PROFLU+ ASSAY
Device Facts
| Record ID | K073029 |
|---|---|
| Device Name | PROFLU+ ASSAY |
| Applicant | Prodesse, Inc. |
| Product Code | OCC · Microbiology |
| Decision Date | Jan 4, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3980 |
| Device Class | Class 2 |
Intended Use
The ProFlu™ Assay is a multiplex Real Time 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. A negative test is presumptive and it is recommended these results be confirmed by cell culture. 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. 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 infections 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.
Device Story
ProFlu+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test; detects/discriminates Influenza A, Influenza B, and RSV nucleic acids. Input: nasopharyngeal swab specimens collected in viral transport medium. Process: nucleic acid isolation/purification via Roche MagNA Pure LC Instrument/Kit; addition of ProFlu+ Supermix (primers/probes); reverse transcription and amplification on Cepheid SmartCycler II instrument. Principle: Taqman chemistry; 5'-3' exonuclease activity cleaves dual-labeled probes; generates fluorescent signal proportional to amplification products. Output: real-time fluorescent intensity monitored by SmartCycler. Used in clinical laboratories; operated by trained laboratory personnel. Results aid clinicians in differential diagnosis of respiratory viral infections; negative results are presumptive and require confirmation by cell culture.
Clinical Evidence
Prospective (n=891) and retrospective (n=60) clinical studies compared ProFlu+ Assay to rapid culture (shell vial) and DFA. Prospective study sensitivity: Influenza A 100%, Influenza B 97.8%, RSV 89.5%. Specificity: Influenza A 92.6%, Influenza B 98.6%, RSV 94.9%. Retrospective study sensitivity: Influenza A 100%, Influenza B 89.5%, RSV 100%. Specificity: Influenza A 96.4%, Influenza B 100%, RSV 97.3%. Reproducibility study (n=450) showed 98% overall agreement.
Technological Characteristics
Multiplex Real Time RT-PCR assay; Taqman chemistry; uses oligonucleotide primers/probes targeting conserved viral genetic regions. Instrumentation: Roche MagNA Pure LC (extraction), Cepheid SmartCycler II (amplification/detection). Detection channels: FAM (Flu A), TET (RSV A/B), Texas Red (Flu B), Cy5 (Internal Control). Software: Cepheid SmartCycler Dx version 1.7b. Reagents include M-MLV reverse transcriptase, RNase inhibitor, and Taq DNA polymerase.
Indications for Use
Indicated for symptomatic patients requiring differential diagnosis of Influenza A, Influenza B, and RSV viral infections. Not intended for detection of Influenza C.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- xTAG™ RVP (Respiratory Viral Panel) (k063765)
Related Devices
- K081030 — MODIFICATION TO PROFLU+ ASSAY · Prodesse, Inc. · May 2, 2008
- K132129 — PRODESSE PROFLU+ ASSAY · Gen-Probe Prodesse, Inc. · Aug 9, 2013
- K092500 — MODIFICATION TO PROFLU+ ASSAY · Prodesse, Inc. · Aug 20, 2009
Submission Summary (Full Text)
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#### 510(k) SUMMARY
October 25, 2007
JAN - 4 203
#### CONTACT
Dr. Karen Harrington Prodesse, Inc. W229 N1870 Westwood Dr. Waukesha, WI 53186
#### NAME OF DEVICE
Trade Name: Requlation Number: Classification Name: ProFlu+ Assay 21 CFR 866.3980 Respiratory Virus Panel Multiplex
#### PREDICATE DEVICE
xTAG Respiratory Viral Panel Luminex Molecular Diagnostics
#### INTENDED USE
The ProFlu+™ Assay is a multiplex Real Time 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 nasopharynqeal (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.
A negative test is presumptive and it is recommended these results be confirmed by cell culture. 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.
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 infections with a novel Influenza A virus are 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
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testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
### PRODUCT DESCRIPTION
The ProFlu+ Assay enables detection and differentiation of Influenza A Virus, Influenza B Virus, Respiratory Syncytial Virus (RSV) (Types A and B), and Internal Control. Nasopharyngeal swab specimens are collected from svmptomatic patients using a polvester, 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 a MagNA Pure LC Instrument (Roche) and the MagNA Pure Total Nucleic Acid Isolation Kit (Roche).
