(220 days)
No
The summary describes a traditional immunofluorescence assay kit for detecting VZV in cell cultures using labeled antibodies and fluorescence microscopy. There is no mention of AI, ML, or any computational analysis beyond standard laboratory procedures.
No.
This device is a diagnostic kit used for the qualitative detection of Varicella-zoster virus (VZV) in cell cultures, which aids in diagnosis rather than directly treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the kit is "intended for use in the qualitative detection of varicella-zoster virus (VZV)," which is a diagnostic purpose.
No
The device is a kit containing reagents and control slides for immunofluorescence testing, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of varicella-zoster virus (VZV) in cell cultures by immunofluorescence". This is a diagnostic purpose, aiming to identify the presence of a specific pathogen.
- Device Description: The device is a "Kit" containing reagents (antibodies, mounting fluid, controls) designed for performing a diagnostic test.
- Performance Studies: The document describes performance studies comparing the device to a currently marketed VZV identification kit, which is typical for IVD devices seeking regulatory clearance.
- Key Metrics: The document provides key metrics like Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA), which are standard performance indicators for diagnostic tests.
- Predicate Devices: The mention of predicate devices (other VZV identification kits) further confirms its classification as an IVD, as regulatory submissions for IVDs often involve comparison to existing cleared devices.
- "Prescription Use" statement: While not explicitly stated in the provided text, the mention of "Prescription Use" in the context of the intended user suggests it's a medical device intended for use in a healthcare setting for diagnostic purposes.
In summary, the device is designed and intended to be used outside of the body (in vitro) to diagnose the presence of a specific condition (VZV infection) by analyzing a biological sample (cell cultures derived from patient specimens). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Diagnostic Hybrids, Inc D3 DFA Varicella-zoster Virus Identification Kit is intended for use in the qualitative detection of varicella-zoster virus (VZV) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decision. Performance testing has not been done on direct patient specimen testing.
Product codes
GQX, GOW
Device Description
The Diagnostic Hybrids, Inc. D3 DFA VARICELLA-ZOSTER IDENTIFICATION KIT includes a DFA Reagent that contains a blend of two fluorescein-labeled murine monoclonal antibodies directed against VZV antigens. The kit includes the following components: VZV DFA Reagent (a blend of two fluorescein labeled murine monoclonal antibodies directed against a recombinant glycoprotein E (gE) from the Ellen strain of VZV, buffered, stabilized, aqueous solution contains Evan's Blue as a counter-stain and 0.1% sodium azide as preservative); Mounting Fluid (An aqueous, buffered, stabilized solution of glycerol and 0.1% sodium azide); VZV Antigen Control Slides (Individually packaged control slides containing wells with cell culture derived positive and negative control cells); PBS Concentrate (One bottle containing a 40X concentrate consisting of 4% sodium azide in Phosphate Buffered Saline (after dilution to 1X with water, the concentration of sodium azide in the solution is 0.1%)).
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
For prescription use only.
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)
Analytical performance:
- Detection limit: The Predicate and Subject MAbs were compared by inoculating 96-well cell culture plates with the appropriate virus stock at a level of 1-TCID50 per well. The plates were incubated at 37℃ for 48 hours and then stained with either the Subject Kit or the Predicate Kit. This assay was performed 4 times with an average of 21.8 and 22.3 positive wells for the Subject and Predicate kits, respectively. The results indicate no statistical difference between the Subject and Predicate kits by a paired t-test.
- Analytical specificity: The VZV DFA Reagent was tested for cross-reactivity against 55 virus strains, 20 host culture cell types, 27 bacterial cultures, and 1 yeast culture. No cross-reactivity was observed for viruses, host cells, or most bacterial cultures. Staining of S. aureus appeared as small points of fluorescence, which could be distinguished from viral antigen binding by morphology.
Comparison studies:
- Method comparison with predicate device: This study included two hundred and fifty-four (254) prospectively collected specimens submitted for Varicella-zoster virus culture. Each specimen was evaluated by D3 DFA VZV Identification Kit and a currently marketed Varicella-zoster virus identification kit (comparison device). 3 of the specimens were not evaluated due to toxic cell culture monolayers, leaving a total of 251 specimens. The evaluations were conducted at three laboratory sites.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (PPA): 100% (95% CI: 91.6% to 100%)
Negative Percent Agreement (NPA): 99.5% (95% CI: 97.3% to 99.9%)
The comparison study reported:
True Positives: 42
False Positives: 1
False Negatives: 0
True Negatives: 208
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3900 Varicella-zoster virus serological reagents.
