(50 days)
No
The device description and performance studies focus on traditional immunofluorescence techniques and manual microscopic examination, with no mention of automated image analysis or AI/ML algorithms.
No.
This device is for in vitro diagnostic (IVD) use to detect and identify Cytomegalovirus (CMV) immediate early antigen (IEA) in cell cultures, not for a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use in the qualitative detection and identification of human Cytomegalovirus (CMV) immediate early antigen (IEA) in cell cultures." This clearly indicates its purpose is to aid in diagnosis by identifying a specific pathogen.
No
The device is a kit containing physical components such as reagents, control slides, and mounting fluid, which are used in a laboratory procedure involving cell culture and fluorescence microscopy. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection and identification of human Cytomegalovirus (CMV) immediate early antigen (IEA) in cell cultures by immunofluorescence". This is a diagnostic purpose, identifying a specific marker of infection.
- Device Description: The device is a "Kit" containing reagents (antibodies, controls, mounting fluid, PBS) designed to perform a specific test on biological samples (cell cultures inoculated with patient samples).
- Performance Studies: The document describes clinical performance studies comparing the device to legally marketed CMV immunofluorescence assay kits, which are themselves IVDs. The metrics reported (positive percent agreement, negative percent agreement) are standard for evaluating the performance of diagnostic tests.
- Predicate Devices: The document lists predicate devices that are also described as "CMV immunofluorescence assay kits," further indicating the device's classification as an IVD.
The device is designed to be used in vitro (outside the body) to diagnose or aid in the diagnosis of a condition (CMV infection) by analyzing a biological sample (cell culture derived from patient specimens). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Diagnostic Hybrids, Inc. device, D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit, is intended for use in the qualitative detection and identification of human cytomegalovirus (CMV) immediate early antigen (IEA) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs).
This product is not intended for use in testing blood or plasma donors and is not intended for use in direct detection of cytomegalovirus in clinical specimens.
Product codes
LIN
Device Description
Two murine derived monoclonal antibodies (MAbs) are used in the Diagnostic Hybrids, Inc. (DHI) device, D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit (CMV-IEA ID Kit), and are directed against CMV immediate early antigen (pp 72). The MAbs used in the Kit have been shown to be highly specific, with no cross-reactivity to other cultured viruses. The MAbs have been labeled by DHI using Fluorescein Isothiocyanate (FITC).
Kit Components:
-
- CMV-IEA DFA Reagent, 10-mL. One dropper bottle containing a mixture of two murine MAbs directed against CMV immediate early antigen (pp 72). The MAbs are both IgG1 (k) isotype. The buffered, stabilized, aqueous solution contains Evans Blue as a counter-stain and 0.1% sodium azide as preservative.
-
- CMV Antigen Control Slides, 5-slides. Individually packaged control slides containing wells with cell culture derived positive and negative control cells. Each slide contains one Negative well of uninfected cells and one Positive well of CMV infected cells. Each slide is intended to be stained only one time.
-
- Mounting Fluid, 7-mL. One dropper bottle of an aqueous, buffered, stabilized solution of glycerol (ph 8.2 ± 0.2) and 0.1% sodium azide.
-
- 40X PBS Concentrate, 25-mL. One bottle containing a 40X concentrate consisting of 4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water) in a phosphate buffered saline (PBS) solution.
Patient samples are inoculated onto susceptible cell monolayers and cultured. After a defined incubation period, the cells to be tested for the presence of CMV-IEA are fixed in acetone. The CMV-IEA DFA Reagent is added to the cells which are then incubated for 15 to 30 minutes at 35° to 37°C, the stained cells are washed with the supplied PBS Solution (diluted), and a drop of the supplied Mounting Fluid is placed on the prepared cells. The cells are examined using a fluorescence microscope. The cells infected with CMV and expressing the CMV-IEA will have apple-green fluorescent nuclei while uninfected cells will contain no fluorescence but will be stained red by the Evans Blue counter-stain.
If no fluorescent cells are found, report result as "No cytomegalovirus detected". If fluorescent cells are found in the CMV-IEA DFA Reagent stained monolayer, report result as "Cytomegalovirus isolated by cell culture".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance:
Staining patterns of the fluorescein-labeled MAbs on CMV infected cells were similar to those of the predicate devices.
