(53 days)
Not Found
No
The device description details a standard RT-PCR assay for detecting viral nucleic acid. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis relies on fluorescent signal detection and comparison to a composite reference method, not on learned patterns or algorithms.
No
Explanation: This device is an in vitro diagnostic test designed to detect human Metapneumovirus (hMPV) nucleic acid for diagnostic purposes, not to treat or alleviate a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Pro hMPV+ Assay is "an in vitro diagnostic test for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid." It further clarifies that the detection of hMPV nucleic acid "aids in the diagnosis of human respiratory hMPV infection."
No
The device description clearly outlines the use of physical components such as nasopharyngeal swabs, viral transport medium, isolation instruments (MagNA Pure LC Instrument, NucliSENS® easyMAG™ System), reagents (MagNA Pure Total Nucleic Acid Isolation Kit, Automated Magnetic Extraction Reagents, Pro hMPV+ Supermix, enzymes), and a Real Time RT-PCR instrument (Cepheid SmartCycler® II). While software is likely involved in the operation of the instruments and analysis of the results, the device as a whole is a complex in vitro diagnostic system with significant hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Pro hMPV+ Assay is a Real Time RT-PCR in vitro diagnostic test for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid..."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
OEM
Device Description
The Pro hMPV+ Assay enables detection human Metapneumovirus and Internal Control nucleic acid. Nasopharyngeal swab specimens are collected from patients with signs and symptoms of a respiratory infection using a polyester, rayon or nylon tipped swab and placed into viral transport medium.
An Internal Control (IC) is added to each sample prior to nucleic acid isolation to monitor for inhibitors present in the specimens. The isolation and purification of the nucleic acids is performed using either a MagNA Pure LC Instrument (Roche) and the MagNA Pure Total Nucleic Acid Isolation Kit (Roche) or a NucliSENS® easyMAG™ System (bioMérieux) and the Automated Magnetic Extraction Reagents (bioMérieux).
The purified nucleic acids are added to Pro hMPV+ Supermix along with enzymes included in the Pro hMPV+ Assay Kit. The Pro hMPV+ Supermix contains oligonucleotide primers and target-specific oligonucleotide probes. The primers are complementary to highly conserved regions of genetic sequences for these respiratory viruses. The probes are dual-labeled with a reporter dye attached to the 5'-end and a quencher dye attached to the 3'-end.
Reverse transcription of the RNA in the sample into complementary DNA (cDNA) and subsequent amplification of DNA is performed in a Cepheid SmartCycler® II instrument. In this process, the probe anneals specifically to the template followed by primer extension and amplification. The Pro hMPV+ Assay is based on Taqman chemistry, which utilizes the 5' - 3' exonuclease activity of the Taq polymerase to cleave the probe thus separating the reporter dye from the quencher. This generates an increase in fluorescent signal upon excitation from a light source. With each cycle, additional reporter dye molecules are cleaved from their respective probes, further increasing fluorescent signal. The amount of fluorescence at any given cycle is dependent on the amount of amplification products present at that time. Fluorescent intensity is monitored during each PCR cycle by the SmartCyclerII instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal swab (NP) 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 1275 eligible NP swab samples were tested with the Pro hMPV+ Assay at the four clinical sites and by the composite reference methods at Prodesse. Of the Pro hMPV+ Assay run on all eligible specimens, 98.1% (1273/1298) of these specimens were successful on the first attempt. The remaining 25 specimens gave "Unresolved" results on the first attempt. Unresolved results occur when the sample is negative for both hMPV and the Internal Control, indicating potentially PCR-inhibiting samples. Of the 25 "Unresolved" specimens on the first attempt with sufficient sample for retest, 8.0% (2/25) gave a valid "negative" result on the second attempt. The remaining 23 samples were "Unresolved" on the second attempt, therefore, were not included in the analysis below. All 23 samples were tested negative by the composite reference methods.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance: Performance characteristics of the Pro hMPV+ Assay were established during a prospective study at 4 U.S. clinical laboratories during the 2008 respiratory virus season (January - March). Specimens used in the study represented excess nasopharyngeal (NP) swab specimens that were prospectively collected from symptomatic individuals suspected of respiratory infection, and were submitted for routine care or analysis by each site. Performance of the Pro hMPV+ Assay was assessed and compared to a predetermined algorithm that used composite reference methods. The composite reference methods consisted of two independent molecular (RT-PCR) tests for two separate gene targets of hMPV followed by bidirectional genetic sequencing. The two comparator methods targeted the Nucleocapsid gene (different region of the gene than targeted by the Pro hMPV+ assay) and the Fusion gene. True hMPV RNA positives were considered as any sample that had bi-directional sequencing data meeting pre-defined quality acceptance criteria for one or both gene targets that matched hMPV sequences deposited in the National Center for Biotechnology Information (NCBI) GenBank database (www.nebi.nlm.nih.gov). True hMPV RNA negatives were considered as any sample that was tested negative by both of the comparator methods. Nucleic acid extractions on the clinical samples were carried out using either the Roche MagNA Pure LC system or the bioMérieux NucliSENS easyMAG during the clinical study. Sample size: 1275. Key results: Percent Positive Agreement 94.1% (85.8% - 97.7%) 95% CI, Percent Negative Agreement 99.3% (98.7% - 99.7%) 95% CI.
