D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT

• K Number: K090073
• Device Name: D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
• Manufacturer: DIAGNOSTIC HYBRIDS, INC.
• Date Cleared: 2009-03-06 ( 53 days)
• Product Code: OMG
• Regulation Number: 866.3980

Intended Use

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 results be confirmed by an FDA cleared hMPV molecular assay.

Device Description

The D DFA Metapneumovirus Identification Kit uses a blend of three hMPV antigen-specific murine MAbs that are directly labeled with fluorescein for detection of hMPV. The reagent detects but does not differentiate between the four recognized subtypes of hMPV (subtypes A1, A2, B1, and B2). Kit Components: - 1. Metapneumovirus DFA Reagent, 5-mL. One dropper bottle containing a blend (see below for MAb discussion) of fluorescein-labeled murine monoclonal antibodies directed against MPV. The buffered, stabilized, aqueous solution contains Evans Blue as a counter-stain and 0.1% sodium azide as a preservative. - 2. hMPV Antigen Control Slides, 5 slides. Five individually packaged control slides, each with a well containing cell culture-derived MPV positive cells and a well containing cell culture-derived negative cells. Each slide is intended to be stained only one time. Control material has been treated to be non-infectious; however normal laboratory precautions are required when the material is handled. - 3. 40X PBS Concentrate, 25-mL. One bottle containing a 40X concentrate consisting of 4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water) in PBS. - 4. Mounting Fluid, 7-mL. One dropper bottle containing an aqueous, buffer-stabilized solution of glycerol and 0.1% sodium azide. The cells to be tested, derived from a clinical specimen or cell culture, are placed onto a glass slide, allowed to air dry and are fixed in acetone. The Metapneumovirus DFA Reagent is added to the cells which are then incubated for 15 to 30 minutes at 35℃ to 37℃ in a humidified chamber or humidified incubator. The stained cclls are then washed with the diluted phosphate buffered saline (PBS), a drop of the supplied Mounting Fluid is added and a coverslip is placed on the prepared cells. The cells are examined using a fluorescence microscope. The hMPV infected cells will fluoresce apple-green. Uninfected cells will contain no fluorescence but will be stained red by the Evans Blue counter-stain. It is recommended that specimens found to contain no fluorescent cells after examination of the direct specimen be confirmed by an FDA cleared hMPV molecular assay.

Predicate Devices

K082688

Reference Devices

K082688

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on a manual immunofluorescence assay using labeled antibodies and fluorescence microscopy for visual interpretation by a user. There is no mention of automated image analysis, algorithms, or any form of AI/ML.

Therapeutic

No.
This device is an in vitro diagnostic (IVD) intended for the qualitative detection and identification of human metapneumovirus (hMPV) antigens, used for diagnostic purposes, not for treating a disease or condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device "is intended for the qualitative detection and identification of human metapneumovirus (hMPV)... from patients with signs and symptoms of acute respiratory infection." The main purpose of the device is to aid in the diagnosis of hMPV infection.

SaMD (Software as a Medical Device)

No

The device is a kit containing physical reagents (antibodies, PBS, mounting fluid) and control slides used in a laboratory procedure involving manual steps (staining, washing, mounting) and examination under a fluorescence microscope. It is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the qualitative detection and identification of human metapneumovirus (hMPV) in nasal and nasopharyngeal swabs and aspirates/washes or cell culture." This describes a test performed on specimens taken from the human body to provide information for diagnosis.
• Device Description: The description details a laboratory test using reagents (monoclonal antibodies) to detect antigens in biological specimens (cells from clinical specimens or cell culture). The process involves staining, incubation, washing, and examination under a microscope to identify the presence of hMPV.
• Clinical Performance Studies: The document describes extensive clinical performance studies conducted at clinical laboratories using patient specimens. This is a standard requirement for demonstrating the performance of an IVD.
• Predicate Device: The mention of a "Predicate Device(s)" (K082688, Pro hMPV+ Assay) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.

All these elements align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 results be confirmed by an FDA cleared hMPV molecular assay.

Product codes

OMG

Device Description

The D DFA Metapneumovirus Identification Kit uses a blend of three hMPV antigen-specific murine MAbs that are directly labeled with fluorescein for detection of hMPV. The reagent detects but does not differentiate between the four recognized subtypes of hMPV (subtypes A1, A2, B1, and B2).

Kit Components:

1. Metapneumovirus DFA Reagent, 5-mL. One dropper bottle containing a blend (see below for MAb discussion) of fluorescein-labeled murine monoclonal antibodies directed against MPV. The buffered, stabilized, aqueous solution contains Evans Blue as a counter-stain and 0.1% sodium azide as a preservative.
2. hMPV Antigen Control Slides, 5 slides. Five individually packaged control slides, each with a well containing cell culture-derived MPV positive cells and a well containing cell culture-derived negative cells. Each slide is intended to be stained only one time. Control material has been treated to be non-infectious; however normal laboratory precautions are required when the material is handled.
3. 40X PBS Concentrate, 25-mL. One bottle containing a 40X concentrate consisting of 4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water) in PBS.
4. Mounting Fluid, 7-mL. One dropper bottle containing an aqueous, buffer-stabilized solution of glycerol and 0.1% sodium azide.