Analytical sensitivity was studied to demonstrate the effectiveness of the D3 CMV-IEA DFA Reagent with a comparator device. This was done by inoculating two 96-well cell culture plates (Hs27) with CMV diluted to 1-TCID50 and incubating for 48 hours. One plate was stained with the subject D3 CMV-IEA DFA Reagent and the other with the comparator. This assay was performed three times, with an average of 35.3 ±2.3 positive wells (out of 96) for the subject device and 38.3 ±2.1 positive wells (out of 96) for the predicate. These results were not statistically different by a paired t-test.
Detection limit for the subject device CMV-IEA ID Kit was studied by serially diluting CMV (starting concentration of 350-TCID50 per mL down to 0.7-TCID50 per mL) and inoculating into Hs27 cells. Plates were centrifuged and incubated. The subject CMV-IEA ID Kit or comparator device was used to stain 3 monolayers of each viral dilution. The number of positive cells per well was counted. The experiment was performed three times. The results suggest comparable detection limits, with 0.7-TCID50 as the minimum viral dilution detected, and no statistical difference by a paired t-test.
Analytical specificity was evaluated through cross-reactivity studies against various viruses, bacteria, and cell lines. No cross-reactivity or non-specific staining was observed, except for Staphylococcus aureus (Protein A producing bacteria will bind the Fc portion of some of the fluorescein-labeled MAb).
Clinical Performance:
A total of 1060 specimens were cultured and stained with one of two comparative devices and the D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit at three external clinical laboratory sites and at the DHI internal laboratory. A total of 34 specimens were excluded from final analysis, resulting in 1026 reported results. Reasons for exclusion were specimen toxicity to cell culture (29), bacterial contamination of cell culture (1), non-specific fluorescence seen prohibiting interpretation (2), and unacceptable specimens (2).
Study site 1: 314 fresh specimens collected in August 2006. No exclusions.
Positive percent agreement compared with Bartels Cytomegalovirus Immediate Early Antigen kit: 94.1% (exact 95% CI range of 73.0, 98.9).
Negative percent agreement compared with Bartels Cytomegalovirus Immediate Early Antigen kit: 99.7% (exact 95% CI range of 98.1, 99.9).
Study site 2: 300 specimens (72 fresh and 228 archival) from August 31 to November 8, 2006. Archival specimens collected June 2005 to September 2006, stored at -70°C. Seven archival specimens excluded due to toxicity.
Combined archival and fresh positive percent agreement compared with Light Diagnostics CMV Direct Immunofluorescence Assay: 100% (exact 95% CI range of 94.7, 100).
Negative percent agreement compared with Light Diagnostics CMV Direct Immunofluorescence Assay: 98.7% (exact 95% CI range of 96.1, 99.5).
Study site 3: 146 fresh specimens from February to May 2007. 18 excluded due to toxicity, contamination, and specimen acceptability.
Positive percent agreement compared with Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay kit: 83.3% (exact 95% CI range of 43.6, 97.0).
Negative percent agreement compared with Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay kit: 100% (exact 95% CI range of 96.9, 100).
Study site 4: 300 frozen prospectively collected specimens from February 2007, stored at -70°C. 9 excluded due to toxicity and non-specific fluorescence.
Positive percent agreement compared with Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay kit: 83.3% (exact 95% CI range of 55.2, 95.3).
Negative percent agreement compared with Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay kit: 100% (exact 95% CI 98.6, 100).
Overall study results indicate that the D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit performs comparably to the legally marketed CMV immunofluorescence assay kits for the qualitative detection and identification of CMV IEA in cell cultures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive percent agreement
Negative percent agreement
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Diagnostic Hybrids. The logo features the company name in bold, sans-serif font, with the words "DIAGNOSTIC" stacked above "HYBRIDS." Below the name is the tagline "Integrating Science and Humanity" in a smaller, italicized font. To the right of the text is a stylized graphic resembling a DNA double helix intertwined with a human figure with arms raised.
510(K) SUMMARY - K081164
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
Applicant:
DIAGNOSTIC HYBRIDS, INC. 1055 East State Street Suite 100 Athens, OHIO 45701
JUN 1 3 2008
Contact Information:
Gail R. Goodrum Vice President, Regulatory Affairs E-mail: goodrum@dhiusa.com Telephone: 740-589-3300 Desk Extension: 740-589-3380 FAX: 740-593-8437
Date of preparation of 510(k) summary:
June 06, 2008
Device Name:
Trade name - D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT Common name - Fluorescent antibody test for identification of Cytomegalovirus (CMV) Classification name - Antisera, Conjugated Fluorescent, Cytomegalovirus Product Code - LIN Regulation - 21 CFR 866.3175, Cytomegalovirus serological reagents
Legally marketed devices to which equivalence is claimed:
-
- K951821, Light Diagnostics CMV Direct Immunofluorescence Assay (Millipore) Intended Use: Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay is intended for pre-cytopathic effect (CPE) detection and identification of immediate early antigen of human CMV in cell culture. This product is not FDA approved for use in testing blood or plasma donors and is not intended for use in direct detection of CMV in clinical specimens.
