Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a traditional immunofluorescence assay using labeled antibodies and manual microscopic examination. There is no mention of automated image analysis, algorithms, or machine learning for interpretation.

Therapeutic

No.
This device is for the identification and diagnosis of influenza A and B viruses, not for treatment or therapy.

Diagnostic

Yes

Explanation: The "Intended Use/Indications for Use" section explicitly states that the device "is intended for the qualitative identification of influenza A virus and influenza B virus... from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs)." This directly implies a diagnostic function. Furthermore, the statement "Negative results do not preclude influenza A or influenza B virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions" reinforces its role in providing diagnostic information, even if not solely relied upon.

SaMD (Software as a Medical Device)

No

The device is a diagnostic kit that includes reagents and requires the use of a fluorescence microscope for examination, indicating it is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states that the device is for the "qualitative identification of influenza A virus and influenza B virus 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 about a person's health status (presence of influenza viruses).
Device Description: The description details a process of using reagents to stain cells from respiratory specimens and then examining them under a fluorescence microscope to identify the presence of influenza viruses based on the staining pattern. This is a typical in vitro diagnostic procedure.
Performance Studies: The document includes performance studies evaluating the device's ability to detect influenza viruses in clinical specimens, comparing its results to other diagnostic methods (DSFA and viral culture). This is a requirement for demonstrating the clinical validity of an IVD.

The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on specimens taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device clearly fits this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit is intended for the qualitative identification of influenza A virus and influenza B virus in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs).

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

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

Product codes (comma separated list FDA assigned to the subject device)

GNW

Device Description

The D3 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit (D3 FastPoint A/B Kit) uses a blend (called a "L-DFA Reagent") of viral antigen-specific murine monoclonal antibodies that are directly labeled with either R-PE (influenza A virus) or fluorescein (influenza B virus) for the rapid identification of influenza A virus and influenza B virus in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection.

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 re-suspension buffer and loaded onto a specimen slide well. The cells are examined using a fluorescence microscope. Cells infected with influenza A virus will exhibit goldenyellow fluorescence due to the PE. Cells infected with influenza B virus 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, nasopharyngeal (swabs and aspirates/washes specimens)

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

Clinical Performance:
Performance of the D FastPoint A/B Kit testing direct respiratory specimens were established during prospective studies at 4 geographically diverse U.S. clinical laboratories during the 2009 respiratory virus seasons (January 2009 - 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 A/B Kit was assessed and compared to a predetermined algorithm that used composite comparator methods. The composite comparator methods for 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.
Total specimens evaluated: 1519.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 Influenza A/B panel consisted of the following:
a. Low level influenza A (Victoria strain) infected cells.
b. Low level influenza B (Taiwan strain) infected cells.
Low level influenza A (Victoria strain) infected cells mixed c. with mid level influenza B (Taiwan strain) infected cells.
d. Low level influenza B (Victoria strain) infected cells mixed with mid level influenza A (Victoria strain) infected cells.
e. Mid level non-infected (negative) cells.
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 x10^5 to 3.5 x10^5 total cells.
Each panel was tested daily in two separate runs for 5-days by four different laboratories (40 total runs).
Results: The presence of influenza A virus infected cells was reported in 100% (120/120) of the wells in which the infected cells were expected. The presence of influenza B virus 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 95% (38/40) of the wells in which infected cells were not present. The total percent agreement for the L-DFA Reagent was 99.3% (278/280).

Analytical Performance: Limit of Detection (LoD):
Model cells for influenza A virus (ATCC Victoria strain), influenza B virus (ATCC Taiwan strain) were diluted with non-infected cells to produce a suspension equivalent to 1,000 infected cells per milliliter. This suspension was then serially diluted. 25-μL 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 8 analytes were defined as the lowest dilutions at which at least 9 out of 10 replicates were detected.
Results: LoD for Influenza A (ATCC Victoria strain) was 50 infected cells/mL. LoD for Influenza B (ATCC Taiwan strain) was 50 infected cells/mL.

Analytical Performance: Analytical reactivity (inclusivity):
Analytical reactivity (inclusivity) of the L-DFA Reagent was evaluated using 13 influenza A virus and 7 influenza B virus strains. Low concentration infected cell suspensions (approximately 4% cells infected, 25-50 infected cells) were prepared for each viral strain. The suspensions were stained with the L-DFA Reagent.
Results: All tested influenza A and B strains showed successful detection with golden-yellow or apple-green fluorescent cells respectively, with varying counts of fluorescent cells.