(a)
Identification. Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.(b)
Classification. Class II (performance standards).
0
AUG 3 0 2007
Image /page/0/Picture/2 description: The image shows the logo for Diagnostic Hybrids. The logo has the words "DIAGNOSTIC HYBRIDS" in bold, stacked on top of each other. To the right of the words is a graphic of a person with their arms raised, next to a DNA helix. The trademark symbol is located at the bottom right of the graphic.
510 (k) Summary
August 29, 2007
- A. 510(k) Number: K070206
- B. Purpose for Submission: New device
- C. Measurand: Varicella Zoster Virus (VZV)
- D. Type of Test: Cell culture method, by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs)
E. Applicant:
Diagnostic Hybrids, Inc. 350 West State Street Athens, OHIO 45701 Tel. 740-593-1784 Fax. 740-597-1546 Contact person: Gail R. Goodrum
F. Proprietary and Established Names:
D DFA Varicella-Zoster Virus Identification Kit Common Name: DFA (Direct Fluorescent Antibody) test kit for the identification of VZV in cell cultures inoculated with patient specimens
G. Regulatory Information:
-
- Regulation section: 866.3900 antiserum, cf, varicella-zoster
-
- Classification: Class II
-
- Product code: GQX
-
- Panel:
Microbiology (83)
H. Intended Use:
-
- Intended use(s):
The Diagnostic Hybrids, Inc D3 DFA Varicella-zoster Virus Identification Kit is intended for use in the qualitative detection of varicella-zoster virus (VZV) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decision. Performance testing has not been done on direct patient specimen testing.
- Intended use(s):
-
- Indication(s) for use:
The Diagnostic Hybrids, Inc D3 DFA Varicella-zoster Virus Identification Kit is intended for use in the qualitative detection of varicella-zoster virus (VZV) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies
- Indication(s) for use:
1
1
(MAbs). Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decision. Performance testing has not been done on direct patient specimen testing.
-
- Special conditions for use statement(s): For prescription use only
- Special instrument requirements: 4. Fluorescence microscope with the correct filter combination for FITC (excitation peak = 490 nm, emission peak = 520nm).
I. Device Description:
The Diagnostic Hybrids, Inc. D3 DFA VARICELLA-ZOSTER IDENTIFICATION KIT includes a DFA Reagent that contains a blend of two fluorescein-labeled murine monoclonal antibodies directed against VZV antigens. The kit includes the following components:
Kit Components:
- VZV DFA Reagent. A blend of two fluorescein labeled murine monoclonal t antibodies directed against a recombinant glycoprotein E (gE) from the Ellen strain of VZV. The buffered, stabilized, aqueous solution contains Evan's Blue as a counter-stain and 0.1% sodium azide as preservative.
- Mounting Fluid. An aqueous, buffered, stabilized solution of glycerol and 0.1% . sodium azide.
- VZV Antigen Control Slides. Individually packaged control slides containing . wells with cell culture derived positive and negative control cells. Each VZV Positive well is identified. The Negative wells contain uninfected cells. Each slide is intended to be stained only one time.
- PBS Concentrate. One bottle containing a 40X concentrate consisting of 4% . sodium azide in Phosphate Buffered Saline (after dilution to 1X with water, the concentration of sodium azide in the solution is 0.1%).
J. Substantial Equivalence Information:
-
- Predicate device name(s):
-
- Light Diagnotics Varicella-zoster (VZV) Direct Immunofluorescence Assay (DFA)
- Light Diagnostics Simulfluor HSV/VZV Immunofluorescence Assay Predicate 510(k) number(s):
The similarities to predicate devices are in indicated use, operating principle, basic design, materials and formulation.