The cells to be tested, derived from a clinical specimen or cell culture, are placed onto a glass slide, allowed to air dry and are fixed in acetone. The Metapneumovirus DFA Reagent is added to the cells which are then incubated for 15 to 30 minutes at 35℃ to 37℃ in a humidified chamber or humidified incubator. The stained cclls are then washed with the diluted phosphate buffered saline (PBS), a drop of the supplied Mounting Fluid is added and a coverslip is placed on the prepared cells. The cells are examined using a fluorescence microscope. The hMPV infected cells will fluoresce apple-green. Uninfected cells will contain no fluorescence but will be stained red by the Evans Blue counter-stain.

It is recommended that specimens found to contain no fluorescent cells after examination of the direct specimen be confirmed by an FDA cleared hMPV molecular assay.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nasal and nasopharyngeal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Analytical sensitivity:
The analytical detection limits on direct specimens for the D3 DFA Metapneumovirus Identification Kit were addressed using quantified cultures of characterized isolates of each of the 4 recognized genetic sublineages of hMPV (A1, A2, B1, and B2). The infected culture cells from a 1,000 infected cells/mL culture were serially diluted with a suspension of uninfected LLC-MK2 cells. 25-µL aliquots from each dilution level were spotted onto 10 replicate microscope slides, then fixed and stained according to the instructions for use described in this product insert. Each cell spot was examined at 200x magnification. Results were reported as numbers of positive replicates for each set of 10. Analytical detection limits for each of the 4 hMPV genetic sublineages were defined as the lowest dilutions at which at least 9 out of 10 replicates were detected.

Detection limit on cell culture amplified specimens of the D3 DFA Metapneumovirus Identification Kit was addressed using a cell culture system. Analytical detection limits on cell culture amplified specimens for hMPV subtypes A1, A2, B1, and B2 were established with results reported in numbers of fluorescent cells per cell monolayer. Each master stock virus preparation was diluted in a ten-fold manner. Eight wells of a 48-well R-Mix cell culture plate were inoculated with 0.2-mL volumes of each dilution. The plates were centrifuged at 700 xg for 60 minutes, and then incubated at 35°C to 37°C for 48-hours. Each well was stained with the D3 DFA Metapneumovirus Identification Kit then examined at 200x magnification and the number of fluorescent cells counted. In this study, the detection limit for the test on cell culture amplified specimens is defined as the lowest inoculum level at which positive wells (i.e. containing fluorescent cells) are observed, in terms of TCID50.

Reproducibility:
Assay reproducibility was assessed at 3 laboratory sites with a panel of proficiency-level antigen control slides. The reproducibility panel consisted of 5 panel members. Each panel member was a 2-well slide spotted with the same cell preparation in each well. The cell preparations used to construct the slides are the following:

1. Non-infected LLC-MK2 cells.
2. Low level hMPV (A1 strain) grown in LLC-MK2 cells (manufactured to contain between 4 to 10% infected cells).
3. Mid level hMPV (A1 strain) grown in LLC-MK2 cells (manufactured to contain between 20 to 30% infected cells).
4. High level hMPV (A1 strain) grown in LLC-MK2 cells (manufactured to contain between 50 to 75% infected cells).

Each panel was tested daily in two separate runs for 5-days by three different laboratories (30 total runs). The panel members were randomized with different slide identification numbers to act as a "blinded" panel. An hMPV Antigen Control Slide (two-well slide, one well contains cell culture-derived hMPV positive cells and one well contains cell culture-derived negative cells) was stained according to the D-DFA Metapneumovirus Identification Kit instructions for use with each run. The following results were recorded for both the control slides and the panel slides:

1. Presence or absence of green fluorescence.
2. Percent of cells exhibiting green fluorescence.

A single lot of D MPV Kit was used. A total of 210 data points were included in the reproducibility study data analysis (7 samples and controls/run X 2 runs/day X 5 days X 3 sites = 210).

Clinical Performance:
Performance characteristics of the DHI D3 DFA Metapneumovirus Identification Kit testing direct respiratory specimens were established during prospective studies at 3 geographically diverse U.S. clinical laboratories during the 2005 and 2006 respiratory virus seasons (December 2005 - April 2006 and December 2006 -March 2007). All specimens used in the studies meeting the inclusion and exclusion criteria represented excess, remnants of respiratory specimens that were prospectively collected from symptomatic individuals suspected of respiratory infection, and were submitted for routine care or analysis by each site, and that otherwise would have been discarded. Individual specimens were delinked from all patient identifiers and given a study sample code. All clinical sites were granted waivers of informed consent by their IRBs for this study.

Performance of the D3 DFA Metapneumovirus Identification Kit was assessed and compared to a predetermined algorithm that used composite comparator methods at clinical study site 1 and 2. The composite comparator methods consisted of viral culture and a validated real-time RT-PCR comparator assay targeting the hMPV nucleocapsid gene followed by bi-directional sequencing analysis. "True" hMPV positive was defined as any sample that either tested positive by viral culture, or had bi-directional sequencing data meeting pre-defined quality acceptance criteria that matched hMPV sequences deposited in the National Center for Biotechnology Information (NCBI) GenBank database (www.ncbi.nlm.nih.gov), with acceptable Evalues . "True" hMPV negative was defined as any sample that tested negative by both viral culture and the hMPV real-time RT-PCR comparator assay.