Clinical Performance:
Study type: Prospective studies.
Sample size: 1519 total specimens from symptomatic individuals.
Key results:
Fresh nasal/nasopharyngeal wash/aspirate (Sites 1, 2, and 3 combined):
Influenza A: Sensitivity 84.8% (56/66), Specificity 99.5% (568/571).
Influenza B: Sensitivity 81.8% (9/11), Specificity 100.0% (617/617).
Fresh nasal/nasopharyngeal swab (Sites 3 and 4 combined):
Influenza A: Sensitivity 87.7% (57/65), Specificity 99.8% (624/625).
Influenza B: Sensitivity 87.9% (203/231), Specificity 99.8% (479/480).

Overall at the four Study Sites, the performance results of the D3 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit, when compared to those of the comparator devices, D3 Ultra Kit, and D3 Duet RSV Kit, demonstrate that the devices detect influenza A virus and influenza B virus antigens in a similar manner.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Fresh nasal/nasopharyngeal wash/aspirate (Sites 1, 2, and 3 combined):
Influenza A:
Sensitivity: 84.8% (56/66) (95% CI: 73.9-92.5%)
Specificity: 99.5% (568/571) (95% CI: 98.5-99.9%)
Influenza B:
Sensitivity: 81.8% (9/11) (95% CI: 48.2-97.7%)
Specificity: 100.0% (617/617) (95% CI: 99.4-100%)

Fresh nasal/nasopharyngeal swab (Sites 3 and 4 combined):
Influenza A:
Sensitivity: 87.7% (57/65) (95% CI: 77.2-94.5%)
Specificity: 99.8% (624/625) (95% CI: 99.1-100%)

Influenza B:
Sensitivity: 87.9% (203/231) (95% CI: 83.7-92.1%)
Specificity: 99.8% (479/480) (95% CI: 98.8-100%)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

D3 Ultra DFA Respiratory Virus Screening & ID Kit (K061101), D3 Duet DFA RSV/Respiratory Virus Screening Kit (K081928)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.3330 Influenza virus serological reagents.

(a)
Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.(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.

Summary

0

OCT 2 1 2009

D³ FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit

9/14/2009 Page 1 of 14

Section 05, 510(k) Summary

Kog2882

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:

September 14, 2009

Device Name:

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

Legally marketed devices to which equivalence is claimed:

D3 Ultra DFA Respiratory Virus Screening & ID Kit (K061101)

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

1

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

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

Performance characteristics for influenza A virus detection and identification were established when influenza A (H3N2) and influenza A (H1N1) were the predominant influenza A strains circulating in the United States. Performance characteristics for influenza A virus detection and identification were established when influenza A H3N2 and influenza A H1N1 were the predominant influenza A strains circulating in the United States. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to a state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

2

Device Description:

The D3 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit (D3 FastPoint A/B Kit) uses a blend (called a "L-DFA Reagent") of viral antigen-specific murine monoclonal antibodies that are directly labeled with either R-PE (influenza A virus) or fluorescein (influenza B virus) for the rapid identification of influenza A virus and influenza B virus in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection.

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 re-suspension buffer and loaded onto a specimen slide well. The cells are examined using a fluorescence microscope. Cells infected with influenza A virus will exhibit goldenyellow fluorescence due to the PE. Cells infected with influenza B virus 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.

Kit Components:

1. D³ FastPoint L-DFA Influenza A/Influenza B Reagent, 4.0-mL. One dropper bottle containing a mixture of PE-labeled murine monoclonal antibodies directed against influenza A virus antigens and FITC-labeled murine monoclonal antibodies directed against influenza B virus antigens. The buffered, stabilized, aqueous solution contains Evans Blue and propidium iodide as counter-stains and 0.1% sodium azide as preservative.
1. 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).
1. Re-suspension Buffer, 6.0-mL. One bottle of a buffered glycerol solution and 0.1% sodium azide.
1. D3 FastPoint L-DFA Influenza A/Influenza B 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 influenza A virus, or influenza B virus. The negative wells contain non-infected cells. Each slide is intended to be stained only one time.

3

Intended Use:

The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit is intended for the qualitative identification of influenza A virus and influenza B virus in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs).

