(144 days)
Not Found
No
The summary describes a PCR-based test system for detecting viral nucleic acids. There is no mention of AI, ML, or any computational methods beyond standard data analysis for performance metrics. The device description focuses on the biological and chemical components (PCR primer mix).
No
Explanation: The device is a diagnostic test used to detect and identify viral nucleic acids, aiding in the diagnosis of respiratory viral infections. It does not provide any treatment or therapy.
Yes
The device is explicitly stated as being intended for the "detection and identification of specific viral nucleic acids... aids in the diagnosis of respiratory viral infection." This clearly indicates its role in assisting diagnosis.
No
The device is a PCR-based test system that detects viral DNA/RNA in clinical specimens, which involves laboratory procedures and hardware components (e.g., PCR machine, reagents). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections." This describes a test performed in vitro (outside the body) on a biological sample (nasopharyngeal swabs) to provide diagnostic information.
- Sample Type: It uses "nasopharyngeal swabs," which are biological specimens collected from a patient.
- Purpose: The results "aids in the diagnosis of respiratory viral infection if used in conjunction with other clinical and laboratory findings." This clearly indicates a diagnostic purpose.
- Device Description: It's described as a "PCR-based test system for detecting the presence / absence of viral DNA / RNA in clinical specimens." This is a common method used in IVD tests.
All these elements align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections. The following virus types and subtypes are identified using RVP: Influenza B, Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection if used in conjunction with other clinical and laboratory findings.
xTAG RVP can also differentiate the hemagglutinin (HA) gene of some Influenza A subtypes H1 and H3 strains. Differentiation of Influenza A HA subtypes is based on both a positive result for the Influenza A matrix gene and an accompanying positive result for the Influenza A HA subtype H1 (circulating prior to the emergence of 2009 H1N1pdm) or Influenza A HA subtype H3. This device cannot differentiate the Influenza A HA subtype 2009 H1N1pdm by design, and may not be able to differentiate potential newly emerging Influenza A HA subtypes.
Product codes
OCC, OEM, OEP, NSU, JJH
Device Description
The modified RVP is a PCR-based test system for detecting the presence / absence of viral DNA / RNA in clinical specimens. The modified device is the same as the predicate device, except for a reformulation of the PCR primer mix.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasopharyngeal swabs
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 369 retrospectively collected left-over clinical samples (nasopharyngeal swabs) obtained primarily from the 2010-2011 influenza season were collected from 14 clinical sites in the United States and Canada. To preserve the confidentiality of the subjects, clinical specimens were individually numbered so the identity of the subject could not be readily ascertained by the investigator or any other individual associated with the study. Nucleic acid extraction was performed either by the clinical site or at Luminex Molecular Diagnostics (LMD), using one of the following methods: BioMerieux EasyMAG, BioMerieux MiniMAG or QIAGEN MinElute Viral Spin Kit, as directed in the instructions for use of the original device. Extracted samples were stored frozen at a temperature of -70℃ until used in the study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance:
Precision/Reproducibility: Same as predicate.
Limit of Detection (LoD):
The LoD for Influenza A subtype H3 was determined using two strains of influenza A comparing results of the predicate for these analytes to those of the modified device (see Table 4).
For each strain, 20 replicates of the dilutions at the estimated LoD level and at least the two bracketing levels were tested.
The results from this LoD study indicate that the modified xTAG® RVP is equivalent to that of the original xTAG® RVP for all target calls.
Carryover Contamination Limit of Blank (LoB): Same as predicate
Analytical Specificity (Reactivity, Cross-Reactivity and Competitive Inhibition):
A total of 48 potentially cross-reactive pathogens (bacterial and viral) were assessed in replicates with RVP. Each replicate underwent a single EasyMag (bioMerieux NucliSENS ) extraction prior to testing. These bacterial pathogens did not cross-react or interfere with any viral target probed by RVP in either the original or modified device.
The original and modified xTAG RVP assays did not generate non-specific positive calls for these viral strains with the following exceptions (where a contaminated sample is suspected in each instance since the result was observed in both the original and modified devices): Flu A H1 (Seasonal) demonstrated some signal for the run control near the cutoff (lambdoid DNA); Parainfluenza 3 demonstrated a low-level influenza A signal; Enterovirus (Echo 13) and Enterovirus (Coxsackie B) showed an Adenovirus signal; and Adenovirus (Type 1. Adenoid 71) showed an H3 (but not influenza A matrix) signal.
For the reactivity study, the initial stocks were diluted to approximately 2x to 3x the LoD established for the two reference strains in the LoD study. At least three replicates per strain were evaluated starting from the extraction step with both original and modified xTAG `RVP assays. Both were able to successfully detect all five H3 strains tested (see Table 8).
Eight additional strains representing other cleared analytes were tested in the analytical reactivity study (Table 10). The initial stocks were diluted to approximately 3 times the LoD established for reference strains. Three replicates per strain were evaluated with both original and modified xTAG RVP assays. Both devices were able to successfully detect all eight strains tested.
Competitive Inhibition Study:
The combinations of analytes tested in the competitive inhibition study are listed in Table 11. Each analyte was tested at two different concentrations, High Positive (HP, approximately at 1.3 to 4-fold dilution of the original stock) and Low Positive (LP, approximately at 2 to 4 times LoD for that analyte). The results show that the modifications made to the device did not inhibit the detection of the competing analytes. The performance of the Original and Modified devices was equivalent. All expected positive calls were present.
