(51 days)
Not Found
No
The device description and performance studies focus on traditional immunofluorescence microscopy and manual interpretation of stained cells. There is no mention of automated image analysis, algorithms, or learning processes that would indicate the use of AI/ML.
No
This device is a diagnostic kit used for the qualitative identification of specific viruses in respiratory specimens. It is not used for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for the qualitative identification of 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)". This description clearly indicates a diagnostic purpose.
No
The device is a diagnostic kit that uses reagents and requires a fluorescence microscope for examination, indicating it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative identification of 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". This involves testing specimens taken from the human body to provide information for diagnosis.
- Device Description: The description details a method for analyzing biological specimens (respiratory specimens) using antibodies and fluorescence microscopy to detect specific viral antigens. This is a typical process for in vitro diagnostic tests.
- Performance Studies: The document describes clinical performance studies conducted in clinical laboratories using patient specimens to evaluate the device's accuracy (sensitivity and specificity) in identifying the target viruses. This is a requirement for demonstrating the performance of an IVD.
- Clinical Setting: The intended user is listed as "Clinical laboratories," which is where IVD tests are typically performed.
- Predicate Devices: The mention of predicate devices with K numbers (K061101 and K081928) indicates that this device is being compared to previously cleared IVDs, further confirming its classification as an IVD.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit is intended for the qualitative identification of 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 parainfluenza virus and adenovirus after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude parainfluenza virus and adenovirus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.
Product codes
GQS, GNY
Device Description
The D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit (D3 FastPoint PIV/ADV Kit) uses a blend (called an "L-DFA Reagent") of viral antigenspecific murine monoclonal antibodies that are directly labeled with either Rphycoerythin (PE) (parainfluenza virus types 1, 2 and 3) or fluorescein isothiocyanate (FITC) (adenovirus) for the qualitative identification of adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3.
Kit Components:
- 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 FITC-labeled 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.
- 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).
- Re-suspension Buffer, 6.0-mL. One bottle of a buffered glycerol solution and 0.1% sodium azide.
- D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Antigen Control Slides, 5-slides. Five individually packaged control slides containing 2 wells with cell culture-derived positive and negative control cells. Each positive well contains cells infected with either parainfluenza virus type 3 or adenovirus. 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 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 degrees Celsius to 37 degrees Celsius 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 parainfluenza virus types 1, 2 and 3 will exhibit golden-yellow fluorescence. Cells infected with 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and nasopharyngeal swabs and aspirates/washes specimens
Indicated Patient Age Range
0 to 1 month
1 month to 2 years
2 years to 12 years
12 years to 21 years
22 years to 30 years
31 years to 40 years
41 years to 50 years
51 years to 60 years
61 years to 70 years
71 years to 80 years
81 years and above
Age Not Reported
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
Clinical Performance:
Performance of the D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit testing direct respiratory specimens was established during prospective studies at 4 geographically diverse U.S. clinical laboratories during the 2009 respiratory virus seasons (January 2009 through March 2009). 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 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit was assessed and compared to a predetermined algorithm that used composite comparator methods. The composite comparator methods for parainfluenza virus and adenovirus consisted of Direct Specimen Fluorescent Antibody (DSFA) test with an FDA-cleared device and viral culture confirmation of all the negatives (as determined by the comparator DSFA test). "True" positive was defined as any sample that either tested positive by the comparator DSFA test or viral culture. "True" negative was defined as any sample that tested negative by both the comparator DSFA test and viral culture.
Sample Size:
Total Specimens Evaluated: 1519
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance: Precision/Reproducibility
Study Type: Reproducibility
Sample Size: The hPIV/adenovirus panel consisted of 5 randomized panel members. Each panel was tested daily in two separate runs for 5-days by four different laboratories (40 total runs).