Reproducibility: The reproducibility of the Pro hMPV+ Assay was evaluated at 3 laboratory sites. Reproducibility was assessed using a panel of 9 simulated samples that included medium positive, low positive (near the assay limit of detection) and "high negative" hMPV samples. Panels and controls were tested at each site by 2 operators for 5 days (9 samples and 3 controls X 2 operators X 5 days X 3 sites = 360). Nucleic acid extraction on the test panel samples were carried out using either the Roche MagNA Pure LC system (Clinical Trial Site #4) or the bioMérieux NucliSENS easyMAG (Site #1 and Site #2). The overall percent agreement with the expected result for the Pro hMPV+ Assay was 99.2%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Percent Positive Agreement 94.1% (85.8% - 97.7%) 95% CI
Percent Negative Agreement 99.3% (98.7% - 99.7%) 95% CI
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for Prodesse. The logo consists of a geometric shape on the left and the word "Prodesse" in a serif font on the right. Below the word "Prodesse" are the words "Real Time Solutions" in a smaller, sans-serif font. The geometric shape is a complex, three-dimensional object made up of many smaller shapes.
Koy2688
NOV - 7 2008
510(k) SUMMARY
November 6, 2008
CONTACT
Dr. Karen Harrington Prodesse, Inc. W229 N1870 Westwood Dr. Waukesha, WI 53186
NAME OF DEVICE
| Trade Name: | Pro hMPV+ Assay |
|---|---|
| Regulation Number: | 21 CFR 866.3980 |
| Classification Name: | OEM |
PREDICATE DEVICE
K063765 - ID-Tag Respiratory Virus Panel, Luminex Molecular Diagnostics, Inc.
INTENDED USE
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.
PRODUCT DESCRIPTION
The Pro hMPV+ Assay enables detection human Metapneumovirus and Internal Control nucleic acid. Nasopharyngeal swab specimens are collected from patients with signs and symptoms of a respiratory infection using a polyester, rayon or nylon tipped swab and placed into viral transport medium.
An Internal Control (IC) is added to each sample prior to nucleic acid isolation to monitor for inhibitors present in the specimens. The isolation and purification of the nucleic acids is performed using either a MagNA Pure LC Instrument (Roche) and the MagNA Pure Total Nucleic Acid Isolation Kit (Roche) or a NucliSENS® easyMAG™ System (bioMérieux) and the Automated Magnetic Extraction Reagents (bioMérieux).
The purified nucleic acids are added to Pro hMPV+ Supermix along with enzymes
1
Image /page/1/Picture/0 description: The image shows the logo for Prodesse. The logo consists of a geometric shape on the left and the word "Prodesse" on the right. Below the word "Prodesse" is the phrase "Real Time Solutions."
included in the Pro hMPV+ Assay Kit. The Pro hMPV+ Supermix contains oligonucleotide primers and target-specific oligonucleotide probes. The primers are complementary to highly conserved regions of genetic sequences for these respiratory viruses. The probes are dual-labeled with a reporter dye attached to the 5'-end and a quencher dye attached to the 3'-end (see table below).
| Analyte | Gene Targeted | Probe
Fluorophore | Absorbance
Peak | Emission
Peak | Instrument
Channel |
|--------------------------|---------------|----------------------|--------------------|------------------|-----------------------|
| human
Metapneumovirus | Nucleocapsid | FAM | 495 nm | 520 nm | FAM |
| Internal Control | NA | Quasar 670 | 647nm | 667nm | Cy5 |
Reverse transcription of the RNA in the sample into complementary DNA (cDNA) and subsequent amplification of DNA is performed in a Cepheid SmartCycler® II instrument. In this process, the probe anneals specifically to the template followed by primer extension and amplification. The Pro hMPV+ Assay is based on Taqman chemistry, which utilizes the 5' - 3' exonuclease activity of the Taq polymerase to cleave the probe thus separating the reporter dye from the quencher. This generates an increase in fluorescent signal upon excitation from a light source. With each cycle, additional reporter dye molecules are cleaved from their respective probes, further increasing fluorescent signal. The amount of fluorescence at any given cycle is dependent on the amount of amplification products present at that time. Fluorescent intensity is monitored during each PCR cycle by the SmartCyclerII instrument.
