 13.2 | 18/90 |
| hMPV Low | ||||||||||
| Positive | ||||||||||
| 2x LoD | 27/30 | 24.5 | 11.07 | 30/30 | 24.6 | 12.4 | 30/30 | 24.6 | 12.8 | 87/90 |
| hMPV Med | ||||||||||
| Positive 5x | ||||||||||
| LoD | 29/30 | 23.1 | 7.58 | 30/30 | 23.3 | 4.9 | 30/30 | 21.7 | 6.4 | 89/90 |
| hMPV | ||||||||||
| Negative | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
| hMPVNegative | ||||||||||
| Control | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
| hMPV Positive | ||||||||||
| Control | 30/30 | 18.89 | 2.49 | 30/30 | 11.8 | 2.5 | 30/30 | 11.4 | 4.2 | 90/90 |
The data from the combined sites indicates that the Quidel Molecular RSV + hMPV assay generates reproducible results for RSV and hMPV when tested with the Cepheid SmartCycler® Il and the Applied Biosystems® 7500 Fast Dx.
Limit of Detection
The analytical sensitivity (limit of detection or LoD) of the Quidel Molecular RSV + hMPV assay was determined using quantified (TCID50/mL) cultures of 2 RSV strains and 4 hMPV strains (1 A1, 1 A2, 1 B1, 1B2) serially diluted in negative nasopharyngeal matrix. Each dilution was extracted in replicates of 20 per concentration of virus using the NucliSENS easyMAG System and tested on both the 7500 Fast Dx or Cepheid SmartCycler® II platforms. Analytical sensitivity (LoD) is defined as the lowest concentration at which 95% of all replicates tested positive.
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| LoD Value Summary for the 7500 Fast Dx & SmartCycler | ||
|---|---|---|
| Virus | LoD TCID50/mL 7500 Fast Dx | LoD TCID50/mL |
| SmartCycler | ||
| RSV A | 6.29E-01 | 1.89E+00 |
| RSV B | 7.5E-01 | 7.5E-01 |
| hMPV-A1 | 1.7E+01 | 2.645E+01 |
| hMPV-A2 | 2.91E+00 | 2.91E+00 |
| hMPV-B1 | 1.05E+00 | 7.88E+00 |
| hMPV-B2 | 2.25E+00 | 2.25E+00 |
Analytical reactivity (inclusivity)
The reactivity of the Quidel Molecular RSV + hMPV assay was evaluated against multiple strains of RSV and hMPV. The clinical panel consisted of 13 RSV strains and 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.
| RSV Inclusivity Panel | ||||
|---|---|---|---|---|
| Subtype | Strain | TCID 50/mL | (7500 Dx) | (SmartCycler) |
| A | Long | $1.89E+0$ | Positive | Positive |
| A | A-2 | $9.38E-1$ | Positive | Positive |
| B | Washington | $1.58E0$ | Positive | Positive |
| B | 9320 | $1.95E+0$ | Positive | Positive |
| NA | WC-026 | NA | Positive | Positive |
| NA | WC-189 | NA | Positive | Positive |
| NA | MHIA - 0022 | NA | Positive | Positive |
| NA | MHIA - 0020 | NA | Positive | Positive |
| NA | MHIA - 0016 | NA | Positive | Positive |
| NA | Chile - 424 | NA | Positive | Positive |
| NA | Chile - 457 | NA | Positive | Positive |
| NA | WC - 229 | NA | Positive | Positive |
| NA | WC - 192 | NA | Positive | Positive |
Sec05 Summary_QM_RSV + hMPV
10
| hMPV Inclusivity Panel | ||||
|---|---|---|---|---|
| Subtype | Strain | TCID50/mL | (7500 Dx) | (SmartCycler) |
| A1 | Italy | 1.11E+2 | Positive | Positive |
| B1 | Italy | 2.20E+0 | Positive | Positive |
| B2 | Italy | 4.50E+1 | Positive | Positive |
| B1 | Peru2-2002 G Gene | 4.17E+2 | Positive | Positive |
| B2 | Peru1-2002 G Gene | 1.26E+2 | Positive | Positive |
| B1 | Peru3-2003 G Gene | 1.26E+2 | Positive | Positive |
| B2 | Peru6-2003 | 5.01E+2 | Positive | Positive |
| A1 | IA3-2002 G Gene | 1.51E+2 | Positive | Positive |
| A1 | IA10-2003 | 3.80E+2 | Positive | Positive |
| B2 | IA18-2003 G Gene | 6.61E+2 | Positive | Positive |
| A2 | IA14-2003 G Gene | 1.95E+2 | Positive | Positive |
| A2 | Clinical Isolate | 1.05E+2 | Positive | Positive |
Analytical specificity (cross-reactivity)
The analytical specificity of the Quidel Molecular RSV + hMPV assay was evaluated by testing a panel consisting of 27 viruses, 24 bacteria and 1 yeast strain representing common respiratory pathogens or flora commonly present in nasopharynx. Samples were extracted using the NucliSENS easyMAG instrument and tested in triplicate. Analytical specificity of the Quidel Molecular RSV + hMPV assay was 100%.
