(303 days)
Cell Culture (used to detect the absence of the HSV 1 and/or HSV 2)
Not Found
No
The device description and performance studies focus on traditional immunofluorescence techniques and manual microscopy interpretation, with no mention of automated image analysis or AI/ML algorithms.
No.
This device is an in vitro diagnostic test used for the qualitative detection and identification of herpes simplex virus. It is not used for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Light Diagnostics™ HSV 1/2 Typing DFA Kit is an in vitro diagnostic test for the qualitative detection and identification of herpes simplex virus type 1 and/or type 2".
No
The device is a kit containing physical reagents (vials, packets, slides) used in conjunction with a fluorescence microscope, not a software-only product.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Light Diagnostics™ HSV 1/2 Typing DFA Kit is an in vitro diagnostic test..." and "For In Vitro Diagnostic Use." This directly identifies the device as an IVD.
N/A
Intended Use / Indications for Use
The Light Diagnostics™ HSV 1/2 Typing DFA Kit is an in vitro diagnostic test for the qualitative detection and identification of herpes simplex virus type 1 and/or type 2 in direct specimens from patients with vesicular lesions and symptoms consistent with herpes infection and for culture confirmation by immunofluorescence. Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Specimens found negative on direct specimen detection should be confirmed by culture.
For In Vitro Diagnostic Use.
Product codes (comma separated list FDA assigned to the subject device)
GQL
Device Description
Light Diagnostics™ HSV 1/2 Typing DFA Kit is a qualitative test that uses specific typing reagents and FITC filter fluorescence microscope to detect and differentiate herpes simplex viruses 1 and 2 in direct specimens from symptomatic patients with lesions and in specimens amplified by cell culture. The kit consists of HSV-1 Typing Reagent vial, HSV-2 Typing Reagent vial, two HSV Control Slides, Phosphate-Buffered Saline packet; Tween 20/Sodium Azide Solution (100X) vial, and Mounting Fluid vial. The kit utilizes specific reagents for the detection and identification of HSV-1 and HSV-2, therefore two cell spots on slides of specimens are required to identify the type of HSV. The HSV-1 Typing Reagent consists of two fluorescein-labeled monoclonal antibodies specific for HSV-1 glycoprotein C and ICP35 respectively. The HSV-2 Typing Reagent consists of two fluorescein-labeled monoclonal antibodies that specifically bind HSV-2 polypeptides. In Western blots these appear as two major bands with molecular weights of between 110-120 kD and between 78-82 kD and are consistent with the monoclonal antibodies recognizing epitopes within glycoprotein G of HSV-2. The typing reagents will bind to HSV-1 or HSV-2 infected cells fixed on microscope slides specifically. Separate cell spots on slides should be prepared for use with each reagent. Unbound reagent is removed by rinsing with phosphate-buffered saline (PBS). Illumination with ultraviolet light allows visualization of the antigen-antibody complexes by fluorescence microscopy. HSV-infected cells will exhibit apple-green fluorescence with the specific reagent while cells stain a dull red due to the presence of Evans blue in the typing reagents. The controls contained in this kit are acetone fixed slides with one well containing HSV-1 infected cells, one well containing HSV-2 infected cells, and one well containing uninfected cells to verify functioning of reagents, culture methodology and functioning of the microscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence microscopy
Anatomical Site
Direct specimens from patients with vesicular lesions
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
A total of 454 specimens collected from 3 clinical sites were included in this study, 258 samples were from the Eastern region of the United States and 196 from the Southeastern region of the US. The specimens include fresh vesicular fluid from herpetic lesions collected from patients with lesions and exhibiting symptoms of HSV 1 or HSV 2 infections.
Clinical samples were submitted to each laboratory in viral transport media. Cells were washed in PBS, dropped onto slides, and fixed in acetone. Slides were stained with the Light Diagnostics™ HSV 1/2 Typing DFA Kit reagents, and another HSV typing reagent for reference, and examined using fluorescence microscopy. All specimens were placed in MRC-5 and/or HNF standard tubes for cell culture. Slides from positive cultures were stained with the Light Diagnostics™ HSV 1/2 Typing DFA Kit reagents, and reference HSV typing reagent and examined using fluorescence microscopy.