SUBSTANTIAL EQUIVALENCE
Clinical Performance
Performance characteristics of the Pro hMPV+ Assay were established during a prospective study at 4 U.S. clinical laboratories during the 2008 respiratory virus season (January - March). Specimens used in the study represented excess nasopharyngeal (NP) swab specimens that were prospectively collected from symptomatic individuals suspected of respiratory infection, and were submitted for routine care or analysis by each site. Demographic details for this patient population are summarized in the following table:
| Gender | Number of Subjects (Percentage of
Total) |
|----------------|---------------------------------------------|
| Female | 617 (48.4%) |
| Male | 654 (51.3%) |
| Not Determined | 4 (0.3%) |
| Age | |
| ≤ 5 years | 596 (46.7%) |
| 6 - 21 years | 254 (19.9%) |
| 22 - 59 years | 219 (17.2%) |
| ≥ 60 years | 206 (16.2%) |
| Not Determined | 0 (0.0%) |
2
Image /page/2/Picture/0 description: The image shows the logo for Prodesse Real Time Solutions. The logo consists of a geometric shape on the left and the word "Prodesse" on the right. Below the word "Prodesse" is the phrase "Real Time Solutions".
Performance of the Pro hMPV+ Assay was assessed and compared to a predetermined algorithm that used composite reference methods. The composite reference methods consisted of two independent molecular (RT-PCR) tests for two separate gene targets of hMPV followed by bidirectional genetic sequencing. The two comparator methods targeted the Nucleocapsid gene (different region of the gene than targeted by the Pro hMPV+ assay) and the Fusion gene. True hMPV RNA positives were considered as any sample that had bi-directional sequencing data meeting pre-defined quality acceptance criteria for one or both gene targets that matched hMPV sequences deposited in the National Center for Biotechnology Information (NCBI) GenBank database (www.nebi.nlm.nih.gov). True hMPV RNA negatives were considered as any sample that was tested negative by both of the comparator methods. Nucleic acid extractions on the clinical samples were carried out using either the Roche MagNA Pure LC system or the bioMérieux NucliSENS easyMAG during the clinical study.
A total of 1275 eligible NP swab samples were tested with the Pro hMPV+ Assay at the four clinical sites and by the composite reference methods at Prodesse. Of the Pro hMPV+ Assay run on all eligible specimens, 98.1% (1273/1298) of these specimens were successful on the first attempt. The remaining 25 specimens gave "Unresolved" results on the first attempt. Unresolved results occur when the sample is negative for both hMPV and the Internal Control, indicating potentially PCR-inhibiting samples. Of the 25 "Unresolved" specimens on the first attempt with sufficient sample for retest, 8.0% (2/25) gave a valid "negative" result on the second attempt. The remaining 23 samples were "Unresolved" on the second attempt, therefore, were not included in the analysis below. All 23 samples were tested negative by the composite reference methods.
| Composite Reference Methods | |||||
|---|---|---|---|---|---|
| Positive | Negative | Total | Comments | ||
| Pro hMPV+ | |||||
| Assay | Positive | 64 | 8 | 72 | Percent Positive Agreement 94.1% |
| (85.8% - 97.7%) 95% CI | |||||
| Negative | 4 | 1199 | 1203 | Percent Negative Agreement 99.3% | |
| (98.7% - 99.7%) 95% CI | |||||
| Total | 68 | 1207 | 1275 |
Reproducibility
The reproducibility of the Pro hMPV+ Assay was evaluated at 3 laboratory sites. Reproducibility was assessed using a panel of 9 simulated samples that included medium positive, low positive (near the assay limit of detection) and "high negative" hMPV samples. Panels and controls were tested at each site by 2 operators for 5 days (9 samples and 3 controls X 2 operators X 5 days X 3 sites = 360). Nucleic acid extraction on the test panel samples were carried out using either the Roche MagNA Pure LC system (Clinical Trial Site #4) or the
3
Image /page/3/Picture/0 description: The image shows the word "Prodesse" in a serif font, next to a geometric logo. The logo is a complex, three-dimensional shape composed of smaller triangles and quadrilaterals. The word "Prodesse" is written in a simple, elegant font, and is positioned to the right of the logo.