-
- K904036, Bartels Cytomegalovirus Immediate Early Antigen Indirect Fluorescent Antibody (Trinity Biotech PLC) Intended Use: Bartels Cytomegalovirus Immediate Early Antigen Indirect Fluorescent Antibody is intended for qualitative detection of CMV pre-cytopathic effect (CPE) immediate early antigen in centrifugation-enhanced inoculated cell cultures. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
1
Device Description:
Two murine derived monoclonal antibodies (MAbs) are used in the Diagnostic Hybrids, Inc. (DHI) device, D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit (CMV-IEA ID Kit), and are directed against CMV immediate early antigen (pp 72). The MAbs used in the Kit have been shown to be highly specific, with no cross-reactivity to other cultured viruses. The MAbs have been labeled by DHI using Fluorescein Isothiocyanate (FITC).
Kit Components:
-
- CMV-IEA DFA Reagent, 10-mL. One dropper bottle containing a mixture of two murine MAbs directed against CMV immediate early antigen (pp 72). The MAbs are both IgG1 (k) isotype. The buffered, stabilized, aqueous solution contains Evans Blue as a counter-stain and 0.1% sodium azide as preservative.
-
- CMV Antigen Control Slides, 5-slides. Individually packaged control slides containing wells with cell culture derived positive and negative control cells. Each slide contains one Negative well of uninfected cells and one Positive well of CMV infected cells. Each slide is intended to be stained only one time.
-
- Mounting Fluid, 7-mL. One dropper bottle of an aqueous, buffered, stabilized solution of glycerol (ph 8.2 ± 0.2) and 0.1% sodium azide.
-
- 40X PBS Concentrate, 25-mL. One bottle containing a 40X concentrate consisting of 4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water) in a phosphate buffered saline (PBS) solution.
Patient samples are inoculated onto susceptible cell monolayers and cultured. After a defined incubation period, the cells to be tested for the presence of CMV-IEA are fixed in acetone. The CMV-IEA DFA Reagent is added to the cells which are then incubated for 15 to 30 minutes at 35° to 37°C, the stained cells are washed with the supplied PBS Solution (diluted), and a drop of the supplied Mounting Fluid is placed on the prepared cells. The cells are examined using a fluorescence microscope. The cells infected with CMV and expressing the CMV-IEA will have apple-green fluorescent nuclei while uninfected cells will contain no fluorescence but will be stained red by the Evans Blue counter-stain.
If no fluorescent cells are found, report result as "No cytomegalovirus detected". If fluorescent cells are found in the CMV-IEA DFA Reagent stained monolayer, report result as "Cytomegalovirus isolated by cell culture".
Intended Use:
The Diagnostic Hybrids, Inc. device, D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit, is intended for use in the qualitative detection and identification of human cytomegalovirus (CMV) immediate early antigen (IEA) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs).
This product is not intended for use in testing blood or plasma donors and is not intended for use in direct detection of cytomegalovirus in clinical specimens.
2
Technological Characteristics:
The Diagnostic Hybrids, Inc. device, D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit, has been compared directly to Bartels Cytomegalovirus Immediate Early Antigen Kit and the Light Diagnostics CMV Direct Immunofluorescence Assay as the legally marketed devices. The technology used in all devices is based on a standard immunofluorescence assay technique utilizing fluorescein-labeled MAbs and viral isolation in cell culture. A summary is provided in Table 5.1 below:
| TABLE 5.1: Technological Characteristics Compared Among DHI Device and Predicate Devices | |||
|---|---|---|---|
| Characteristic | Subject Device | ||
| DHI | Predicate | ||
| Bartels | |||
| (K904036) | Predicate | ||
| Light Diagnostics | |||
| (K951821) | |||
| Immediate Early Antigen | X | X | X |
| MAb Directly Labeled with Fluorescein | X | -- | X |
| MAb Indirect labeled with Fluorescein | |||
| (requires labeled secondary anti-mouse | |||
| antibody) | -- | X | -- |
| Culture Confirmation | X | X | X |
Non-Clinical Performance:
Staining patterns of the fluorescein-labeled MAbs on CMV infected cells were similar to those of the predicate devices.