No differences between the modified and the original xTAG "RVP were observed in reactivity, cross-reactivity or competitive inhibition studies.
Clinical Comparison Studies (Accuracy):
The accuracy study evaluated the positive agreement and negative agreement between the original and modified xTAG RVP devices.
All Flu A matrix positive samples (158) from either the original or modified xTAG "RVP device were bi-directionally sequenced for Flu A subtype H3. 132 of the 158 samples were found to be Flu A H3 sequence positive (see Table 13), leaving 26 samples that were Flu A H3 sequence negative. Four out of these 26 Flu A H3 sequencing negative samples were H1 positive by both the original RVP and the modified RVP assays. Three samples out of the 26 did not have adequate sample left over and therefore could not be sequenced. The remaining 19 samples (4+3+19=26) were sequenced with an in-house designed set of 2009 H1N1pdm primers and the majority of these samples (13) were 2009 H1N1pdm positive.
Positive agreement and negative agreement for each analyte were evaluated between the original and modified xTAG RVP devices (see Table 14).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive agreement for Influenza A H3 Target. Modified xTAG RVP against Sequencing:
Percent Positive Agreement (TP/TP+FN): 121/132=91.7% (95% CI: 87.82%-96.91%)
Clinical Comparison of Modified xTAG® RVP and Original xTAG® RVP:
- Influenza A: Positive Percent Agreement (PPA) 98.09% (154/157), Confidence Interval 94.52%-99.60%; Negative Percent Agreement (NPA) 99.06% (210/212), Confidence Interval 96.63%-99.89%
- Influenza A H1: PPA 100% (4/4), Confidence Interval 39.76% - 100.00%; NPA 100% (365/365), Confidence Interval 98.99% - 100.00%
- Influenza A H3: PPA 100% (80/80), Confidence Interval 95.49%-100.00%; NPA 85.47% (247/289), Confidence Interval 80.87%-89.32%
- Influenza B: PPA 100% (30/30), Confidence Interval 88.43% - 100.00%; NPA 100% (339/339), Confidence Interval 98.92% - 100.00%
- RSV A: PPA 100% (23/23), Confidence Interval 85.18% - 100.00%; NPA 99.71% (345/346), Confidence Interval 98.40%-99.99%
- RSV B: PPA 96.30% (26/27), Confidence Interval 81.03%-99.91%; NPA 100% (342/342), Confidence Interval 98.93% - 100.00%
- Parainfluenza 1: PPA 100% (6/6), Confidence Interval 54.07% - 100.00%; NPA 99.72% (362/363), Confidence Interval 98.47%-99.99%
- Parainfluenza 2: PPA 100% (8/8), Confidence Interval 63.06% - 100.00%; NPA 99.72% (360/361), Confidence Interval 98.47%-99.99%
- Parainfluenza 3: PPA 100% (24/24), Confidence Interval 85.75% - 100.00%; NPA 100% (345/345), Confidence Interval 98.94% - 100.00%
- hMPV: PPA 96.43% (27/28), Confidence Interval 81.65%-99.91%; NPA 100% (341/341), Confidence Interval 98.92% - 100.00%
- Rhinovirus: PPA 92.16% (47/51), Confidence Interval 81.12%-97.82%; NPA 99.69% (317/318), Confidence Interval 98.26%-99.99%
- Adenovirus: PPA 100% (5/5), Confidence Interval 47.82% - 100.00%; NPA 100% (364/364), Confidence Interval 98.99% - 100.00%
Predicate Device(s)
K063765, K081843, K091667, K112199
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
FEB '1 7 2012
Luminex.
Luminex Molecular Diagnostics
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
510(k) Number: K112781
Purpose for Submission: Modification to PCR primer mix of the previously cleared xTAG® RVP (K112199) originally cleared under K063765 to improve reactivity to influenza A/H3 strains.
Measurand: Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza B, Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus
Type of Test: Qualitative nucleic acid multiplex test
Applicant: Luminex Molecular Diagnostics Inc.
Proprietary and Established Names: xTAG Respiratory Viral Panel (RVP)
Regulatory Information:
| Product Code | Classification | Regulation Section | Review Panel |
|---|---|---|---|
| OCC, OEM, | |||
| OEP, NSU, JJH | Class II | 21 CFR 866.3980 Respiratory viral panel | |
| multiplex nucleic acid assay | Microbiology | ||
| (83) |
Intended Use:
The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections. The following virus types and subtypes are identified using RVP: Influenza B, Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection if used in conjunction with other clinical and laboratory findings.
xTAG RVP can also differentiate the hemagglutinin (HA) gene of some Influenza A subtypes H1 and H3 strains. Differentiation of Influenza A HA subtypes is based on both a positive result for the Influenza A matrix gene and an accompanying positive result for the Influenza A HA subtype H1 (circulating prior to the emergence of 2009 H1N1pdm) or Influenza A HA subtype H3. This device cannot differentiate the Influenza A HA subtype 2009 H1N1pdm by design, and may not be able to differentiate potential newly emerging Influenza A HA subtypes.
1
Luminex Molecular Diagnostics
Positive results do not rule out bacterial infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection.
Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
The RVP assay cannot adequately detect Adenovirus species C, or serotypes 7a and 41. It is recommended that specimens found to be negative for Adenovirus after examination using RVP be confirmed by an alternate method (e.g., FDA cleared molecular test or cell culture). The RVP primers for detection of rhinovirus cross-react with enterovirus. A rhinovirus reactive result should be confirmed by an alternate method (e.g. cell culture).
Performance characteristics for Influenza A virus were established when Influenza A HA subtype H3, subtype H1 (prior to the emergence of 2009 H1N1pdm), and when subtype 2009 H1N1pdm were the predominant Influenza A 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 a 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.
Indication(s) for use: Same as intended use.
Special conditions for use statement(s): N/A
Special instrument requirements: Luminex 100 or 200 instrument with IS or xPONENT software
Device Description:
The modified RVP is a PCR-based test system for detecting the presence / absence of viral DNA / RNA in clinical specimens. The modified device is the same as the predicate device, except for a reformulation of the PCR primer mix.
Substantial Equivalence Information:
a. Predicate device name(s): xTAG Respiratory Viral Panel
b. Predicate 510(k) number(s): K063765, K081843, K091667 and K112199
c. Comparison with predicate:
The following table compares the modified xTAG Respiratory Viral Panel with the xTAG Respiratory Viral Panel (K063765, K081843, K091667, K112199).
2
Luminex.
Luminex Molecular Diagnostics
| Item | Modified Device
(K112781) | Predicates
(K063765, K081483, K091667, K112199) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | xTAG® RVP | xTAG® RVP |
| Manufacturer | Luminex Molecular Diagnostics | Luminex Molecular Diagnostics |
| Specimen Types | Nasopharyngeal swabs | Nasopharyngeal swabs |
| Amplification Method | Multiplex end point RT-PCR | Multiplex end point RT-PCR |
| Test Format | Multiplex bead-based universal array
sorting on Luminex 100/200 instrument | Multiplex bead-based universal array sorting
on Luminex 100/200 instrument |
| Detection Method | Fluorescence based | Fluorescence based |
| Quality Control | Internal Control (E. coli phage MS2),
Run Control (bacteriophage Lambda
DNA), rotating analyte control and
negative controls | Internal Control (E. coli phage MS2) and Run
Control (bacteriophage Lambda DNA),
rotating analyte control and negative controls |
| Results | Qualitative | Qualitative |
| Instrument | LX100 or LX200 with xMAP system (IS
or xPONENT) | LX100 or LX200 with xMAP system (IS or
xPONENT) |
| Intended Use | Same as predicate | See above |
| Targets Reported | Influenza A, Influenza A subtype H1,
Influenza A subtype H3, Influenza B,
Respiratory Syncytial Virus A,
Respiratory Syncytial Virus B,
Parainfluenza 1, Parainfluenza 2,
Parainfluenza 3, Human
Metapneumovirus, Rhinovirus, and
Adenovirus | Influenza A, Influenza A subtype H1, Influenza
A subtype H3, Influenza B, Respiratory
Syncytial Virus A, Respiratory Syncytial Virus
B, Parainfluenza 1, Parainfluenza 2,
Parainfluenza 3, Human Metapneumovirus,
Rhinovirus, and Adenovirus |
| Sample Preparation | QIAGEN QIAamp MinElute, Biomérieux
NucliSENS® EasyMag®, and Biomérieux
MiniMag™ | QIAGEN QIAamp MinElute, Biomérieux
NucliSENS® EasyMag®, and Biomérieux
MiniMag™ |
| Amplification Enzyme | xTAG® OneStep Enzyme Mix and
ancillary reagent TaKaRa Taq™ Hot Start | xTAG® OneStep Enzyme Mix and ancillary
reagent TaKaRa Taq™ Hot Start |
| Primer Mixes | Two primer mixes (1 for PCR and 1 for
TSPE). Modified PCR primer mix | Two primer mixes (1 for PCR and 1 for TSPE) |
| Software | xTAG Data Analysis Software RVP (US) | xTAG Data Analysis Software RVP (US) |
| Table 1: Comparison between Modified (New) Device and Predicate |
|---|
| ----------------------------------------------------------------- |
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Standards/Guidance Documents referenced (if applicable):
Table 2: Guidance Documents
| Title | Date | |
|---|---|---|
| 1 | Class II Special Controls Guidance: Respiratory Viral Panel Multiplex | |
| Nucleic Acid Assay | Oct. 9, 2009 | |
| 2 | Class II Special Control Guidance Document: Testing for Detection and | |
| Differentiation of Influenza A Virus Subtypes Using Multiplex Assays | Oct. 9, 2009 | |
| 3 | Guidance (Draft) for Establishing the Performance Characteristics of In | |
| Vitro Diagnostic Devices for the Detection or Detection and | ||
| Differentiation of Influenza Viruses | Feb. 15, 2008 | |
| 4 | Guidance for In Vitro Diagnostic Devices to Detect Influenza A Viruses: | |
| Labeling and Regulatory Path | May 1, 2007 | |
| 5 | Class II Special Controls Guidance: Reagents for Detection of Specific | |
| Novel Influenza A Viruses | Mar. 22, 2006 | |
| 6 | Class II Special Control Guidance Document: "Testing for Human | |
| Metapneumovirus (hMPV) Using Nucleic Acid Assays" | Oct. 9, 2009 | |
| 7 | Guidance for the Content of Premarket Submissions for Software | |
| Contained in Medical Devices | May 11, 2005 | |
| 8 | Guidance document for Format for Traditional and Abbreviated 510(k)s | Aug. 12, 2005 |
Table 3: Standards
| | Standards
No. | Recognition
Number
(FDA) | Standards Title | Date |
|---|------------------|--------------------------------|-------------------------------------------------------------------------------|------------|
| 1 | MM13-A | 7-191 | Collection, Transport, Preparation and
Storage of Specimens | 03/18/2009 |
| 2 | MM03-A2 | 7-132 | Molecular Diagnostic Methods for Infectious
Diseases (2nd edition) | 09/09/2008 |
| 3 | EP12-A2 | 7-152 | User Protocol for Evaluation of Qualitative
Test Performance (2nd edition) | 09/09/2008 |
| 4 | ISO14971 | 5-40 | Medical devices - Application of risk
management to medical devices | 09/12/2007 |
Test Principle:
Same as predicate
Performance Characteristics:
Analytical Performance:
Precision/Reproducibility: Same as predicate.
