(112 days)
HerpeSelect 1 and 2 Immunoblot IgG, HerpeSelect-2 ELISA IgG
HerpeSelect 1 and 2 Immunoblot IgG
No
The device is described as a rapid lateral flow assay, which is a traditional immunoassay technology. There is no mention of AI, ML, or image processing in the description or performance studies.
No
Explanation: This device is a diagnostic test intended for detecting antibodies to HSV-2. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test is "intended for qualitatively detecting the presence or absence of human IgG class antibodies to herpes simplex virus type 2 (HSV-2)" and "is indicated for testing sexually active adults or pregnant women to aid in the presumptive diagnosis of HSV-2 infection." This direct aim to facilitate a diagnosis classifies it as a diagnostic device.
No
The device is described as a "Rapid Lateral Flow assay," which is a physical test kit that uses a biological sample (blood or serum) to produce a visual result. This is a hardware-based diagnostic device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a rapid test for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human whole blood or serum. This involves testing a sample taken from the human body to provide information about a physiological state (presence of antibodies indicating infection).
- Device Description: It's described as a "Rapid Lateral Flow assay for the qualitative detection of human IgG class antibodies to HSV-2." This is a common format for IVD tests that analyze biological samples.
- Sample Type: It uses human whole blood or serum, which are biological specimens.
- Purpose: The test is intended to "aid in the presumptive diagnosis of HSV-2 infection," which is a diagnostic purpose.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HerpeSelect® Express is a rapid test intended for qualitatively detecting the presence or absence of human IgG class antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (venous or capillary) or serum. The test is indicated for testing sexually active adults or pregnant women to aid in the presumptive diagnosis of HSV-2 infection.
The HerpeSelect® Express IgG device has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised patients. This kit is not intended for self-testing, and this test is neither FDA cleared nor approved for testing blood or plasma donors.
Product codes
MYF
Device Description
Rapid Lateral Flow assay for the qualitative detection of human IgG class antibodies to HSV-2
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
Adults. Not indicated for pediatrics.
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
Pregnant Women (n = 401)
- Data Source: External Investigator I (n = 161), External Investigator II (n = 120), and External Investigator III (n = 120) assessed the device's agreement in subjects from pre-natal clinics. External investigator I was a medical school clinic in Southeastern United States; External investigator II was a pre-natal clinic located in the Mid-Atlantic Region of the United States; and External investigator III was an Ob-GYN practice in the Mid-Atlantic Region of the United States.
- Annotation Protocol: The capillary and venous whole blood and sera from sequential prospective subjects were collected, tested, and masked at the external investigator sites. The masked sera sample was submitted to the Focus laboratory and tested in the reference methods. The Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG was the typing reference method for calculation of sensitivity and specificity.
Sexually Active Adults (n = 575)
- Data Source: External investigator I (n = 195), External investigator II (n = 190), and External investigator III (n = 190) assessed the device's agreement with sexually active adult subjects at medical school, student and public health clinics. External investigator I was a medical school clinic in Southeastern United States; External investigator II was a public health clinic located in the Rocky Mountain Region of the United States; and External investigator III was a student health clinic in the Southeastern United States.
- Annotation Protocol: The capillary and venous whole blood and sera from sequential prospective subjects were collected, tested, and masked at the external investigator sites. The masked sera sample was submitted to the Focus laboratory and tested in the reference methods. The Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG was the typing reference method for calculation of sensitivity and specificity.
Non-Sexually Active Adults (Low Prevalence) (n = 104)
- Data Source: External investigator I (n = 46) and External investigator II (n = 58) assessed the device's agreement with nonsexually active adult subjects (low prevalence) from a metropolitan and student population. External investigator I was a medical school clinic in Southeastern United States: External investigator II was an STD clinic located in the Pacific Northwest.
- Annotation Protocol: The capillary and venous whole blood and sera from sequential prospective subjects were collected, tested, and masked at the external investigator sites. The masked sera sample was submitted to the Focus laboratory and tested in the reference methods. The Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG was the typing reference method for calculation of sensitivity and specificity.
CDC HSV/CMV Panel (n = 100)
- Data Source: A serum panel obtained from the CDC.
- Annotation Protocol: Results from the panel were previously received during studies for the Plexus HerpeSelect Multi-Analyte Diagnostic. These results were masked from the person performing the testing with the Express device and the person performing the data analysis.