Culture was used for confirmation and comparison.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1) Non-clinical evaluation:
The specificity of the HSV-1 and HSV-2 Typing Reagents were examined on slides prepared from HSV-1 and HSV-2 reference strains and previously typed clinical isolates after cell culture. The Typing Reagents were also tested on slides prepared from a variety of other viruses, bacteria and cell lines and showed no cross-reaction. HSV-1 and HSV-2 Typing Reagents were type-specific, showing no cross-reaction.
2) Clinical Evaluation:
Comparison studies were performed using Light Diagnostics™ HSV 1/2 Typing DFA Kit on direct specimens and the predicate device on specimens that grew on culture. The comparison studies were also performed using both kits on specimens that grew on culture.
Sample size: 454 specimens collected from 3 clinical sites (258 from Eastern US, 196 from Southeastern US).
16 specimens were excluded from HSV-1 direct specimen analysis and 18 specimens were excluded from HSV-2 direct specimen analysis due to insufficient numbers of cells. Culture results were not recorded for three specimens.
Key Results:
Direct specimen testing compared to culture:
- HSV-1 detection (n=438):
- Sensitivity: 84% (87/104) (95% Confidence Interval: 75-90%)
- Specificity: 99% (331/334) (95% Confidence Interval: 97-99%)
- HSV-2 detection (n=436):
- Sensitivity: 85% (57/67) (95% Confidence Interval: 75-92%)
- Specificity: 99% (367/369) (95% Confidence Interval: 98-99%)
Culture testing using Light Diagnostics™ HSV 1/2 Typing DFA Kit compared to predicate HSV typing reagent in culture amplified specimens:
- HSV-1 detection (n=176):
- Sensitivity: 100% (105/105) (95% Confidence Interval: 97-100%)
- Specificity: 100% (71/71) (95% Confidence Interval: 95-100%)
- HSV-2 detection (n=176):
- Sensitivity: 100% (70/70) (95% Confidence Interval: 97-100%)
- Specificity: 100% (106/106) (95% Confidence Interval: 97-100%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Direct specimen testing compared to culture:
- HSV-1 detection:
- Sensitivity: 84% (87/104)
- Specificity: 99% (331/334)
- HSV-2 detection:
- Sensitivity: 85% (57/67)
- Specificity: 99% (367/369)
Culture testing using Light Diagnostics™ HSV 1/2 Typing DFA Kit compared to predicate HSV typing reagent:
- HSV-1 detection:
- Sensitivity: 100% (105/105)
- Specificity: 100% (71/71)
- HSV-2 detection:
- Sensitivity: 100% (70/70)
- Specificity: 100% (106/106)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cell Culture (used to detect the absence of the HSV 1 and/or HSV 2)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
0
Image /page/0/Picture/1 description: The image shows the Millipore logo. The logo consists of a large letter "M" with the left half in black and the right half in a light color. To the right of the "M" is the word "MILLIPORE" in a vertical arrangement.
APR - 1 2009
510(k) Notification for Light Diagnostics™ HSV 1/2 Typing DFA Kit
510(k) SUMMARY
| Submitter: | Millipore Corp. (formerly Chemicon International, Inc.)
28820 Single Oak Drive
Temecula, CA 92590
Tel: (951) 676-8080
Fax: (951) 514-4482 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Cindy Penny |
| Date Prepared: | Tuesday, May 29, 2008 |
| Product Name | |
| Trade Name:
Common Name:
Classification Name: | Light Diagnostics™ HSV 1/2 Typing DFA Kit
Immunofluorescence Assay
Herpes simplex virus (21 CFR 866.3305, Product Code GOL) |
Intended Use
The Light Diagnostics™ HSV 1/2 Typing DFA Kit is an in vitro diagnostic test for the qualitative detection and identification of herpes simplex virus type 1 and/or type 2 in direct specimens from patients with vesicular lesions and symptoms consistent with herpes infection and for culture confirmation by immunofluorescence. Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Specimens found negative on direct specimen detection should be confirmed by culture.
For In Vitro Diagnostic Use.