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

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

Characteristics	D³ FastPoint A/B 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 Influenza A/ Influenza B Virus Identification Kit is intended for the qualitative identification of influenza A virus and influenza B virus in nasal and	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.	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,
Characteristics	D³ FastPoint
A/B Kit
(Subject Device)	D³ Ultra Kit
510(k) #K061101	D³ Duet RSV Kit
510(k) # K081928
	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	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).	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.
	that specimens
found to be negative
for influenza 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.	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.	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	influenza A virus,
influenza B virus	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 L-DFA Reagent
contains 4 MAbs to
influenza A virus,
influenza B virus	The Respiratory
Virus DFA
Screening Reagent
contains 15 MAbs to	The RSV/Respiratory
Virus DFA Screening
Reagent contains 15
MAbs to 7 different
Table 5.1: Characteristics of the D³ FastPoint L-DFA Influenza A/Influenza B Kit are
compared to those of the following Diagnostic Hybrids (DHI) predicate devices
Characteristics	D³ FastPoint
A/B Kit
(Subject Device)	D³ Ultra Kit
510(k) #K061101	D³ Duet RSV Kit
510(k) # K081928
		respiratory viruses
(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), plus 2
MAbs to respiratory
syncytial virus.
	Direct labeling,	Direct labeling,	Direct labeling,
Labeling method	- using R-
Phycoerythrin (R-
PE) to label the
MAbs to influenza
A virus.		- using R-
Phycoerythrin (R-PE)
to label the MAbs to
respiratory syncytial
virus.
	- using fluorescein
isothiocyanate
(FITC) to label
influenza B virus,
MAbs.	- using fluorescein
isothiocyanate
(FITC) to label all
MAbs with
fluorescein.	- using fluorescein
isothiocyanate (FITC) to
label all other MAbs
with fluorescein.
R-Phycoerythrin-labeled
MAbs	influenza A virus	None	respiratory syncytial
virus
Fluorescein-labeled MAbs	influenza B virus	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	Influenza A and B:
The fluorescence is
cytoplasmic or
bright nuclear or
both. Cells appear	Influenza A and B:
The fluorescence is
cytoplasmic, nuclear
or both.
Cytoplasmic	Influenza A and B:
The fluorescence is
cytoplasmic, nuclear
or both. Cytoplasmic
staining is often
Characteristics of the D³ FastPoint L-DFA Influenza A/Influenza B Kit are compared to those of the following Diagnostic Hybrids (DHI) predicate devices
Characteristics	D³ FastPoint A/B Kit (Subject Device)	D³ Ultra Kit 510(k) #K061101	D³ Duet RSV Kit 510(k) # K081928
	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.	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.
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.	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.
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 (for influenza A virus strains; MAbs are reactive with all listed strains)	13 influenza A strains: Influenza A Mexico/4108/2009 (H1N1) from CDC, Influenza A California/07/2009 (H1N1) from CDC, Aichi (H3N2), Mal (H1N1), Hong Kong (H3N2), Denver (H1N1), Port Chalmers (H3N2), Victoria (H3N2), New Jersey (H1N1), WS (H1N1), PR (H1N1), Wisconsin (H3N2), WS (H1N1)	10 influenza A strains: Aichi (H3N2), Mal (H1N1), Hong Kong (H3N2), Denver (H1N1), Port Chalmers (H3N2), Victoria (H3N2), New Jersey (H1N1), WS (H1N1), PR,(H1N1), A/NWS/33 (H1N1)	10 influenza A strains:
Aichi (H3N2), Mal (H1N1), Hong Kong (H3N2), Denver (H1N1), Port Chalmers (H3N2), Victoria (H3N2), New Jersey (H1N1), WS (H1N1), PR (H1N1), A/NWS/33 (H1N1)
Table 5.1: Characteristics of the D3 FastPoint L-DFA Influenza A/Influenza B Kit are
compared to those of the following Diagnostic Hybrids (DHI) predicate devices
Characteristics	D3 FastPoint
A/B Kit
(Subject Device)
A/NWS/33 (H1N1)	D3 Ultra Kit
510(k) #K061101	D3 Duet RSV Kit
510(k) # K081928
Analytical specificity (for
Influenza B virus strains;
MAbs are reactive with all
listed strains)	7 influenza B
strains: Hong Kong,
Maryland, Mass,
GL, Taiwan,
B/Lee/40, Russia	7 influenza B
strains: Hong Kong,
Maryland, Mass,
GL, Taiwan,
B/Lee/40, Russia	7 influenza B strains:
Hong Kong, Maryland,
Mass, GL, Taiwan,
B/Lee/40, Russia
Analytical
specificity
(cross-reactivity
studies; various
strains of
microorganisms
and cell lines)	Viruses	22	31	32
	Bacteria	22	18	25
	Chlamydia spp.	1	1	3
	Yeast	1	0	1
	Protozoan	1	0	1
	Cell lines	N/A	17	17