Key Results:
The combined data from the four Study Sites demonstrated reproducible detection of parainfluenza virus type 1 (hPIV-1) by the R-PE labeled MAbs and reproducible detection of adenovirus by the FITC-labeled MAbs. The presence of hPIV-1 infected cells was reported in 100% (120/120) of the wells in which the infected cells were expected. The presence of adenovirus infected cells was reported in 100% (120/120) of the wells in which the infected cells were expected. The absence of infected cells was reported in 100% (40/40) of the wells in which infected cells were not present. The total percent agreement for the D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit was 100% (280/280).
Limit of Detection (LoD)
Study Type: Analytical LoD using dilution series of infected model cells.
Sample Size: Not explicitly stated as a single number but involved testing 10 replicate microscope slides for each dilution level.
Key Results:
- Adenovirus (ATCC type 1): 100 infected cells/mL
- hPIV-1 (ATCC strain C-35): 100 infected cells/mL
- hPIV-2 (ATCC strain Greer): 25 infected cells/mL
- hPIV-3 (ATCC strain C243): 50 infected cells/mL
Analytical reactivity (inclusivity)
Study Type: Inclusivity evaluation
Sample Size: 3 hPIV and 10 adenovirus strains were evaluated.
Key Results: All strains tested showed positive fluorescent cells, indicating reactivity.
Clinical Performance:
Study Type: Prospective studies
Sample Size: 1519 total specimens evaluated from 4 clinical laboratories during January-March 2009.
Key Results:
- Prevalence in the studied population: Adenovirus 0.9%, hPIV 2.6%.
- Performance for Nasal/Nasopharyngeal Wash/Aspirate:
- Parainfluenza Virus: Sensitivity 92.0% (23/25), Specificity 99.3% (599/603)
- Adenovirus: Sensitivity 92.3% (12/13), Specificity 100% (619/619)
- Performance for Nasal/Nasopharyngeal Swab:
- Parainfluenza Virus: Sensitivity 92.9% (13/14), Specificity 100% (668/668)
- Adenovirus: Sensitivity 100% (1/1), Specificity 100% (680/680) (Note: Sensitivity for adenovirus from swab specimens was noted as not adequately established due to low prevalence).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Performance: Nasal/Nasopharyngeal Wash/Aspirate
Parainfluenza Virus:
- Sensitivity: 92.0% (23/25) (95% CI: 74.0-99.0%)
- Specificity: 99.3% (599/603) (95% CI: 98.3-99.8%)
Adenovirus:
- Sensitivity: 92.3% (12/13) (95% CI: 64.0-99.8%)
- Specificity: 100% (619/619) (95% CI: 99.4-100%)
Clinical Performance: Nasal/Nasopharyngeal Swab
Parainfluenza Virus:
- Sensitivity: 92.9% (13/14) (95% CI: 66.1-99.8%)
- Specificity: 100% (668/668) (95% CI: 99.4-100%)
Adenovirus:
- Sensitivity: 100% (1/1) (95% CI: N/A)
- Specificity: 100% (680/680) (95% CI: 99.5-100%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3400 Parainfluenza virus serological reagents.
(a)
Identification. Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
Diagnostic Hybrids, Inc.
D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit
10/30/2009 DEC 2 3 2009 Page 1 of 13
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 30, 2009
Device Name:
Trade name - D2 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit Common name - D3 FastPoint Parainfluenza Virus/Adenovirus Identification Kit Classification name - Parainfluenza virus serological reagents, Adenovirus serological reagents Product Code - GQS, GNY Regulation - 21 CFR 866.3400, 21 CFR 866.3020 Regulatory Class - Class I 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
1
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.
D3 Duet DFA RSV/Respiratory Virus Screening Kit (K081928)
Intended Use: The Diagnostic Hybrids, Inc. device, D3 Duet DFA RSV/Respiratory Virus Screening Kit (D5 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
2
culture should not be attempted in these cases unless a BSL3+ facility is available to receive and culture specimens.
