D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT

K091171 · Diagnostic Hybrids, Inc. · OMG · Sep 11, 2009 · Microbiology

Device Facts

• Record ID: K091171
• Device Name: D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
• Applicant: Diagnostic Hybrids, Inc.
• Product Code: OMG · Microbiology
• Decision Date: Sep 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Intended Use

The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA Respiratory Virus Identification Kit is intended for the qualitative identification of influenza A virus, influenza B virus, respiratory syncytial virus, human metapneumovirus, adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3 in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs). It is recommended that specimens found to be negative for influenza A virus, influenza B virus, respiratory syncytial virus, adenovirus or parainfluenza viruses after examination of the direct specimen result be confirmed by cell culture. Specimens found to be negative for human metapneumovirus after examination of the direct specimen results should be confirmed by an FDA cleared human metapneumovirus molecular assay. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Performance characteristics for influenza A virus detection and identification were established when influenza A (H3N2) and influenza A (H1N1) were the predominant influenza A strains circulating in the United States. Since influenza strains display antigenic drift and shift from year to year, performance characteristics may vary. If infection with a novel influenza A virus is suspected, based on clinical and epidemiological screening criteria communicated by public health authorities, collect specimens following appropriate infection control precautions and submit to state or local health departments, 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

The D3 FastPoint L-DFA Respiratory Virus Identification Kit is an in vitro diagnostic assay for identifying respiratory viruses in clinical specimens. It utilizes three reagent blends containing murine monoclonal antibodies (MAbs) directly labeled with either R-Phycoerythrin (R-PE) or fluorescein isothiocyanate (FITC). Input samples (nasal/nasopharyngeal swabs or aspirates) are processed in a liquid suspension format, permeabilized, and stained with the reagents. After a 5-minute incubation and centrifugation, the cell pellet is re-suspended and loaded onto a slide for examination via fluorescence microscopy. The device provides visual output: golden-yellow fluorescence (R-PE) indicates influenza A, RSV, or parainfluenza; apple-green fluorescence (FITC) indicates influenza B, hMPV, or adenovirus. Non-infected cells appear red due to Evans Blue counter-stain; nuclei appear orange-red due to propidium iodide. The test is performed in clinical laboratories by trained personnel. Results assist healthcare providers in diagnosing respiratory infections, though negative results require confirmation by cell culture or molecular assays. The device benefits patients by enabling rapid identification of viral pathogens to guide clinical management.

Clinical Evidence

Clinical performance was established in a prospective study at 4 U.S. laboratories (Jan-Mar 2009) using 1,519 clinical specimens. Comparator methods included DSFA, viral culture, and for hMPV, a validated real-time RT-PCR with bi-directional sequencing. Sensitivity for NP wash/aspirate specimens ranged from 68.8% (hMPV) to 98.6% (RSV), with specificities of 99.3-100%. For NP swab specimens, sensitivity ranged from 54.5% (hMPV) to 97.5% (RSV), with specificities of 99.8-100%. Adenovirus sensitivity in swabs was not adequately established due to low prevalence.

Technological Characteristics

Direct immunofluorescence assay using 18 murine monoclonal antibodies. Labels: R-Phycoerythrin (R-PE) and Fluorescein isothiocyanate (FITC). Fixative: Proprietary non-acetone based system. Counter-stains: Propidium Iodide and Evans Blue. Form factor: Liquid suspension format in 3 reagent vials. Requires fluorescence microscopy for visualization. No software or electronic components.

Indications for Use

Indicated for qualitative identification of influenza A, influenza B, RSV, hMPV, adenovirus, and screening for parainfluenza virus types 1, 2, and 3 in nasal/nasopharyngeal swabs and aspirates/washes from symptomatic patients.

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

• D3 Ultra DFA Respiratory Virus Screening & ID Kit (k061101)
• D3 Duet DFA RSV/Respiratory Virus Screening Kit (k081928)
• D3 DFA Metapneumovirus Identification Kit (k090073)

Submission Summary (Full Text)

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# 6691171

### D3 FastPoint L-DFA Respiratory Virus Identification Kit

8/24/2009 Page 1 of 23

## Section 05, 510(k) Summary

### Applicant:

DIAGNOSTIC HYBRIDS, INC. 1055 East State Street Suite 100 Athens, OHIO 45701

### Contact Information:

Ronald H. Lollar, Senior Director Product Realization, Management and Marketing 1055 East State Street Suite 100 Athens, Ohio 45701 740-589-3300 - Corporate number 740-589-3373 - Desk phone [phone] - Fax [e-mail]

