VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST

K092957 · Nanosphere, Inc. · OCC · Oct 21, 2009 · Microbiology

Device Facts

• Record ID: K092957
• Device Name: VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
• Applicant: Nanosphere, Inc.
• Product Code: OCC · Microbiology
• Decision Date: Oct 21, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Indications for Use

The Verigene® Respiratory Virus Nucleic Acid Test is a qualitative multiplexed nucleic acid test for the detection of respiratory virus nucleic acids in nasopharyngeal swab specimens. The test is indicated for use as an aid in the diagnosis of respiratory viral infection in patients with signs and symptoms of respiratory infection. The test is intended for use in clinical laboratories.

Device Story

Verigene® Respiratory Virus Nucleic Acid Test is a qualitative multiplex in vitro diagnostic assay. It processes purified nucleic acids from nasopharyngeal swab specimens using the Verigene® System. The system performs automated detection and identification of Influenza A, Influenza B, and RSV. It is intended for use by healthcare professionals as an aid in differential diagnosis. Results are provided to clinicians to assist in patient management decisions, though negative results require culture confirmation. The device does not detect Influenza C.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Nucleic acid-based detection; multiplexed assay. Fundamental technology remains identical to predicate K083088. No changes to materials, sensing principle, or energy source.

Indications for Use

Indicated for symptomatic patients with suspected viral upper respiratory infection to detect and identify Influenza A, Influenza B, and RSV nucleic acids from nasopharyngeal swab specimens.

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

To: THE FILE

RE: DOCUMENT NUMBER K092957

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

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: Verigene® Respiratory Virus Nucleic Acid Test (K083088)

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 which includes instructions for use and package labeling.

3. The modification of the device consisted of expanded reactivity table to include reactivity information for four 2009 Influenza A H1N1 clinical cultured isolates. This modification has not had any effect or caused any changes to the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of this device.

4. Comparison Information (similarities and differences):

Reactivity data was added to the analytical sensitivity table. There were no changes made to the device.

5. A declaration of conformity with design controls.

Sponsor provided a signed statement that:

a) All verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

b) 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.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. I recommend the device be determined substantially equivalent to the previously cleared device.