Device Description:
The D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit (D3 FastPoint PIV/ADV Kit) uses a blend (called an "L-DFA Reagent") of viral antigenspecific murine monoclonal antibodies that are directly labeled with either Rphycoerythin (PE) (parainfluenza virus types 1, 2 and 3) or fluorescein isothiocyanate (FITC) (adenovirus) for the qualitative identification of adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3.
Kit Components:
- D3 FastPoint L-DFA PIV/Adenovirus Reagent, 4.0-mL. One dropper bottle 1. containing a mixture of PE-labeled murine monoclonal antibodies directed against parainfluenza virus types 1, 2, or 3 antigens and FITC-labeled 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.
- 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).
- Re-suspension Buffer, 6.0-mL. One bottle of a buffered glycerol solution and 3. 0.1% sodium azide.
- D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Antigen Control Slides, 4. 5-slides. Five individually packaged control slides containing 2 wells with cell culture-derived positive and negative control cells. Each positive well contains cells infected with either parainfluenza virus type 3 or adenovirus. 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 parainfluenza virus types 1, 2 and 3 will exhibit golden-yellow fluorescence. Cells infected with adenovirus will exhibit apple
3
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 Parainfluenza Virus/Adenovirus Identification Kit is intended for the qualitative identification of 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 parainfluenza virus and adenovirus after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude parainfluenza virus and adenovirus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.
| TABLE 5.1: Characteristics of the D³ FastPoint PIV/ADV Kit are compared to those of the
| following Diagnostic Hybrids (DHI) predicate devices | ||||
|---|---|---|---|---|
| Characteristics | D³ FastPoint PIV/ADV Kit | |||
| (Subject Device) | D³ Ultra Kit | |||
| 510(k) #K061101 | D³ Duet RSV Kit | |||
| 510(k) # K081928 | ||||
| Intended Use | The Diagnostic Hybrids, Inc. device, D³ FastPoint L-DFA | |||
| Parainfluenza Virus/ | ||||
| Adenovirus Identification | ||||
| Kit is intended for the | ||||
| qualitative identification of | ||||
| 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 parainfluenza | ||||
| virus and adenovirus after | ||||
| examination of the direct | ||||
| specimen result be confirmed | The Diagnostic | |||
| Hybrids, Inc. D³ | ||||
| Ultra™ 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). | 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). | ||||
| TABLE 5.1: | Characteristics of the D³ FastPoint PIV/ADV Kit are compared to those of the following Diagnostic Hybrids (DHI) predicate devices | |||
| Characteristics | D³ FastPoint PIV/ADV Kit | |||
| (Subject Device) | D³ Ultra Kit | |||
| 510(k) #K061101 | D³ Duet RSV Kit | |||
| 510(k) # K081928 | ||||
| by cell culture. Negative | ||||
| results do not preclude | ||||
| parainfluenza virus and | ||||
| adenovirus infection and | ||||
| should not be used as the | ||||
| sole basis for diagnosis, | ||||
| treatment or other | ||||
| management decisions. | 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. | 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. | ||||
| Target Viruses | 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 | influenza A virus, | |||
| influenza B virus, | ||||
| respiratory | ||||
| syncytial virus, | ||||
| adenovirus, | ||||
| parainfluenza virus | ||||
| type 1, | ||||
| parainfluenza virus | ||||
| type 2, | ||||
| parainfluenza virus | ||||