Predicate Device
-
- Cell Culture (used to detect the absence of the HSV 1 and/or HSV 2)
Note: MRC-5 and HNF Cell Lines were used to assist clinicians in determining if the patient specimens were infected with HSV-1 and/or HSV-2 by cytopatic effect (CPE) observation. Culture grown from cells inoculated with patient specimens uses the presence of CPE in the cells to identify the presence or absence of HSV in the originating patient specimen.
- Cell Culture (used to detect the absence of the HSV 1 and/or HSV 2)
1
Image /page/1/Picture/0 description: The image shows the Millipore logo. The logo consists of a large, stylized letter "M" with the left half filled in black and the right half outlined. To the right of the "M" is the word "MILLIPORE" in a vertical arrangement, with the letters stacked on top of each other.
Device Description
Light Diagnostics™ HSV 1/2 Typing DFA Kit is a qualitative test that uses specific typing reagents and FITC filter fluorescence microscope to detect and differentiate herpes simplex viruses 1 and 2 in direct specimens from symptomatic patients with lesions and in specimens amplified by cell culture. The kit consists of HSV-1 Typing Reagent vial, HSV-2 Typing Reagent vial, two HSV Control Slides, Phosphate-Buffered Saline packet; Tween 20/Sodium Azide Solution (100X) vial, and Mounting Fluid vial. The kit utilizes specific reagents for the detection and identification of HSV-1 and HSV-2, therefore two cell spots on slides of specimens are required to identify the type of HSV. The HSV-1 Typing Reagent consists of two fluorescein-labeled monoclonal antibodies specific for HSV-1 glycoprotein C and ICP35 respectively. The HSV-2 Typing Reagent consists of two fluorescein-labeled monoclonal antibodies that specifically bind HSV-2 polypeptides. In Western blots these appear as two major bands with molecular weights of between 110-120 kD and between 78-82 kD and are consistent with the monoclonal antibodies recognizing epitopes within glycoprotein G of HSV-2. The typing reagents will bind to HSV-1 or HSV-2 infected cells fixed on microscope slides specifically. Separate cell spots on slides should be prepared for use with each reagent. Unbound reagent is removed by rinsing with phosphate-buffered saline (PBS). Illumination with ultraviolet light allows visualization of the antigen-antibody complexes by fluorescence microscopy. HSV-infected cells will exhibit apple-green fluorescence with the specific reagent while cells stain a dull red due to the presence of Evans blue in the typing reagents. The controls contained in this kit are acetone fixed slides with one well containing HSV-1 infected cells, one well containing HSV-2 infected cells, and one well containing uninfected cells to verify functioning of reagents, culture methodology and functioning of the microscope.
Technological Comparison of Methods
Comparison with Culture:
The performance characteristics of Light Diagnostics™ HSV 1/2 Typing DFA Kit will be established by direct evaluation of clinical specimens and smear made from culture specimens using the predicate device.
An FDA cleared direct immunofluorescence test for HSV-1 and HSV-2 was used in the study to confirm with the direct specimens testing, amplified culture material, and HSV typing. The reference device is a direct immunofluorescence test intended for the detection and identification of HSV-1 and HSV-2 following amplification in cell culture or by direct examination of clinical specimens prepared by cytospin. Specimens found to be negative on direct specimen examination was tested by cell culture.
2
Image /page/2/Picture/0 description: The image shows the Millipore company logo. The logo consists of a stylized letter "M" with the left half in solid black and the right half in a textured gray. To the right of the "M" is the word "MILLIPORE" in a vertical arrangement. The letters are stacked on top of each other. The letters are in a sans-serif font, and the trademark symbol "TM" is located at the bottom left of the image.