### Date of preparation of 510(k) summary:

April 17, 2009

### Device Name:

Trade name - D3 FastPoint L-DFA Respiratory Virus Identification Kit Common name - Respiratory virus DFA assay Classification name - Antisera, Cf, Influenza Virus A, B, C Product Code - GNW Regulation - 21 CFR 866.3330, Class I, Influenza virus serological reagents; Panel Microbiology (83)

## Legally marketed devices to which equivalence is claimed:

### D3 Ultra DFA Respiratory Virus Screening & ID Kit (k061101)

Intended Use: The Diagnostic Hybrids, Inc. D3 Ultra DFA (direct fluorescent antibody) Respiratory Virus Screening & ID Kit (D3 Ultra) is intended for the qualitative detection and identification of the influenza A, influenza B, respiratory syncytial virus (RSV), adenovirus, parainfluenza 1, parainfluenza 2 and parainfluenza 3 virus in respiratory specimens, by either direct detection or cell culture method, by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). It is recommended that specimens found to be negative after examination of the direct specimen

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result 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.

- Performance characteristics for influenza A 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 departments for testing. Viral culture should not be attempted in these cases unless a BSL3+ facility is available to receive and culture specimens.

### D3 Duet DFA RSV/Respiratory Virus Screening Kit (k081928)

The Diagnostic Hybrids, Inc. device, D3 Duet DFA RSV/Respiratory Virus Screening Kit (D3 Duet RSV Kit), is intended for the qualitative detection and identification of respiratory syncytial virus, while screening for influenza A virus, influenza B virus, adenovirus, and parainfluenza virus types 1, 2 and 3 viral antigens, in nasal and nasopharyngeal swabs and aspirates or in cell culture. The assay detects viral antigens by immunofluorescence using monoclonal antibodies (MAbs), from patients with signs and symptoms of respiratory infection.

It is recommended that specimens found to be negative after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.

Performance characteristics for influenza A virus detection and identification were established when influenza A (H3N2) and influenza A (H1N1) were the predominant influenza A strains circulating in the United States. Performance characteristics for influenza A virus detection and identification were established when influenza A H3N2 and influenza A H1N1 were the predominant influenza A strains circulating in the United States. 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

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attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

### D3 DFA Metapneumovirus Identification Kit (k090073)

The Diagnostic Hybrids, Inc. device, D3 DFA Metapneumovirus Identification Kit (DJ MPV Kit), is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in nasal and nasopharyngeal swabs and aspirates/washes or cell culture. The assay detects hMPV antigens by immunofluorescence using a blend of three monoclonal antibodies (MAbs), from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV.

Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. It is recommended that specimens found to be negative after examination of the direct specimen results be confirmed by an FDAcleared hMPV molecular assay.

#### Device Description:

The D3 FastPoint L-DFA Respiratory Virus Identification Kit uses three blends (each called a "L-DFA Reagent") of viral antigen-specific murine monoclonal antibodies that are directly labeled with either R-PE (influenza A virus, respiratory syncytial virus, and parainfluenza virus) or fluorescein (influenza B virus, metapneumovirus, and adenovirus) for the rapid identification of respiratory viruses in nasal and nasopharyngeal swabs and aspirates from patients with signs and symptoms of respiratory infection.

Kit Components:

- 1. D3 FastPoint L-DFA Influenza A/Influenza B Reagent, 4.0-mL. One dropper bottle containing a mixture of PE-labeled murine monoclonal antibodies directed against influenza A virus antigens and FITC-labeled murine monoclonal antibodies directed against influenza B virus antigens. The buffered, stabilized, aqueous solution contains Evans Blue and propidium iodide as counter-stains and 0.1% sodium azide as preservative.
- 2. D3 FastPoint L-DFA RSV/MPV Reagent, 4.0-mL. One dropper bottle containing a mixture of PE-labeled murine monoclonal antibodies directed against respiratory syncytial virus antigens and FITC-labeled murine monoclonal antibodies directed against metapneumovirus antigens. The buffered, stabilized, aqueous solution contains Evans Blue and propidium iodide as counter-stains and 0.1% sodium azide as preservative.