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Luminex Molecular Diagnostics
Limit of Detection (LoD):
The LoD for Influenza A subtype H3 was determined using two strains of influenza A comparing results of the predicate for these analytes to those of the modified device (see Table 4).
| Strain ID | Analyte | Modified xTAG ® RVP | Original xTAG ® RVP | ||
|---|---|---|---|---|---|
| TCID50/mL | |||||
| (at | |||||
| estimated | |||||
| LoD) | Average MFI | ||||
| from 22 | |||||
| replicates at | |||||
| LoD | TCID50/mL (at | ||||
| estimated | |||||
| LoD) | Average MFI | ||||
| from 22 | |||||
| replicates at | |||||
| LoD | |||||
| A/Victoria/3/75 | Flu A | ||||
| Matrix | 0.4768 | 1806.84 | 0.4768 | 1776.05 | |
| A/Victoria/3/75 | Flu A H3 | 0.4768 | 974.36 | 7.629 | 1219.64 |
| A/Perth/16/2009 | Flu A | ||||
| Matrix | 0.1347 | 1225.16 | 0.5388* | 2796.07 | |
| A/Perth/16/2009 | Flu A H3 | 0.1347 | 706.39 | 8.621 | 1441.16 |
| Table 4: Comparison of (LoD) for Influenza A H3 between Modified and Original RVP | ||
|---|---|---|
*Note: This LoD level was achieved with 22 out of 22 replicates making the correct Flu A Matrix POS call. At 0.1347 TCID30/mL (one dilution below 0.5388 TCID5/mL level), 18 out of 22 replicates made the correct Flu A Matrix POS call with the original xTAG RVP assay. The remaining 4 replicates displayed MFI values of 226, 295, 249, 219, just below the cut-off, thus generating "No Call" results for Flu A Matrix.
In addition, the limit of detection study compared the LoD of the modified xTAG RVP assay with the original xTAG RVP assay for all targets in the RVP panel using one strain for each target (Table 5). For each strain, 20 replicates of the dilutions at the estimated LoD level and at least the two bracketing levels were tested.
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Image /page/5/Picture/0 description: The image shows the word "Luminex." in a bold, sans-serif font. The word is black against a white background. There is a dot above the "i" in "Luminex."
| | | Dilution Levels (L1 and
L3 are at 4 fold below
and above the
estimated LOD,
respectively) | | Original xTAG® RVP | | | Modified xTAG® RVP | | |
|--------------|-----------------------|-------------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------------------|-------------------------------------------|------------------------------------|------------------------------------------------|-------------------------------------------|--|
| Analyte | Strain ID | | TCID50/mL (at
estimated
LoD) | Average MFI
from 20
replicates at
LoD | No. of POS
Calls from 20
replicates | TCID50/mL (at
estimated
LoD) | Average MFI
from 20
replicates at
LoD | No. of POS
Calls from 20
replicates | |
| Flu A Matrix | Solomon Island/3/2006 | L1 | 1.91E+00 | 3464.9 | 20 | 1.91E+00 | 2914.9 | 20 | |
| | | L2 (LOD Level) | 4.77E-01 | 3059.4 | 20 | 4.77E-01 | 2099.6 | 19 | |
| | | L3 | 1.19E-01 | 229.8 | 2 | 1.19E-01 | 209.9 | 1 | |
| Flu A H1 | Solomon Island/3/2006 | L1 | 1.91E+00 | 944.3 | 20 | 1.91E+00 | 721.9 | 19 | |
| | | L2 (LOD Level) | 4.77E-01 | 857.1 | 20 | 4.77E-01 | 492.9 | 19 | |
| | | L3 | 1.19E-01 | 72.7 | 0 | 1.19E-01 | 74.2 | 0 | |
| Influenza B | Brisbane/33/08 | L1 | 7.82E-01 | 1872.8 | 20 | 7.82E-01 | 2101.9 | 20 | |
| | | L2 (LOD Level) | 1.96E-01 | 923.9 | 20 | 1.96E-01 | 753.1 | 20 | |
| | | L3 | 4.89E-02 | 187.5 | 2 | 4.89E-02 | 206.4 | 2 | |
| RSV A | Long | L1 | 7.63E-02 | 2473.4 | 20 | 7.63E-02 | 2694.7 | 20 | |
| | | L2 (LOD Level) | 1.91E-02 | 595.4 | 20 | 1.91E-02 | 595.9 | 20 | |
| | | L3 | 4.77E-03 | 159.4 | 0 | 4.77E-03 | 212.3 | 1 | |
| RSV B | Wash/18537/62 | L1 | 4.88E+00 | 2820.2 | 20 | 4.88E+00 | 3604.8 | 20 | |
| | | L2 (LOD Level) | 1.22E+00 | 923.5 | 20 | 1.22E+00 | 921.2 | 20 | |