| Similarities | ||
|---|---|---|
| Light Diagnostics™ HSV 1/2 Typing | ||
| DFA Kit | Reference Device for HSV 1 | |
| and HSV 2 | ||
| Intended Use | In vitro diagnostic test for the qualitative | |
| detection and identification of herpes | ||
| simplex virus type 1 and/or type 2 in | ||
| direct specimens from patients with | ||
| vesicular lesions and symptoms consistent | ||
| with herpes infection and for culture | ||
| confirmation by immunofluorescence. | ||
| Negative results do not preclude an | ||
| infection and should not be used as the | ||
| sole basis for diagnosis, treatment or other | ||
| management decisions. Specimens found | ||
| negative on direct specimen detection | ||
| should be confirmed by culture. | In vitro diagnostic test for | |
| direct immunofluorescence test | ||
| intended for the detection and | ||
| identification of herpes simplex | ||
| virus type 1 (HSV-1) or herpes | ||
| simplex virus type 2 (HSV-2) | ||
| following amplification in cell | ||
| culture or by direct | ||
| examination of clinical | ||
| specimens prepared by | ||
| cytospin. Specimens found to | ||
| be negative on direct specimen | ||
| examination should be tested | ||
| by cell culture. | ||
| Method | Directly labeled fluorescent antibodies | |
| specific to HSV-1 and HSV-2 to identify | ||
| the presence of these viruses in patient | ||
| specimens. | Directly labeled fluorescent | |
| antibodies specific to HSV-1 | ||
| and HSV-2 to identify the | ||
| presence of these viruses in | ||
| patient specimens. | ||
| HSV 1 Antibody | The HSV-1 Typing Reagent consists of | |
| two fluorescein-labeled monoclonal | ||
| antibodies specific for HSV-1 | ||
| glycoprotein C and ICP35 respectively. | The primary component | |
| specific to HSV-1 will bind to | ||
| the glycoprotein C and a | ||
| capsid-associated protein in | ||
| HSV-1 infected cells | ||
| HSV 2 Antibody | The HSV-2 Typing Reagent consists of | |
| two fluorescein-labeled monoclonal | ||
| antibodies that specifically bind HSV-2 | ||
| polypeptides. In Western blots these | ||
| appear as two major bands with molecular | ||
| weights of between 110-120 kD and | ||
| between 78-82 kD and are consistent with | ||
| the monoclonal antibodies recognizing | ||
| epitopes within glycoprotein G of HSV-2. | The secondary component, | |
| specific for HSV-2, will bind | ||
| to the glycoprotein G in HSV-2 | ||
| infected cells. | ||
| Instruments | ||
| required, but not | ||
| provided | Fluorescence microscope with 100 watt mercury or halogen lamp, appropriate filter | |
| combination for FITC (excitation peak = 490 | ||
| nm, emission peak = 520nm), 100x, 200x and | ||
| 400x magnification (dry objective) | Fluorescence microscope with 100 | |
| watt mercury or halogen lamp, | ||
| appropriate filter combination for | ||
| FITC (excitation peak = 490 nm, | ||
| emission peak = 520nm), 100x, | ||
| 200x and 400x magnification (dry | ||
| objective) | ||
| Light Diagnostics™ HSV 1/2 | ||
| Typing DFA Kit | Reference Test for HSV 1 | |
| and HSV 2 | ||
| Labeling method | Two separate reagents, each of which | |
| contains FITC-labeled monoclonal | ||
| antibodies directed against either HSV- | ||
| 1 or HSV-2. Two separate wells are | ||
| necessary to detect and identify both | ||
| viruses in one sample. Illumination | ||
| with ultraviolet light allows | ||
| visualization of the antigen-antibody | ||
| complexes by fluorescence | ||
| microscopy. HSV-infected cells will | ||
| exhibit apple-green fluorescence with | ||
| the specific reagent while cells stain a | ||
| dull red due to the presence of Evans | ||
| blue in the typing reagents. | One reagent contains specific | |
| monoclonal antibodies directed | ||
| against HSV-1 and HSV-2 and | ||
| tagged with two different | ||
| fluorescent labels. This allows | ||
| simultaneous visualization and | ||
| identification of both HSV-1 and | ||
| HSV-2-infected cells in one well. | ||
| When an FITC filter set is used, | ||
| HSV-1 infected cells will exhibit | ||
| apple-green fluorescence and | ||
| HSV-2 infected cells will exhibit | ||
| yellow-gold fluorescence. The | ||
| uninfected cells will stain a dull | ||
| red due to the presence of Evans | ||
| blue in the reagent. |
..... ci ....
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Image /page/3/Picture/0 description: The image shows a logo with the letter 'M' in two different styles. The left side of the 'M' is solid black, while the right side is a textured gray. To the right of the 'M' is the word 'MILLIPORE' in a vertical orientation, with the letters stacked on top of each other.
