(220 days)
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.
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, Mounting Fluid, VZV Antigen Control Slides, PBS Concentrate.
Here's a breakdown of the acceptance criteria and study information for the Diagnostic Hybrids, Inc. D3 DFA Varicella-zoster Virus Identification Kit, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device rather than defining strict, pre-specified acceptance criteria with numerical targets. Instead, the performance is reported as agreement with the predicate device.
| Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance |
|---|---|---|
| Positive Percent Agreement (PPA) | Demonstrate high agreement with the predicate device for positive VZV detection. | 100% (95% CI: 91.6% to 100%) |
| Negative Percent Agreement (NPA) | Demonstrate high agreement with the predicate device for negative VZV detection. | 99.5% (95% CI: 97.3% to 99.9%) |
| Cross-Reactivity | No cross-reactivity with common respiratory and other relevant microorganisms/cell lines (except for Protein A producing Staphylococcus aureus, which is distinguishable by morphology). | No cross-reactivity observed for 55 virus strains, 20 host culture cell types, 26 bacterial cultures, and 1 yeast culture. Staphylococcus aureus showed small, bright dots of fluorescence, distinguishable from viral antigen binding. |
| Detection Limit (Comparison) | Comparable detection limit to the predicate device. | No "statistical difference" between the subject and predicate kits in detecting 1-TCID50 per well (average 21.8 positive wells for subject vs. 22.3 for predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 251 specimens (after excluding 3 specimens due to toxic cell culture monolayers from an initial 254 prospectively collected specimens).
- Data Provenance: Prospectively collected specimens. The country of origin is not explicitly stated, but it was collected at "three laboratory sites" which typically implies within the country of submission (USA for FDA approval).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the test set was established by comparison to a currently marketed Varicella-zoster virus identification kit (the predicate device) which serves as the reference method. No independent experts are mentioned as having adjudicated or established ground truth in this particular type of study (method comparison). The "experts" in this context would be the technicians and microbiologists performing and interpreting the predicate device's results. Their specific qualifications are not detailed in the summary, but it's implied they are qualified laboratory personnel accustomed to these types of assays.
4. Adjudication Method for the Test Set
The adjudication method was a direct comparison between the D3 DFA VZV Identification Kit and a predicate device, serving as the "comparison device." There is no mention of an independent expert adjudication process for discordant results. The table presented shows agreement and disagreement between the two kits.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a method comparison study between two diagnostic kits, not an evaluation of human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
Yes, a standalone performance study was done. The study evaluates the performance of the D3 DFA Varicella-zoster Virus Identification Kit itself (using immunofluorescence read by a human under a microscope) against a predicate device. This is the "algorithm only" in the context of a laboratory assay, where the "algorithm" is the entire test procedure and the interpretation criteria provided. There is no automated image analysis or AI component involved in the reading of this specific device; it relies on human observation through a fluorescence microscope.
7. Type of Ground Truth Used
The ground truth used was established by comparison to a legally marketed predicate device (Light Diagnostics Varicella-zoster (VZV) Direct Immunofluorescence Assay or Light Diagnostics Simulfluor HSV/VZV Immunofluorescence Assay) which also uses immunofluorescence for VZV detection in cell cultures. This is a form of "reference method" ground truth.
8. Sample Size for the Training Set
The 510(k) summary does not explicitly describe a separate "training set" as would be common for machine learning applications. This is a traditional diagnostic kit submission. The "training" for such a kit involves the development and optimization of the antibodies and reagents by the manufacturer. The data presented in the performance characteristics section (Analytical performance, Analytical Specificity, Comparison Studies) are primarily for validation and demonstrate the kit's performance, not for training a model.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" and associated ground truth establishment in the context of statistical model training is not applicable to this type of device (an immunofluorescence assay kit). The development of the kit itself involves internal R&D and quality control, ensuring the antibodies correctly bind to VZV antigens. This developmental process would involve testing against known positive and negative VZV samples, where "ground truth" would be established by standard microbiological techniques (e.g., cell cultures, PCR, viral isolation) for VZV positivity. However, this is part of product development, not a separate "training set" study as described for AI/ML devices.