| type 3 | ||||
| Monoclonal antibodies | ||||
| (MAbs) | The D³ FastPoint L-DFA | |||
| PIV/Adenovirus Reagent | ||||
| contains 9 MAbs to | ||||
| adenovirus (3) and | ||||
| parainfluenza virus (6) | 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 | ||||
| TABLE 5.1: Characteristics of the D³ FastPoint PIV/ADV Kit are compared to those of the | ||||
| following Diagnostic Hybrids (DHI) predicate devices | ||||
| Characteristics | D³ FastPoint PIV/ADV Kit | |||
| (Subject Device) | D³ Ultra Kit | |||
| 510(k) #K061101 | D³ Duet RSV Kit | |||
| 510(k) # K081928 | ||||
| syncytial virus. | ||||
| Labeling method | Direct labeling |
-
using R-Phycoerythrin (R-
PE) to label the MAbs to
parainfluenza virus types 1,
2, and 3. -
using fluorescein
isothiocyanate (FITC) to
label the MAbs to
adenovirus. | 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
(FITC) to label all
other MAbs with
fluorescein. | |
| R-Phycoerythrin-labeled
MAbs | parainfluenza virus types 1,
2, and 3 | None | respiratory syncytial
virus | |
| Fluorescein-labeled MAbs | adenovirus | 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,
adenovirus,
parainfluenza virus
type 1, parainfluenza
virus type 2,
parainfluenza virus
type 3 | |
| Cell Fixative | Proprietary Non-Acetone
based system | Acetone | Acetone | |
| Cell Counter-stain | Propidium Iodide, Evans
Blue | Evans Blue | Evans Blue | |
| Performance characteristics | | | | |
| Staining patterns | Parainfluenza 1, 2, 3: The
fluorescence is cytoplasmic.
Cells appear round.
Adenovirus: The
fluorescence is cytoplasmic
or bright nuclear or both.
Cells appear round.
Negative: Cells fluoresce
red due to the Evans Blue
counter-stain.
Nuclei: Cell Nuclei
fluoresce orange-red due to
the Propidium Iodide
counter-stain. | Influenza A and B:
The fluorescence is
cytoplasmic, nuclear
or both.
Cytoplasmic
staining is often
punctate with large
inclusions while
nuclear staining is
uniformly bright.
Respiratory
Syncytial Virus:
The fluorescence is
cytoplasmic and
punctate with small
inclusions in the
syncytia. | Influenza A and
B: The
fluorescence is
cytoplasmic,
nuclear or both.
Cytoplasmic
staining is often
punctate with large
inclusions while
nuclear staining is
uniformly bright.
Respiratory
Syncytial Virus:
The fluorescence
is cytoplasmic and
punctate with
small inclusions in
the syncytia. | |
| TABLE 5.1: Characteristics of the D³ FastPoint PIV/ADV Kit are compared to those of the
following Diagnostic Hybrids (DHI) predicate devices | | | | |
| Characteristics | | D³ FastPoint PIV/ADV Kit
(Subject Device) | D³ Ultra Kit
510(k) #K061101 | D³ Duet RSV Kit
510(k) # K081928 |
| | | | 3: The fluorescence
is cytoplasmic and
punctate with
irregular inclusions.
Types 2 and 3 cause
the formation of
syncytia.
Adenovirus: The
fluorescence is
cytoplasmic and
punctate or bright
nuclear or both.
Negative: Cells
fluoresce red due to
the Evans Blue
counter-stain. | Parainfluenza 1,
2, 3: The
fluorescence is
cytoplasmic and
punctate with
irregular
inclusions. Types
2 and 3 cause the
formation of
syncytia.
Adenovirus: The
fluorescence is
cytoplasmic and
punctate or bright
nuclear or both.
Negative: Cells
fluoresce red due
to the Evans Blue
counter-stain. |
| Analytical
specificity
(cross-
reactivity
studies; various
strains of
microorganism
s and cell lines) | Viruses | Device Reagents are not reactive with these numbers of microorganisms | | |
| | Viruses | 59 | 31 | 32 |
| | Bacteria | 22 | 18 | 25 |
| | Chlamydia
spp. | 1 | 1 | 3 |
| | Yeast | 1 | 0 | 1 |
| | Protozoan | 0 | 0 | 1 |
| | Cell lines | N/A | 17 | 17 |
Technological Characteristics, Compared to Predicate Device:
Sec05 FastPoint PIV-ADV 09OCT30
4
" Diagnostic Hybrids, Inc.
.