Differences
Performance Data for Light Diagnostics™ HSV 1/2 Typing DFA Kit
1) Non-clinical evaluation:
The specificity of the HSV-1 and HSV-2 Typing Reagents were examined on slides prepared from HSV-1 and HSV-2 reference strains and previously typed clinical isolates after cell culture. The table below shows the results. HSV-1 and HSV-2 Typing Reagents were type-specific, showing no cross-reaction. The Typing Reagents were also tested on slides prepared from a variety of other viruses, bacteria and cell lines and showed no cross-reaction.
Cross-reactivity against common viruses, bacteria, and cell lines
| Organism | HSV-1 Reagent
Result | HSV-2
Reagent Result |
|------------------------------------------------------------------------|-------------------------|-------------------------|
| Herpes Viruses | | |
| Herpes simplex virus type 1; ATCC VR733/735 - Clinical
isolates (8) | + | - |
| Herpes simplex virus type 2; ATCC VR734 - Clinical
isolates(7) | - | + |
| Varicella zoster virus; Oka strain | - | - |
| Cytomegalovirus; Clinical isolate 70-35 | - | - |
| Human herpes virus 6; strain Z-29 | - | - |
| Epstein-Barr virus; Human Lymph. P3HR1 | - | - |
| Other viruses | | |
| Organism | HSV-1 Reagent Result | HSV-2 Reagent Result |
| Adenovirus; CDC strains V5002 | - | - |
| Influenza A; Clinical isolate | - | - |
| Influenza B Clinical isolate | - | - |
| Mumps; CDC V5004 | - | - |
| Parainfluenza 1; CDC V6004 | - | - |
| Parainfluenza 2; CDC V7003 | - | - |
| Parainfluenza 3; CDC V5003 | - | - |
| Parainfluenza 4; ATCC strain VR-1378 | - | - |
| Respiratory syncytial virus; CDC strain A2 | - | - |
| Rubella; VR315 strain M-33 | - | - |
| Bacteria | | |
| Bordetella bronchiseptica | - | - |
| Bordetella pertussis | - | - |
| Branhamella catarrhalis | - | - |
| Candida albicans | - | - |
| Chlamydia pneumonia | - | - |
| Chlamydia trachomatis | - | - |
| Corynebacterium diptheriae | - | - |
| E. coli | - | - |
| Legionella micdadei | - | - |
| Legionella pneumophila | - | - |
| Mycobacterium tuberculosis | - | - |
| Mycoplasma hominis | - | - |
| Mycoplasma pneumoniae | - | - |
| Neisseria Meningitidis | - | - |
| Pneumocystis carinii pneumonia | - | - |
| Staphylococcus aureus | * | * |
| Staphylococcus epidermidis | - | - |
| Streptococcus pneumonia | - | - |
| Streptococcus pyogenes | - | - |
| Trichomonas vaginalis | - | - |
| Cell Lines | | |
| MRC-5 | - | - |
| A549 | - | - |
| Vero | - | - |
| LLC-MK2 | - | - |
| Hep-2 | - | - |
4
Image /page/4/Picture/0 description: The image shows the Millipore logo. The logo consists of a large letter M, with the left half of the M in solid black and the right half in a lighter shade. To the right of the M, the word "MILLIPORE" is written vertically in a simple, sans-serif font.
510(k) Notification for Light Diagnostics™ HSV 1/2 Typing DFA Kit
*Protein A, produced by certain bacteria, will bind the Fc portion of the monoclonal antibodies used in the Light Diagnostics™ HSV 1/2 Typing DFA Kit HSV-1 and HSV-2 reagents. Staining, however, can be differentiated by size and morphology. The presence of Staphylococcus aureus, a Protein A producer, will result in small (0.8um) fluorescent spheres.
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Image /page/5/Picture/0 description: The image shows a logo with a large letter 'M'. The left half of the 'M' is solid black, while the right half is filled with a gray dot pattern. To the right of the 'M', the word 'MILLIPORE' is written vertically, with the letters stacked on top of each other. The letters are in a simple, sans-serif font.
2) Clinical Evaluation:
Specimens were collected from three sites from symptomatic patients with lesions. The comparison studies were performed using Light Diagnostics™ HSV 1/2 Typing DFA Kit on direct specimens and the predicate device on specimens that grew on culture. The comparison studies were also performed using both kits on specimens that grew on culture.