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- 3. D3 FastPoint L-DFA PIV/Adenovirus Reagent, 4.0-mL. One dropper bottle containing a mixture of PE-labeled murine monoclonal antibodies directed against parainfluenza virus types 1, 2, or 3 antigens and FITClabeled murine monoclonal antibodies directed against adenovirus antigens. The buffered, stabilized, aqueous solution contains Evans Blue and propidium iodide as counter-stains and 0.1% sodium azide as preservative.
- 4. 40X PBS Concentrate, 25-mL. One bottle of 40X PBS concentrate containing 4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water).
- 5. Re-suspension Buffer, 6.0-mL. One bottle of a buffered glycerol solution and 0.1% sodium azide.
- 6. D3 FastPoint L-DFA Respiratory Virus Antigen Control Slides, 5-slides. Five individually packaged control slides containing 6 wells with cell culture-derived positive and negative control cells. Each positive well is identified as to the virus infected cells present, i.e., influenza A virus, influenza B virus, respiratory syncytial virus, metapneumovirus, parainfluenza virus, and adenovirus. The negative wells contain noninfected cells. Each slide is intended to be stained only one time.

The cells to be tested are derived from respiratory specimens from patients with signs and symptoms of respiratory infection. The cells are permeabilized and stained concurrently in a liquid suspension format in 3 separate vials, each containing one of the 3 above reagents. After incubating at 35℃ to 37℃ for 5 minutes, the stained cell suspensions are rinsed with 1X PBS. The rinsed cells are pelleted by centrifugation and then re-suspended with the resuspension buffer and loaded onto a specimen slide well. The cells are examined using a fluorescence microscope. Cells infected with influenza A virus, respiratory syncytial virus, or parainfluenza virus types 1, 2 and 3 will exhibit goldenyellow fluorescence due to the PE. Cells infected with influenza B virus, metapnemovirus or adenovirus will exhibit apple-green fluorescence due to the FITC. Non-infected cells will exhibit red fluorescence due to the Evans Blue counter-stain. Nuclei of intact cells will exhibit orange-red fluorescence due to the propidium iodide.

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### Intended Use:

The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA Respiratory Virus Identification Kit is intended for the qualitative identification of influenza A virus, influenza B virus, respiratory syncytial virus, human metapneumovirus, adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3 in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs).

It is recommended that specimens found to be negative for influenza A virus, influenza B virus, respiratory syncytial virus, adenovirus or parainfluenza viruses after examination of the direct specimen result be confirmed by cell culture. Specimens found to be negative for human metapneumovirus after examination of the direct specimen results should be confirmed by an FDA cleared human metapneumovirus molecular assay. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.

Performance characteristics for influenza A virus detection and identification were established when influenza A (H3N2) and influenza A (H1N1) were the predominant influenza A strains circulating in the United States. Since influenza strains display antigenic drift and shift from year to year, performance characteristics may vary. If infection with a novel influenza A virus is suspected, based on clinical and epidemiological screening criteria communicated by public health authorities, collect specimens following appropriate infection control precautions and submit to state or local health departments, for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.2