Technological Characteristics, Compared to Predicate Device:

www.cdc.gov

2 FDA Guidance Document: In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path; Issued 4/10/2006

DHI-FastPoint Flu A-B_Scc05_510(k) Summary_09-0914

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D3 FastPoint L-DFA Respiratory Virus Identification Kit

Section 05, Page 5 of 14

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DHI-FastPoint Flu A-B_Sec05_510(k) Summary_09-0914

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・

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DHI-FastPoint Flu A-B_Scc05_510(k) Summary_09-0914

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D3 FastPoint L-DFA Respiratory Virus Identification Kit

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9/14/2009 Section 05, Page 7 of 14

DHI-FastPoint Flu A-B_Sec05_510(k) Summary_09-0914

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7

D3 FastPoint L-DFA Respiratory Virus Identification Kit

Although the D FastPoint L-DFA Influenza A/Influenza B Reagent has been shown to detect the 2009 H1N1 virus in two culture isolates, the performance characteristics of this device with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established. The D3 FastPoint L-DFA Influenza A/Influenza B DFA Reagent can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.

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 Influenza A/B panel consisted of the following:

a. Low level influenza A (Victoria strain) infected cells.
b. Low level influenza B (Taiwan strain) infected cells.
Low level influenza A (Victoria strain) infected cells mixed c. with mid level influenza B (Taiwan strain) infected cells.
d. Low level influenza B (Victoria strain) infected cells mixed with mid level influenza A (Victoria strain) infected cells.
e. Mid level non-infected (negative) cells.

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 x105 to 3.5 x105 total cells.

8

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-yellow fluorescence.
Presence or absence of apple-green fluorescence. C.
d. Percent of cells exhibiting apple-green fluorescence.

For the L-DFA Reagent, the combined data from the four Study Sites demonstrated reproducible detection of influenza A virus by the R-PE labeled MAbs and reproducible detection of influenza B virus by the FITClabeled MAbs. The presence of influenza A virus infected cells was reported in 100% (120/120) of the wells in which the infected cells were expected. The presence of influenza B virus 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 95% (38/40) of the wells in which infected cells were not present. The total percent agreement for the L-DFA Reagent was 99.3% (278/280):

Table 5.2: Reproducibility Study Results using the L-DFA Reagent
Site	Panel
Member
Concentration	Negative
No
infected
cells	Flu A
Low
Level
4 to 10%
infected
cells	Flu B
Low
Level
4 to 10%
infected
cells	Mixed Infection		Mixed Infection	Total
%
Agreement
				Flu A
Mid
Level
20 to
30%
infected
cells	Flu B Low
Level
4 to 10%
infected
cells	Flu A
Low Level
4 to 10%
infected
cells	Flu B Mid
Level
20 to 30%
infected
cells
Site
1	Agreement
with
Expected result	8/10
(80%)	10/10
(100%)	10/10
(100%)	10/10
(100%)	10/10
(100%)	10/10
(100%)	10/10
(100%)	68/70
(97.1%)
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	38/40
(95%)	40/40
(100%)	40/40
(100%)	40/40
(100%)	40/40
(100%)	40/40
(100%)	40/40
(100%)	278/280
(99.3%)
	95% CI	83.1 -
99.4%	91.2 -
100%	91.2 -
100%	91.2 -
100%	91.2 -
100%	91.2 -
100%	91.2 -
100%	97.4 -
99.9%

Limit of Detection

Analytical Limit of Detections (LoDs) of the L-DFA Reagent was addressed using dilution series of infected model cells. Model cells for influenza A virus