The results are summarized below.
A total of 454 specimens collected from 3 clinical sites were included in this study, 258 samples were from the Eastern region of the United States and 196 from the Southeastern region of the US. The specimens include fresh vesicular fluid from herpetic lesions collected from patients with lesions and exhibiting symptoms of HSV 1 or HSV 2 infections.
Clinical samples were submitted to each laboratory in viral transport media. Cells were washed in PBS, dropped onto slides, and fixed in acetone. Slides were stained with the Light Diagnostics™ HSV 1/2 Typing DFA Kit reagents, and another HSV typing reagent for reference, and examined using fluorescence microscopy. All specimens were placed in MRC-5 and/or HNF standard tubes for cell culture. Slides from positive cultures were stained with the Light Diagnostics™ HSV 1/2 Typing DFA Kit reagents, and reference HSV typing reagent and examined using fluorescence microscopy.
Sixteen specimens were excluded from HSV-1 direct specimen analysis and 18 specimens were excluded from HSV-2 direct specimen analysis, because of insufficient numbers of cells on the direct specimen slides. The results of the remaining direct specimen slides were compared to the results of culture isolation.
Culture results were not recorded for three specimens. Analysis was performed on the remaining specimens.
Compared to culture, direct specimen testing using the Light DiagnosticsTM HSV 1/2 Typing DFA Kit had a sensitivity of 84% (87/104) (95% Confidence Interval of 75-90%) and specificity of 99% (331/334) (95% Confidence Interval of 97% to 99%)for the detection of HSV-1; and a sensitivity of 85% (57/67) (95% Confidence Interval of 75-92%) and specificity of 99% (367/369)) (95% Confidence Interval of 98% to 99%) for the detection of HSV-2. Refer to Table 1 and Table 2.
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Image /page/6/Picture/0 description: The image shows a logo with a large letter 'M' split into two distinct halves. The left half of the 'M' is solid black, while the right half is textured with a gray pattern. To the right of the 'M', the word 'MILLIPORE' is written vertically, with the letters stacked on top of each other. The text is oriented so that it reads from bottom to top.
Data from all clinical sites was combined and summarized below.
Direct specimen testing results combined from all sites
Detection of HSV-1 in Direct Specimens using Light Diagnostics™ HSV 1/2 Table 1 Typing DFA Kit vs. Culture Confirmation with HSV typing reagent.
| DETECTING HSV-1 | | Culture
Confirmation with
Predicate HSV
typing reagent | | Total | Comments |
|-----------------------------------------------------|----------|-----------------------------------------------------------------|----------|-------|-------------------------------------------------|
| | | Positive | Negative | | |
| Light
Diagnostics™ | Positive | 87 | 3 | 90 | Sensitivity 84% (87/104)
(75-90%) 95% CI |
| HSV 1/2
Typing DFA
Kit on Direct
Specimens | Negative | 17 | 331 | 348 | Specificity 99%
(331/334)
(97-99%) 95% CI |
| | Total | 104 | 334 | 438 | |
Table 2
Detection of HSV-2 in Direct Specimens using Light Diagnostics™ HSV 1/2 Typing DFA Kit vs. Culture Confirmation with HSV typing reagent.
| DETECTING HSV-2 | | Culture
Confirmation with
Predicate HSV
typing reagent | | | |
|------------------------------------------------------------------------------|----------|-----------------------------------------------------------------|----------|-------|----------------------------------------------|
| | | Positive | Negative | Total | Comments |
| Light
Diagnostics™
HSV 1/2
Typing DFA
Kit on Direct
Specimens | Positive | 57 | 2 | 59 | Sensitivity 85% (57/67)
(75-92%) 95% CI |
| | Negative | 10 | 367 | 377 | Specificity 99% (367/369)
(98-99%) 95% CI |
| | Total | 67 | 369 | 436 | |
Culture testing using the Light Diagnostics™ HSV 1/2 Typing DFA Kit had a sensitivity of 100% (105/105) (95% Confidence Interval of 97-100%) and specificity of 100% (71/71) (95% Confidence Interval of 95% to 100%) for the detection of HSV-1; and a sensitivity of 100% (70/70) (95% Confidence Interval of 97-100%) and specificity of 100% (106/106))
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Image /page/7/Picture/0 description: The image shows a logo with a stylized letter "M" and the word "MILLPORE" written vertically on the right side. The left part of the "M" is solid black, while the right part has a dotted pattern. The letters in "MILLPORE" are arranged vertically, with each letter stacked on top of the other.