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use | For the qualitative detection | |
| of Varicella-Zoster Virus | ||
| (VZV) in cultures by | ||
| immunofluorescence using | 1. The Light Diagnostics Varicella-zoster | |
| (VZV) Direct Immunofluorescence Assay | ||
| (DFA) is intended for the qualitative | ||
| detection and identification of GPI and | ||
| Similarities | ||
| Item | Device | Predicate |
| fluoresceinated monoclonal | ||
| antibodies (MAb's). | ||
| Negative results do not | ||
| preclude an infection and | ||
| should not be used as the sole | ||
| basis for diagnosis, treatment | ||
| or other management | ||
| decision. Performance | ||
| testing has not been done on | ||
| direct patient specimen | ||
| testing. | immediate early antigen of VZV from | |
| vesicular lesions. The kit is intended for | ||
| use in culture confirmation with standard | ||
| tube cultures and shell vials and is | ||
| presumptive in the detection and | ||
| identification of VZV from direct | ||
| specimens. |
- The Light Diagnostics Simulfluor
HSV/VZV Immunofluorescence Assay is
intended for the simultaneous detection
and identification of herpes simplex
viruses (HSV) 1 and 2 and varicella-
zoster virus (VZV) from patients with
vesicular, oral, genital, or skin lesions,
using direct specimens and culture
confirmation. Specimens found to be
negative on direct specimen examination
must be confirmed with culture. |
| Basic principle | DFA (Direct Fluorescent
Antibody) test -
Immunofluorescence using
fluoresceinated monoclonal
antibodies (MAbs) | 1. DFA (Direct Fluorescent Antibody)
test-Immunofluorescence using
fluoresceinated monoclonal antibodies. - DFA (Direct Fluorescent Antibody)
test-Immunofluorescence using
fluoresceinated monoclonal antibodies. |
| Antibody | Blend of murine monoclonal
antibodies (MAbs) directed
against two antigenic sites on
the VZV recombinant
protein, glycoprotein E. | Predicates 1 and 2: Blend of murine
monoclonal antibodies (MAbs) directed
against two antigens, glycoprotein I and
the immediate early antigen of VZV. |
| Instrumentation
(required but not
provided) | Fluorescence microscope
with the filter combination
for FITC (excitation peak =
490 nm, emission peak =
520nm). | Fluorescence microscope with filter
combination for FITC (excitation peak =
490 nm, emission peak = 520nm). |
| Sample type | Swabs of lesion specimens | Swabs of lesion specimens |
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Diagnostic Hybrids, Inc.
K. Standard/Guidance Document Referenced (if applicable): N/A
L. Test Principle:
The test kit uses viral antigen-specific murine monoclonal antibodies that are directly labeled with fluorescein for rapid detection and identification of VZV. The cells to be tested, derived from cell culture, are fixed in acetone. The VZV DFA Reagent is added to the cells to determine the presence of viral antigens. After
3
incubating at 35℃ to 37℃, the stained cells are rinsed with the diluted PBS Concentrate, a drop of the supplied Mounting Fluid is added and a coverslip is placed on the prepared cells. The cells are examined using a fluorescence microscope. VZV-infected cells will be stained with viral specific apple-green fluorescence when stained with the VZV DFA Reagent while uninfected cells will contain no fluorescence but will be stained dull red by the Evan's Blue counter-stain.
Interpretation of results:
It is recommended that controls be examined first to ensure proper test performance before examination of the specimens. A positive reaction is one in which bright apple-green fluorescence is observed in the infected cells. Uninfected cells will stain dull red due to the Evan's Blue counter-stain included in the VZV DFA Reagent. If no fluorescent cells are found, report result as, "No varicella-zoster virus detected. If fluorescent cells are found, report result as, "varicella-zoster virus isolated by cell culture".
Technologists should not confuse the dried out edge of monolayer or cell clumps which may brightly fluoresce due to entrapment of antibody with virus-specific staining. Occasionally, dead, rounded cells due to specimen toxicity or improper cell storage may nonspecifically stain a dull olive green due to trapped antibody. Adequate humidity while staining and adequate washing between steps will help to eliminate this type of nonspecific staining.
M. Performance Characteristics (if/when applicable):
-
- Analytical performance:
- Precision/Reproducibility: a. Not applicable
- b. Linearity/assav reportable range: Not applicable
- Traceability, Stability, Expected values (controls, calibrators, or methods): C. Not applicable
- d. Detection limit:
The Predicate and Subject MAbs were compared by inoculating 96-well cell culture plates with the appropriate virus stock at a level of 1-TCID50 per well. The plates were incubated at 37℃ for 48 hours and then stained with either the Subject Kit or the Predicate Kit. All plates were stained according to the product inserts. This assay was performed 4 times with an average of 21.8 and 22.3 positive wells for the Subject and Predicate kits, respectively. The results indicate no statistical difference between the Subject and Predicate kits by a paired t-test.