## Technological Characteristics, Compared to Predicate Device:

| Table 5.1: Characteristics of the D³ FastPoint L-DFA Kit are compared to those of the following<br>Diagnostic Hybrids (DHI) predicate devices | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | D³ FastPoint L-DFA Kit Subject Device | D³ Ultra Kit<br>510(k) #k061101 | D³ Duet RSV Kit<br>510(k) # k081928 | D³ MPV Kit<br>510(k) # k090073 |
| Intended Use | The Diagnostic<br>Hybrids, Inc. device,<br>D³ FastPoint L-DFA<br>Respiratory Virus<br>Identification Kit is<br>intended for the | The Diagnostic<br>Hybrids, Inc. D³<br><i>Ultra</i> ™ DFA (direct<br>fluorescent<br>antibody)<br>Respiratory Virus | The Diagnostic<br>Hybrids, Inc. device,<br>D³ Duet DFA<br>RSV/Respiratory<br>Virus Screening Kit,<br>is intended for the | The Diagnostic<br>Hybrids, Inc. device<br>D³ DFA<br>Metapneumovirus<br>Identification Kit, is<br>intended for the |
| Characteristics | D³ FastPoint L-DFA Kit Subject Device | D³ Ultra Kit 510(k) #k061101 | D³ Duet RSV Kit 510(k) # k081928 | D³ MPV Kit 510(k) # k090073 |
| | qualitative<br>identification of<br>influenza A<br>virus, influenza B<br>virus, respiratory<br>syncytial virus,<br>human<br>metapneumovirus,<br>adenovirus and to<br>screen for the<br>presence of<br>parainfluenza virus<br>types 1, 2, and 3 in<br>nasal and<br>nasopharyngeal<br>swabs and<br>aspirates/washes<br>specimens from<br>patients with signs<br>and symptoms of<br>respiratory infection<br>by direct detection<br>of<br>immunofluorescence<br>using monoclonal<br>antibodies (MAbs).<br><br>It is recommended<br>that specimens<br>found to be negative<br>for influenza A<br>virus, influenza B<br>virus, respiratory<br>syncytial virus,<br>adenovirus or<br>parainfluenza<br>viruses after<br>examination of the<br>direct specimen<br>result be confirmed<br>by cell culture.<br><br>Specimens found to<br>be negative for<br>human<br>metapneumovirus<br>after examination of<br>the direct specimen<br>results should be<br>confirmed by an<br>FDA cleared human | Screening & ID Kit<br>is intended for the<br>qualitative detection<br>and identification of<br>the influenza A,<br>influenza B,<br>respiratory syncytial<br>virus (RSV),<br>adenovirus,<br>parainfluenza 1,<br>parainfluenza 2 and<br>parainfluenza 3<br>virus in respiratory<br>specimens, by either<br>direct detection or<br>cell culture method,<br>by<br>immunofluorescence<br>using monoclonal<br>antibodies (MAbs).<br><br>It is recommended<br>that specimens<br>found to be negative<br>after examination of<br>the direct specimen<br>result be confirmed<br>by cell culture.<br><br>Negative results do<br>not preclude<br>respiratory virus<br>infection and should<br>not be used as the<br>sole basis for<br>diagnosis, treatment<br>or other<br>management<br>decisions. | qualitative detection<br>and identification of<br>respiratory syncytial<br>virus, while<br>screening for<br>influenza A virus,<br>influenza B virus,<br>adenovirus, and<br>parainfluenza virus<br>types 1, 2 and 3 viral<br>antigens, in nasal<br>and nasopharyngeal<br>swabs and aspirates<br>or in cell culture.<br>The assay detects<br>viral antigens by<br>immunofluorescence<br>using monoclonal<br>antibodies (MAbs),<br>from patients with<br>signs and symptoms<br>of respiratory<br>infection.<br><br>It is recommended<br>that specimens<br>found to be negative<br>after examination of<br>the direct specimen<br>result be confirmed<br>by cell culture.<br><br>Negative results do<br>not preclude<br>influenza virus<br>infection and should<br>not be used as the<br>sole basis for<br>diagnosis, treatment<br>or other<br>management<br>decisions. | qualitative detection<br>and identification of<br>human<br>metapneumovirus<br>(hMPV) in nasal and<br>nasopharyngeal<br>swabs and<br>aspirates/washes or<br>cell culture. The<br>assay detects hMPV<br>antigens by<br>immunofluorescenc<br>e using a blend of<br>three monoclonal<br>antibodies (MAbs),<br>from patients with<br>signs and symptoms<br>of acute respiratory<br>infection. This<br>assay detects but is<br>not intended to<br>differentiate the fou<br>recognized genetic<br>sub-lineages of<br>hMPV.<br><br>Negative results do<br>not preclude hMPV<br>infection and should<br>not be used as the<br>sole basis for<br>diagnosis, treatment<br>or other<br>management<br>decisions. It is<br>recommended that<br>specimens found to<br>be negative after<br>examination of the<br>direct specimen<br>results be confirmed<br>by an FDA-cleared<br>hMPV molecular<br>assay. |