Analytical sensitivity was studied for purposes of demonstrating the effectiveness of the D3 CMV-IEA DFA Reagent with that of a comparator device. This was done by first inoculating two 96-well cell culture plates (Hs27) with CMV diluted to a value of 1-TCID50 and incubating at 37°C for 48 hours; then, one plate was stained with the subject D3 CMV-IEA DFA Reagent and the other plate was stained using the CMV-IEA DFA Reagent from the comparator device. This assay was performed three times, with an average of 35.3 ±2.3 positive wells out of a total 96 wells detected with the subject, and an average of 38.3 ±2.1 positive wells out of a total 96 wells with the predicate. These results were not statistically different by a paired t-test".
Detection limit for the subject device CMV-IEA ID Kit was addressed under the conditions: CMV, at a starting concentration 350-TCID50 per mL, was serially diluted to a final value of 0.7-TCID50 per mL using 2-fold dilutions. Each dilution was inoculated into confluent monolayers of Hs27 cells contained in multi-well plates, centrifuged at 700 xg for 60 minutes and incubated at 35° to 37°C for 48 hours. The subject CMV-IEA ID Kit or the comparator device, was used to stain 3 monolayers of each viral dilution according to the respective device's product insert. The number of positive cells per well was counted. The experiment was performed three times. The results suggest that the detection limit of both fluorescent antibody stains are
DHI-CMV-IE Sec05 510k-Summary_rev_08-0609 (2).doc
a Microsoft Office Excel, Microsoft Corporation
3
D² DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
Section 05, 510(k) Summary
comparable, with 0.7-TCID50 as the minimum viral dilution detected, as indicated by at least one well having no detectable infection. These results were not statistically different by a paired t-test3.
Analytical specificity was evaluated according to cross reactivity studies against a number of strains of viruses, strains of bacteria, and different cell lines. No crossreactivity or non-specific staining with any of the other agents was observed, except for Staphylococcus aureus (Protein A producing bacteria will bind the Fc portion of some of the fluoresccin-labeled MAb), which was cross-reactive with the CMV-IEA DFA Reagent. Microorganisms and cell lines which were evaluated against the CMV-IEA DFA Reagent are listed in Table 5.2, below:
| TABLE 5.2: Microorganisms tested for Cross-Reactivity with D3 CMV-IEA DFA Reagent | |||||
|---|---|---|---|---|---|
| Virus (no reactivity with CMV-IEA DFA Reagent) | Strain or Type | Inoculum (TCID50) | Organism | Strain or Type | Inoculum (TCID50) |
| Adenovirus | Type 1 | 1,400 | RSV | Long | 1,400 |
| Adenovirus | Type 3 | 1,400 | RSV | Wash | 1,400 |
| Adenovirus | Type 5 | 1,400 | RSV | 9320 | 1,400 |
| Adenovirus | Type 6 | 1,400 | Parainfluenza 1 | C-35 | 1,400 |
| Adenovirus | Type 7 | 1,400 | Parainfluenza 2 | Greer | 1,400 |
| Adenovirus | Type 8 | 1,400 | Parainfluenza 3 | C 243 | 1,400 |
| Adenovirus | Type 10 | 1,400 | Parainfluenza 4a | M-25 | 1,400 |
| Adenovirus | Type 13 | 1,400 | Parainfluenza 4b | CH19503 | 1,400 |
| Adenovirus | Type 14 | 1,400 | HSV-1 | IF | 140 |
| Adenovirus | Type 31 | 1,400 | HSV-1 | MacIntyre | 140 |
| Influenza A | Aichi | 1,400 | HSV-2 | MS | 140 |
| Influenza A | Malaya | 1,400 | HSV-2 | Strain G | 140 |
| Influenza A | Hong Kong | 1,400 | VZV | Webster | 140 |
| Influenza A | Denver | 1,400 | VZV | Ellen | 140 |
| Influenza A | Port Chalmers | 1,400 | VZV | AV92-3 | 140 |
| Influenza A | Victoria | 1,400 | Epstein-Barr | ||
| Influenza A | New Jersey | 1,400 | Rubeola | Commercially available slides stained b | |