Analvtical specificity:
The VZV DFA Reagent was tested for cross-reactivity against a wide variety of cells and microorganisms. No cross-reactivity was observed for 55 virus strains (cultured and processed for staining) or for 20 host culture cell types. Twenty-seven (27) bacterial cultures and one (1) yeast culture were stained and examined for cross-reactivity, including Staphylococcus aureus, a protein-A-producing bacterium. Staining of S. aureus appeared as small points of
4
fluorescence while all other bacterial cultures were negative. [Protein A will specifically bind to the Fc portions of conjugated antibodies. Such binding can be distinguished from viral antigen binding on the basis of morphology, i.e., S. aureus-bound fluorescence appears as small (~1 micron diameter), bright dots. No cross-reactivity was observed for the other 26 bacterial cultures or for the one yeast culture.
Stringent conditions for cross-reactivity testing were achieved by using a high concentration of the VZV DFA Reagent and relatively high titers of microorganisms. The DFA Reagent was prepared at 1.5X the concentration that is provided in the kit. Viruses were prepared as infected cell monolayers (150 to 2100 TCID50 viruses, depending on the particular virus, were inoculated into a shell vial culture and incubated for 24 to 48 hours, to yield a 3+ to 4+ infection), and processed and stained with the 1.5X DFAs according to the procedure detailed in the product inserts. Some viruses were tested as commercially prepared slides. Bacterial strains were cultured, processed as suspensions, then spotted on microscope slides (at CFU's ranging from 6.4x104 to 6x10'/well in a 10 uL dot, depending on the bacterium), then stained with the 1.5X DFAs according to the procedure in the product insert. Cell cultures were stained as confluent monolayers.
| Organism | Strain or
Type | Inoculum
Concentration
(TCID50) | Organism | Strain or
Type | Inoculum
Concentration
(TCID50) |
|-------------|-------------------|---------------------------------------|-----------------|-------------------|-----------------------------------------------|
| Adenovirus | Type 1 | 350 | RSV | Long | 350 |
| Adenovirus | Type 5 | 350 | RSV | Wash | 350 |
| Adenovirus | Type 6 | 350 | RSV | 9320 | 350 |
| Adenovirus | Type 7 | 350 | Parainfluenza 1 | C-35 | Commercially
available slides
stained.1 |
| Adenovirus | Type 8 | 350 | Parainfluenza 2 | Greer | Commercially
available slides
stained.1 |
| Adenovirus | Type 10 | 350 | Parainfluenza 3 | C 243 | Commercially
available slides
stained.1 |
| Adenovirus | Type 14 | 350 | HSV-1 | 1F | 150 |
| Adenovirus | Type 18 | 350 | HSV-1 | CWOH 0026 | 150 |
| Adenovirus | Type 31 | 350 | HSV-1 | CWOH 0015 | 150 |
| Influenza A | Aichi | 2,100 | HSV-1 | MacIntyre | 150 |
| Influenza A | Mal | 2,100 | HSV-2 | MS | 150 |
| Influenza A | Hong Kong | 2,100 | HSV-2 | Strain G | 150 |
| Influenza A | Denver | 2,100 | CMV | Towne | 700 |
| Influenza A | Port Chalmers | 2,100 | CMV | Davis | 700 |
| Influenza A | Victoria | 2,100 | CMV | AD169 | 700 |
| Influenza A | PR | 2,100 | Echovirus | 4 | Commercially
available slides
stained.1 |
| Influenza B | Hong Kong | 350 | Echovirus | 6 | Commercially
available slides
stained.1 |
| Influenza B | Maryland | 350 | Echovirus | 9 | Commercially
available slides
stained.1 |
| Influenza B | Mass | 350 | Echovirus | 11 | Commercially
available slides
stained.1 |
| Influenza B | Taiwan | 350 | Echovirus | 30 | Commercially
available slides
stained.1 |
| Influenza B | GL | 350 | Echovirus | 34 | Commercially
available slides
stained.1 |
| Influenza B | Russia | 350 | Coxsackievirus | B1 | Commercially
available slides
stained.1 |
Virus Strains Tested for Cross Reactivity with VZV DFA Reagent
1 Test material is from commercially available prepared slides. Each positive well contains 10 to 50% reactive cells.
5
Diagnostic Hybrids, Inc.