Cross-Reactivity (n = 213)
- Data Source: Samples that were sero-negative and sero-positive by at least one of Herpes Simplex 1 Virus (HSV-1), Rubella virus, Varicella-Zoster virus (VZV), Epstein-Barr virus (EBV), Cytomegalovirus (CMV), Rheumatoid Factor (RF), Anti-nuclear Antibodies (ANA).
- Annotation Protocol: Not explicitly stated, but implies the samples were characterized based on IgG results for the listed viruses/factors.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Studies
| Study | Criteria | Specificity and Sensitivity with HerpeSelect Immunoblot |
|---|---|---|
| Pregnant Women (Indicated population) in Serum | Specificity | 92.3% (108/117) |
| Sensitivity | 96.1% (271/282) | |
| Pregnant Women (Indicated population) in Venous Whole Blood | Specificity | 93.2% (109/117) |
| Sensitivity | 97.2% (274/282) | |
| Pregnant Women (Indicated population) in Capillary Whole Blood | Specificity | 94.9% (111/117) |
| Sensitivity | 95.4% (269/282) | |
| Sexually Active Adults (Indicated population) in Serum | Specificity | 92.9% (210/226) |
| Sensitivity | 91.8% (315/343) | |
| Sexually Active Adults (Indicated population) in Venous Whole Blood | Specificity | 93.4% (211/226) |
| Sensitivity | 92.4% (317/343) | |
| Sexually Active Adults (Indicated population) in Capillary Whole Blood | Specificity | 93.4% (211/226) |
| Sensitivity | 92.4% (317/343) | |
| Non-Sexually Active Adults (Low Prevalence Population) in Serum | Specificity | 0% (0/2) |
| Sensitivity | 100% (101/101) | |
| Non-Sexually Active Adults (Low Prevalence Population) in Venous Whole Blood | Specificity | 0% (0/2) |
| Sensitivity | 100% (101/101) | |
| Non-Sexually Active Adults (Low Prevalence Population) in Capillary Whole Blood | Specificity | 0% (0/2) |
| Sensitivity | 100% (101/101) | |
| CDC HSV/CMV Panel | Specificity | 100% (35/35) |
| Sensitivity | 98.5% (64/65) | |
| Cross-reactivity: | Overall Cross-reactivity | 4.2% (9/213) |
| Inter-Lot Reproducibility | %CV |
§ 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/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, sans-serif font. A curved, black shape is to the left of the word, resembling a stylized crescent or swoosh. Below the word "FOCUS" is a horizontal line, and below that is the word "Diagnostics" in a smaller, sans-serif font.
510(k) Summarv of Safety and Effectiveness HerpeSelect 1 and 2 Plexus IgG Catalog No. RT0920G Prepared May 31, 2007 Revised September 21, 2007 Page 1 of 13
| Applicant | Focus Diagnostics, Inc.
10703 Progress Way
Cypress, California 90630
USA |
|--------------------------------|-----------------------------------------------------------------------------------|
| Establishment Registration No. | 2023365 SEP 24 2007 |
| Contact Person | Constance Bridges
tel 714.220.1900
fax 714.995.6921
cbridges@focusdx.com |
| Summary Date | May 31, 2007 |
| Proprietary Name | HerpeSelect Express IgG |
| Generic Name | Herpes Simplex Virus Types 1 and 2 Serological Assays |
| Classification | Class II |
| Predicate Devices | HerpeSelect 1 and 2 Immunoblot IgG
HerpeSelect-2 ELISA IgG |
| Reference Method | HerpeSelect 1 and 2 Immunoblot IgG |
Device Description
Rapid Lateral Flow assay for the qualitative detection of human IgG class antibodies to HSV-2
Intended Use
HerpeSelect® Express is a rapid test intended for qualitatively detecting the presence of human InC class antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (venous or capillary) or serum. The test is indicated for testing sexually active adults or pregnant women to aid in the presumptive diagnosis of HSV-2 infection.
The HerpeSelect® Express IgG device has not been established for use in the pediation for neonatal screening, or for testing immunocompromised patients. This kit is not intended for self-test is neither FDA cleared nor approved for testing blood or plasma donors.