9

(ATCC Victoria strain), influenza B virus (ATCC Taiwan strain) were diluted with non-infected cells to produce a suspension equivalent to 1,000 infected cells per milliliter. This level theoretically vields 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-μL 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 8 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 L-DFA Reagent
Virus Strain	Infected cells/mL	Number of replicates with positive cells	LOD determination
Influenza A
(ATCC Victoria
strain)	500	10/10	50 infected cells/mL
	100	10/10
	50	10/10
	25	5/10
	12.5	3/10
	6	2/10
	3	0/10
	1.5	2/10
	0.8	0/10
	0.4	0/10
Influenza B
(ATCC Taiwan strain)	2000	10/10	50 infected cells/mL
	400	10/10
	200	10/10
	100	10/10
	50	10/10
	25	7/10
	12.5	4/10
	6	2/10
	3	0/10
	1.5	0/10

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Analytical reactivity (inclusivity)

Analytical reactivity (inclusivity) of the L-DFA Reagent was evaluated using 13 influenza A virus and 7 influenza B virus strains. Low concentration infected cell suspensions (approximately 4% cells infected, 25-50 infected cells) were prepared for each viral strain. The suspensions were stained with the L-DFA Reagent.

| Table 5.4: Analytical Reactivity (inclusivity) of the L-DFA Reagent on various influenza A virus and influenza

B virus strains
Influenza Strains	Infected Cell Concentration
(as multiples of the respective
established LoD concentration	L-DFA Reagent Results
Influenza A Mexico/4108/2009
(H1N1) from CDC*	20x LoD	19 Golden-yellow fluorescent cells
Influenza A California/07/2009
(H1N1) from CDC*	20x LoD	26 Golden-yellow fluorescent cells
Influenza A Wisconsin/56/2005
(H3N2)	20x LoD	39 Golden-yellow fluorescent cells
Influenza A WS, VR-1520 (H1N1)	20x LoD	67 Golden-yellow fluorescent cells
Influenza A Hong Kong, VR-544
(H3N2)	20x LoD	13 Golden-yellow fluorescent cells
Influenza A New Jersey, VR-897
(H1N1)	20x LoD	15 Golden-yellow fluorescent cells
Influenza A A/NWS/33 (H1N1)	20x LoD	10 Golden-yellow fluorescent cells
Influenza A Victoria, VR-822 (H3N2)	20x LoD	10 Golden-yellow fluorescent cells
Influenza A PR, VR-95 (H1N1)	20x LoD	20 Golden-yellow fluorescent cells
Influenza A Port Chalmers, VR-810
(H3N2)	20x LoD	8 Golden-yellow fluorescent cells
Influenza A Aichi, VR-547 (H3N2)	20x LoD	28 Golden-yellow fluorescent cells
Influenza A Denver, VR-546 (H1N1)	20x LoD	30 Golden-yellow fluorescent cells
Influenza A Mal, VR-98 (H1N1)	20x LoD	21 Golden-yellow fluorescent cells
Influenza B GL/1739/54, VR-103	20x LoD	13 Apple-green fluorescent cells
Influenza B Taiwan/2/62, VR-295	20x LoD	44 Apple-green fluorescent cells
Influenza B Hong Kong/5/72, VR-823	20x LoD	21 Apple-green fluorescent cells
Influenza B Maryland/1/59, VR-296	20x LoD	22 Apple-green fluorescent cells
Influenza B Russia, VR-790	20x LoD	36 Apple-green fluorescent cells
Influenza B B/Lee/40	20x LoD	41 Apple-green fluorescent cells
Influenza B Massachusetts, VR-523	20x LoD	67 Apple-green fluorescent cells

Although the D3 FastPoint L-DFA Influenza A/Influenza B Reagent has been shown to detect the 2009 H1N1 influenza virus in two culture isolates, the performance characteristics of this device with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established. The D3 FastPoint L-DFA Influenza A/Influenza B DFA Reagent can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.

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Clinical Performance:

Performance of the D FastPoint A/B Kit testing direct respiratory specimens were established during prospective studies at 4 geographically diverse U.S. clinical laboratories during the 2009 respiratory virus seasons (January 2009 - 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 A/B Kit was assessed and compared to a predetermined algorithm that used composite comparator methods. The composite comparator methods for 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 Influenza A/B viruses within this population as determined by the D3 FastPoint A/B Kit direct specimen testing is noted in Table 5.5 below:

Table 5.5: Influenza A/B Virus Prevalence
Age	Total
Specimens
Evaluated	Flu A

positive

(prevalence) | Flu B

positive

(prevalence) |
| 0 - 1 month | 55 | 0 | 0 |
| > 1 month to 2 years | 577 | 27 (4.7%) | 20 (3.5%) |
| > 2 years to 12 years | 391 | 43 (11.0%) | 104 (26.6%) |
| > 12 years to 21 years | 173 | 19 (11.0%) | 41 (23.7%) |
| 22 years to 30 years | 57 | 3 (5.3%) | 14 (24.6%) |
| 31 years to 40 years | 71 | 9 (12.7%) | 9 (12.7%) |
| 41 years to 50 years | 52 | 5 (9.6%) | 5 (9.6%) |
| 51 years to 60 years | 46 | 3 (6.5%) | 3 (6.5%) |
| 61 years to 70 years | 33 | 2 (6.1%) | 2 (6.1%) |
| 71 years to 80 years | 16 | 2 (12.5%) | 1 (6.3%) |
| 81 years and above | 7 | 0 | 0 |
| Age Not Reported | 41 | 2 (4.9%) | 14 (34.1%) |
| Total | 1519 | 115 (7.6%) | 213 (14.0%) |

Tables 5.6 and 5.7 below show the study results of the NP wash/aspirate specimen type (Sites 1, 2, and 3 combined):

12

: 1000

.

:

D3 FastPoint L-DFA Respiratory Virus Identification Kit

9/14/2009 Section 05, Page 13 of 14

Table 5.6: Influenza A
Fresh nasal/nasopharyngeal
wash/aspirate	Comparator DSFA
(negatives followed by culture with DFA)
DHI DSFA	Positive	Negative	Total
Positive	56	3	59
Negative	10	568	578
Total	66	571	637
			95% CI
Sensitivity	56/66	84.8%	73.9-92.5%
Specificity	568/571	99.5%	98.5-99.9%

Table 5.7: Influenza B
Fresh nasal/nasopharyngeal
wash/aspirate	Comparator DSFA
(negatives followed by culture with DFA)
DHI DSFA	Positive	Negative	Total
Positive	9	0	9
Negative	2	617	619
Total	11	617	628
			95% CI
Sensitivity	9/11	81.8%	48.2-97.7%
Specificity	617/617	100.0%	99.4-100%

Tables 5.8 and 5.9 below show the study results of the NP swab specimen type (Sites 3 and 4 combined):

Table 5.8: Influenza A
Fresh nasal/nasopharyngeal
swab	Comparator DSFA
(negatives followed by culture with DFA)
DHI DSFA	Positive	Negative	Total
Positive	57	1	58
Negative	8	624	632
Total	65	625	690
			95% CI
Sensitivity	57/65	87.7%	77.2-94.5%
Specificity	624/625	99.8%	99.1-100%

Table 5.9: Influenza B
Fresh nasal/nasopharyngeal
swab	Comparator DSFA
(negatives followed by culture with DFA)
DHI DSFA	Positive	Negative	Total
Positive	203	1	204
Negative	28	479	507
Total	231	480	711
			95% CI
Sensitivity	203/231	87.9%	83.7-92.1%
Specificity	479/480	99.8%	98.8-100%

:

DHI-FastPoint Flu A-B_Sec05_510(k) Summary_09-0914

13

D3 FastPoint L-DFA Respiratory Virus Identification Kit

Section 05, Page 14 of 14

Overall at the four Study Sites, the performance results of the D3 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit, when compared to those of the comparator devices, D3 Ultra Kit, and D3 Duet RSV Kit, demonstrate that the devices detect influenza A virus and influenza B virus antigens in a similar manner.

14

Image /page/14/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993 ・

OCT 2 1 2009

Mr. Ronald Lollar Senior Director, Product Realization, Management, and Marketing Diagnostic Hybrids Inc. 1055 East State Street Suite 100 Athens, OH 45701

Re: K092882

Trade/Device Name: D3 FastPoint L-DFA Influenza A/ Influenza B Virus Identification Kit

Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: Class I Product Code: GNX Dated: September 14, 2009 Received: September 18, 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

15

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).

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) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Siyastgum

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

16

Indications for Use

510(k) Number (if known): K092882

Device Name: D2 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit

Indications For Use:

The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit is intended for the qualitative identification of influenza A virus and influenza B virus in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs).

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

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

AND/OR Over-The-Counter Use Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

signature
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1

510(k)	k09 2882
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2FDA Guidance Document: In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path; Issued 4/10/2006