| | | L3 | 3.05E-01 | 202.0 | 2 | 3.05E-01 | 337.8 | 12 | |
| hMPV | CDC Isolate | L1 | 1.60E+00 | 5844.5 | 20 | 1.60E+00 | 6284.475 | 20 | |
| | | L2 (LOD Level) | 4.00E-01 | 1395.625 | 20 | 4.00E-01 | 1494.4 | 20 | |
| | | L3 | 1.00E-01 | 345.5 | 14 | 1.00E-01 | 466.125 | 16 | |
| Para-1 | C-35 | L1 | 3.91E-01 | 2188.2 | 20 | 3.91E-01 | 2062.5 | 20 | |
| | | L2 (LOD Level) | 9.77E-02 | 865.7 | 20 | 9.77E-02 | 749.5 | 20 | |
| | | L3 | 2.44E-02 | 164.8 | 4 | 2.44E-02 | 240.9 | 6 | |
| Para-2 | Greer | L1 | 7.63E-01 | 5113.1 | 20 | 7.63E-01 | 5889.8 | 20 | |
| | | L2 (LOD Level) | 1.91E-01 | 4238.5 | 20 | 1.91E-01 | 5340.9 | 20 | |
| | | L3 | 4.77E-02 | 467.0 | 14 | 4.77E-02 | 675.3 | 15 | |
| Para-3 | Zeptometrix 0810016CF | L1 | 1.00E+01 | 3206.1 | 20 | 1.00E+01 | 2524.6 | 20 | |
| | | L2 (LOD Level) | 2.51E+00 | 729.5 | 20 | 2.51E+00 | 1148.5 | 20 | |
| | | L3 | 6.27E-01 | 38.8 | 0 | 6.27E-01 | 8.3 | 0 | |
| Adenovirus | Type 1 | L1 | 4.07E+01 | 1272.1 | 20 | 4.07E+01 | 737.8 | 20 | |
| | | L2 (LOD Level) | 1.02E+01 | 494.1 | 20 | 1.02E+01 | 468.3 | 19 | |
| | | L3 | 2.54E+00 | 193.6 | 2 | 2.54E+00 | 158.6 | 0 | |
| Rhinovirus | Type 54 | L1 | 3.00E-02 | 3052.7 | 20 | 3.00E-02 | 3773.0 | 20 | |
| | | L2 (LOD Level) | 7.50E-03 | 1006.6 | 20 | 7.50E-03 | 1387.2 | 20 | |
| | | L3 | 1.88E-03 | 399.6 | 13 | 1.88E-03 | 366.3 | 13 | |
Table 5: Summary of Limit of Detection (LoD) for the non-H3 Targets
The results from this LoD study indicate that the modified xTAG® RVP is equivalent to that of the original xTAG® RVP for all target calls.
Carryover Contamination Limit of Blank (LoB): Same as predicate
Analytical Specificity (Reactivity, Cross-Reactivity and Competitive Inhibition):
A total of 48 potentially cross-reactive pathogens (bacterial and viral) were assessed in replicates with RVP. Each replicate underwent a single EasyMag (bioMerieux NucliSENS ) extraction prior to testing.
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Table 6: Bacterial pathogens assessed as potential cross-reactive species in the RVP Assay
| Organism | Strain | Titer
Tested | Titer
Units | Flu A matrix | Flu A H1 | Flu A H3 | Flu B | Para 1 | Para 2 | Para 3 | RSV A | RSV B | Rhinovirus | Metapneumovirus | Adenovirus |
|----------------------------------------|--------------------------------------------------------|--------------------|----------------|--------------|-----------------------------------------------------------------|----------|-------|--------|--------|--------|-------|-------|------------|-----------------|------------|
| Bordetella pertussis | NEQAS 1505 | 13.66 | Ct* | - | - | - | - | - | - | - | - | - | - | - | - |
| Corynebacterium glutamicum | Type strain 534 [NCIB
10025] | $6.00 \times 10^8$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Escherichia coli | ATCC 8739 | $5.60 \times 10^8$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Haemophilus influenzae | Type b (Zeptometrix
0801680) | $2.63 \times 10^8$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Lactobacillus casei | 03 [7, IAM 12473, Orland L-
323, R.P. Tittsler 303] | $6.00 \times 10^8$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Legionella pneumophila | ATCC 33152 | 15.42 | Ct* | - | - | - | - | - | - | - | - | - | - | - | - |
| Moraxella (Branhamella)
catarrhalis | Ne 11 | $5.00 \times 10^4$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Mycobacterium avium subsp.
avium | ATCC 15769 | $2.50 \times 10^4$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Mycobacterium intracellulare | ATCC 13209 | $2.50 \times 10^4$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Mycoplasma pneumoniae | M129 | $5.63 \times 10^6$ | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Neisseria elongata subsp.
