XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)

K112199 · Luminex Molecular Diagnostics, Inc. · OCC · Sep 1, 2011 · Microbiology

Device Facts

• Record ID: K112199
• Device Name: XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
• Applicant: Luminex Molecular Diagnostics, Inc.
• Product Code: OCC · Microbiology
• Decision Date: Sep 1, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

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 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. 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. It is recommended that specimens found to be negative for Influenza B, Respiratory Syncytial Virus subtype A and B, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3 and Adenovirus, after examination using RVP be confirmed by cell culture. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. 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. Due to seasonal prevalence, performance characteristics for Influenza A/H1 were established primarily with retrospective specimens. The RVP assay cannot adequately detect Adenovirus species C, or serotypes 7a and 41. 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/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 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.

Device Story

xTAG RVP is a qualitative multiplex nucleic acid assay; processes nasopharyngeal swab samples to detect respiratory viral nucleic acids. Utilizes multiplex PCR and bead-based detection technology; identifies specific viral targets (Influenza, RSV, Parainfluenza, hMPV, Rhinovirus, Adenovirus). Used in clinical laboratory settings by trained technicians. Output provides identification of viral pathogens to aid clinicians in diagnosis; results must be interpreted alongside clinical presentation and other laboratory findings. Benefits include rapid simultaneous identification of multiple respiratory viruses, facilitating appropriate patient management and infection control.

Clinical Evidence

Performance characteristics established using clinical specimens. Influenza A/H1 performance established primarily with retrospective specimens. Limitations noted regarding detection of specific Adenovirus species/serotypes and cross-reactivity of Rhinovirus primers with enterovirus. Clinical diagnosis requires correlation with additional laboratory testing and clinical presentation.

Technological Characteristics

Qualitative nucleic acid multiplex test; utilizes multiplex PCR and bead-based detection technology. Designed for use with nasopharyngeal swab specimens. Requires laboratory infrastructure for molecular diagnostic testing.

Indications for Use

Indicated for the qualitative detection of multiple respiratory viral nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K112199

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.

xTAG Respiratory Viral Panel (RVP), K091667

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling. There is a labeling change to add the xPONENT version of the TDAS software. This labeling change does not affect the intended use.

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This modification adds the assay specific software protocol (TDAS) that will allow the xTAG RVP kit to be used with xPONENT software. The fundamental scientific technology has not changed.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling and a description of the parameters and settings in the new xPONENT version of the TDAS software as well as a wet test comparing the results of the old and new TDAS versions to assure that comparable results were generated.

Table 5a: Results for xTAG RVP T-A: Analyzing 14 targets for each of 189 samples

| Concordance Between: | ABS / PRES calls | NEG Calls | POS calls | “No Call” Calls | Overall Calls |
| --- | --- | --- | --- | --- | --- |
| IS (TDAS 1.11) and IS (TDAS 1.30) | 348 / 348 = 100% | 1815 / 1815 = 100% | 166 / 166 = 100% | 139 / 139 = 100% | 2468 / 2468 = 100% |
| xPONENT (TDAS 1.30) and IS (TDAS 1.30) | 348 / 348 = 100% | 1814 / 1815 = 99.9% | 166 / 166 = 100% | 122 / 139 = 87.8% | 2450 / 2468 = 99.3% |

- PRES: the recommended Internal / Run Control is detected (MFI ≥ 300)
- ABS: the recommended Internal / Run Control is not detected (MFI < 300)
- No Call: unable to determine presence or absence of the Internal / Run Control due to an assay-specific criterion not being met.
- POS: the viral target is detected (i.e. analyte signal falls within the positive zone: MFI ≥300)
- NEG: the viral target is not detected (i.e. analyte signal falls within the negative zone: MFI <150)

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

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c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

All Design Control Activities Summary documents were contained in the submission including the signed statements.