The purified nucleic acids are added to ProFlu+ Supermix along with enzymes included in the ProFlu+ Detection Kit. The ProFlu+ 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<br>Peak | Emission<br>Peak | Instrument<br>Channel |
|-------------------|-------------------------------|-------------------|--------------------|------------------|-----------------------|
| Influenza A Virus | Matrix | FAM | 495 nm | 520 nm | FAM |
| RSV A | Polymerase | Cal Orange 560 | 540 nm | 561 nm | TET |
| RSV B | Polymerase | Cal Orange 560 | 540 nm | 561 nm | TET |
| Influenza B Virus | Non-structural<br>NS1 and NS2 | Cal Red 610 | 595 nm | 615 nm | Texas Red |
| Internal Control | NA | Quasar 670 | 647 nm | 667 nm | Cy5 |
Reverse transcription of the RNA in the sample into complementary DNA (cDNA) and subsequent amplification of DNA is performed in a Cepheid SmartCvcler® II instrument. In this process, the probe anneals specifically to the template followed by primer extension and amplification. The ProFlu+ Assay is based on Tagman chemistry, which utilizes the 5' - 3' exonuclease activity of the Tag 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 SmartCycler instrument.
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## SUBSTANTIAL EQUIVALENCE
#### Clinical Performance
Performance characteristics of the ProFlu+ Assay were established during a prospective study at 3 U.S. clinical laboratories and a retrospective study at 1 U.S. site during the 2007 respiratory virus season (February - April). Samples used for this study were nasopharyngeal (NP) swab specimens that were collected for routine influenza or RSV testing by each site.
The reference method was rapid culture (shell vial) followed by direct fluorescent antibody (DFA) screening and identification.
A total of 891 NP swab samples were tested with the ProFlu+ Assay and by culture. Five (5) samples that initially gave unresolved results remained unresolved upon retesting with the ProFlu+ Assay and are not included in the analysis below. All 5 samples were culture negative.
A total of 23 samples were DFA Respiratory Virus Screen positive (screening reagent detects Influenza A and B, RSV, Parainfluenza 1, 2 and 3 and Adenovirus), but contained too few cells to obtain a specific positive identification. 21 of these 23 samples were also positive by the ProFlu+ Assay (9 Influenza A positive, 11 Influenza B positive and 1 RSV positive) and genetic sequencing analysis confirmed the identification of the specific virus. The other 2 DFA screen positive samples were negative by the ProFlu+ Assay and sequence analysis confirmed that they were negative for Influenza A, Influenza B and RSV; these 2 samples were considered true negatives. Discrepant analysis for samples where ProFlu+ Assay and culture results were in disagreement was performed using RT-PCR with virus specific primers obtained from literature followed by sequencing.
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## Results from Prospective Study:
### Influenza A Comparison Results
| | Reference Method | | | |
|----------|------------------|----------|-------|------------------------------------------|
| | Positive | Negative | Total | Comments |
| Positive | 127 | 52a | 179 | Sensitivity 100% (97.1% - 100%) 95% CI |
| Negative | 0 | 647 | 647 | Specificity 92.6% (90.4% - 94.3%) 95% CI |
| Total | 127 | 699 | 826 | |
ª Forty-three (43) samples positive for Influenza A by sequence analysis, 8 samples negative for Influenza A by sequence analysis, and 1 sample unavailable for sequence analysis.
### Influenza B Comparison Results
| | Reference Method | | | |
|------------------------------|------------------|----------|-------|------------------------------------------|
| | Positive | Negative | Total | Comments |
| ProFlu+<br>Assay<br>Positive | 45 | 11a | 56 | Sensitivity 97.8% (88.7% - 99.6%) 95% CI |
| ProFlu+<br>Assay<br>Negative | 1b | 769 | 770 | Specificity 98.6% (97.5% - 99.2%) 95% CI |
| ProFlu+<br>Assay<br>Total | 46 | 780 | 826 | |
ª Eleven (11) samples positive for Influenza B by sequence analysis.
