PROPARAFLU+ASSAY
Device Facts
| Record ID | K091053 |
|---|---|
| Device Name | PROPARAFLU+ASSAY |
| Applicant | Prodesse, Inc. |
| Product Code | OOU · Microbiology |
| Decision Date | Nov 20, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3980 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence, Pediatric |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K091053 · Nov 20, 2009 | PROPARAFLU+ASSAY | Prodesse, Inc. | Excess nasopharyngeal (NP) swab specimens from routine clinical care; Frozen clinical NP swab samples | The sponsor used prospective and retrospective clinical cohorts to establish the clinical performance (sensitivity and specificity) of the ProParaflu+ Assay compared to standard-of-care cell culture/DFA methods. | Prospective clinical study; Retrospective clinical study; Excess clinical specimens; Clinical performance |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| ProParaflu+ Prospective Study; Prospective clinical study; Follow-up/Duration: May 2008 - September 2009; Study Period: May 2008 - September 2009 | Symptomatic individuals suspected of respiratory infection; Sample Size: 857; Number of Sites: 4 | Cell culture (rapid or traditional) followed by direct fluorescent antibody (DFA) screening | Sensitivity and specificity for HPIV-1, HPIV-2, and HPIV-3 |
| ProParaflu+ Retrospective Study; Retrospective study | Symptomatic individuals; Sample Size: 91 | Direct fluorescent antibody (DFA) | Sensitivity and specificity for HPIV-1 |
Indications for Use
The ProParaflu+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of Parainfluenza 1 Virus, Parainfluenza 2 Virus and Parainfluenza 3 Virus (HPIV-1, HPIV-2 and HPIV-3) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections. This assay targets the conserved regions of the Hemagglutinin-Neuraminidase (HN) gene of HPIV-1, HPIV-2 and HPIV-3, respectively. The detection and discrimination of HPIV-1, HPIV-2 and HPIV-3 nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings. This test is not intended to detect Parainfluenza 4a or Parainfluenza 4b Viruses. Negative test results are presumptive and should be confirmed by cell culture. Negative results do not preclude Parainfluenza 1, 2 or 3 virus infections and should not be used as the sole basis for treatment or other management decisions.
Device Story
ProParaflu+ Assay is a multiplex Real Time RT-PCR test for HPIV-1, HPIV-2, and HPIV-3. Input: nucleic acids extracted from nasopharyngeal swabs using bioMérieux NucliSENS easyMAG or Roche MagNA Pure LC. Process: Taqman-based RT-PCR amplification on Cepheid SmartCycler II instrument; primers target conserved HN gene regions; dual-labeled probes (FAM, Cal Orange 560, Cal Red 610) generate fluorescent signals upon cleavage by Taq polymerase. Output: qualitative detection/discrimination of HPIV types. Used in clinical laboratories by trained personnel. Results interpreted via instrument software to aid diagnosis alongside clinical findings. Benefits: rapid identification of specific HPIV types to support clinical management.
Clinical Evidence
Clinical performance established via prospective study (n=857) and retrospective study (n=91) comparing ProParaflu+ to cell culture/DFA. Prospective sensitivity: HPIV-1 88.9%, HPIV-2 96.3%, HPIV-3 97.3%. Specificity: HPIV-1 99.9%, HPIV-2 99.8%, HPIV-3 99.2%. Reproducibility study (3 sites, 12-member panel) showed 97.8% overall agreement.
Technological Characteristics
Multiplex Real Time RT-PCR assay. Targets: HPIV-1, HPIV-2, HPIV-3 HN genes. Chemistry: Taqman (5'-3' exonuclease activity). Instrumentation: Cepheid SmartCycler II. Detection: Fluorescence-based (FAM, Cal Orange 560, Cal Red 610, Quasar 670). Extraction: Automated (NucliSENS easyMAG or MagNA Pure LC).
Indications for Use
Indicated for symptomatic individuals of all ages exhibiting signs/symptoms of respiratory tract infection. Used for qualitative detection and discrimination of HPIV-1, HPIV-2, and HPIV-3 nucleic acids from nasopharyngeal swab specimens. Not intended for HPIV-4a or HPIV-4b detection.