K070206 510(k) Summary Page 6 of 8
| Poliovirus | Type 1 | Commercially available slides
stained.1 |
|----------------|--------------------------------------------|--------------------------------------------|
| Poliovirus | Type 2 | Commercially available slides
stained.1 |
| Poliovirus | Type 3 | Commercially available slides
stained.1 |
| Epstein-Barr | Commercially available slides
stained.1 | |
| Rubeola | Commercially available slides
stained.1 | |
| Mumps | | |
| Coxsackievirus | B2 | available slides |
| Coxsackievirus | B3 | stained. |
| Coxsackievirus | B4 | |
| Coxsackievirus | B5 | |
| Coxsackievirus | B6 | |
Cell Lines Tested for Cross Reactivity with VZV DFA Reagent
| A549 | Mv1Lu | RD |
|---|---|---|
| BGMK | HFF | RhMK II |
| HEp-2 | McCoy | R-Mix |
| LLC-MK2 | NCI-H292 | Vero |
| MDCK | pCMK | WI-38 |
| MRC-5 | pRhMK | Vero 76 |
| MRHF | pRK |
Bacteria and Yeast Tested for Cross Reactivity with VZV DFA Reagent
| BACTERIA | CFU TESTED |
|---|---|
| Acinetobacter calcoaceticus | 9.7 x 105 |
| Bordetella bronchiseptica | 1.7 x 106 |
| Bordetella pertussis | 4.6 x 106 |
| Corynebacterium diphtheriae | 2.5 x 106 |
| Escherichia coli | 2.6 x 105 |
| Gardnerella vaginalis | 5.0 x 105 |
| Haemophilis influenzae type A | 9.3 x 105 |
| Klebsiella pneumoniae | 6.4 x 106 |
| Legionella pneumophila | 6.5 x 104 |
| Moraxella cartarrhalis | 6.4 x 104 |
| Neisseria gonorrhoeae | 1.3 x 106 |
| Proteus mirabilis | 2.1 x 106 |
| Pseudomonas aeruginosa | 1.0 x 107 |
| Salmonella enteriditis | 2.5 x 106 |
| Salmonella typhimurium | 1.7 x 106 |
| Staphylococcus aureus | 1.0 x 107 |
| Streptococcus agalactiae | 9.6 x 106 |
| Streptococcus pneumoniae | 8.0 x 105 |
| Streptococcus pyogenes | 2.9 x 107 |
| Acholeplasma laidlawi | ~6 x 107 |
| Mycoplasma hominis | ~6 x 104 |
| Mycoplasma orale | ~6 x 104 |
| Mycoplasma pneumoniae | ~6 x 104 |
| Mycoplasma salivarium | ~6 x 104 |
| Ureaplasma uralyticum | ~6 x 104 |
6
Diagnostic Hybrids, Inc.
| Chlamydophila pneumoniae | 10 to 50% |
|---|---|
| Chlamydia trachomatis | 10 to 50% |
| YEAST | |
| Candida glabrata | $8.7 x 10^6$ |
f. Assav cut-off:
Not applicable
- Comparison studies:
a. Method comparison with predicate device: This study included two hundred and fifty-four (254) prospectively collected specimens submitted for Varicella-zoster virus culture. Each specimen was evaluated by D DFA VZV Identification Kit and a currently marketed Varicellazoster virus identification kit (comparison device). Tube cultures were tested as evidence of infection (e.g. CPE) was observed; if no evidence of infection was observed after 14-days, the tubes were tested at that time. Shell vial and multiwell plate cultures were tested at a minimum of 72-hours. All 254 specimens were cultured; however, 3 of the specimens were not evaluated because they produced toxic cell culture monolayers, leaving a total of 251 specimens to be included in the Performance Characteristics. The evaluations were conducted at three laboratory sites. Percent Agreement between the D+ DFA VZV and comparison tests was calculated and tabulated for all tested specimens. These results are summarized in the table below:
Image /page/6/Figure/7 description: This image shows a table comparing D3 DFA VZV to a comparison device. The table shows that there were 42 true positives, 1 false positive, 0 false negatives, and 208 true negatives. The positive percent agreement (PPA) is 100% with a 95% confidence interval of 91.6% to 100%. The negative percent agreement (NPA) is 99.5% with a 95% confidence interval of 97.3% to 99.9%.
| Percent Agreement of All Tests | ||
|---|---|---|
-
b. Matrix comparison:
n/a -
- Clinical studies:
2 "Positive Percent Agreement", or "PPA", values were calculated according to {{Total Number of Positive Results in Agreement by both DHI and Comparison Tests) divided by [(Total Number of Positive Results in Aereement by both DHI and Comparison Tests) plus (Number of Results Positive by the Comparison Test but Negative by the DHI test)]} multiplied by 100%.