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Sec05_FastPoint_PIV-ADV_09OCT30
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Analytical Performance:
Precision/Reproducibility:
Assay precision, intra-assay variability and inter assay variability were assessed with a reproducibility panel consisting of 5 randomized panel members.
The hPIV/adenovirus panel consisted of the following
- a. Low level parainfluenza virus type 1 (C-35 strain) infected cells.
- b. Low level adenovirus (ATCC type 1) infected cells.
- Low level parainfluenza virus type 1 (C-35 strain) infected cells mixed c. with mid level adenovirus (ATCC type 1) infected cells.
- d. Low adenovirus (ATCC type 1) infected cells mixed with mid level parainfluenza virus type 1 (C-35 strain) infected cells.
- Mid level non-infected (negative) cells. e.
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The low level is estimated to contain between 4 to 10% infected cells in the sample. The mid level is estimated to contain between 20 to 25% infected cells in the sample. Each sample contains 2.5 x 102 to 3.5 x 102 total cells.
Each panel was tested daily in two separate runs for 5-days by four different laboratories (40 total runs). The following results were recorded:
- a. Presence or absence of golden-yellow fluorescence.
- b. Percent of cells exhibiting golden-vellow fluorescence.
- c. Presence or absence of apple-green fluorescence.
- d. Percent of cells exhibiting apple-green fluorescence.
For the D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit, the combined data from the four Study Sites demonstrated reproducible detection of parainfluenza virus type 1 (hPIV-1) by the R-PE labeled MAbs and reproducible detection of adenovirus by the FITC-labeled MAbs. The presence of hPIV-1 infected cells was reported in 100% (120/120) of the wells in which the infected cells were expected. The presence of adenovirus infected cells was reported in 100% (120/120) of the wells in which the infected cells were expected. The absence of infected cells was reported in 100% (40/40) of the wells in which infected cells were not present. The total percent agreement for the D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit was 100% (280/280):
| TABLE 5.2: Reproducibility Study Results using the L-DFA Reagent | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Site | Panel | ||||||||
| Member | Negative | Adenovirus | |||||||
| Low Level | hPIV Low | ||||||||
| Level | Mixed Infection | Mixed Infection | |||||||
| Concentration | No | ||||||||
| infected | |||||||||
| cells | 4 to 10% | ||||||||
| infected | |||||||||
| cells | 4 to 10% | ||||||||
| infected | |||||||||
| cells | Adenovirus | ||||||||
| Mid Level | |||||||||
| Site | |||||||||
| 1 | Agreement | ||||||||
| with | |||||||||
| Expected result | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (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%) | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (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%) | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (100%) | 70/70 | ||||||||
| (100%) | |||||||||
| Site | |||||||||
| 4 | Agreement | ||||||||
| with | |||||||||
| Expected result | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (100%) | 10/10 | ||||||||
| (100%) | 70/70 | ||||||||
| (100%) | |||||||||
| Total Agreement with | |||||||||
| Expected | |||||||||