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
- ID Tag Respiratory Virus Panel, Luminex Molecular Diagnostics (K063765)
Submission Summary (Full Text)
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K09/053
Page 1 of 7 Date: November 5, 2009
## Attachment D 510(k) SUMMARY
#### CONTACT
NOV 2 0 2009
Karen Harrington Gen-Probe Prodesse, Inc. W229 N1870 Westwood Dr. Waukesha, WI 53186
### NAME OF DEVICE
Trade Name: Regulation Number: Classification Name:
ProParaflu+TM Assay 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay
## PREDICATE DEVICE
K063765 - ID Tag Respiratory Virus Panel, Luminex Molecular Diagnostics
#### INTENDED USE
The ProParaflu+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of Parainfluenza 1 Virus, Parainfluenza 2 Virus and Parainfluenza 3 Virus (HPIV-1, HPIV-2 and HPIV-3) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections. This assay targets the conserved regions of the Hemagglutinin-Neuraminidase (HN) gene of HPIV-1, HPIV-2 and HPIV-3, respectively. The detection and discrimination of HPIV-1, HPIV-2 and HPIV-3 nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings. This test is not intended to detect Parainfluenza 4a or Parainfluenza 4b Viruses.
Negative test results are presumptive and should be confirmed by cell culture. Negative results do not preclude Parainfluenza 1, 2 or 3 virus infections and should not be used as the sole basis for treatment or other management decisions.
#### PRODUCT DESCRIPTION
The ProParaflu+ Assay enables the detection and differentiation of Parainfluenza 1 Virus, Parainfluenza 2 Virus, Parainfluenza 3 Virus and an Internal Control (IC) nucleic acid. Nasopharyngeal swab specimens from symptomatic patients using a polyester, rayon or nylon tipped swab and place into viral transport medium. The IC is added to every sample prior to nucleic acid extraction to monitor for inhibitors present in the specimens.
Isolation and purification of nucleic acids is performed using the bioMérieux NucliSENS
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easyMAG automated extractor and the Automated Magnetic Extraction Reagents or the Roche MagNA Pure LC Instrument and the MagNA Pure Total Nucleic Acid Isolation Kit.
The purified nucleic acids are added to the ProParaflu+ Supermix along with enzymes included in the ProParaflu+ Detection Kit. The ProParaflu+ Supermix contains oligonucleotide primers that are complementary to highly conserved regions of hemagglutinin neuraminidase gene for each human Parainfluenza type (1, 2 and 3). 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).
RT-PCR amplification is performed in a Cepheid SmartCycler® II instrument. During this process, the primers and probes anneal specifically to the template (if present) followed by primer extension and amplification. The ProParaflu+ 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 the fluorescent signal. The amount of fluorescence at any given cycle is dependent on the amount of amplification product present at that time. Fluorescent intensity is monitored during each PCR cycle by the real-time instrument. Results are analyzed and interpreted as presented by the software.
| Analyte | Gene Targeted | Probe<br>Fluorophore | Absorbance<br>Peak | Emission<br>Peak | Instrument<br>Channel |
|--------------------------|--------------------------------|----------------------|--------------------|------------------|-----------------------|
| Parainfluenza 1<br>Virus | Hemagglutinin<br>neuraminidase | FAM | 495 nm | 520 nm | FAM |
| Parainfluenza 3<br>Virus | Hemagglutinin<br>neuraminidase | Cal Orange 560 | 540 nm | 561 nm | TET |
| Parainfluenza 2<br>Virus | Hemagglutinin<br>neuraminidase | Cal Red 610 | 595 nm | 615 nm | Texas Red |
| Internal Control | NA | Quasar 670 | 647 nm | 667 nm | Cy5 |
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### SUBSTANTIAL EQUIVALENCE
#### Clinical Performance
The clinical performance of the ProParaflu+ Assay was established during a prospective study at 4 U.S. clinical laboratories during May 2008 - September 2009. 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 analysis. Demographic details for this patient population are summarized in the following table.
| Sex | Number of Subjects |
|---------------|--------------------|
| Female | 407 (47.5%) |
| Male | 450 (52.5%) |
| Age (yrs) | |
| ≤ 5 years | 580 (67.7%) |
| 6 - 21 years | 168 (19.6%) |
| 22 - 59 years | 67 (7.8%) |
| ≥ 60 years | 42 (4.9%) |
Gender and Age Demographic Detail for ProParaflu+ Prospective Study
Performance of the ProParaflu+ Assay was compared to the reference method of cell culture (rapid or traditional) followed by direct fluorescent antibody (DFA) screening and HPIV type identification.
