← Product Code [OOU](/submissions/MI/subpart-d%E2%80%94serological-reagents/OOU) · K153223

# ProParaFlu+ Assay (K153223)

_Hologic, Inc. · OOU · Dec 9, 2015 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OOU/K153223

## Device Facts

- **Applicant:** Hologic, Inc.
- **Product Code:** [OOU](/submissions/MI/subpart-d%E2%80%94serological-reagents/OOU.md)
- **Decision Date:** Dec 9, 2015
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.3980
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The Prodesse® ProParaflu®+ Assay is a multiplex Real-Time PCR (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

The ProParaflu+ Assay is a multiplex RT-PCR diagnostic test for identifying HPIV-1, HPIV-2, and HPIV-3. Input consists of nasopharyngeal swab specimens collected in viral transport medium. A Universal Internal Control is added to monitor for inhibitors. Nucleic acids are isolated using either the Roche MagNA Pure LC or bioMérieux NucliSENS easyMAG system. Purified nucleic acids are combined with ProParaflu+ Supermix containing target-specific primers and dual-labeled probes. The Cepheid SmartCycler II instrument performs reverse transcription and PCR amplification. Taqman chemistry utilizes 5'-3' exonuclease activity to cleave probes, releasing reporter dyes and increasing fluorescent signal proportional to amplification. The instrument monitors fluorescence in real-time. Results are interpreted by laboratory personnel to aid in clinical diagnosis of respiratory infections. The assay provides qualitative detection; negative results are presumptive and require confirmation by cell culture. The device is intended for use in clinical laboratory settings.

## Clinical Evidence

No clinical data provided. The submission relies on bench testing and analytical performance characterization, including the identification of limited reactivity with specific viral variants (CAP samples ID2-08 and ID2-02) via sequencing analysis.

## Technological Characteristics

Multiplex nucleic acid amplification assay. Analyte: RNA. Instrumentation: bioMérieux NucliSENS easyMAG or Roche MagNA Pure (extraction) and Cepheid SmartCycler II (amplification). Controls: Internal control per sample; external control per batch. Time to result: ~4 hours.

## Regulatory 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

- ProParaFlu®+ Assay ([K132238](/device/K132238.md))
- ProParaFlu®+ Assay ([K091053](/device/K091053.md))

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: K153223

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

1. The names and 510(k) numbers of the SUBMITTER'S previously cleared device.
K132238 – ProParaFlu®+ Assay, Hologic, Inc.
K091053 – ProParaFlu®+ Assay, Prodesse, Inc.

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, including a statement that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.
Changes to the labeling include adding "Rx only" under the IVD symbol on the first page of the Instructions for Use and updating the Limitations section of the Instructions for Use regarding limited reactivity with the 2014 CAP sample ID2-08 and the 2015 CAP sample ID2-02. The following limitation was included: "The ProParaflu+ assay has limited reactivity with the 2014 CAP sample ID2-08 and the 2015 CAP sample ID2-02. Sequencing analysis of the CAP samples revealed that the HPIV3 target sequences of the CAP samples match the sequence of HPIV3/Homo sapiens/PER/FLU8889/2007 strain in GenBank (GenBank Accession # KJ672604), and the limited reactivity is most likely due to a viral mutation in the probe binding region. Negative results may be obtained for samples containing this variant especially at low titers. If the ProParaflu+ assay does not indicate a positive result when an HPIV-3 infection is suspected, the specimen should be retested for HPIV-3 using an independent method (e.g. cell culture or molecular IVD)".
The fundamental scientific technology of the modified device has not changed.

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

|  Similarities  |   |   |
| --- | --- | --- |
|  Element | Modified Prodesse ProParaflu+ Assay | Current Prodesse ProParaflu+ Assay (K091053)  |
|  Organisms Detected | Same | HPIV-1, HPIV-2, and HPIV-3  |
|  Analyte | Same | RNA  |
|  Technological Principles | Same | Multiplex nucleic acid amplification  |
|  Specimen Types | Same | Nasopharyngeal Swab  |

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Page 2 of 3

|  Similarities  |   |   |
| --- | --- | --- |
|  Element | Modified Prodesse ProParaflu+ Assay | Current Prodesse ProParaflu+ Assay (K091053)  |
|  User Complexity | Same | High  |
|  Sample Preparation Method | Same | Up front sample processing is required to extract nucleic acid  |
|  Instrumentation | Same | bioMérieux NucliSENS easyMAG or Roche MagNA Pure and Cepheid SmartCycler II Instrument  |
|  Time to result | Same | Approximately 4 hours  |
|  Controls | Same | Internal control in each sample. External control processed with each batch of samples  |
|  Differences  |   |   |
| --- | --- | --- |
|  Element | Modified Prodesse ProParaflu+ Assay | Current Prodesse ProParaflu+ Assay (K091053)  |
|  Limitations | Limited reactivity with the 2014 CAP sample ID2-08 and the 2015 CAP sample ID2-02 | Did not include information regarding limited reactivity with the 2014 CAP sample ID2-08 and the 2015 CAP sample ID2-02  |

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

The risks of potentially missing the variant strain of the HPIV-3 virus, HPIV3/Homo sapiens/PER/FLU8889/2007 when testing with the ProParaflu+ Assay were evaluated by reviewing the Failure Mode Effects Analysis (FMEA) that had been performed during product development to determine whether the Instructions for Use (IFU) update creates new risks or failure modes or affects the risk priority number (RPN) value.

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

No new risks were identified for testing HPIV3/Homo sapiens/PER/FLU8889/2007 with the ProParaflu+ Assay. All RPNs were in categories "As Low As Reasonably Possible" (ALARP) or "Low Risk Category" and therefore, no additional risk control activities were necessary. No additional concerns of safety and efficacy were identified.

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Page 3 of 3

No device modifications were made. The Limitations section of the ProParaflu+ Assay IFU was updated to include a statement of limited reactivity with select HPIV-3 strains as described in section 3 above. To monitor for additional mutations over time, a monthly query will be performed against GenBank to retrieve all sequences for HPIV that encompass the target region and generate alignments against the sequences in production designs.

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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OOU/K153223](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OOU/K153223)

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