Organisms used for the study were the following:
Viruses
Influenza A/Mexico/4108/2009, Influenza B/Florida/04/2006, Adenovirus 1/Adenoid 71, Adenovirus 2, Adenovirus 3, Adenovirus 4, Adenovirus 5, Adenovirus 7, Adenovirus 11, Adenovirus 14, Adenovirus 31, Coronavirus NL63, Coronavirus 229E. Coronavirus OC43, Coxsackievirus B4, Coxsackievirus B5/10/2006, Cytomegalovirus, Echovirus 7, Echovirus 9, Echovirus 6, Echovirus
11
- Enterovirus 71. Enterovirus 70, Epstein Barr Virus, HSV Type 1 Maclnytre strain. Human Rhinovirus. HSV Type 2 G strain. Measles virus. Mumps virus. Parainfluenza Type 1, Parainfluenza Type 2, Parainfluenza Type 3, Parainfluenza Type 4. Varicella Zoster Virus
Bacteria
Bordetella pertussis. . Bordetella bronchiseptica, Chlamydophila pneumonia. Chlamydia trachomatis, Legionella pneumophila, Mycobacterium intracellulare, Mvcobacterium tuberculosis. Mycobacterium avium. Mycoplasma pneumoniae, Haemophilus influenza. Pseudomonas aeruginosa, Proteus vulgaris, Proteus mirabilis. Neisseria gonorrhoeae, Neisseria menigitidis, Neisseria mucosa, Klebsiella pneumonia, Escherichia coli, Moraxella catarrhalis, Corynebacterium diptheriae, Lactobacillus plantarum, Streptococcus pneumonia, Streptococcus pyogenes, Streptococcus salivarius, Staphylococcus epidermidis, Staphylococcus aureus
Yeast
Candida albicans
Clinical Performance:
Performance characteristics of the Ouidel Molecular RSV + hMPV assay using the Cepheid SmartCycler® II instrument and the Applied Biosystems® 7500 Fast Dx platform were established during a prospective study during the 2012 respiratory virus season (January to March 2012). Samples used for this study were fresh (414) and frozen (600) swab specimens that were collected for routine respiratory virus testing four sites across the United States. A single specimen was collected per patient and tested (direct specimen DFA and culture with DFA) for RSV immediately after collection. The specimens were extracted with the bioMériuex easyMAG and tested with Ouidel Molecular RSV + hMPV assay. Aliquots of each specimen were sent to a central location for testing with a FDA Cleared hMPV molecular test.
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Cepheid SmartCycler® II
One thousand and fourteen (1014) specimens were tested by both the subject and comparative methods for RSV. Five specimens were contaminated in cell culture (0.5%). Results for the remaining 1009 specimens are detailed in the table below.
| Combined Site - Respiratory syncytial virus | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| DSFA & Cell | ||||||||||
| Culture | ||||||||||
| w/DFA | 95% CI | |||||||||
| POS | NEG | Total | Sensitivity | 97.9% | 93.9% | 99.3% | ||||
| QM RSV + | ||||||||||
| hMPV | POS | 137 | 21* | 158 | Specificity | 97.6% | 96.3% | 98.4% | ||
| NEG | 3 | 848 | 851 | |||||||
| Total | 140 | 869 | 1009 | Prevalence | 13.9% |
- All originally discordant specimens were positive for RSV by an FDA-cleared RT-PCR assay. All specimens were also positive for RSV by bi-directional sequence analysis.