Performance of the D3 DFA Metapneumovirus Identification Kit at clinical study site 3 was evaluated and compared only to the validated hMPV real-time RT-PCR followed by bi-directional sequencing analysis comparator assay described above. Any sample that had bi-directional sequencing data meeting pre-defined quality acceptance criteria that matched hMPV sequences deposited in the National Center for Biotechnology Information (NCBI) GenBank database (www.ncbi.nlm.nih.gov), with acceptable E-values, was considered as hMPV positive, and the real-time hMPV RT-PCR comparator assay negatives were considered as hMPV negatives at this site.

• Study Site 1:
  Study Site 1 evaluated a total of 1564 fresh respiratory specimens submitted, December 2006 through March 2007, to the laboratory for respiratory virus testing. Slides were prepared from Phosphate Buffered Saline (PBS)-washed cells from the fresh specimens and fixed according to the prescribed protocol. The slides were stained in accordance with the procedure in the product insert.
  Of the 1564 fresh respiratory specimens tested, 1509 were nasal wash/nasopharyngeal aspirate specimens. 27 were further excluded from the performance analysis due to insufficient volume for the comparator methods, resulting in a total of 1482 fresh nasal wash/nasopharyngeal aspirate specimens for analysis.

• Study Site 2:
  Study Site 2 evaluated a total of 371 fresh respiratory specimens submitted, December 2005 through January 2006, to the laboratory for respiratory virus testing. Slides were prepared from Phosphate Buffered Saline (PBS)-washed cells from the fresh specimens and fixed according to the prescribed protocol. The slides were stained in accordance with the procedure in the product insert.
  Of the 371 fresh respiratory specimens tested, all were nasal/nasopharyngeal swab specimens. 3 were excluded from the performance analysis due to insufficient volume for the comparator methods, resulting in a total of 368 fresh nasal/nasopharyngeal swab specimens for analysis.

• Study Site 3:
  Study Site 3 evaluated a total of 174 fresh respiratory specimens submitted. March 2006 through April 2006, to the laboratory for respiratory virus testing. Slides were prepared from Phosphate Buffered Saline (PBS)-washed cells from the fresh specimens and fixed according to the prescribed protocol. The slides were stained in accordance with the procedure in the product insert.
  Of the 174 fresh respiratory specimens tested, 62 were nasal wash/nasopharyngeal aspirate specimens, and 110 were nasal/nasopharyngeal swab specimens. Of the 62 nasal wash/nasopharyngeal aspirate specimens, 30 were excluded from the performance analysis due to insufficient volume for the comparator method, resulting in a total of 32 fresh nasal wash/nasopharyngeal aspirate specimens for analysis. Of the 110 nasal/nasopharyngeal swab specimens, 44 were excluded from the performance analysis due to insufficient volume for the comparator method, resulting in a total of 66 fresh nasal/nasopharyngeal swab specimens for analysis.

Cultured Cells Testing:
Performance characteristics of the DHI D DFA Metapneumovirus Identification Kit testing cultured cell specimens were established during a prospective study at DHI during the 2007 respiratory virus seasons (January - April 2008). All specimens used in the studies meeting the inclusion and exclusion criteria represented excess. remnants of respiratory specimens that were prospectively collected from symptomatic individuals suspected of respiratory infection, and were submitted for routine care or analysis by each collection site, and that otherwise would have been discarded. Individual specimens were delinked from all patient identifiers and given a study sample code.

Performance of the D3 DFA Metapneumovirus Identification Kit testing cultured cell specimens was evaluated and compared to the same validated hMPV real-time RT-PCR followed by bi-directional sequencing analysis comparator assay as described earlier, at clinical study site 4. Any cultured cell specimen that had bidirectional sequencing data meeting pre-defined quality acceptance criteria that matched hMPV sequences deposited in the National Center for Biotechnology Information (NCBI) GenBank database (www.ncbi.nlm.nih.gov), with acceptable Evalues, was considered as hMPV positive, and the real-time hMPV RT-PCR comparator assay negative cultured cell specimens were considered as hMPV negatives.

• Study Site 4:
  Study Site 4 evaluated a total of 74 freeze-thawed nasopharyngeal swab specimens that were cultured and stained in accordance with the D3 DFA Metapneumovirus Identification Kit procedure.

Summary of Performance Studies

Analytical Performance:
The MAbs all recognize a hMPV protein, approximately 46 kiloDaltons in size, which corresponds with the size of hMPV nucleoprotein, but do not compete with one another for binding sites (as demonstrated by SDS-PAGE analyses, against lysates of cell culture infected with hMPV subtypes A1, A2, B1, and B2).

Analytical specificity of the MPV DFA Reagent was evaluated against other respiratory viruses (multiple strains of adenovirus, influenza A, influenza B, respiratory syncytial virus, and parainfluenza types 1, 2, and 3), as well as strains of 8 other viruses, and 30 other microorganisms that could be encountered in a respiratory specimen, cell culture contamination, or laboratory processing.

Reproducibility:
Study Type: Reproducibility Study
Sample Size: 210 data points (7 samples and controls/run x 2 runs/day x 5 days x 3 sites)
Key Results: The combined data from the three sites demonstrated that the detection of hMPV occurs in a reproducible manner. The presence of hMPV infected cells was reported in 100% (120/120) of the wells in which infected cells were present. The combined data from the three sites also demonstrated that no hMPV was detected in non-infected cells. The absence of hMPV was reported in 100% (90/90) of the wells in which infected cells were not present. The total percent agreement for the D3 DFA Metapneumovirus Identification Kit was 100% (210/210).