| Influenza A | PR | 1,400 | Mumps | ||
| Influenza A | WS | 1,400 | Echovirus | Types 4, 6, 9, 11, 30, 34 | Commercially available slides stained. |
| Influenza B | Hong Kong | 1,400 | |||
| Influenza B | Maryland | 1,400 | Coxsackievirus | Types B1, B2, B3, B4, B5, B6 | |
| Influenza B | Mass | 1,400 | |||
| Influenza B | Taiwan | 1,400 | Poliovirus | Types 1, 2, 3 | |
| Influenza B | GL | 1,400 | |||
| Influenza B | Russia | 1,400 | |||
| BACTERIA | Result | CFU TESTED | BACTERIA | Result | CFU TESTED |
| Acholeplasma laidlawii | Negative | ~6 x 107 | Mycoplasma | ||
| salivarium | Negative | ~6 x 107 | |||
| Acinetobacter | |||||
| calcoaceticus | Negative | 9.7 x 105 | Neisseria | ||
| gonorrhoeae | Negative | 1.3 x 106 | |||
| Bordetella | |||||
| bronchiseptica | Negative | 1.7 x 105 | Proteus mirabilis | Negative | 2.1 x 106 |
| Bordetella pertussis | Negative | 4.6 x 106 | Pseudomonas | ||
| aeruginosa | Negative | 1.0 x 107 | |||
| Corynebacterium | |||||
| diphtheriae | Negative | 2.5 x 106 | Salmonella enteriditis | Negative | 2.5 x 106 |
| Escherichia coli | Negative | 2.6 x 105 | Salmonella | ||
| typhimurium | Negative | 1.8 x 106 |
b Test material is from commercially available prepared slides. Each positive well contains 10 to 50% reactive cells.
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Diagnostic Hybrids, Inc.
| Gardnerella vaginalis | Negative | 5.0 x 105 | Staphylococcus
aureus | POSITIVE | 1.0 x 107 |
|-----------------------------------------------------|-----------|-----------|------------------------------|----------------|-------------------------------------------|
| Haemophilis influenzae
type A | Negative | 9.3 x 105 | Streptococcus
agalactiae | Negative | 9.6 x 106 |
| Klebsiella pneumoniac | Negative | 6.4 x 106 | Streptococcus
pneumoniae | Negative | 8.0 x 105 |
| Legionella pneumophila | Negative | 6.5 x 104 | Streptococcus
pyogenes | Negative | 2.9 x 107 |
| Moraxella cartarrhalis | Negative | 6.4 x 104 | Ureaplasma
uralyticum | Negative | ~6 x 104 |
| Mycoplasma hominis | Negative | ~6 x 104 | Chlamydiophila
pneumoniae | Negative | Commercially available
slides stained. |
| Mycoplasma orale | Negative | ~6 x 104 | Chlamydiophila
psittaci | Negative | Commercially available
slides stained. |
| Mycoplasma
pneumoniae | Negative | ~6 x 104 | Chlamydia
trachomatis | Negative | Commercially available
slides stained. |
| YEAST | | | PROTOZOAN | | |
| Candida glabrata | Negative | 8.7 x 106 | Trichomonas
vaginalis | Negative | Commercially available
slides stained. |
| CELL LINES (no reactivity with CMV-IEA DFA Reagent) | | | | | |
| A549 | Monolayer | MRC-5 | Monolayer | RhMK II | Cell Spot |
| BGMK | Monolayer | MRIIF | Monolayer | RK (passage 1) | Monolayer |
| HEp-2 | Monolayer | Mv1Lu | Monolayer | R-Mix | Monolayer |
| HFF / Hs27 | Monolayer | NCI-H292 | Monolayer | Vero | Cell spot |
| LLC-MK2 | Monolayer | pCMK | Cell spot | Vero 76 | Cell spot |
| McCoy | Monolayer | pRhMK | Cell spot | WI-38 | Cell spot |
| MDCK | Monolayer | RD | Monolayer | | |
Section 05, 510(k) Summary
SECTION 05- 5 of 6
Clinical Performance:
A total of 1060 specimens were cultured and stained with one of two comparative devices and the D DFA Cytomegalovirus Immediate Early Antigen Identification Kit at three external clinical laboratory sites and at the DHI internal laboratory. A total of 34 specimens were excluded from final analysis, resulting in a total of 1026 results reported. Reasons for exclusion were specimen toxicity to cell culture (29), bacterial contamination of cell culture (1), non-specific fluorescence seen prohibiting interpretation (2), and unacceptable specimens (2).
