MODIFICATION TO PROFLU+ ASSAY

K092500 · Prodesse, Inc. · OCC · Aug 20, 2009 · Microbiology

Device Facts

• Record ID: K092500
• Device Name: MODIFICATION TO PROFLU+ ASSAY
• Applicant: Prodesse, Inc.
• Product Code: OCC · Microbiology
• Decision Date: Aug 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Indications for Use

The ProFlu+™ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the rapid and qualitative detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids isotated and purified from nasopharyngeal (NP) swab specimens obtained from symptomatic patients. This test is intended for use to aid in the differential diagnosis of Influenza A, Influenza B and RSV viral infections in humans and is not intended to detect Influenza C. Negative results do not preclude influenza or RSV virus infection and should not be used as the sole basis for treatment or other management decisions. It is recommended that negative RSV results be confirmed by 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 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 state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Device Story

ProFlu™ Plus is an in vitro diagnostic assay for qualitative detection of influenza A and B viral antigens in nasal and nasopharyngeal swabs. Modification involves updating package insert analytical reactivity table to include reactivity data for 2009 H1N1 influenza virus clinical isolates. Device uses established scientific technology; modification does not alter fundamental operation. Healthcare providers use results to aid in diagnosis of respiratory infection. Verification and validation activities confirmed performance against predetermined acceptance criteria.

Clinical Evidence

Bench testing only. Analytical reactivity data provided for clinical isolates of 2009 H1N1 influenza A virus, confirmed via CDC Real-time RTPCR (rRTPCR) Protocol for Detection and Characterization of Swine Influenza (version 2009).

Technological Characteristics

Multiplex Real Time RT-PCR assay. Utilizes Taqman chemistry with dual-labeled oligonucleotide probes (reporter/quencher). Instrumentation: Cepheid SmartCycler II. Nucleic acid isolation: Roche MagNA Pure LC or bioMérieux NucliSENS easyMAG. Internal control included to monitor inhibition. Connectivity: standalone instrument processing.

Indications for Use

Indicated for the qualitative detection of influenza A and B viral antigens in nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.

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

• ProFlu™ Plus (K073029)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

To: THE FILE

RE: DOCUMENT NUMBER K092500

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: ProFlu™ Plus, K073029, cleared on January 4, 2008

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.

3. A description of the device MODIFICATION(S), including clearly product labeling in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the modification of the ProFlu™ Plus package insert to update the analytical reactivity table to include reactivity data on the clinical isolates of 2009 H1N1 influenza virus cultured and titered. Cultures confirmed positive for 2009 H1N1 (swine) Influenza A strain using CDC Real-time RTPCR (rRTPCR) Protocol for Detection and Characterization of Swine Influenza (version 2009).

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which included:

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

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

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.

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. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.