{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 detectionof Varicella-Zoster Virus(VZV) in cultures byimmunofluorescence using | 1. The Light Diagnostics Varicella-zoster(VZV) Direct Immunofluorescence Assay(DFA) is intended for the qualitativedetection and identification of GPI and |
| Similarities | ||
| Item | Device | Predicate |
| fluoresceinated monoclonalantibodies (MAb's).Negative results do notpreclude an infection andshould not be used as the solebasis for diagnosis, treatmentor other managementdecision. Performancetesting has not been done ondirect patient specimentesting. | immediate early antigen of VZV fromvesicular lesions. The kit is intended foruse in culture confirmation with standardtube cultures and shell vials and ispresumptive in the detection andidentification of VZV from directspecimens.2. The Light Diagnostics SimulfluorHSV/VZV Immunofluorescence Assay isintended for the simultaneous detectionand identification of herpes simplexviruses (HSV) 1 and 2 and varicella-zoster virus (VZV) from patients withvesicular, oral, genital, or skin lesions,using direct specimens and cultureconfirmation. Specimens found to benegative on direct specimen examinationmust be confirmed with culture. | |
| Basic principle | DFA (Direct FluorescentAntibody) test -Immunofluorescence usingfluoresceinated monoclonalantibodies (MAbs) | 1. DFA (Direct Fluorescent Antibody)test-Immunofluorescence usingfluoresceinated monoclonal antibodies.2. DFA (Direct Fluorescent Antibody)test-Immunofluorescence usingfluoresceinated monoclonal antibodies. |
| Antibody | Blend of murine monoclonalantibodies (MAbs) directedagainst two antigenic sites onthe VZV recombinantprotein, glycoprotein E. | Predicates 1 and 2: Blend of murinemonoclonal antibodies (MAbs) directedagainst two antigens, glycoprotein I andthe immediate early antigen of VZV. |
| Instrumentation(required but notprovided) | Fluorescence microscopewith the filter combinationfor FITC (excitation peak =490 nm, emission peak =520nm). | Fluorescence microscope with filtercombination for FITC (excitation peak =490 nm, emission peak = 520nm). |
| Sample type | Swabs of lesion specimens | Swabs of lesion specimens |
{2}------------------------------------------------
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 orType | InoculumConcentration(TCID50) | Organism | Strain orType | InoculumConcentration(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 | Commerciallyavailable slidesstained.1 |
| Adenovirus | Type 8 | 350 | Parainfluenza 2 | Greer | Commerciallyavailable slidesstained.1 |
| Adenovirus | Type 10 | 350 | Parainfluenza 3 | C 243 | Commerciallyavailable slidesstained.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 | Commerciallyavailable slidesstained.1 |
| Influenza B | Hong Kong | 350 | Echovirus | 6 | Commerciallyavailable slidesstained.1 |
| Influenza B | Maryland | 350 | Echovirus | 9 | Commerciallyavailable slidesstained.1 |
| Influenza B | Mass | 350 | Echovirus | 11 | Commerciallyavailable slidesstained.1 |
| Influenza B | Taiwan | 350 | Echovirus | 30 | Commerciallyavailable slidesstained.1 |
| Influenza B | GL | 350 | Echovirus | 34 | Commerciallyavailable slidesstained.1 |
| Influenza B | Russia | 350 | Coxsackievirus | B1 | Commerciallyavailable slidesstained.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 slidesstained.1 |
|---|---|---|
| Poliovirus | Type 2 | Commercially available slidesstained.1 |
| Poliovirus | Type 3 | Commercially available slidesstained.1 |
| Epstein-Barr | Commercially available slidesstained.1 | |
| Rubeola | Commercially available slidesstained.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 1Values are# pos / total | Site 2Values are# pos / total | Site 3Values are# pos / total | |||||
|---|---|---|---|---|---|---|---|
| Age | F | M | F | M | F | M | |
| TOTALS | 63 | 36 | 10 | 10 | 80 | 40 | |
| <2y | 0/1 | 0/4 | 0 | 0/2 | 0 | 0/1 | |
| 2y to 10y | 0 | 0/1 | 0/1 | 0/1 | 1/3 | 0/2 | |
| 10y to18y | 1/6 | 1/3 | 1/1 | 1/1 | 0/4 | 0/3 | |
| 18y to 40y | 0/18 | 1/3 | 0/1 | 0/1 | 0/39 | 0/13 | |
| >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 |
{8}------------------------------------------------
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).
§ 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).