A total of 857 eligible NP swab samples were tested with the ProParaflu+ Assay and by culture across four clinical sites. Of the ProParaflu+ Assay run on all eligible specimens, 99.2% (852/857) of these specimens were successful on the first attempt. The remaining 5 gave "Unresolved" results on the first attempt. Unresolved results occur when the sample is negative for all three HPIVs and the Internal Control, indicating potentially PCR-inhibiting samples. Of the 5 "Unresolved" specimens on the first attempt, 60.0% (3/5) gave a valid result on the second attempt. The remaining 2 were "Unresolved" on the second attempt and are not included in the analysis below. Both samples were culture negative.
Discrepant analysis for samples where ProParaflu+ Assay and culture results were in disagreement was performed using RT-PCR with virus specific primers obtained from literature® 9 (and different from those used in ProParaflu+) followed by bi-directional sequencing.
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# Prospective Study
| | | Culture/DFA | | | |
|----------------------|----------|-------------|----------|-------|-------------------------------------------|
| | | Positive | Negative | Total | |
| ProParaflu+<br>Assay | Positive | 16 | 1a | 17 | Sensitivity 88.9% (67.2% - 96.9%) 95% CI |
| | Negative | 2b | 838 | 840 | Specificity 99.9% (99.3% - 100.0%) 95% CI |
| | Total | 18 | 839 | 857 | |
# Parainfluenza 1 Comparison Results
4One (1) sample positive for HPIV-1 by bi-directional sequence analysis.
bTwo (2) samples negative for HPIV-1 by bi-directional sequence analysis. One sample positive for HPIV-3 by ProParaflu+ and bi-directional sequence analysis.
# Parainfluenza 2 Comparison Results
| | | Culture/DFA | | | |
|----------------------|----------|-------------|----------|-------|---------------------------------------------|
| | | Positive | Negative | Total | |
| ProParaflu+<br>Assay | Positive | 26 | 2a | 28 | Sensitivity 96.3% (81.7% - 99.3%)<br>95% CI |
| | Negative | 1b | 828 | 829 | Specificity 99.8% (99.1% - 99.9%)<br>95% CI |
| | Total | 27 | 830 | 857 | |
4Two (2) samples positive for HPIV-2 by bi-directional sequence analysis.
bOne (1) sample negative for HPIV-2 by bi-directional sequence analysis.
# Parainfluenza 3 Comparison Results
| | | Culture/DFA | | | |
|----------------------|----------|-------------|----------|-------|---------------------------------------------|
| | | Positive | Negative | Total | |
| ProParaflu+<br>Assay | Positive | 36 | 8a | 44 | Sensitivity 97.3% (86.2% - 99.5%)<br>95% CI |
| | Negative | 1b | 812 | 813 | Specificity 99.2% (98.1% - 99.5%)<br>95% CI |
| | Total | 37 | 820 | 857 | |
4Seven (7) samples positive for HPIV-3 and one (1) sample negative for HPIV-3 by bidirectional sequence analysis.
bone (1) sample negative for HPIV-3 by bi-directional sequence analysis.
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## Retrospective Study
Due to a minimal number of HPIV-1 positive samples, a retrospective study was also conducted using a total of 91 frozen NP swab samples that had been previously tested by direct DFA. Demographic details for this patient population are summarized in the following table.
Gender and Age Demographic Detail for ProParaflu+ Retrospective Study
| Sex | Number of Subjects |
|---------------|--------------------|
| Female | 40 (44.4%) |
| Male | 50 (55.6%) |
| Age (yrs) | |
| ≤ 5 years | 81 (90.0%) |
| 6 - 21 years | 5 (5.6%) |
| 22 – 59 years | 2 (2.2%) |
| ≥ 60 years | 2 (2.2%) |
# Parainfluenza 1 Comparison Results
| | | <i>DFA</i> | | | |
|------------------------------|----------|------------|----------|-------|---------------------------------------------|
| | | Positive | Negative | Total | |
| <i>ProParaflu+<br/>Assay</i> | Positive | 24 | 0 | 24 | Sensitivity 82.8% (65.4% - 92.4%)<br>95% CI |
| | Negative | 5a | 62 | 67 | Specificity 100% (94.2% - 100%)<br>95% CI |
| | Total | 29 | 62 | 91 | |
4Five (5) samples negative for HPIV-1 by bi-directional sequence analysis.