Clinical Performance:

• Study Site 1:
  Study Type: Clinical Performance Study
  Sample Size: 1482 fresh nasal wash/nasopharyngeal aspirate specimens
  Key Results:
  Sensitivity: 53.0% (122/230)
  Specificity: 99.8% (1249/1252)

• Study Site 2:
  Study Type: Clinical Performance Study
  Sample Size: 368 fresh nasal/nasopharyngeal swab specimens
  Key Results:
  Sensitivity: 70.7% (41/58)
  Specificity: 99.7% (309/310)

• Study Site 3:
  Study Type: Clinical Performance Study
  Sample Size:
  Fresh Nasal Wash/Nasopharyngeal Aspirate: 32 specimens
  Fresh Nasal/Nasopharyngeal Swab: 66 specimens
  Key Results:
  Fresh Nasal Wash/Nasopharyngeal Aspirate:
  Positive Percent Agreement: 100.0% (9/9)
  Negative Percent Agreement: 100.0% (23/23)
  Fresh Nasal/Nasopharyngeal Swab:
  Positive Percent Agreement: 75.0% (3/4)
  Negative Percent Agreement: 100.0% (62/62)

• Cultured Cells Testing - Study Site 4:
  Study Type: Clinical Performance Study
  Sample Size: 74 freeze-thawed nasopharyngeal swab specimens amplified in cell culture
  Key Results:
  Positive Percent Agreement: 83.3% (5/6)
  Negative Percent Agreement: 100.0% (68/68)

Key Metrics

Analytical sensitivity (LoD):
For direct specimens:
hMPV subtype A1: 25 infected cells/mL
hMPV subtype A2: 200 infected cells/mL
hMPV subtype B1: 50 infected cells/ml
hMPV subtype B2: 100 infected cells/mL

For cell culture amplified specimens (fluorescent staining cells per cell monolayer):
hMPV A1, 50-TCID50: 47,39,41,31,26,30, 21,29
hMPV A1, 5-TCID50: 0,0,0,3,1,0,2,0
hMPV A1, 0.5-TCID50: 0,0,0,0,0,0,0,0
hMPV A2, 50-TCID50: 10,13,23,13,23,15, 17,12
hMPV A2, 5-TCID50: 3,1,1,4,2,2,0,0
hMPV A2, 0.5-TCID50: 0,0,0,0,0,0,0,0
hMPV B1, 50-TCID50: 36,56,23,41,28,29, 34,28
hMPV B1, 5-TCID50: 4,7,0,3,1,0,4,4
hMPV B1, 0.5-TCID50: 0,0,0,0,0,0,0,0
hMPV B2, 50-TCID50: 25,49,36,41,53,68, 43,27
hMPV B2, 5-TCID50: 0,3,1,1,5,6,3,5
hMPV B2, 0.5-TCID50: 0,0,0,0,0,0,0,0

Reproducibility:
Total Agreement with Expected result: 100% (210/210), 95% CI: 98.3%-100%
For individual panel members and controls: 100% agreement.

Clinical Performance - Study Site 1 (Fresh Nasal Wash/Nasopharyngeal Aspirate):
Sensitivity: 53.0% (122/230), 95% CI: 46.6%-59.5%
Specificity: 99.8% (1249/1252), 95% CI: 99.3%-99.9%

Clinical Performance - Study Site 2 (Fresh Nasal/Nasopharyngeal Swab):
Sensitivity: 70.7% (41/58), 95% CI: 57.3%-81.9%
Specificity: 99.7% (309/310), 95% CI: 98.2%-100%

Clinical Performance - Study Site 3 (Fresh Nasal Wash/Nasopharyngeal Aspirate):
Positive Percent Agreement: 100.0% (9/9), 95% CI: 66.4%-100%
Negative Percent Agreement: 100.0% (23/23), 95% CI: 85.2%-100%

Clinical Performance - Study Site 3 (Fresh Nasal/Nasopharyngeal Swab):
Positive Percent Agreement: 75.0% (3/4), 95% CI: 19.4%-99.4%
Negative Percent Agreement: 100.0% (62/62), 95% CI: 94.2%-100%

Cultured Cells Testing - Study Site 4 (Freeze-thawed Nasopharyngeal Swab Amplified in Cell Culture):
Positive Percent Agreement: 83.3% (5/6), 95% CI: 35.9%-99.6%
Negative Percent Agreement: 100.0% (68/68), 95% CI: 99.7%-100%

Predicate Device(s)

K082688

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.

(a)
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.
(b)
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.

Summary

0

K090073

SECTION 05, 510(K) SUMMARY

Applicant:

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

Contact Information:

Gail R. Goodrum Vice President, Regulatory Affairs E-mail: goodrum(@dhiusa.com Telephone: [phone] FAX: [phone]

Date of preparation of 510(k) summary:

December 22, 2008

Device Name:

Trade name - D3 DFA Metapneumovirus Identification Kit Common name - Fluorescent antibody test for detecting human metapneumovirus Classification name - (blank) Product Code - OMG Regulation - 21 CFR 866.3980, Class II, Respiratory viral panel multiplex nucleic acid assay reagents; Panel Microbiology (83)

Legally marketed device to which equivalence is claimed:

K082688, Pro hMPV+ Assay

Intended Use: The Pro hMPV+ Assay is a Real Time RT-PCR in vitro diagnostic test for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid isolated and purified from nasopharyngeal swab (NP) specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This assay targets a highly conserved region of the Nucleocapsid gene of hMPV. The detection of hMPV nucleic acid from symptomatic patients aids in the diagnosis of human respiratory hMPV infection if used in conjunction with other clinical and laboratory findings. This test is not intended to differentiate the four 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.

