(281 days)
Not Found
No
The device description details a standard enzyme immunoassay (EIA) process involving chemical reactions and optical density readings. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies focus on traditional metrics like sensitivity and specificity compared to culture methods.
No.
This device is designed for detection and diagnosis of herpes simplex virus (HSV), not for treating or preventing a disease.
Yes
The device is an enzyme immunoassay designed for direct detection of herpes simplex virus, which indicates its purpose is to diagnose the presence of the virus in patient samples.
No
The device description clearly lists multiple physical components (microwells, controls, buffers, solutions, pipet, holder, sealer) and describes a laboratory-based assay procedure involving incubation, washing, and reading at specific wavelengths, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "designed for detection of herpes simplex virus (HSV)" and is used for "direct detection from genital or other skin vesicles/ulcerated lesions or asymptomatic genital specimens". This indicates it's used to test samples taken from the human body to provide information about a person's health status (presence of HSV).
- Device Description: The description details a "microwell-based sandwich EIA" system with components like "Capture Antibody-coated microwells, Positive Control, Negative Control, Extraction Buffer, Enzyme Conjugate, etc." This is a typical setup for an in vitro diagnostic assay.
- Assay Procedure: The step-by-step procedure involves adding samples and reagents, incubating, washing, and reading results, all of which are characteristic of an in vitro test performed on a biological sample.
The core function of the device is to analyze a biological sample (specimens from lesions or genital areas) outside of the body to diagnose or detect a specific condition (presence of HSV). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Premier HSV is a qualitative enzyme immunoassay designed for detection of herpes simplex virus (HSV) . The test is intended to be used for direct detection from genital or other skin vesicles/ulcerated lesions or asymptomatic genital specimens to rapidly confirm the presence of HSV. The test can also be used in conjunction with cell cultures inoculated with these specimens.
Product codes (comma separated list FDA assigned to the subject device)
83IGC
Device Description
The Premier HSV Plus assay system is a microwell-based sandwich EIA for the detection of herpes simplex virus. Each kit contains the following components:
a. Capture Antibody-coated microwells 1 x 96
b. Positive Control 6.5ml
c. Negative Control 6.5ml
d. Extraction Buffer 15ml
e. Enzyme Conjugate 10ml
f. 20X Wash Buffer 50ml
g. Substrate 10ml
h. Stop Solution 10ml
i. Transfer Pipet 96
j. Microwell Strip Holder 1X
k. Microwell Strip Sealer 2X
The assay is performed by adding two free drops (or 50μl) of Extraction Buffer to all wells. Then add four free drops (200µl) each of positive and negative control to the control wells, or 200μl of sample into appropriate wells and incubate 90 minutes at 37-39°C. Wash 5X with wash buffer. Add two free drops (100µl) of enzyme conjugate to each well, cover and incubate 30 minutes at 37-39°C. Then wash 5X with a five minute soak. Add two free drops (100µl) of substrate to all wells and incubate ten minutes at room temperature. Add two free drops (50wl) of Stop Solution to each well. Wait two minutes and read at 450/630nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
genital or other skin vesicles/ulcerated lesions or asymptomatic genital specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Trial Results: Comparison of the performance of Premier HSV Plus Direct EIA and Spin-Amp EIA procedure to culture with FA confirmation of positives.
Direct EIA vs Culture with FA Confirmation:
Specimen Type: Genital Symptomatic, N=393. Relative Sensitivity: Initial 88.9% (152/171), Resolved 93.1% (161/173). Relative Specificity: Initial 98.2% (218/222), Resolved 100% (220/220).
Specimen Type: Genital Asymptomatic, N=78. Relative Sensitivity: Initial 80% (4/5), Resolved 83.3% (5/6). Relative Specificity: Initial 98.6% (72/73), Resolved 100% (72/72).
Specimen Type: Oral, N=42. Relative Sensitivity: Initial 92.9% (13/14), Resolved 92.9% (13/14). Relative Specificity: Initial 100% (28/28), Resolved 100% (28/28).
Specimen Type: Others*, N=43. Relative Sensitivity: Initial 92.3% (12/13), Resolved 92.3% (12/13). Relative Specificity: Initial 100% (30/30), Resolved 100% (30/30).
Total, N=556. Relative Sensitivity: Initial 89.2% (181/203), Resolved 92.7% (191/206). Relative Specificity: Initial 98.6% (348/353), Resolved 100% (350/350).
*Skin lesion specimens other than genital, oral, and ocular.
Spin-Amp EIA vs Culture with FA Confirmation:
Specimen Type: Genital Symptomatic, N=393. Relative Sensitivity: Initial 98.3% (168/171), Resolved 99.4% (173/174). Relative Specificity: Initial 97.3% (216/222), Resolved 99.5% (218/219).