| result | 40/40 | ||||||||
| (100%) | 40/40 | ||||||||
| (100%) | 40/40 | ||||||||
| (100%) | 40/40 | ||||||||
| (100%) | 40/40 | ||||||||
| (100%) | 40/40 | ||||||||
| (100%) | 40/40 | ||||||||
| (100%) | 280/280 | ||||||||
| (100%) | |||||||||
| 95% CI | 91.2 - | ||||||||
| 100% | 91.2 - | ||||||||
| 100% | 91.2 - | ||||||||
| 100% | 91.2 - | ||||||||
| 100% | 91.2 - | ||||||||
| 100% | 91.2 - | ||||||||
| 100% | 91.2 - | ||||||||
| 100% | 98.7 - | ||||||||
| 100% |
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Limit of Detection:
Analytical Limit of Detection (LoD) of the L-DFA Reagent was addressed using dilution series of infected model cells. Model cells for parainfluenza virus types 1, 2, and 3 (ATCC strains C-35, Greer, and C243) and adenovirus (ATCC type 1) were diluted with non-infected cells to produce a suspension equivalent to 1,000 infected cells per milliliter. This level theoretically yields approximately 25 infected cells per 25-uL of suspension. This suspension was then serially diluted to a theoretical level of less than 1 cell per milliliter. (NOTE: This level was the target to begin with a low positive level. Actual starting levels vary, however, and are within 1 dilution of the 25 infected cell target level). 25-uL aliquots from each dilution level were spotted onto 10 replicate microscope slides, and then 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 analytes were defined as the lowest dilutions at which at least 9 out of 10 replicates were detected. LoD study results are summarized in Table 5.3 below:
| TABLE 5.3: | Limit of Detections of the D³ FastPoint L-DFA PIV/Adenovirus Reagent | ||
|---|---|---|---|
| Virus Strain | Infected cells/mL | Number of replicates with positive cells | LOD determination |
| Adenovirus | |||
| (ATCC type 1) | 1000 | 10/10 | 100 infected cells/mL |
| 200 | 10/10 | ||
| 100 | 9/10 | ||
| 50 | 5/10 | ||
| 25 | 1/10 | ||
| 12.5 | 0/10 | ||
| 6 | 0/10 | ||
| 3 | 0/10 | ||
| 1.5 | 0/10 | ||
| 0.8 | 0/10 | ||
| hPIV-1 | |||
| (ATCC strain C-35) | 500 | 10/10 | 100 infected cells/mL |
| 100 | 10/10 | ||
| 50 | 6/10 | ||
| 25 | 2/10 | ||
| 12.5 | 1/10 | ||
| 6 | 0/10 | ||
| 3 | 0/10 | ||
| 1.5 | 0/10 | ||
| 0.8 | 0/10 | ||
| 0.4 | 0/10 | ||
| hPIV-2 | |||
| (ATCC strain Greer) | 500 | 10/10 | 25 infected cells/mL |
| 100 | 10/10 | ||
| 50 | 10/10 | ||
| 25 | 9/10 | ||
| 12.5 | 6/10 | ||
| 6 | 5/10 | ||
| 3 | 3/10 | ||
| 1.5 | 1/10 | ||
| 0.8 | 0/10 |
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D' FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit 10/30/2009 Section 05, Page 10 of 13
| TABLE 5.3: | Limit of Detections of the D³ FastPoint L-DFA PIV/Adenovirus Reagent | ||
|---|---|---|---|
| Virus Strain | Infected cells/mL | Number of replicates with positive cells | LOD determination |
| hPIV-3 | |||
| (ATCC strain C243) | 1000 | 10/10 | |
| 200 | 10/10 | ||
| 100 | 10/10 | ||
| 50 | 9/10 | ||
| 25 | 6/10 | 50 infected cells/mL | |
| 12.5 | 2/10 | ||
| 6 | 0/10 | ||
| 3 | 0/10 | ||
| 1.5 | 0/10 | ||
| 0.8 | 0/10 |
Analytical reactivity (inclusivity):
Analytical reactivity (inclusivity) of the D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit was evaluated using 3 hPIV and 10 adenovirus strains. Low concentration infected cell suspensions (approximately 4% cells infected, 25 to 50 infected cells) were prepared for each viral strain. The suspensions were stained with the kit.