(95% Confidence Interval of 95% to 100%) for the detection of HSV-2. Refer to Table 5 and Table 6.
Culture testing results combined from all sites
Table 3
Detection of HSV-1 using Light Diagnostics™ HSV 1/2 Typing DFA Kit vs. HSV typing reagent in culture amplified specimens.
| DETECTING HSV-1 | | | Predicate HSV
typing reagent | | |
|-------------------------------------------------------------------------------|----------|----------|---------------------------------|-------|---------------------------------------------------|
| | | Positive | Negative | Total | Comments |
| Light
Diagnostics™
HSV 1/2
Typing DFA
Kit on Culture
Specimens | Positive | 105 | 0 | 105 | Sensitivity 100%
(105/105)
(97-100%) 95% CI |
| | Negative | 0 | 71 | 71 | Specificity 100%
(71/71)
(95-100%) 95% CI |
| | Total | 105 | 71 | 176 | |
Table 4
Detection of HSV-2 using Light Diagnostics IM HSV 1/2 Typing DFA Kit vs. HSV typing reagent in culture amplified specimens.
| DETECTING HSV-2 | Predicate HSV typing reagent | |||||
|---|---|---|---|---|---|---|
| Positive | Negative | Total | Comments | |||
| Light | ||||||
| Diagnostics™ | ||||||
| HSV 1/2 | ||||||
| Typing DFA | ||||||
| Kit on Culture | ||||||
| Specimens | Positive | 70 | 0 | 70 | Sensitivity 100% | |
| (70/70) | ||||||
| (95-100%) 95% CI | ||||||
| Negative | 0 | 106 | 106 | Specificity 100% | ||
| (106/106) | ||||||
| (97-100%) 95% CI | ||||||
| Total | 70 | 106 | 176 |
Conclusions Drawn from Evaluation:
Light Diagnostics™ HSV 1/2 Typing DFA Kit uses a standard direct immunofluorescence assay procedure for the detection of HSV type 1 and type 2 in patient specimens and in cell culture. The monoclonal antibodies used in the reagent have been characterized to ensure specificity and reliability of the product. In clinical evaluations, the performance
8
Image /page/8/Picture/0 description: The image shows the Millipore logo. The logo consists of a stylized letter "M" with the left half in solid black and the right half in a lighter shade, possibly gray or a textured pattern. To the right of the "M", the word "MILLIPORE" is printed vertically in a simple, sans-serif font.
characteristics of the reagents were shown to be substantially equivalent to cell culture and the predicate reagent.
The characterization and clinical evaluation of the Light Diagnostics™ HSV 1/2 Typing DFA Kit demonstrates the safety and effectiveness of this product when used as intended as described in the product insert.
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Cindy Penny Regulatory Affairs Manager Millipore Corporation 28820 Single Oak Drive Temecula, CA 92590
APR -1 2009
APR - 1 2009
Re: K081527
Trade/Device Name: Light Diagnostics™ HSV ½ Typing DFA Kit Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological reagents Regulatory Class: Class II Product Code: GQL Dated: February 27, 2009 Received: March 3, 2009
Dear Ms. Penny:
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 (OS) regulation (21 CFR Part 820).
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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 yours,
Sally attaym
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
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Indication for Use
KD-81527 510(k) Number (if known): _
Device Name: Light Diagnostics™ HSV 1/2 Typing DFA Kit
Indication for Use:
The Light Diagnostics™ HSV 1/2 Typing DFA Kit is an in vitro diagnostic test for the qualitative detection and identification of herpes simplex virus type 2 in direct specimens from patients with vesicular lesions and symptoms consistent with herpes infection and for culture confirmation by immunofluorescence. Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Specimens found negative on direct specimen detection should be confirmed by culture.
Prescription Use __ · √ (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Uwe Schief
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k): K081527
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