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# ProParaflu Assay 510(k) Submission
### Reproducibility
The reproducibility of the ProParaflu+ Assay was evaluated at 3 laboratory sites. Reproducibility was assessed using a panel of 12 simulated samples that included medium positive, low positive (near the assay limit of detection, ≥95% positive), intermediate (1 log below the assay limit of detection), and high negative (below the assay limit of detection, <5% positive) samples. Panels and controls were tested at each site by 2 operators for 5 days. The overall percent agreement with the expected result for the ProParaflu+ Assay was 97.8%.
| Panel Member ID | HPIV-1 high negative" | HPIV-1 low positive | HPIV-1 medium positive | HPIV-2 high negative" | HPIV-2 low positive | HPIV-2 medium positive | HPIV-3 high negative" | HPIV-3 low positive | HPIV-3 medium positive | Para Extraction Control | Para RNA Control HPIV-1 | HPIV-2 | HPIV-3 | Negative Control | Total % Agreement | |
|-----------------------|--------------------------------------|--------------------------------|------------------------|-----------------------|---------------------|------------------------|-----------------------|---------------------|------------------------|-------------------------|-------------------------|---------------|---------------|------------------|-------------------|------------------|
| Concentration | 0.001 X LoD | 2 X LoD | 10X LoD | 0.001 X LoD | 2 X LoD | 10X LoD | 0.01 X LoD | 2 X LoD | 10X LoD | N/A | N/A | N/A | N/A | N/A | | |
| Site 1 | Agreement with Expected Result | 10/10<br>100% | 8/10<br>80% | 9/9<br>100% | 10/10<br>100% | 9/9<br>100% | 9/10<br>90% | 10/10<br>100% | 9/10<br>90% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 114/118<br>96.6% |
| | Mean Ct Value | 27.73 | 28.31 | 26.33 | 27.90 | 28.62 | 26.27 | 27.76 | 31.21 | 29.47 | 27.33 | 27.37 | 29.37 | 28.61 | 27.69 | |
| | % CV | 2.87 | 1.55 | 1.60 | 2.84 | 0.85 | 1.25 | 2.43 | 3.21 | 1.91 | 1.60 | 1.05 | 0.43 | 0.81 | 1.67 | |
| | Site 2 | Agreement with Expected Result | 8/10<br>80% | 8/10<br>80% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% |
| Mean Ct Value | | 28.59 | 28.47 | 26.12 | 28.83 | 28.91 | 26.61 | 28.30 | 31.64 | 29.51 | 27.56 | 23.86 | 26.09 | 25.23 | 28.68 | |
| % CV | | 1.36 | 1.72 | 1.26 | 2.80 | 1.31 | 1.83 | 1.18 | 2.17 | 2.66 | 2.47 | 1.48 | 1.12 | 0.92 | 1.15 | |
| Site 3 | | Agreement with Expected Result | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% |
| | Mean Ct Value | 26.35 | 29.91 | 27.67 | 26.28 | 29.51 | 27.44 | 26.67 | 33.13 | 30.43 | 28.61 | 28.73 | 30.98 | 29.84 | 26.46 | |
| | % CV | 0.88 | 0.81 | 1.25 | 1.35 | 0.57 | 2.25 | 4.13 | 2.36 | 1.02 | 1.54 | 3.31 | 3.39 | 3.19 | 1.04 | |
| | Total Agreement with Expected Result | 28/30<br>93.3% | 26/30<br>86.7% | 29/29<br>100% | 30/30<br>100% | 29/29<br>100% | 29/30<br>96.7% | 30/30<br>100% | 29/30<br>96.7% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | | | 30/30<br>100% | 350/358<br>97.8% |
| 95% CI | 78.7% -<br>98.2% | 70.3% -<br>94.7% | 88.3% -<br>100% | 88.6% -<br>100% | 88.3% -<br>100% | 83.3%-<br>99.4% | 88.6% -<br>100% | 83.3%-<br>99.4% | 88.6%-<br>100% | 88.6%-<br>100% | 88.6% - 100% | | | 88.6%-<br>100% | 95.6% -<br>98.9% | |
| Overall Mean Ct Value | 27.56 | 28.90 | 26.72 | 27.67 | 29.03 | 26.79 | 27.58 | 32.02 | 29.80 | 27.83 | 26.65 | 28.81 | 27.89 | 27.62 | | |
| Overall % CV | 3.88 | 2.87 | 2.95 | 4.55 | 1.57 | 2.54 | 3.68 | 3.61 | 2.42 | 2.75 | 8.13 | 7.49 | 7.39 | 3.54 | | |
*Average Ct value for the Internal Control (IC)
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An additional reproducibility study was performed to assess samples that were at an intermediate concentration, below the assay's LoD but above the "high negatives" tested during the original reproducibility study. The percent positive for the intermediate member across all sites was 56.7% for HPIV-1 (mean Ct = 35.1), 86.7% for HPIV-2 (mean Ct = 33.0), and 30.0% for HPIV-3 (mean Ct = 37.1). This result was expected as the intermediate concentration should be positive in the range of 5 - 95% as the samples were lower concentration than the LoD concentration (≥ 95% positive) and higher than the "high negative" concentration (< 5% positive).