| TABLE 5.4: Analytical Reactivity (inclusivity) of the D 3 FastPoint L-DFA PIV/Adenovirus Reagent on
| various hPIV and adenovirus strains | ||
|---|---|---|
| Parainfluenza and Adenovirus | ||
| Strains | Infected Cell Concentration (as | |
| multiples of the respective | ||
| established LoD concentration | D3 FastPoint L-DFA | |
| PIV/Adenovirus Reagent Results | ||
| Parainfluenza 1 C-35 | 10x LoD | 9 Golden-yellow fluorescent cells |
| Parainfluenza 2 Greer | 10x LoD | 11 Golden-yellow fluorescent cells |
| Parainfluenza 3 C-243 | 10x LoD | 22 Golden-yellow fluorescent cells |
| Adenovirus 1 VR-1 | 10x LoD | 26 Apple-green fluorescent cells |
| Adenovirus 3 VR-3 | 10x LoD | 17 Apple-green fluorescent cells |
| Adenovirus 5 VR-5 | 10x LoD | 15 Apple-green fluorescent cells |
| Adenovirus 6 VR-6 | 10x LoD | 22 Apple-green fluorescent cells |
| Adenovirus 7 VR-7 | 10x LoD | 16 Apple-green fluorescent cells |
| Adenovirus 8 VR-1366 | 10x LoD | 29 Apple-green fluorescent cells |
| Adenovirus 10 VR-1087 | 10x LoD | 34 Apple-green fluorescent cells |
| Adenovirus VR-14 | 10x LoD | 37 Apple-green fluorescent cells |
| Adenovirus Dewitt ATCC Strain | 10x LoD | 15 Apple-green fluorescent cells |
| Adenovirus 31 VR-1109 | 10x LoD | 42 Apple-green fluorescent cells |
Clinical Performance:
Performance of the D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit testing direct respiratory specimens was established during prospective studies at 4 geographically diverse U.S. clinical laboratories during the 2009 respiratory virus seasons (January 2009 through March 2009). All specimens used in the studies meeting the inclusion and exclusion criteria represented excess, remnants of respiratory specimens that were prospectively collected from symptomatic
Sec05 FastPoint PIV-ADV 09OCT30
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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 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit was assessed and compared to a predetermined algorithm that used composite comparator methods. The composite comparator methods for parainfluenza virus and adenovirus consisted of Direct Specimen Fluorescent Antibody (DSFA) test with an FDA-cleared device and viral culture confirmation of all the negatives (as determined by the comparator DSFA test). "True" positive was defined as any sample that either tested positive by the comparator DSFA test or viral culture. "True" negative was defined as any sample that tested negative by both the comparator DSFA test and viral culture.
Prevalence of adenovirus and hPIV (human parainfluenza virus) within this population as determined by the D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit direct specimen testing is noted in Table 5.5 below:
| TABLE 5.5: Parainfluenza Virus/Adenovirus Prevalence | |||
|---|---|---|---|
| Age | Total | ||
| Specimens | Adenovirus |
positive | hPIV
positive |
| | Evaluated | (prevalence) | (prevalence) |
| 0 to 1 month | 55 | 0 | 1 (1.8%) |
| > 1 month to 2 years | 577 | 11 (1.9%) | 29 (5.0%) |
| > 2 years to 12 years | 391 | 1 (0.3%) | 6 (1.5%) |
| > 12 years to 21 years | 173 | 0 | 2 (1.2%) |
| 22 years to 30 years | 57 | 0 | 1 (1.8%) |
| 31 years to 40 years | 71 | 0 | 0 |
| 41 years to 50 years | 52 | 0 | 0 |
| 51 years to 60 years | 46 | 0 | 0 |
| 61 years to 70 years | 33 | 0 | 0 |
| 71 years to 80 years | 16 | 0 | 0 |
| 81 years and above | 7 | 0 | 1 (14.3%) |
| Age Not Reported | 41 | 1 (2.4%) | 0 |
| Total | 1519 | 13 (0.9%) | 40 (2.6%) |
Tables 5.6 and 5.7 below show the study results of the NP wash/aspirate specimen type (Study Sites 1, 2, and 3 combined):
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| TABLE 5.6: Parainfluenza Virus | |||
|---|---|---|---|
| Fresh nasal/nasopharyngeal | |||
| wash/aspirate | Comparator DSFA | ||
| (negatives followed by culture with DFA) | |||
| DHI DSFA | Positive | Negative | Total |
| Positive | 23 | 4 | 27 |
| Negative | 2 | 599 | 601 |
| Total | 25 | 603 | 628 |