º One (1) sample negative for Influenza B by sequence analysis.
One (1) sample negative for Influenza B by sequence analysis.
### RSV Comparison Results
| | Reference Method | | | | |
|---------------|------------------|----------|-------|-----|------------------------------------------|
| | Positive | Negative | Total | | |
| ProFlu+ Assay | Positive | 34a | 40a | 74 | Sensitivity 89.5% (75.9% - 95.8%) 95% CI |
| | Negative | 4b | 748 | 752 | Specificity 94.9% (93.2% - 96.2%) 95% CI |
| | Total | 38 | 788 | 826 | |
8 Thirty-four (34) samples positive for RSV by sequence analysis, 3 samples negative for RSV by sequence analysis, and 3 samples unavailable for sequence analysis.
ر One (1) sample positive for RSV by sequence analysis and 3 samples negative for RSV by sequence analysis.
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## Results from Retrospective Study
# Influenza A Comparison Results
| ProFlu+ Assay | Reference Method | | | Comments |
|---------------|------------------|----------|-------|------------------------------------------|
| | Positive | Negative | Total | |
| Positive | 5 | 2a | 7 | Sensitivity 100% (56.6% - 100%) 95% CI |
| Negative | 0 | 53 | 53 | Specificity 96.4% (87.7% - 99.0%) 95% CI |
| Total | 5 | 55 | 60 | |
ª One (1) samples positive for Influenza A by sequence analysis and 1 sample negative for Influenza A by sequence analysis
# Influenza B Comparison Results
| | | Reference Method | | | |
|---------------|----------|------------------|----------|-------|------------------------------------------|
| | | Positive | Negative | Total | Comments |
| ProFlu+ Assay | Positive | 17 | 0 | 17 | Sensitivity 89.5% (68.6% - 97.1%) 95% CI |
| | Negative | 2a | 41 | 43 | Specificity 100% (91.4% - 100%) 95% CI |
| | Total | 19 | 41 | 60 | |
Two (2) samples positive for Influenza B by sequence analysis.
### RSV Comparison Results
| | | Reference Method | | | |
|------------------|----------|------------------|----------|-------|------------------------------------------|
| | | Positive | Negative | Total | |
| ProFlu+<br>Assay | Positive | 23 | 1a | 24 | Sensitivity 100% (85.7% - 100%) 95% CI |
| | Negative | 0 | 36 | 36 | Specificity 97.3% (86.2% - 99.5%) 95% CI |
| | Total | 23 | 37 | 60 | |
a One sample positive for RSV by sequence analysis.
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# Reproducibility
The reproducibility of the ProFlu+ Assay was evaluated at 3 laboratory sites. Reproducibility was assessed using a panel of 10 simulated samples that included medium and low (near the assay limit of detection) Influenza A, Influenza B, or RSV positive and negative samples. Panels and controls were tested at each site by 2 operators for 5 days (10 samples and 5 controls X 2 operators X 5 days X 3 sites = 450). The overall percent agreement for the ProFlu+ Assay was 98%.