Nine hundred and sixty (960) specimens were tested by both the subject and comparative devices for hMPV (the comparator device was unavailable to complete comparison testing). Nine specimens were invalid in the comparative device (0.9%). Results for the remaining 951 specimens are detailed in the table below.
| Combined Site - Human metapneumovirus | ||||||||
|---|---|---|---|---|---|---|---|---|
| Pro hMPV+ | 95% CI | |||||||
| POS | NEG | Total | Positive percent agreement | 96.7% | 92.4% | 98.6% | ||
| QM RSV + hMPV | POS | 145 | 3* | 148 | Negative percent agreement | 99.6% | 98.9% | 99.9% |
| NEG | 5 | 798 | 803 | |||||
| Total | 150 | 801 | 951 | Prevalence | 15.8% |
- All originally discordant specimens were positive for hMPV by bi-directional sequence analysis.
13
Applied Biosystems 7500 Fast Dx
One thousand and fourteen (1014) specimens were tested by both the subject and comparative methods for RSV. Five specimens were contaminated in cell culture (0.5%). Two specimens were invalid in the subject methods (0.2%). Results for the remaining 1,007 specimens are detailed in the table below.
| Combined Site - Respiratory syncytial virus | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| DSFA & Cell | |||||||||
| Culture w/DFA | 95% CI | ||||||||
| POS | NEG | Total | Sensitivity | 98.6% | 94.9% | 99.6% | |||
| QM RSV + hMPV | POS | 138 | 28* | 166 | Specificity | 96.8% | 95.4% | 97.8% | |
| NEG | 2 | 839 | 841 | ||||||
| Total | 140 | 867 | 1007 | Prevalence | 13.9% |
*25 of 28 originally discordant specimens were positive for RSV by a FDA-cleared RT-PCR assay. 27 of 28 specimens were positive for RSV by bi-directional sequence analysis.
Nine hundred and fifty seven (957) specimens were tested by both the subject and comparative devices for hMPV (the comparator device was unavailable to complete comparison testing). Nine (9) specimens were invalid in the comparative device (0.9%). Two (2) specimens were invalid in the subject methods (0.2%). Results for the remaining 946 specimens are detailed in the table below.
| Combined Site - Human metapneumovirus | ||||||||
|---|---|---|---|---|---|---|---|---|
| Pro hMPV+ | 95% CI | |||||||
| POS | NEG | Total | Positive | |||||
| percent | ||||||||
| agreement | 98.0% | 94.3% | 99.3% | |||||
| QM RSV + | ||||||||
| hMPV | POS | 147 | 6* | 153 | Negative | |||
| percent | ||||||||
| agreement | 99.3% | 98.4% | 99.7% | |||||
| NEG | 3 | 790 | 793 | |||||
| Total | 150 | 796 | 946 | Prevalence | 15.9% |
- All originally discordant specimens were positive for hMPV by bi-directional sequence analysis.
Conclusions
Quidel Molecular RSV + hMPV Assay yielded good sensitivity and specificity for RSV. with nasal and nasopharyngeal swabs when compared to a direct specimen DFA and cell culture with DFA.
14
Quidel Molecular RSV + hMPV Assay 7/20/2012 . Section 05, Page 15 of 15
Quidel Molecular RSV + hMPV Assay yielded good positive and negative percent agreement with nasal and nasopharyngeal swabs compared to a 510(k) cleared molecular device.
.
15
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/15/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Quidel Corporation C/O Ronald H. Lollar 1055 East State Street, Suite 100 Athens, Ohio 45701
March 8, 2013
Re: K122189
Trade/Device Name: Quidel® Molecular RSV + hMPV Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: Class II Product Code: OEM, OCC Dated: January 28, 2013 Received: January 29, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
16
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 Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Uwesschierf -S for
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
17
510(k) Number (if known): K122189
Device Name: Quidel® Molecular RSV + hMPV Assay
Indication for Use:
The Quidel Molecular RSV + hMPV assay is a multiplex Real Time RT-PCR assay for the qualitative detection and identification of respiratory syncytial virus and human metapneumovirus RNA extracted from nasal and nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of respiratory syncytial virus and human metapneumovirus infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV.
Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Prescription Use Over-The-Counter Use AND/OR X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tamara V. Feldblyum -S 2013.03.08 15:11:17 -05'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health 510(k) K122189