elongata | NCTC 10660 | $2.50 \times 10^4$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Neisseria meningitides | Zeptometrix 0801511 | $3.37 \times 10^8$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Pseudomonas aeruginosa | ATCC15442 | $4.00 \times 10^8$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Staphylococcus aureus | Zepto 0801638 | $4.00 \times 10^8$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Staphylococcus epidermidis | ATCC 12228 | $4.00 \times 10^8$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Streptococcus pneumoniae | Type 59 | 15.95 | Ct | - | - | - | - | - | - | - | - | - | - | - | - |
| Streptococcus pyogenes | ATCC 51500 | $2.0 \times 10^8$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Streptococcus salivarius | 75 [NCTC 8618] | $6.00 \times 10^8$ | cfu/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| | | | | | Analyte, Results Positive (+) or Negative (-) for
Reactivity | | | | | | | | | | |
| Organism | Strain | Titer
Tested | Titer
Units | Flu A matrix | Flu A H1 | Flu A H3 | Flu B | Para 1 | Para 2 | Para 3 | RSV A | RSV B | Rhinovirus | Metapneumovirus | Adenovirus |
| Flu A H1 (Seasonal) | A/New Caledonia/20/99 | 5.00 x 10³ | TCID50/mL | + | + | - | - | - | - | - | - | - | - | - | - |
| Influenza B | B/Russia/69 | 3.16 x 106 | TCID50/mL | - | - | - | + | - | - | - | - | - | - | - | - |
| Influenza B | B/Mass/3/66 | 3.16 x 102 | TCID50/mL | - | - | - | + | - | - | - | - | - | - | - | - |
| Parainfluenza 1 | C-35 | 1.58 x 105 | TCID50/mL | - | - | - | - | + | - | - | - | - | - | - | - |
| Parainfluenza 2 | Greer | 5.00 x 105 | TCID50/mL | - | - | - | - | - | + | - | - | - | - | - | - |
| Parainfluenza 3 | C-243 | 5.00 x 104 | TCID50/mL | - | - | - | - | - | - | + | - | - | - | - | - |
| Parainfluenza 4A | Unknown | 4.17 x 105 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Parainfluenza 4B | Unknown | 2.45 x 105 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| RSV A | Long | 5.00 x 104 | TCID50/mL | - | - | - | - | - | - | - | + | - | - | - | - |
| RSV B | Wash/18537/62 | 1.00 x 104 | TCID50/mL | - | - | - | - | - | - | - | - | + | - | - | - |
| Enterovirus (Echo 13) | Del Carmen | 5.00 x 107 | TCID50/mL | - | - | - | - | - | - | - | - | - | + | - | - |
| Enterovirus (Coxsackie B) | Unknown | 5.00 x 106 | TCID50/mL | - | - | - | - | - | - | - | - | - | + | - | - |
| Enterovirus Type 68 | Fermon | 1.00 x 106 | TCID50/mL | - | - | - | - | - | - | - | - | - | + | - | - |
| Enterovirus Type 69 | Toluca-1 | 2.00 x 104 | TCID50/mL | - | - | - | - | - | - | - | - | - | + | - | - |
| Rhinovirus | Strain 1A | 1.26 x 105 | TCID50/mL | - | - | - | - | - | - | - | - | - | + | - | - |
| Rhinovirus | Type 60 | 5.00 x 107 | TCID50/mL | - | - | - | - | - | - | - | - | - | + | - | - |
| HMPV | CAN97-83 (CDC Isolate
26583) | 5.00 x 103 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | + | - |
| Adenovirus | Type 1, Adenoid 71 | 5.00 x 105 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | + |
| Adenovirus | Type 1 | 4.17 x 106 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | + |
| Adenovirus | Type 7A | 5.37 x 106 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | + |
| Coronavirus 229E | 229E | 5.00 x 106 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Coronavirus NL63 | NL63 | 5.00 x 106 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Coronavirus OC43 | OC43 | 5.00 x 106 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Varicella Zoster virus | Isolate A | 1.86 x 104 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Measles virus | Unknown | 1.26 x 106 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Cytomegalovirus | AD-169 | 9.55 x 106 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Epstein-Barr virus | B95-8 | 3.00 x 109 | cp/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Mumps virus | N/A (Zeptometrix) | 7.57 x 104 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | - |
| Mumps virus | N/A (Cultured from
parotid swab) | 16.36 | Ct | - | - | - | - | - | - | - | - | - | - | - | - |
| Herpes simplex virus | McIntyre | 1.45 x 1010 | TCID50/mL | - | - | - | - | - | - | - | - | - | - | - | - |
These bacterial pathogens did not cross-react or interfere with any viral target probed by RVP in either the original or modified device.
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Table 7: Viral pathogens assessed as potential cross-reactive species in the RVP Assay
The original and modified xTAG RVP assays did not generate non-specific positive calls for these viral strains with the following exceptions (where a contaminated sample is suspected in each instance since the result was observed in both the original and modified devices): Flu A H1 (Seasonal) demonstrated some signal for the run control near the cutoff (lambdoid DNA);
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Luminex.
Luminex Molecular Diagnostics
Parainfluenza 3 demonstrated a low-level influenza A signal; Enterovirus (Echo 13) and Enterovirus (Coxsackie B) showed an Adenovirus signal; and Adenovirus (Type 1. Adenoid 71) showed an H3 (but not influenza A matrix) signal.
For the reactivity study, the initial stocks were diluted to approximately 2x to 3x the LoD established for the two reference strains in the LoD study. At least three replicates per strain were evaluated starting from the extraction step with both original and modified xTAG `RVP assays. Both were able to successfully detect all five H3 strains tested (see Table 8).