Specimen Type: Genital Asymptomatic, N=78. Relative Sensitivity: Initial 100% (5/5), Resolved 100% (6/6). Relative Specificity: Initial 98.6% (72/73), Resolved 100% (72/72).
Specimen Type: Oral, N=42. Relative Sensitivity: Initial 92.9% (13/14), Resolved 92.9% (13/14). Relative Specificity: Initial 100% (28/28), Resolved 100% (28/28).
Specimen Type: Others*, N=43. Relative Sensitivity: Initial 100% (13/13), Resolved 100% (13/13). Relative Specificity: Initial 100% (30/30), Resolved 100% (30/30).
Total, N=556. Relative Sensitivity: Initial 98.0% (199/203), Resolved 99.0% (205/207). Relative Specificity: Initial 98.0% (346/353), Resolved 99.7% (348/349).
Reproducibility:
Intra-assay variability:
HSV-1 (H): Mean O.D. Range 1.01 - 1.55, C.V. Range 1.8 - 17.4%
HSV-1 (M): Mean O.D. Range 0.52 - 0.92, C.V. Range 1.5 - 13.5%
HSV-1 (L): Mean O.D. Range 0.33 - 0.44, C.V. Range 3.9 - 13.4%
HSV-2 (H): Mean O.D. Range 1.36 - 1.61, C.V. Range 1.4 - 13.9%
HSV-2 (M): Mean O.D. Range 0.33 - 0.48, C.V. Range 1.3 - 12.4%
HSV-2 (L): Mean O.D. Range 0.17 - 0.33, C.V. Range 1.9 - 14.1%
Negative Control: Mean O.D. Range 0.08 - 0.12, C.V. Range 2.4 - 18.7%
Inter-assay variability:
HSV-1 (H): Mean O.D. Range 1.26 - 1.48, C.V. Range 8.8 - 29.9%
HSV-1 (M): Mean O.D. Range 0.54 - 0.62, C.V. Range 0.8 - 21.9%
HSV-1 (L): Mean O.D. Range 0.37 - 0.44, C.V. Range 14.7 - 22.0%
HSV-2 (H): Mean O.D. Range 1.36 - 1.46, C.V. Range 0.8 - 16.0%
HSV-2 (M): Mean O.D. Range 0.39 - 0.40, C.V. Range 18.6 - 32.7%
HSV-2 (L): Mean O.D. Range 0.21 - 0.29, C.V. Range 6.9 - 18.4%
Negative Control: Mean O.D. Range 0.09 - 0.10, C.V. Range 12.0 - 29.5%
Sensitivity Limits: The sensitivity of Premier HSV Plus for HSV-1 and HSV-2 is 10 TCID-0 units and 30 TCID-0 units respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity, Relative Specificity, C.V. Range
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.
Premier HSV
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
MAY 2 3 196
Meridian Diagnostics, Inc. Cincinnati, OH 45244
510(k) Notification Premier HSV Plus
APPENDIX A - 510(k) Summary
- Identification Information A.
-
- Submitter's Information:
-
a. Submitter's Name and Address:
Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, Ohio 45244
- b. Phone Number: 1-513-271-3700
- Contact Person: Allen D. Nickol, Ph.D. C. Director, Scientific & Requlatory Affairs
- d.. Date Summary Prepared: August 11, 1995
-
- Name of Device: Premier HSV Plus
- Classification Name: Enzyme Linked Immunosorbent a. Assay, Herpes Simplex Virus (83IGC)
- Predicate Equivalent Device: 3. Premier HSV
1
Meridian Diagnostics, Inc. Cincinnati, OH 45244
- Description of Device: The Premier HSV Plus assay system 4 . is a microwell-based sandwich EIA for the detection of herpes simplex virus. Each kit contains the following components:
| a. | Capture Antibody-coated microwells | 1 x 96 |
|---|---|---|
| b. | Positive Control | 6.5ml |
| c. | Negative Control | 6.5ml |
| d. | Extraction Buffer | 15ml |
| e. | Enzyme Conjugate | 10ml |
| f. | 20X Wash Buffer | 50ml |
| g. | Substrate | 10ml |
| h. | Stop Solution | 10ml |
| i. | Transfer Pipet | 96 |
| j. | Microwell Strip Holder | 1X |
| k. | Microwell Strip Sealer | 2X |
The assay is performed by adding two free drops (or 50μl) of Extraction Buffer to all wells. Then add four free drops (200µl) each of positive and negative control to the control wells, or 200μl of sample into appropriate wells and incubate 90 minutes at 37-39°C. Wash 5X with wash buffer. Add two free drops (100µl) of enzyme conjugate to each well, cover and incubate 30 minutes at 37-39°C. Then wash 5X with a five minute soak. Add two free drops (100µl) of substrate to all wells and incubate ten minutes at room temperature. Add two free drops (50wl) of Stop Solution to each well. Wait two minutes and read at 450/630nm.