6 2009 MAR

1

Diagnostic Hybrids, Inc.

D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT

Device Description:

The D DFA Metapneumovirus Identification Kit uses a blend of three hMPV antigen-specific murine MAbs that are directly labeled with fluorescein for detection of hMPV. The reagent detects but does not differentiate between the four recognized subtypes of hMPV (subtypes A1, A2, B1, and B2).

Kit Components:

• 1. Metapneumovirus DFA Reagent, 5-mL. One dropper bottle containing a blend (see below for MAb discussion) of fluorescein-labeled murine monoclonal antibodies directed against MPV. The buffered, stabilized, aqueous solution contains Evans Blue as a counter-stain and 0.1% sodium azide as a preservative.
• 2. hMPV Antigen Control Slides, 5 slides. Five individually packaged control slides, each with a well containing cell culture-derived MPV positive cells and a well containing cell culture-derived negative cells. Each slide is intended to be stained only one time. Control material has been treated to be non-infectious; however normal laboratory precautions are required when the material is handled.
• 3. 40X PBS Concentrate, 25-mL. One bottle containing a 40X concentrate consisting of 4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water) in PBS.
• 4. Mounting Fluid, 7-mL. One dropper bottle containing an aqueous, buffer-stabilized solution of glycerol and 0.1% sodium azide.

The cells to be tested, derived from a clinical specimen or cell culture, are placed onto a glass slide, allowed to air dry and are fixed in acetone. The Metapneumovirus DFA Reagent is added to the cells which are then incubated for 15 to 30 minutes at 35℃ to 37℃ in a humidified chamber or humidified incubator. The stained cclls are then washed with the diluted phosphate buffered saline (PBS), a drop of the supplied Mounting Fluid is added and a coverslip is placed on the prepared cells. The cells are examined using a fluorescence microscope. The hMPV infected cells will fluoresce apple-green. Uninfected cells will contain no fluorescence but will be stained red by the Evans Blue counter-stain.

It is recommended that specimens found to contain no fluorescent cells after examination of the direct specimen be confirmed by an FDA cleared hMPV molecular assay.

Intended Use:

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

2

Diagnostic Hybrids, Inc.

D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT

02/27/2009 Section 5 - Page 3 of 13

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.

Technological Characteristics, Compared to Predicate Device:

TABLE 1:	Technological Characteristics Comparison of Devices
D3 DFA Metapneumovirus Identification
Kit (Subject)	Pro hMPV+ Assay (Predicate)	DHI Human Metapneumovirus
Real-Time, Reverse Transcription
PCR Assay (Reference)
Target:
Searches of the National Center for
Biotechnology Information (NCBI)
databasesa yielded presumptive evidence that
the target for each of the 3 MAb clones is the
MPV nucleoprotein. Nine proteins are
known to be encoded in the hMPV genome.b
Of the nine proteins, only the nucleoprotein
is of a size equivalent to the 46 kDa size
noted on the Western of the 3 MAb clones.	The Pro hMPV+ Supermix contains
oligonucleotide primers and target-
specific oligonucleotide probes. The
primers are complementary to highly
conserved regions of genetic
sequences of the nucleocapsid of
hMPV.	The DHI Human Metapneumovirus
Real-Time, Reverse Transcription
PCR Assay master mix contains
oligonucleotide primers and target-
specific oligonucleotide probes. The
primers are complementary to highly
conserved sequences within the
nucleocapsid gene of hMPV.
Specimen:
Nasal and nasopharyngeal swabs and
aspirates or cell culture.	Nasopharyngeal swab specimens
using a polyester, rayon or nylon
tipped swab and placed into viral
transport medium	Nasal and nasopharyngeal swabs and
aspirates or cell culture.
Detection Methods:
The assay detects specific hMPV viral
antigens by immunofluorescence using
monoclonal antibodies (MAbs). The cells to
be tested, derived from a clinical specimen or
cell culture, are placed onto a glass slide and
allowed to air dry. The cells are fixed in
acetone. The hMPV DFA reagent is added to
the cells which are then incubated for 15 to
30 minutes at 35° to 37°C in a humidified
chamber or humidified incubator. The
stained cells are then washed with the diluted
phosphate buffered saline (PBS), a drop of
the supplied Mounting Fluid is added and a
coverslip is placed on the prepared cells. The
cells are examined using a fluorescence
microscope. The hMPV infected cells will	Reverse transcription of the RNA in
the sample into complementary DNA
(cDNA) and subsequent
amplification of DNA is performed
in a Cepheid SmartCycler®II
instrument. In this process, the probe
anneals specifically to the template
followed by primer extension and
amplification. The Pro hMPV+
Assay is based on TaqMan
chemistry, which utilizes the 5' - 3'
exonuclease activity of the Taq
polymerase to cleave the probe thus
separating the reporter dye from the
quencher. This generates an increase
in fluorescent signal upon excitation	Reverse transcription of the RNA in
the sample into complementary DNA
(cDNA) and subsequent amplification
of DNA is performed in a Stratagene
Mx3000p instrument. In this process,
the probe anneals specifically to the
template followed by primer extension
and amplification. The DHI Human
Metapneumovirus Real-Time, Reverse
Transcription Assay is based on
TaqMan chemistry, which utilizes the
5'-3' exonuclease activity of the Taq
polymerase to cleave the probe thus
separating the reporter dye from the
quencher. This generates an increase
in fluorescent signal upon excitation
fluoresce apple-green. Uninfected cells will	from a light source. With each cycle,	from a light source. With each cycle.
TABLE 1:	Technological Characteristics Comparison of Devices
D³ DFA Metapneumovirus Identification
Kit (Subject)	Pro hMPV+ Assay (Predicate)	DHI Human Metapneumovirus
Real-Time, Reverse Transcription
PCR Assay (Reference)
contain no fluorescence but will be stained
red by the Evans Blue counter-stain.	additional reporter dye molecules are
cleaved from their respective probes,
further increasing fluorescent signal.
The amount of fluorescence at any
given cycle is dependent on the
amount of amplification products
present at that time. Fluorescent
intensity is monitored during each
PCR cycle by the SmartCycler II
instrument.	additional reporter dye molecules are
cleaved from their respective probes,
further increasing fluorescent signal.
The amount of fluorescence at any
given cycle is dependent on the
amount of amplification products
present at that time. Fluorescent
intensity is monitored during each
PCR cycle by the Stratagene Mx3000p
instrument.
Analytical sensitivity:
Analytical detection limits on direct
specimens for the D³ DFA
Metapneumovirus Identification Kit
were addressed using quantified cultures
of characterized isolates of each of the 4
recognized genetic sublineages of hMPV
(A1, A2, B1, and B2). The infected
culture cells from a 1,000 infected
cells/mL culture were serially diluted
with a suspension of uninfected LLC-
MK2 cells. 25-µL aliquots from each
dilution level were spotted onto 10
replicate microscope slides, then fixed
and stained according to the instructions
for use described in this product insert.
Each cell spot was examined at 200x
magnification. Results were reported as
numbers of positive replicates for each
set of 10. Analytical detection limits for
each of the 4 hMPV genetic sublineages
were defined as the lowest dilutions at
which at least 9 out of 10 replicates were
detected. Based on this testing the LoD
for each subtype was A1= 25 infected
cells/mL, A2 = 200 infected cells/mL, B1 =
50 infected cells/ml., B2 = 100 infected
cells/mL.
Detection limit on cell culture amplified
specimens of the D³ DFA Metapneumovirus
Identification Kit was addressed using a cell
culture system. Analytical detection limits on
cell culture amplified specimens for hMPV
subtypes A1, A2, B1, and B2 were
established with results reported in numbers
of fluorescent cells per cell monolayer. Each
master stock virus preparation was diluted in
a ten-fold manner. Eight wells of a 48-well
R-Mix cell culture plate were inoculated with	The analytical sensitivity (limit of
detection or LoD) of the Pro hMPV+
Assay was determined using
quantified (TCID₅₀/mL) cultures of 2
hMPV (subtype A2 and subtype B2)
strains serially diluted in
nasopharyngeal clinical matrix. Each
viral strain was extracted using the
Roche MagNA Pure LC and tested in
replicates of 20 per concentration of
virus. Analytical sensitivity (LoD) as
defined as the lowest concentration at which 3 95% of all replicates tested
positive, ranged from 102 to 101
TCID₅₀/mL.D Concentration
hMPV subtype A2 102 TCID₅₀/mL
hMPV subtype B2 101 TCID₅₀/mL	Analytical validation of the real-
time hMPV RT-PCR followed by
bi-directional sequencing analysis
comparator assay included
analytical sensitivity and reactivity
study, analytical specificity study,
and extraction efficiency study.
The analytical sensitivity (limit of
detection or LoD) of the real-time
hMPV RT-PCR followed by bi-
directional sequencing analysis
comparator assay was determined
using quantified (TCID₅₀/mL)
stocks of the 4 hMPV (subtypes
A1, A2, B1 and B2) strains diluted
in hMPV negative nasopharyngeal
clinical matrix, and ranged from 10