| Table 5.1: Characteristics of the D³ FastPoint L-DFA Kit are compared to those of the following<br>Diagnostic Hybrids (DHI) predicate devices | | | | |
| Characteristics | D³ FastPoint L-DFA<br>Kit Subject Device | D³ Ultra Kit<br>510(k) #k061101 | D³ Duet RSV Kit<br>510(k) # k081928 | D³ MPV Kit<br>510(k) # k090073 |
| | metapneumovirus<br>molecular assay.<br>Negative results do<br>not preclude<br>respiratory virus<br>infection and should<br>not be used as the<br>sole basis for<br>diagnosis, treatment<br>or other<br>management<br>decisions. | | | |
| Target Viruses | influenza A virus,<br>influenza B virus,<br>respiratory syncytial<br>virus,<br>metapneumovirus,<br>adenovirus,<br>parainfluenza virus<br>type 1,<br>parainfluenza virus<br>type 2,<br>parainfluenza virus<br>type 3 | influenza A virus,<br>influenza B virus,<br>respiratory<br>syncytial virus,<br>adenovirus,<br>parainfluenza virus<br>type 1,<br>parainfluenza virus<br>type 2,<br>parainfluenza virus<br>type 3 | influenza A virus,<br>influenza B virus,<br>respiratory<br>syncytial virus,<br>adenovirus,<br>parainfluenza virus<br>type 1,<br>parainfluenza virus<br>type 2,<br>parainfluenza virus<br>type 3 | metapneumovirus |
| Monoclonal antibodies<br>(MAbs) | The D³ FastPoint L-<br>DFA Reagents<br>contain 18 MAbs to<br>8 different<br>respiratory viruses<br>(influenza A virus,<br>influenza B virus,<br>respiratory syncytial<br>virus,<br>metapneumovirus,<br>adenovirus,<br>parainfluenza virus<br>type 1,<br>parainfluenza virus<br>type 2,<br>parainfluenza virus<br>type 3) | The Respiratory<br>Virus DFA<br>Screening Reagent<br>contains 15 MAbs to<br>7 different<br>respiratory viruses<br>(influenza A virus,<br>influenza B virus,<br>respiratory syncytial<br>virus, adenovirus,<br>parainfluenza virus<br>type 1,<br>parainfluenza virus<br>type 2,<br>parainfluenza virus<br>type 3) | The<br>RSV/Respiratory<br>Virus DFA<br>Screening Reagent<br>contains 15 MAbs to<br>7 different<br>respiratory viruses<br>(influenza A virus,<br>influenza B virus,<br>adenovirus,<br>parainfluenza virus<br>type 1, parainfluenza<br>virus type 2,<br>parainfluenza virus<br>type 3), plus 2 MAbs<br>to respiratory<br>syncytial virus. | The<br>Metapneumovirus<br>DFA Reagent<br>contains 3 MAbs to<br>metapneumovirus |
| Labeling method | Direct labeling,<br>- using R-<br>Phycoerythrin (R-<br>PE) to label the | Direct labeling, | Direct labeling,<br>- using R-<br>Phycoerythrin (R-<br>PE) to label the | Direct labeling, |
| Table 5.1: Characteristics of the D³ FastPoint L-DFA Kit are compared to those of the following<br>Diagnostic Hybrids (DHI) predicate devices. | | | | |
| Characteristics | D³ FastPoint L-DFA<br>Kit Subject Device | D³ Ultra Kit<br>510(k) #k061101 | D³ Duet RSV Kit<br>510(k) # k081928 | D³ MPV Kit<br>510(k) # k090073 |
| | A virus, RSV and<br>parainfluenza virus<br>types 1, 2 and 3. | | syncytial virus. | |
| | - using fluorescein<br>isothiocyanate<br>(FITC) to label<br>influenza B virus,<br>metapneumovirus<br>and adenovirus<br>MAbs with<br>fluorescein. | - using fluorescein<br>isothiocyanate<br>(FITC) to label all<br>MAbs with<br>fluorescein. | - using fluorescein<br>isothiocyanate<br>(FITC) to label all<br>other MAbs with<br>fluorescein. | - using fluorescein<br>isothiocyanate<br>(FITC) to label all<br>MAbs with<br>fluorescein. |
| R-Phycoerythrin-labeled<br>MAbs | influenza A virus,<br>respiratory syncytial<br>virus, parainfluenza<br>virus type 1,<br>parainfluenza virus<br>type 2,<br>parainfluenza virus<br>type 3 | None | respiratory syncytial<br>virus | None |
| Fluorescein-labeled MAbs | influenza B virus,<br>metapneumovirus,<br>adenovirus | influenza A virus,<br>influenza B virus,<br>respiratory syncytial<br>virus, adenovirus,<br>parainfluenza virus<br>type 1,<br>parainfluenza virus<br>type 2,<br>parainfluenza virus<br>type 3 | influenza A virus,<br>influenza B virus,<br>adenovirus,<br>parainfluenza virus<br>type 1, parainfluenza<br>virus type 2,<br>parainfluenza virus<br>type 3 | metapneumovirus |
| Cell Fixative | Proprietary Non-<br>Acetone based<br>system | Acetone | Acetone | Acetone |
| Cell Counter-stain | Propidium Iodide,<br>Evans Blue | Evans Blue…