- Clinical studies:
3 "95% CI" refers to 95% Confidence Intervals, which were calculated according to Exact method (Clopper, C. and S. Pearson, Biometrika 26:404-413, 1934).
4 "Negative Percent Agreement", or "NPA", values were calculated according to {[Total Number of Negative Results in Agreement by both DHI and Comparison Tests) divided by {(Total Number of Negative Results in Agreement by both DHI and Comparison Tests) plus (Number of Results Negative by the Comparison Test but Positive by the DHI test) } multiplied by 100%.
7
- Clinical Sensitivity: a.
- Not applicable.
- Clinical specificity: b. Not applicable.
- Other clinical supportive data (when a. and b. are not applicable): C. Not applicable.
- Clinical cut-off: 4. Not applicable
-
- Expected values/Reference range:
The clinical studies used only specimens collected and cultured for the presence of VZV. Most of the specimen types used in the clinical studies were swabs taken from skin lesions (with two taken as respiratory specimens (NP) and one CSF). Specimens were taken from the following body sites (and presented as # positive/# specimens).
Specimen sources
| Source | Total specimens | Unknown +/Total | Genital +/Total | Penis +/Total | Vaginal +/Total | Cervical +/Total | Rectal +/Total | Perineum** +/Total | Eyelid +/Total | Face +/Total | Mouth* +/Total | Skin† +/Total | NP+/Total | CSF/Brain +/Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | 99 | 0/8 | 0/1 | 0/0 | 0/0 | 0/0 | 0/1 | 0/11 | 0/1 | 4/14 | 0/2 | 17/61 | 0/0 | 0/0 |
| Site 2 | 35 | 0/0 | 0/0 | 1/2 | 0/0 | 0/0 | 0/0 | 1/3 | 0/0 | 0/2 | 0/0 | 9/27 | 0/1 | 0/0 |
| Site 3 | 120 | 2/51 | 0/6 | 0/1 | 0/9 | 0/1 | 0/0 | 0/3 | 0/0 | 1/9 | 0/5 | 4/33 | 1/1 | 0/1 |
| *mouth: mouth, lip, tongue, gum, throat | ||||||||||||||
| **perineum: groin, buttock, gluteal, coccyx, sacral, pubic, perianal | ||||||||||||||
| †skin: skin lesion, skin, finger, wrist, chest, axilla, abdomen, thigh, blister |
Demographics by age and gender for the specimens that were tested at the 3 study sites are tabulated below. Of the specimens evaluated in these studies (which had been submitted to the laboratories as swabs taken from lesions for both HSV and VZV testing), a large proportion were from patients between the ages of 18 and 40. The specimen demographics are listed in the Table below.
Demographics by Age and Gender
| | Site 1
Values are
pos / total | | Site 2
Values are
pos / total | | Site 3
Values are
pos / total | | |
|-------------------------|---------------------------------------|------|---------------------------------------|------|---------------------------------------|------|--|
| Age | F | M | F | M | F | M | |
| TOTALS | 63 | 36 | 10 | 10 | 80 | 40 | |
| 40y | 11/38 | 7/24 | 3/6 | 4/5 | 2/33 | 5/21 | |
| Age not reported | 0/0 | 1/1 | 0/1 | 0 | 1/1 | 0 | |
| Age/gender not reported | 0 | | | 1/12 | 0 | | |
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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 3 0 2007
Gail R. Goodrum Vice President, Regulatory and Quality Affairs DIAGNOTIC HYBRIDS, INC. 350 West State Street Athens, OH 45701
- Re: K070206
Trade/Device Name: D3 DFA Varicella-zoster Virus Identification Kit Regulation Number: 21 CFR 866.3900 Regulation Name: Varicella-zoster virus Serological Reagents Regulatory Class: Class II Product Code: GOW Dated: July 27, 2007 Received: July 31, 2007
Dear Ms. Goodrum:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
9
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
10
Indications for Use
510(k) Number (if known): _K070206
Device Name: Diagnostic Hybrids D3 DFA Varicella-zoster Virus Identification Kit
Indications for Use: The Diagnostic Hybrids, Inc D3 DFA Varicella-zoster Virus Identification Kit is intended for use in the qualitative detection of varicella-zoster virus (VZV) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decision.
Performance testing has not been done on direct patient specimen testing.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Uve Schef
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
2070206 510(k).