| 95% CI | |||
| Sensitivity | 23/25 | 92.0% | 74.0-99.0% |
| Specificity | 599/603 | 99.3% | 98.3-99.8% |
| TABLE 5.7: Adenovirus | |||
|---|---|---|---|
| Fresh nasal/nasopharyngeal | |||
| wash/aspirate | Comparator DSFA | ||
| (negatives followed by culture with DFA) | |||
| DHI DSFA | Positive | Negative | Total |
| Positive | 12 | 0 | 12 |
| Negative | 1 | 619 | 620 |
| Total | 13 | 619 | 632 |
| 95% CI | |||
| Sensitivity | 12/13 | 92.3% | 64.0-99.8% |
| Specificity | 619/619 | 100% | 99.4-100% |
Tables 5.8 and 5.9 below show the study results of the NP swab specimen type (Study Sites 3 and 4 combined):
| TABLE 5.8: Parainfluenza Virus | |||
|---|---|---|---|
| Fresh nasal/nasopharyngeal | |||
| swab | Comparator DSFA | ||
| (negatives followed by culture with DFA) | |||
| DHI DSFA | Positive | Negative | Total |
| Positive | 13 | 0 | 13 |
| Negative | 1 | 668 | 669 |
| Total | 14 | 668 | 682 |
| 95% CI | |||
| Sensitivity | 13/14 | 92.9% | 66.1-99.8% |
| Specificity | 668/668 | 100% | 99.4-100% |
| TABLE 5.9: Adenovirus | |||
|---|---|---|---|
| Fresh nasal/nasopharyngeal | |||
| swab | Comparator DSFA | ||
| (negatives followed by culture with DFA) | |||
| DHI DSFA | Positive | Negative | Total |
| Positive | 1 | 0 | 1 |
| Negative | 0 | 680 | 680 |
| Total | 1 | 680 | 681 |
| 95% CI | |||
| Sensitivity | 1/1 | 100% | N/A |
| Specificity | 680/680 | 100% | 99.5-100% |
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Note: The sensitivity performance of the D3 FastPoint PIV/ADV Kit detecting adenovirus from direct nasal/nasopharyngeal swab specimens has not been adequately established in the clinical study due to low adenovirus prevalence at the clinical study sites. However, the same MAb pool for adenovirus was validated in previous clinical trials for a number of FDA-cleared DSFA devices. Users may wish to further evaluate the sensitivity performance of this kit detecting adenovirus using prospective nasal/nasopharyngeal swab samples.
Overall at the four Study Sites, the performance results of the D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit, when compared to those of the comparator devices, D3 Ultra DFA Respiratory Virus Screening & ID Kit and D3 Duet DFA RSV/Respiratory Virus Screening Kit, demonstrate that the devices detect parainfluenza virus and adenovirus antigens in a similar manner.
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Image /page/13/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper half of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
Mr. Ronald H. Lollar Senior Director Product Realization, Management and Marketing Diagnostic Hybrids, Inc 1055 East State Street, Suite 100 Athens, Ohio 45701
DEC 2 3 2009
Re: K093415
Trade/Device Name: D3 FastPoint L- DFA Parainfluenza Virus/Adenovirus Identification Kit Regulation Number: 21 CFR & 866.3400 Regulation Name: Parainfluenza Virus Serological Reagents Regulatory Class: I Product Code: GQS, GNY Dated: October 30, 2009 Received: November 2, 2009
Dear Mr. Lollar:
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
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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).
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5461. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Une Schuf for
Sally A. Hoivat, 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
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510(k) Number (if known): K093415
Device Name: D³ FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit
Indication for Use:
The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit is intended for the qualitative identification of 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 parainfluenza virus and adenovirus after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude parainfluenza virus and adenovirus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Uve Schuf
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093415