Table 8: Influenza A Subtype H3 Strains Tested in the Reactivity Study
| A/Port Chalmers/1/73 |
|---|
| A/Hong Kong/8/68 |
| A2/Aichi2/68 |
| A/Alice |
| MRC2 |
The following four additional strains were identified from the clinical sample data set in the accuracy study (Table 9).
Table 9: Influenza A Subtype H3 Strains Tested in the Accuracy Study
| A/District of Columbia/WRAIR0301/2010(H3N2) |
|---|
| A/Texas/NHRC0001/2011(H3N2) |
| A/South Carolina/AF2724/2011(H3N2) |
| A/lasi/47326/2010(H3N2) |
Eight additional strains representing other cleared analytes were tested in the analytical reactivity study (Table 10). The initial stocks were diluted to approximately 3 times the LoD established for reference strains. Three replicates per strain were evaluated with both original and modified xTAG RVP assays. Both devices were able to successfully detect all eight strains tested.
| Flu A H1 | A/New Caledonia/20/99
(H1N1) |
|-----------------|---------------------------------|
| Flu B | B/Malaysia/2506/04 |
| RSV A | AUS/A2/61 |
| RSV B | B WV/14617/'85 |
| Parainfluenza 3 | C-243 |
| Rhinovirus | Type 39 |
| hMPV | Type 8, strain Peru6-2003 B2 |
| Adenovirus | Type 3 |
Table 10: Additional Strains Tested in the Reactivity Study
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Luminex Molecular Diagnostics
Competitive Inhibition Study
The combinations of analytes tested in the competitive inhibition study are listed in Table 11. Each analyte was tested at two different concentrations, High Positive (HP, approximately at 1.3 to 4-fold dilution of the original stock) and Low Positive (LP, approximately at 2 to 4 times LoD for that analyte). The results show that the modifications made to the device did not inhibit the detection of the competing analytes. The performance of the Original and Modified devices was equivalent. All expected positive calls were present.
| Count | Analyte 1 | Concentration | Analyte 2 | Concentration |
|---|---|---|---|---|
| 1 | Flu A H3, strain | |||
| A/Victoria/3/75 | HP | RSV A, strain Long | LP | |
| 2 | Flu A H3, strain | |||
| A/Victoria/3/75 | LP | RSV A, strain Long | HP | |
| 3 | Flu A H3, strain | |||
| A/Victoria/3/75 | HP | RSV B, strain | ||
| Wash/18537/62 | LP | |||
| 4 | Flu A H3, strain | |||
| A/Victoria/3/75 | LP | RSV B, strain | ||
| Wash/18537/62 | HP | |||
| 5 | Flu A H3, strain | |||
| A/Victoria/3/75 | HP | Rhinovirus, Type | ||
| 54 | LP | |||
| 6 | Flu A H3, strain | |||
| A/Victoria/3/75 | LP | Rhinovirus, Type | ||
| 54 | HP | |||
| 7 | Flu A H3, strain | |||
| A/Victoria/3/75 | HP | hMPV 5, Peru3- | ||
| 2003 B1 | LP | |||
| 8 | Flu A H3, strain | |||
| A/Victoria/3/75 | LP | hMPV 5, Peru3- | ||
| 2003 B1 | HP | |||
| 9 | Flu A H3, strain | |||
| A/Victoria/3/75 | HP | Adenovirus, Type | ||
| 1 | LP | |||
| 10 | Flu A H3, strain | |||
| A/Victoria/3/75 | LP | Adenovirus, Type | ||
| 1 | HP |
Table 11. Analyte Combinations Tested in the Competitive Inhibition Study
No differences between the modified and the original xTAG "RVP were observed in reactivity, cross-reactivity or competitive inhibition studies.
Clinical Comparison Studies (Accuracy)
The accuracy study evaluated the positive agreement and negative agreement between the original and modified xTAG RVP devices. Table 12 shows the list of analytes tested by both the original and modified xTAG RVP Assays.
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Table 12: Analytes Tested
| Human Influenza A |
|---|
| Human H1 seasonal subtype of Influenza A |
| Human H3 subtype of Influenza A |
| Influenza B |
| RSV A |
| RSV B |
| Human Metapneumovirus |
| Rhinovirus / Enterovirus |
| Parainfluenza 1 |
| Parainfluenza 2 |
| Parainfluenza 3 |
| Adenovirus |
A total of 369 retrospectively collected left-over clinical samples (nasopharyngeal swabs) obtained primarily from the 2010-2011 influenza season were collected from 14 clinical sites in the United States and Canada. To preserve the confidentiality of the subjects, clinical specimens were individually numbered so the identity of the subject could not be readily ascertained by the investigator or any other individual associated with the study. Nucleic acid extraction was performed either by the clinical site or at Luminex Molecular Diagnostics (LMD), using one of the following methods: BioMerieux EasyMAG, BioMerieux MiniMAG or QIAGEN MinElute Viral Spin Kit, as directed in the instructions for use of the original device. Extracted samples were stored frozen at a temperature of -70℃ until used in the study.