| | Panel Member ID | HPIV-1 intermediate | HPIV-2 intermediate | HPIV-3 intermediate | Para Extraction Control | Parainfluenza RNA Control | | | Negative Controla |
|--------|--------------------------------------|---------------------|---------------------|---------------------|-------------------------|---------------------------|---------------|---------------|-------------------|
| | Concentration | 0.1 X LoD | 0.1 X LoD | 0.1 X LoD | N/A | HPIV-1 | HPIV-2 | HPIV-3 | N/A |
| Site 1 | Agreement with Positive Result | 4/10<br>40% | 8/10<br>80% | 1/10<br>10% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10*<br>100% |
| Site 1 | Average Ct Value | 35.5 | 33.3 | 36.9 | 27.9 | 28.8 | 30.4 | 29.5 | 28.4 |
| Site 1 | % CV | 6.19 | 2.78 | N/A | 3.80 | 1.13 | 0.88 | 0.89 | 3.47 |
| Site 2 | Agreement with Positive Result | 8/10<br>80% | 10/10<br>100% | 7/10<br>70% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% |
| Site 2 | Average Ct Value | 34.4 | 32.2 | 37.3 | 27.5 | 29.0 | 30.6 | 29.9 | 27.7 |
| Site 2 | % CV | 1.38 | 2.22 | 1.50 | 2.92 | 1.04 | 0.89 | 0.72 | 2.80 |
| Site 3 | Agreement with Positive Result | 5/10<br>50% | 8/10<br>80% | 1/10<br>10% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% | 10/10<br>100% |
| Site 3 | Average Ct Value | 35.9 | 33.7 | 35.8 | 28.6 | 29.7 | 31.5 | 30.3 | 27.9 |
| Site 3 | % CV | 2.44 | 2.90 | N/A | 2.75 | 1.92 | 1.69 | 1.46 | 1.94 |
| | Total Agreement with Positive Result | 17/30<br>56.7% | 26/30<br>86.7% | 9/30<br>30.0% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% |
| | 95% CI | 39.2% -<br>72.6% | 70.3% -<br>94.7% | 16.7% -<br>47.9% | 88.7 -<br>100% | 88.7 - 100% | | | 88.7 - 100% |
| | Overall Average Ct Value | 35.1 | 33.0 | 37.1 | 28.0 | 29.1 | 30.8 | 29.9 | 28.0 |
| | Overall % CV | 3.68 | 3.25 | 1.89 | 3.46 | 1.91 | 1.92 | 1.53 | 2.92 |
ª Average Ct value for the Internal Control (IC)
*Agreement with Negative result
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Image /page/7/Picture/0 description: The image contains a logo and some text. The logo is a circular emblem with a stylized image of an eagle or bird in the center. The text is partially visible and appears to be part of the circular emblem. The text is not fully legible, but it seems to be related to a government agency or organization.
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Dr. Karen Harrington Manager, Clinical Affairs Prodesse Inc. W229 N1870 Westwood Drive Waukesha, WI 53186
NOV 2 0 2009
Re: K091053
> Trade/Device Name: ProParaflu+ "M Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: Class II Product Code: OQU Dated: October 14, 2009 Received: October 15, 2009
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
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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 marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Fally weArb
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): k091053
Device Name: ProParaflu+TM Assay
Indication For Use:
The ProParaflu+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of Parainfluenza 1 Virus, Parainfluenza 2 Virus and Parainfluenza 3 Virus (HPIV-1, HPIV-2 and HPIV-3) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections. This assay targets the conserved regions of the Hemagglutinin-Neuraminidase (HN) gene of HPIV-1, HPIV-2 and HPIV-3. respectively. The detection and discrimination of HPIV-1, HPIV-2 and HPIV-3 nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings. This test is not intended to detect Parainfluenza 4a or Parainfluenza 4b Viruses.
Negative test results are presumptive and should be confirmed by cell culture. Negative results do not preclude Parainfluenza 1, 2 or 3 virus infections and should not be used as the sole basis for 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)
the Schuf
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k091053