| Panel<br>Member ID | Site 1 | | | Site 2 | | | Site 3 | | | Total<br>Agreement with<br>expected<br>result (%) | 95%<br>Confidence<br>Interval |
|-----------------------------------|-----------------------------------------|-----------|------|-----------------------------------------|-----------|------|-----------------------------------------|-----------|------|---------------------------------------------------|-------------------------------|
| | Agreement<br>with<br>expected<br>result | AVE<br>CT | %CV | Agreement<br>with<br>expected<br>result | AVE<br>CT | %CV | Agreement<br>with<br>expected<br>result | AVE<br>CT | %CV | | |
| Negative (2<br>Panel<br>Members) | 20/20 | 30.5 | 3.2% | 20/20 | 31.2 | 7.1% | 19*/20 | 32.2 | 2.4% | 59/60<br>(98%) | 91% - 100% |
| Influenza A<br>Low Positive | 10/10 | 36.0 | 3.3% | 9/10 | 36.4 | 3.9% | 7/10 | 37.8 | 5.3% | 26/30<br>(87%) | 70% - 95% |
| Influenza A<br>Medium<br>Positive | 10/10 | 32.6 | 1.4% | 10/10 | 33.4 | 4.0% | 10/10 | 33 | 2.5% | 30/30<br>(100%) | 89% - 100% |
| Influenza B<br>Low Positive | 10/10 | 32.7 | 1.4% | 10/10 | 32.6 | 1.4% | 10/10 | 32.2 | 1.9% | 30/30<br>(100%) | 89% - 100% |
| Influenza B<br>Medium<br>Positive | 10/10 | 30.5 | 1.3% | 10/10 | 30.1 | 0.7% | 10/10 | 29.7 | 0.8% | 30/30<br>(100%) | 89% - 100% |
| RSV A Low<br>positive | 8/10 | 30.1 | 8.3% | 8/10 | 32.5 | 6.2% | 8/10 | 30.7 | 6.8% | 24/30<br>(80%) | 63% - 90% |
| RSV A<br>medium<br>positive | 10/10 | 29.5 | 3.0% | 10/10 | 29.5 | 3.0% | 10/10 | 29.2 | 2.7% | 30/30<br>(100%) | 89% - 100% |
| RSV B low<br>positive | 10/10 | 31.9 | 3.5% | 10/10 | 32.3 | 5.5% | 10/10 | 31.8 | 5.1% | 30/30<br>(100%) | 89% - 100% |
| RSV B<br>medium<br>positive | 10/10 | 29.5 | 1.9% | 10/10 | 29.5 | 4.0% | 10/10 | 28.7 | 4.2% | 30/30<br>(100%) | 89% - 100% |
| Influenza A<br>RNA Control | 10/10 | 33.5 | 1.6% | 10/10 | 32.9 | 4.2% | 10/10 | 34.4 | 0.9% | 30/30<br>(100%) | 89% - 100% |
| Influenza B<br>RNA Control | 10/10 | 32.8 | 1.4% | 10/10 | 32.1 | 3.1% | 10/10 | 33.8 | 1.3% | 30/30<br>(100%) | 89% - 100% |
| RSV A RNA<br>Control | 10/10 | 33.7 | 1.8% | 10/10 | 32.3 | 3.1% | 10/10 | 34.8 | 1.5% | 30/30<br>(100%) | 89% - 100% |
| RSV B RNA<br>Control | 10/10 | 32.1 | 1.6% | 10/10 | 31.9 | 4.3% | 10/10 | 35.2 | 2.5% | 30/30<br>(100%) | 89% - 100% |
| Negative<br>Control | 10/10 | 28.9 | 4.0% | 10/10 | 29.6 | 5.2% | 10/10 | 30.2 | 1.4% | 30/30<br>(100%) | 89% - 100% |
| Total<br>Agreement<br>All | 148/150 (99%) | | | 147/150 (98%) | | | 144/150 (96%) | | | 439/450<br>(98%) | 96% - 99% |
* 1 negative sample Unresolved (IC = FAIL). C- values for Influenza A, Influenza B and RSV were negative, however.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FDA CDRH DMC
4 2008 JAN
Received
Re: k073029
Waukesha. WI 53186
Prodesse, Inc.
Karen Harrington, Ph.D.
Manager, Clinical Affairs
W229 N1870 Westwood Dr.
Trade/Device Name: ProFluTM Plus Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: Class II Product Code: OCC Dated: October 25, 2007 Received: October 26, 2007
Dear Dr. 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, 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 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).
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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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, 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 240-276-3474. 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 attaym
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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# Indication for Use
510(k) Number (if known):
12073029
Device Name: ProFlu+ Assay
Indication For Use:
The ProFlu+™ Assay is a multiplex Real Time 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.
A negative test is presumptive and it is recommended these results be confirmed by cell culture. 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.
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 infections with a novel Influenza A virus are 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.
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 (OVD)
Ule Schef
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
(1)(k) 2073029
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