-
- Intended Use: The Premier HSV is a qualitative enzyme immunoassay designed for detection of herpes simplex virus (HSV) . The test is intended to be used for direct detection from genital or other skin vesicles/ulcerated lesions or asymptomatic genital specimens to rapidly confirm the presence of HSV. The test can also be used in conjunction with cell cultures inoculated with these specimens.
2
Meridian Diagnostics, Inc. Cincinnati, OH 45244
510(k) Notification Premier HSV Plus
Comparison with Predicate Devices: 6.
- a. Both assays employ enzyme immunoassay technology
- Both methodologies are specific for detection of HSV b. antigens.
-
- Clinical Trial Results: Comparison of the performance of Premier HSV Plus Direct EIA and Spin-Amp EIA procedure to culture with FA confirmation of positives
Direct EIA vs Culture with FA Confirmation
| Relative Sensitivity | Relative Sensitivity | ||||
|---|---|---|---|---|---|
| Specimen | |||||
| Type | N | Initial | Resolved | Initial | Resolved |
| Genital | |||||
| Symptomatic | 393 | 88.9% (152/171) | 93.1% (161/173) | 98.2% (218/222) | 100% (220/220) |
| Genital | |||||
| Asymptomatic | 78 | 80% (4/5) | 83.3% (5/6) | 98.6% (72/73) | 100% (72/72) |
| Oral | 42 | 92.9% (13/14) | 92.9% (13/14) | 100% (28/28) | 100% (28/28) |
| Others* | 43 | 92.3% (12/13) | 92.3% (12/13) | 100% (30/30) | 100% (30/30) |
| Total | 556 | 89.2% (181/203) | 92.7% (191/206) | 98.6% (348/353) | 100% (350/350) |
Skin lesion specimens other than genital, oral, and ocular.
Spin-Amp EIA vs Culture with FA Confirmation
| Relative Sensitivity | Relative Sensitivity | ||||
|---|---|---|---|---|---|
| Specimen | |||||
| Type | N | Initial | Resolved | Initial | Resolved |
| Genital | |||||
| Symptomatic | 393 | 98.3% (168/171) | 99.4% (173/174) | 97.3% (216/222) | 99.5% (218/219) |
| Genital | |||||
| Asymptomatic | 78 | 100% (5/5) | 100% (6/6) | 98.6% (72/73) | 100% (72/72) |
| Oral | 42 | 92.9% (13/14) | 92.9% (13/14) | 100% (28/28) | 100% (28/28) |
| Others* | 43 | 100% (13/13) | 100% (13/13) | 100% (30/30) | 100% (30/30) |
| Total | 556 | 98.0% (199/203) | 99.0% (205/207) | 98.0% (346/353) | 99.7% (348/349) |
3
Meridian Diagnostics, Inc. Cincinnati, OH 45244
510(k) Notification Premier HSV Plus
Additional Information/Nonclinical Test Results B.
- Reproducibility 1.
- Intra-assay variability a.
| Sample | Mean O.D. Range | C.V. Range |
|---|---|---|
| HSV-1 (H) | 1.01 - 1.55 | 1.8 - 17.4% |
| HSV-1 (M) | 0.52 - 0.92 | 1.5 - 13.5% |
| HSV-1 (L) | 0.33 - 0.44 | 3.9 - 13.4% |
| HSV-2 (H) | 1.36 - 1.61 | 1.4 - 13.9% |
| HSV-2 (M) | 0.33 - 0.48 | 1.3 - 12.4% |
| HSV-2 (L) | 0.17 - 0.33 | 1.9 - 14.1% |
| Negative Control | 0.08 - 0.12 | 2.4 - 18.7% |
Intra-assay Variation
b. Inter-assay variability
Inter-Assay Variation
| Sample | Mean O.D. Range | C.V. Range |
|---|---|---|
| HSV-1 (H) | 1.26 - 1.48 | 8.8 - 29.9% |
| HSV-1 (M) | 0.54 - 0.62 | 0.8 - 21.9% |
| HSV-1 (L) | 0.37 - 0.44 | 14.7 - 22.0% |
| HSV-2 (H) | 1.36 - 1.46 | 0.8 - 16.0% |
| HSV-2 (M) | 0.39 - 0.40 | 18.6 - 32.7% |
| HSV-2 (L) | 0.21 - 0.29 | 6.9 - 18.4% |
| Negative Control | 0.09 - 0.10 | 12.0 - 29.5% |
- Sensitivity Limits: The sensitivity of Premier HSV Plus 2 . for HSV-1 and HSV-2 is 10 TCID-0 units and 30 TCID-0 units respectively.