Who is the manufacturer of D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT?

Diagnostic Hybrids, Inc. filed the 510(k) submission for D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT (K093233).

What is the FDA product code for D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT?

OMG. It is classified under 21 CFR 866.3980 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT?

D³ Ultra DFA Respiratory Virus Screening & ID Kit (K061101); D³ Duet DFA RSV/Respiratory Virus Screening Kit (K081928); D³ DFA MPV Identification Kit (K090073).

Who can help prepare an FDA 510(k) submission like D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT

K093233 · Diagnostic Hybrids, Inc. · OMG · Dec 4, 2009 · Microbiology

Device Facts

Record ID	K093233
Device Name	D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
Applicant	Diagnostic Hybrids, Inc.
Product Code	OMG · Microbiology
Decision Date	Dec 4, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3980
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Diagnostic Hybrids, Inc. device, D³ FastPoint L-DFA RSV/MPV Identification Kit is intended for the qualitative identification of respiratory syncytial virus and human metapneumovirus 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 respiratory syncytial virus 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 syncytial virus and human metapneumovirus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.

Device Story

The D³ FastPoint L-DFA RSV/MPV Identification Kit is a direct fluorescence antibody (DFA) test for rapid identification of RSV and hMPV in respiratory specimens. The device uses a reagent blend of murine monoclonal antibodies (MAbs) directly labeled with R-PE (for RSV) or fluorescein (for hMPV). Clinical specimens are permeabilized and stained in liquid suspension using a sapogenin-based surfactant, then rinsed, pelleted, and re-suspended for microscopic examination. The device is used in clinical laboratories by trained personnel. A fluorescence microscope (200-400X) is required for visualization. RSV-infected cells exhibit golden-yellow fluorescence; hMPV-infected cells exhibit apple-green fluorescence; non-infected cells appear red due to Evans Blue counter-stain; nuclei appear orange-red due to propidium iodide. The output is a qualitative visual assessment of viral presence. This rapid identification assists clinicians in managing patients with respiratory symptoms, though negative results require confirmation by cell culture (RSV) or molecular assay (hMPV).

Clinical Evidence

Prospective clinical study at 4 U.S. sites (n=1519) during 2009 respiratory season. Comparator: composite of DSFA, viral culture, and hMPV real-time RT-PCR/sequencing. RSV sensitivity 98.6% (NP wash/aspirate) and 97.5% (NP swab); specificity 99.8% and 100%. hMPV sensitivity 68.8% (NP wash/aspirate) and 54.5% (NP swab); specificity 100%.

Technological Characteristics

Direct immunofluorescence assay using murine monoclonal antibodies. RSV-specific MAbs labeled with R-phycoerythrin (PE); hMPV-specific MAbs labeled with fluorescein isothiocyanate (FITC). Proprietary non-acetone cell fixative. Counter-stains: Propidium Iodide and Evans Blue. Manual liquid suspension staining format. Requires fluorescence microscopy for visualization. Reagents include sodium azide preservative.

Indications for Use

Indicated for qualitative identification of RSV and hMPV in nasal/nasopharyngeal swabs and aspirates/washes from symptomatic patients of all ages. Prescription use only.

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 MPV Identification Kit (K090073)