Study site 1 collected and cultured a total of 314 fresh specimens during August, 2006. There were no specimens excluded from final analysis. A wide variety of specimen sources were cultured from a diverse age population. The DS DFA Cytomegalovirus Immediate Early Antigen Identification Kit positive percent agreement compared with Bartels Cytomegalovirus Immediate Early Antigen kit for cultured specimens had a positive percent agreement of 94.1% (exact 95% C1 range of 73.0, 98.9) and a negative percent agreement of 99.7% (exact 95% CI range of 98.1, 99.9).
Study site 2 cultured a total of 300 specimens (72 fresh and 228 archival) specimens from August 31 through November 8, 2006. The archival specimens were collected from June, 2005 through September, 2006. They were stored at -70° C until re-
Staining of S. aureus appeared as small points of fluorescence while all other cultures were negative. This will be noted in labeling in the section "Limitations of the Assay": The Protein A produced by the bacterium, Staphylococcus aureus, will bind the Fc portion of the fluorescein-labeled monoclonal antibodies used in this kit. Such binding can be distinguished from viral antigen binding on the basis of morphology, i.e., S. aureusbound fluorescence appears as small (~1 micron diameter), bright dots. Results from cell cultures with hacterial contamination must, therefore, be interpreted with caution."
5
Diagnostic Hybrids, Inc.
D3 DFA Cytomegalovirus Immediate early antigen Identification Kit
Section 05, 510(k) Summary
cultured for this study. The specimens were not selected for this study based on previous culture results. Of the 228 archival specimens, seven were excluded from the final analysis due to toxicity in cell culture. The D DFA Cytomegalovirus Immediate Early Antigen Identification Kit combined archival and fresh positive percent agreement, compared with Light Diagnostics CMV Direct Immunofluorescence Assay, for cultured specimens had positive percent agreement of 100% (exact 95% CI range of 94.7, 100) and a negative percent agreement of 98.7% (exact 95% CI range of 96.1, 99.5).
Study site 3 tested specimens from February 2007 through May 2007. A total of 146 fresh specimens were cultured. Of these 146 specimens, 18 were excluded from the final analysis due to toxicity, contamination, and specimen acceptability. The D DFA Cytomegalovirus Immediate Early Antigen Identification Kit positive percent agreement, compared with Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay kit for culture confirmation specimens. had a positive percent agreement of 83.3% (exact 95% CI range of 43.6, 97.0) and a negative percent agreement of 100% (exact 95% CI range of 96.9, 100).
Study site 4 cultured 300 specimens that were collected at a clinical reference laboratory located in the Eastern U.S. in February, 2007. These frozen prospectively collected specimens were stored at -70° C until cultured for this study. The specimens were not selected for this study based on previous culture results. Of these 300 archival specimens, 9 were excluded from the final analysis due to toxicity and nonspecific fluorescence. The D DFA Cytomegalovirus Immediate Early Antigen Identification Kit positive percent agreement, compared with Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay kit for culture confirmation specimens, had a positive percent agreement of 83.3% (exact 95% CI range of 55.2, 95.3) and a negative percent agreement range of 100% (exact 95% CI 98.6. 100).
The overall study results indicate that the D DFA Cytomegalovirus Immediate Early Antigen Identification Kit performs comparably to the legally marketed CMV immunofluorescence assay kits for the qualitative detection and identification of CMV IEA in cell cultures.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 3 2008
Gail R. Goodrum Vice President of Regulatory Affairs Diagnostic Hybrids, Inc. 1055 East State Street Suite 100 Athens, OH 45701
Re: K081164
Trade/Device Name: D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit Regulation Number: 21 CFR 866.3175 Regulation Name: Cytomegalovirus Serological Reagents Regulatory Class: Class II Product Code: LIN Dated: April 21, 2008 Received: April 24, 2008
Dear Ms. Goodrum:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
7
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sally attym
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
8
Indications for Use
510(k) Number (if known): K081164
Device Name: D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit
Indications for Use: The Diagnostic Hybrids, Inc. device, D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit, is intended for use in the qualitative detection and identification of human Cytomegalovirus (CMV) immediate early antigen (IEA) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs).
This product is not intended for use in testing blood or plasma donors and is not intended for use in direct detection of cytomegalovirus in clinical specimens.
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 GDRH2 Office of Device Evaluation (ODE) D C 120 Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K081164 510(k)_