All Flu A matrix positive samples (158) from either the original or modified xTAG "RVP device were bi-directionally sequenced for Flu A subtype H3. 132 of the 158 samples were found to be Flu A H3 sequence positive (see Table 13), leaving 26 samples that were Flu A H3 sequence negative. Four out of these 26 Flu A H3 sequencing negative samples were H1 positive by both the original RVP and the modified RVP assays. Three samples out of the 26 did not have adequate sample left over and therefore could not be sequenced. The remaining 19 samples (4+3+19=26) were sequenced with an in-house designed set of 2009 H1N1pdm primers and the majority of these samples (13) were 2009 H1N1pdm positive.
| 95% CI | |||
|---|---|---|---|
| Sequencing POS for H3 | 132 Samples | ||
| Modified xTAG® RVP POS | 121 Samples | Lower | Upper |
| Percent Positive Agreement | |||
| (TP/TP+FN) | 121/132=91.7% | 87.82% | 96.91% |
Table 13: Positive agreement for Influenza A H3 Target. Modified xTAG RVP against Sequencing
Positive agreement and negative agreement for each analyte were evaluated between the original and modified xTAG RVP devices (see Table 14).
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| Analyte | Positive
Percent
Agreement
(PPA) | Confidence Interval | Negative
Percent
Agreement
(NPA) | Confidence Interval |
|-----------------|-------------------------------------------|---------------------|-------------------------------------------|---------------------|
| Influenza A | 98.09%
(154/157) | 94.52%-99.60% | 99.06%
(210/212) | 96.63%-99.89% |
| Influenza A H1 | 100%
(4/4) | 39.76% - 100.00% | 100%
(365/365) | 98.99% - 100.00% |
| Influenza A H3 | 100%
(80/80) | 95.49%-100.00% | 85.47%
(247/289) | 80.87%-89.32% |
| Influenza B | 100%
(30/30) | 88.43% - 100.00% | 100%
(339/339) | 98.92% - 100.00% |
| RSV A | 100%
(23/23) | 85.18% - 100.00% | 99.71%
(345/346) | 98.40%-99.99% |
| RSV B | 96.30%
(26/27) | 81.03%-99.91% | 100%
(342/342) | 98.93% - 100.00% |
| Parainfluenza 1 | 100%
(6/6) | 54.07% - 100.00% | 99.72%
(362/363) | 98.47%-99.99% |
| Parainfluenza 2 | 100%
(8/8) | 63.06% - 100.00% | 99.72%
(360/361) | 98.47%-99.99% |
| Parainfluenza 3 | 100%
(24/24) | 85.75% - 100.00% | 100%
(345/345) | 98.94% - 100.00% |
| hMPV | 96.43%
(27/28) | 81.65%-99.91% | 100%
(341/341) | 98.92% - 100.00% |
| Rhinovirus | 92.16%
(47/51) | 81.12%-97.82% | 99.69%
(317/318) | 98.26%-99.99% |
| Adenovirus | 100%
(5/5) | 47.82% - 100.00% | 100%
(364/364) | 98.99% - 100.00% |
Table 14: Clinical Comparison of Modified xTAG® RVP and Original xTAG® RVP
Clinical Cut-off: Not applicable.
Expected values/ reference range: Not applicable.
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10903 New Hampshire Avenue Silver Spring, MD 20993
Luminex Molecular Diagnostics, Inc. c/o Ms. Lubna Syed Director, Regulatory Affairs 439 University Avenue, Suite 900 Toronto. Ontario. M5G 1Y8. CANADA
FEB 1 7 2012
Re: K112781
. Trade Name: xTAG®Respiratory Viral Panel (RVP) Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Regulatory Class: Class II Product Code: OCC, OEM, OEP, NSU, JJH Dated: December 19, 2011 Received: December 22, 2011
Dear Ms. Syed:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
13
Page 2 - Lubna Syed
will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/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 vours.
Uve Saf for
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
14
Indications for Use
510(k) Number (if known): K112781
xTAG® Respiratory Viral Panel (RVP) Device Name:
The xTAG Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections. The following virus types and subtypes are identified using RVP: Influenza A, Influenza B, Respiratory Syncytial Virus subtype A. Respiratory Syncytial Virus subtype B. Parainfluenza 1. Parainfluenza 2. and Parainfluenza 3 virus. Human Metapneumovirus, Rhinovirus, and Adenovirus. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection if used in conjunction with other clinical and laboratory findings.
xTAG RVP can also differentiate the hemagglutinin (HA) gene of some Influenza A subtypes H1 and H3 strains. Differentiation of Influenza A HA subtypes is based on both a positive result for the Influenza A matrix gene and an accompanying positive result for the Influenza A HA subtype HI (circulating prior to the emergence of 2009 HIN1pdm) or Influenza A HA subtype H3. This device cannot differentiate the Influenza A HA subtype 2009 H1N1pdm by design, and may not be able to differentiate potential newly emerging Influenza A HA subtypes.
Positive results do not rule out bacterial infection, or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection.
Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
The RVP assay cannot adequately detect Adenovirus species C, or serotypes 7a and 41. It is recommended that specimens found to be negative for Adenovirus after examination using RVP be confirmed by an alternate method (e.g., FDA cleared molecular test or cell culture). The RVP primers for detection of rhinovirus cross-react with enterovirus. A rhinovirus reactive result should be confirmed by an alternate method (e.g. cell culture).
Performance characteristics for Influenza A virus were established when Influenza A-HA subtype H3, subtype H1 (prior to the emergence of 2009 H1N1pdm), and when subtype 2009 H1N1pdm were the predominant Influenza A 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 a 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.
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Prescription Use __ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Taruna Feldble
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112781