Real Time Solutions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
bioMérieux NucliSENS easyMAG (Site #1 and Site #2). The overall percent agreement with the expected result for the Pro hMPV+ Assay was 99.2%.
| | Panel
Member ID | hMPV A2
High
Negative* | hMPV A2
Low
Positive | hMPV A2
Moderate
Positive | hMPV B2
High
Negative* | hMPV B2
Low
Positive | hMPV B2
Moderate
Positive | hMPV
RNA
Control | Negative
Control* | Extraction
Control
hMPV A2 | |
|--------|-----------------------------------------------|------------------------------|----------------------------|---------------------------------|------------------------------|----------------------------|---------------------------------|------------------------|----------------------|----------------------------------|----------------------|
| | Concentration | 0.01 X LoD | 2 X LoD | 10 X LoD | 0.01 X LoD | 2 X LoD | 10 X LoD | NA | NA | NA | Total %
Agreement |
| | | 1 x 100
TCID50/mL | 2 x 102
TCID50/mL | 1 x 103
TCID50/mL | 1 x 101
TCID50/mL | 2 x 101
TCID50/mL | 1 x 102
TCID50/mL | | | | |
| Site 1 | Agreement
with
Expected
result | 15/15
(100%) | 15/15
(100%) | 15/15
(100%) | 15/15
(100%) | 15/15
(100%) | 15/15
(100%) | 10/10
(100%) | 10/10
(100%) | 10/10
(100%) | 120/120
(100%) |
| | Average Ct
Value | 26.6 | 29.2 | 27.1 | 27.5 | 29.3 | 26.6 | 32.5 | 26.2 | 33.1 | |
| | % CV | 1.53 | 2.84 | 1.21 | 1.97 | 2.20 | 1.68 | 0.81 | 0.80 | 2.73 | |
| Site 2 | Agreement
with
Expected
result | 15/15
(100%) | 14/15
(93.3%) | 15/15
(100%) | 15/15
(100%) | 13/15
(86.7%) | 15/15
(100%) | 10/10
(100%) | 10/10
(100%) | 10/10
(100%) | 117/120
(97.5%) |
| | Average Ct
Value | 25.8 | 30.7 | 26.9 | 26.9 | 30.7 | 26.3 | 32.8 | 25.6 | 32.9 | |
| | % CV | 0.54 | 3.95 | 2.88 | 1.44 | 4.14 | 1.25 | 1.37 | 0.98 | 4.86 | |
| Site 4 | Agreement
with
Expected
result | 15/15
(100%) | 15/15
(100%) | 15/15
(100%) | 15/15
(100%) | 15/15
(100%) | 15/15
(100%) | 10/10
(100%) | 10/10
(100%) | 10/10
(100%) | 120/120
(100%) |
| | Average Ct
Value | 27.4 | 30.5 | 27.8 | 28.5 | 29.4 | 27.0 | 33.6 | 27.6 | 28.8 | |
| | % CV | 1.45 | 2.15 | 2.13 | 3.00 | 3.80 | 2.50 | 1.09 | 1.87 | 3.08 | |
| | Total
Agreement
with Expected
result | 45/45
(100%) | 44/45
(97.8%) | 45/45
(100%) | 45/45
(100%) | 43/45
(95.6%) | 45/45
(100%) | 30/30
(100%) | 30/30
(100%) | 30/30
(100%) | 357/360
(99.2%) |
| | 95% CI | 92.1%-100% | 88.4%-99.6% | 92.1%-100% | 92.1%-100% | 85.2%-98.8% | 92.1%-100% | 88.6%-100% | 88.6%-100% | 88.6%-100% | 97.6%-99.7% |
| | Overall
Average Ct
Value | 26.6 | 30.1 | 27.63 | 27.6 | 29.7 | 26.6 | 33.0 | 26.5 | 31.6 | |
| | Overall %CV | 2.85 | 3.73 | 2.57 | 3.29 | 3.97 | 2.16 | 1.72 | 3.49 | 7.36 | |
·
Overall %CV - 2.85 - 2.85 - 2.85 - - - 3.73 - - - 3.73 - - - 2.85
- Average Ct value calculated for the Internal Control (IC)
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Image /page/4/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol, which is three curved shapes that resemble a person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged vertically along the left side of the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Karen Harrington Manager, Clinical Affairs Prodesse, Inc. W229 N1870 Westwood Drive Waukesha, WI 53186
NOV - 7 2008
Re: K082688
Trade/Device Name: Pro 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: September 12th, 2008 Received: September 15th, 2008
Dear Ms. Harrington:
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. Iisting 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 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); 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
5
Page 2 -
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 2 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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-049. 1, Alea, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-34710 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attym
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
6
Indication for Use
510(k) Number (if known): K082688
Device Name: Pro hMPV+ Assay
Indication For Use:
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 conservired 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.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 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)
Uwe Schaf
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
6082688 510(k)