• 50 TCID₅₀/mL. | |
  | TABLE 1: Technological Characteristics Comparison of Devices | | | |
  | D³ DFA Metapneumovirus Identification Kit (Subject) | Pro hMPV+ Assay (Predicate) | DHI Human Metapneumovirus Real-Time, Reverse Transcription PCR Assay (Reference) | |
  | 0.2-mL volumes of each dilution. The plates were centrifuged at 700 xg for 60 minutes, and then incubated at 35°C to 37°C for 48-hours. Each well was stained with the D³ DFA Metapneumovirus Identification Kit then examined at 200x magnification and the number of fluorescent cells counted. In this study, the detection limit for the test on cell culture amplified specimens is defined as the lowest inoculum level at which positive wells (i.e. containing fluorescent cells) are observed, in terms of TCID₅₀. Table 1.1 below summarizes the results: | | | |
  | TABLE 1.1: Limit of Detection of the D³ DFA Metapneumovirus Identification Kit for Cell Culture Amplified Specimens (values are numbers of fluorescent staining cells per cell monolayer) | | | |
  | Virus Strain | Conc. of Inoculum | Fluorescent staining cells/well | |
  | hMPV A1 | 50-TCID₅₀ | 47,39,41,31,26,30, 21,29 | |
  | | 5-TCID₅₀ | 0,0,0,3,1,0,2,0 | |
  | | 0.5-TCID₅₀ | 0,0,0,0,0,0,0,0 | |
  | hMPV A2 | 50-TCID₅₀ | 10,13,23,13,23,15, 17,12 | |
  | | 5-TCID₅₀ | 3,1,1,4,2,2,0,0 | |
  | | 0.5-TCID₅₀ | 0,0,0,0,0,0,0,0 | |
  | hMPV B1 | 50-TCID₅₀ | 36,56,23,41,28,29, 34,28 | |
  | | 5-TCID₅₀ | 4,7,0,3,1,0,4,4 | |
  | | 0.5-TCID₅₀ | 0,0,0,0,0,0,0,0 | |
  | hMPV B2 | 50-TCID₅₀ | 25,49,36,41,53,68, 43,27 | |
  | | 5-TCID₅₀ | 0,3,1,1,5,6,3,5 | |
  | | 0.5-TCID₅₀ | 0,0,0,0,0,0,0,0 | |
  | Analytical specificity (cross reactivity studies; various strains of microorganisms and cell lines): | | | |
  | Viruses | 59 | 26 | 14 |
  | Bacteria | 25 | 21 | 0 |
  | Chlamydia spp. | 3 | 2 | 0 |
  | Yeast | 1 | 1 | 0 |
  | Protozoan | 1 | 0 | 0 |
  | | TABLE 1: Technological Characteristics Comparison of Devices | | |
  | D³ DFA Metapneumovirus Identification
  Kit (Subject) | | Pro hMPV+ Assay (Predicate) | DHI Human Metapneumovirus
  Real-Time, Reverse Transcription
  PCR Assay (Reference) |
  | Cell lines | 17 | 0 | 0 |
  | Human genomic
  DNA | | | 1 |
  | Human total RNA | | | 1 |

ª NCBI (National Center for Biotechnology Information) internet web site http://www.ncbi.nlm.nih.gov/

DHI-MPV_Sec05_510k-Summary_09FEB27_Corrected.doc

8 Proteins encoded in hMPV genome are nucleoprotein, matrix protein, fusion glycoprotein precursor, matrix protein M2-1, matrix protein M2-2, small hydrophobic protein attachment glycoprotein G, RNA dependent RNA polymerase.

3

f

D³ DFA METAPNEUMOVIRUS IDENTIFICATION KIT

02/27/2009 Section 5 - Page 4 of 13

4

02/27/2009 Section 5 - Page 5 of 13

DHI-MPV_Sec05_510k-Summary_09FEB27_Corrected.doc

5

02/27/2009 Section 5 - Page 6 of 13

Analytical Performance:

The MAbs all recognize a hMPV protein, approximately 46 kiloDaltons in size, which corresponds with the size of hMPV nucleoprotein, but do not compete with one another for binding sites (as demonstrated by SDS-PAGE analyses, against lysates of cell culture infected with hMPV subtypes A1, A2, B1, and B2).

Analytical specificity of the MPV DFA Reagent was evaluated against other respiratory viruses (multiple strains of adenovirus, influenza A, influenza B, respiratory syncytial virus, and parainfluenza types 1, 2, and 3), as well as strains of 8 other viruses, and 30 other microorganisms that could be encountered in a respiratory specimen, cell culture contamination, or laboratory processing.

Reproducibility

Assay reproducibility was assessed at 3 laboratory sites with a panel of proficiencylevel antigen control slides. The reproducibility panel consisted of 5 panel members. Each panel member was a 2-well slide spotted with the same cell preparation in each well. The cell preparations used to construct the slides are the following:

• 1. Non-infected LLC-MK2 cells.
• 2. Low level hMPV (A1 strain) grown in LLC-MK2 cells (manufactured to contain between 4 to 10% infected cells).
• 3. Mid level hMPV (A1 strain) grown in LLC-MK2 cells (manufactured to contain between 20 to 30% infected cells).
• 4. High level hMPV (A1 strain) grown in LLC-MK2 cells (manufactured to contain between 50 to 75% infected cells).

Each panel was tested daily in two separate runs for 5-days by three different laboratories (30 total runs). The panel members were randomized with different slide identification numbers to act as a "blinded" panel. An hMPV Antigen Control Slide (two-well slide, one well contains cell culture-derived hMPV positive cells and one well contains cell culture-derived negative cells) was stained according to the D-DFA Metapneumovirus Identification Kit instructions for use with each run. The following results were recorded for both the control slides and the panel slides:

6

02/27/2009 Section 5 - Page 7 of 13

• 1. Presence or absence of green fluorescence.
• 2. Percent of cells exhibiting green fluorescence.

A single lot of D MPV Kit was used. A total of 210 data points were included in the reproducibility study data analysis (7 samples and controls/run X 2 runs/day X 5 days X 3 sites = 210). The combined data from the three sites demonstrated that the detection of hMPV occurs in a reproducible manner. The presence of hMPV infected cells was reported in 100% (120/120) of the wells in which infected cells were present. The combined data from the three sites also demonstrated that no hMPV was detected in non-infected cells. The absence of hMPV was reported in 100% (90/90) of the wells in which infected cells were not present. The total percent agreement for the D' DFA Metapneumovirus Identification Kit was 100% (210/210). The Table below summarizes the reproducibility study results:

	Reproducibility Study Results
	Panel
Member	hMPV A1
Low Level	hMPV A1
Mid Level	hMPV A1
High Level	hMPV A1
Negative	Positive
Control	Negative
Control	Total %
Agreement
	Concentration	4 to 10%
infected
cells	20 to 30%
infected
cells	50 to 75%
infected
cells	Non-infected
cells	50 to 75%
infected
cells	Non-infected
cells
Site 1	Agreement with
Expected result	10/10
(100%)	10/10
(100%)	10/10
(100%)	20/20
(100%)	10/10
(100%)	10/10
(100%)	70/70
(100%)
Site 2	Agreement with
Expected result	10/10
(100%)	10/10
(100%)	10/10
(100%)	20/20
(100%)	10/10
(100%)	10/10
(100%)	70/70
(100%)
Site 3	Agreement with
Expected result	10/10
(100%)	10/10
(100%)	10/10
(100%)	20/20
(100%)	10/10
(100%)	10/10
(100%)	70/70
(100%)
	Total Agreement
with Expected
result	30/30
(100%)	30/30
(100%)	30/30
(100%)	60/60
(100%)	30/30
(100%)	30/30
(100%)	210/210
(100%)
	95% CI	88.4%-
100%	88.4%-
100%	88.4%-
100%	94.0%-100%	88.4%-
100%	88.4%-100%	98.3%-100%

Clinical Performance:

Performance characteristics of the DHI D3 DFA Metapneumovirus Identification Kit testing direct respiratory specimens were established during prospective studies at 3 geographically diverse U.S. clinical laboratories during the 2005 and 2006 respiratory virus seasons (December 2005 - April 2006 and December 2006 -March 2007). All specimens used in the studies meeting the inclusion and exclusion criteria represented excess, remnants of respiratory specimens that were prospectively collected from symptomatic individuals suspected of respiratory infection, and were submitted for routine care or analysis by each site, and that otherwise would have been discarded. Individual specimens were delinked from all patient identifiers and given a study sample code. All clinical sites were granted waivers of informed consent by their IRBs for this study.

7

02/27/2009 Section 5 - Page 8 of 13

Performance of the D3 DFA Metapneumovirus Identification Kit was assessed and compared to a predetermined algorithm that used composite comparator methods at clinical study site 1 and 2. The composite comparator methods consisted of viral culture and a validated real-time RT-PCR comparator assay targeting the hMPV nucleocapsid gene followed by bi-directional sequencing analysis". "True" hMPV positive was defined as any sample that either tested positive by viral culture, or had bi-directional sequencing data meeting pre-defined quality acceptance criteria that matched hMPV sequences deposited in the National Center for Biotechnology Information (NCBI) GenBank database (www.ncbi.nlm.nih.gov), with acceptable Evalues . "True" hMPV negative was defined as any sample that tested negative by both viral culture and the hMPV real-time RT-PCR comparator assay..

Performance of the D3 DFA Metapneumovirus Identification Kit at clinical study site 3 was evaluated and compared only to the validated hMPV real-time RT-PCR followed by bi-directional sequencing analysis comparator assay described above. Any sample that had bi-directional sequencing data meeting pre-defined quality acceptance criteria that matched hMPV sequences deposited in the National Center for Biotechnology Information (NCBI) GenBank database (www.ncbi.nlm.nih.gov), with acceptable E-values, was considered as hMPV positive, and the real-time hMPV RT-PCR comparator assay negatives were considered as hMPV negatives at this site.

Study Site 1

Study Site 1 evaluated a total of 1564 fresh respiratory specimens submitted. December 2006 through March 2007, to the laboratory for respiratory virus testing. Slides were prepared from Phosphate Buffered Saline (PBS)-washed cells from the fresh specimens and fixed according to the prescribed protocol. The slides were stained in accordance with the procedure in the product insert.

Therefore an E-Value ranging from 2e-67 to 2e-77 has a very low probability of occurring purely by chance.

DHI-MPV_Scc05_510k-Summary_09FEB27_Corrected.doc

6 Analytical validation of the real-time hMPV RT-PCR followed by bi-directional sequencing assay included analytical sensitivity and reactivity study, analytical specificity study, and extraction efficiency study. The analytical sensitivity (limit of detection or LoD) of the real-time hMPV RT-PCR followed by bi-directional sequencing analysis comparator assay was determined using quantified (TCIDs) mL) stocks of the 4 hMPV (subtypes A1, A2, B1 and B2) strains diluted in hMPV negative nasopharyngeal clinical matrix, and ranged from 10 - 50 TCIDsofmL.

d The E-values generated from the clinical trials range from a low of 2e-67. The E-Value from NCBI BLAST Alignment indicates the statistical significance of a given pair-wise alignment and reflects the size of the database and the scoring system used. The lower the li-Value, the more significant the hit. A sequence alignment that has an E-Value of 1c-3 means that this similarity has a 1 in 1000 chance of occurring by chance alone. (http://www.ncbi.nlm.nih.gov/books/bv.fcgi'?rid=handbook.section.614}.

8

02/27/2009 Section 5 - Page 9 of 13

Sex	F	M
Total	687	877
Age: Trade/Device Name: D3 DFA Metapneumovirus Identification Kit Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: Class II Product Code: OMG Dated: December 22, 2008 Received: January 12, 2009

6 2009

MAR

Dear Ms. Goodrum:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

__, and I am not going to apologize for it.

14

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k). premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sally attaym

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

15

Indication for Use

510(k) Number (if known): K090073

Device Name: D DFA Metapneumovirus Identification Kit

Indication For Use:

The Diagnostic Hybrids, Inc. device, Dr 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 sublineages 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.

Prescription Use X And/Or (21 CFR Part 801 Subpart D)

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Uwe Schof

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K090073