Related Devices

K091171 — D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT · Diagnostic Hybrids, Inc. · Sep 11, 2009
K090073 — D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT · Diagnostic Hybrids, Inc. · Mar 6, 2009
K081928 — D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT · Diagnostic Hybrids, Inc. · Dec 23, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ 1093233 Diagnostic Hybrids, Inc. ### D3 FastPoint L-DFA RSV/MPV Identification Kit 10/06/2009 Page 1 of 14 # 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 740-593-8437 -- Fax lollar@dhiusa.com #### Date of preparation of 510(k) summary: October 5. 2009 #### Device Name: Trade name - D FastPoint L-DFA RSV/MPV Identification Kit Common name - RSV/MPV DFA assay Classification name - Respiratory viral panel multiplex nucleic acid assay Product Code - OMG, LKT Regulation - 21 CFR 866.3980 Regulatory Class - Class II 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 # DEC - 4 2009 {1}------------------------------------------------ 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 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. ### D' Duet DFA RSV/Respiratory Virus Screening Kit (k081928) Intended Use: 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 {2}------------------------------------------------ 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 BSL3+ facility is available to receive and culture specimens. ### D3 DFA Metapneumovirus Identification Kit (k090073) Intended Use: The Diagnostic Hybrids, Inc. device, D3 DFA Metapneumovirus Identification Kit (D3 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 FDA-cleared hMPV molecular assay. ### Device Description: The D3 FastPoint L-DFA RSV/MPV Identification Kit uses a blend (called a "L-DFA Reagent'") of viral antigen-specific murine monoclonal antibodies that are directly labeled with either R-phycoerythin (PE) (respiratory syncytial virus) or fluorescein isothiocyanate (FITC) (human metapneumovirus) for the rapid identification of respiratory syncytial virus and human metapneumovirus in nasal and nasopharyngeal swabs and aspirates from patients with signs and symptoms of respiratory infection. ### Kit Components: - D3 FastPoint L-DFA RSV/MPV Reagent, 4.0-mL. One dropper bottle 1. containing a mixture of PE-labeled murine monoclonal antibodies directed against respiratory syncytial virus antigens and FITC-labeled murine monoclonal antibodies directed against human metapneumovirus antigens. The buffered, stabilized, aqueous solution contains Evans Blue and propidium iodide as counter-stains and 0.1% sodium azide as preservative. - 40X PBS Concentrate, 25-mL. One bottle of 40X PBS concentrate containing 2. 4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water). {3}------------------------------------------------ - Re-suspension Buffer, 6.0-mL. One bottle of a buffered glycerol solution and 3. 0.1% sodium azide. - D3 FastPoint L-DFA RSV/MPV Antigen Control Slides, 5-slides. Five 4. individually packaged control slides containing 2 wells with cell culture-derived positive and negative control cells. Each positive well contains cells infected with either respiratory syncytial virus or human metapneumovirus. The negative wells contain non-infected cells. Each slide is intended to be stained only one time. - D3 FastPoint L-DFA Specimen Slides and Coverslips, 50-slides with 5. coverslips. Fifty pack of 3-well specimen slides. 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 with the L-DFA Reagent. 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 RSV will exhibit golden-yellow fluorescence due to the PE. Cells infected with hMPV 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. ### Intended Use: The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA RSV/MPV Identification Kit is intended for the qualitative identification of respiratory syncytial virus and human metapneumovirus 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 respiratory syncytial virus 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 syncytial virus and human metapneumovirus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. · {4}------------------------------------------------ · | TABLE 5.1: Characteristics of the D3 FastPoint L-DFA Kit are compared to those of the following Diagnostic Hybrids (DHI) predicate devices | | | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----| | Characteristics | D3 FastPoint RSV/MPV Identification Kit (Subject Device) | D3 Ultra Kit 510(k) #k061101 | D3 Duet RSV Kit 510(k) # k081928 | D3 MPV Kit 510(k) # k090073 | | | Intended Use | The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA RSV/MPV Identification Kit is intended for the qualitative identification of respiratory syncytial virus and human metapneumovirus 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 respiratory syncytial virus 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 | The Diagnostic Hybrids, Inc. D3 UltraTM DFA (direct fluorescent antibody) Respiratory Virus Screening & ID Kit 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 monoclonal antibodies (MAbs). 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 respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. | The Diagnostic Hybrids, Inc. device, D3 Duet DFA RSV/Respiratory Virus Screening 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 | The Diagnostic Hybrids, Inc. device, D3 DFA Metapneumovirus Identification 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 | | | TABLE 5.1: Characteristics of the D3 FastPoint L-DFA Kit are compared to those of the following Diagnostic Hybrids (DHI) predicate devices | | | | | | | Characteristics | D3 FastPoint RSV/MPV Identification Kit (Subject Device) | D3 Ultra Kit 510(k) #k061101 | D3 Duet RSV Kit 510(k) # k081928 | D3 MPV Kit 510(k) # k090073 | | | | not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. | | decisions. | results be confirmed by an FDA-cleared hMPV molecular assay. | | | Target Viruses | respiratory syncytial virus, metapneumovirus | influenza A virus, influenza B virus, respiratory syncytial virus, adenovirus, parainfluenza virus type 1, parainfluenza virus type 2, parainfluenza virus type 3 | influenza A virus, influenza B virus, respiratory syncytial virus, adenovirus, parainfluenza virus type 1, parainfluenza virus type 2, parainfluenza virus type 3 | metapneumovirus | | | Monoclonal antibodies (MAbs) | The D3 FastPoint L- DFA RSV/MPV Reagent contain 5 MAbs to respiratory syncytial virus (2) and metapneumovirus (3) | The Respiratory Virus DFA Screening Reagent contains 15 MAbs to 7 different respiratory viruses (influenza A virus, influenza B virus, respiratory syncytial virus, adenovirus, parainfluenza virus type 1, parainfluenza virus type 2, parainfluenza virus type 3) | The RSV/Respiratory Virus DFA Screening Reagent contains 15 MAbs to 7 different respiratory viruses (influenza A virus, influenza B virus, adenovirus, parainfluenza virus type 1, parainfluenza virus type 2, parainfluenza virus type 3), plus 2 MAbs to respiratory syncytial virus. | The Metapneumovirus DFA Reagent contains 3 MAbs to metapneumovirus | | | Labeling method | Direct labeling - using R- Phycoerythrin (R- PE) to label the MAbs to RSV. | Direct labeling - using fluorescein isothiocyanate (FITC) to label all MAbs with fluorescein. | Direct labeling - using R- Phycoerythrin (R- PE) to label the MAbs to respiratory syncytial virus. - using fluorescein isothiocyanate | Direct labeling - using fluorescein isothiocyanate (FITC) to label all MAbs with fluorescein. | | | | | | | | | | TABLE 5.1: Characteristics of the D³ FastPoint L-DFA Kit are compared to those of the following Diagnostic Hybrids (DHI) predicate devices | | | | | | | Characteristics | D³ FastPoint RSV/MPV Identification Kit (Subject Device) | D³ Ultra Kit 510(k) #k061101 | D³ Duet RSV Kit 510(k) #k081928 | D³ MPV Kit 510(k) # k090073 | | | | (FITC) to label the MAbs to metapneumovirus. | | (FITC) to label all other MAbs with fluorescein. | | | | R-Phycoerythrin-labeled MAbs | respiratory syncytial virus | None | respiratory syncytial virus | None | | | Fluorescein-labeled MAbs | metapneumovirus | influenza A virus, influenza B virus, respiratory syncytial virus, adenovirus, parainfluenzavirus type 1, parainfluenzavirus type 2, parainfluenzavirus type 3 | influenza A virus, influenza B virus, adenovirus, parainfluenzavirus type 1, parainfluenza virus type 2, parainfluenzavirus type 3 | metapneumovirus | | | Cell Fixative | Proprietary Non- Acetone based system | Acetone | Acetone | Acetone | | | Cell Counter-stain | Propidium Iodide, Evans Blue | Evans Blue | Evans Blue | Evans Blue | | | Performance characteristics | | | |…

D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

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Submission Summary (Full Text)

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D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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Special Control Matches

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