Test Principle
HerpeSelect® Express is an immunochromatographic test that uses purified antigen bound to a nitrocellulose membrane to detect HSV-2 antibodies. Sample is added to the sample well and filtered through the blood separation membrane in the lid of the housing. The lid of the housing is opened after sample addition, where a buffer well is accessible. The buffer is added to the buffer well to cause the sample and antibody-gold conjugate specific for human IgG deposited between the buffer pad and the sample deposition zone to migrate across the nitrocellulose membrane until captured by human IgG. As the sample continues to migrate, the HSV-2 test line captures any HSV-2 antibodies present in the sample. If there is no HSV-2 antibody present in the sample no test line is seen. The sample control line, which captures human IgG present in the sample. Formation of a pink line in the control zone of the device indicates the device is working correctly.
EXPECTED VALUES
An outside investigator assessed the device with masked, prospected samples from 1) sexually active adults (n = 575), and 2) from pregnant women (n = 401). The reference method was the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG. The observed prevalences and the hypothetical predictive values for the two populations are shown below. The positive value will decrease proportionally to the prevalence of HSV infection as reflected in the following table.
1
Image /page/1/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with a curved, black shape resembling an eye or a stylized checkmark to the left of the word. Below the word "FOCUS" is the word "Diagnostics" in a smaller, non-bold, sans-serif font, underlined with a thin black line.
510(k) Summary of Safety and Effectiveness HerpeSelect 1 and 2 Plexus IgG Catalog No. RT0920G Prepared May 31, 2007 Revised September 21, 2007 Page 2 of 13
| Observed Rate of Positives in Indicated Populations | ||||
|---|---|---|---|---|
| Observed Prevalence | HerpeSelect Express | |||
| In Sera | HerpeSelect Express | |||
| In Venous Whole Blood | HerpeSelect Express | |||
| In Capillary Whole Blood | HerpeSelect | |||
| Immunoblot | ||||
| HSV-2 positives(+) | ||||
| with Pregnant Women | (118/400) 29.5% | (118/400) 29.5% | (124/400) 31.0% | (117/399) 29.3% |
| HSV-2 positives(+) | ||||
| with Sexually Active | ||||
| Adults | (241/573) 42.1% | (240/573) 41.9% | (243/573) 42.4% | (226/570) 39.6% |
Prevalence vs. Hypothetical Predictive Values (In Pregnant Women)
| Serum | Venous Whole Blood | Capillary Whole Blood | ||||
|---|---|---|---|---|---|---|
| Prevalence | PPV | NPV | PPV | NPV | PPV | NPV |
| 50% | 96.7% | 94.8% | 97.0% | 93.4% | 95.7% | 94.9% |
| 40% | 95.2% | 96.5% | 95.6% | 95.5% | 93.7% | 96.6% |
| 30% | 92.7% | 97.7% | 93.4% | 97.1% | 90.5% | 97.8% |
| 25% | 90.8% | 98.2% | 91.6% | 97.7% | 88.1% | 98.2% |
| 20% | 88.1% | 98.7% | 89.1% | 98.3% | 84.7% | 98.7% |
| 15% | 83.9% | 99.0% | 85.3% | 98.8% | 79.7% | 99.1% |
| 10% | 76.6% | 99.4% | 78.5% | 99.2% | 71.2% | 99.4% |
| 5% | 60.8% | 99.7% | 63.3% | 99.6% | 53.9% | 99.7% |
Prevalence vs. Hypothetical Predictive Values (In Sexually Active Adults)
| Serum | Venous Whole Blood | Capillary Whole Blood | ||||
|---|---|---|---|---|---|---|
| Prevalence | PPV | NPV | PPV | NPV | PPV | NPV |
| 50% | 92.0% | 93.6% | 92.5% | 93.3% | 92.0% | 93.7% |
| 40% | 88.4% | 95.7% | 89.1% | 95.4% | 88.5% | 95.7% |
| 30% | 83.1% | 97.2% | 84.1% | 97.0% | 83.1% | 97.2% |
| 25% | 79.3% | 97.8% | 80.4% | 97.7% | 79.3% | 97.8% |
| 20% | 74.2% | 98.3% | 75.5% | 98.2% | 74.2% | 98.3% |
| 15% | 67.0% | 98.8% | 68.5% | 98.7% | 67.0% | 98.8% |
| 10% | 56.1% | 99.2% | 57.8% | 99.2% | 56.1% | 99.3% |
| 5% | 37.7% | 99.6% | 39.3% | 99.6% | 37.7% | 99.6% |
Note: Sexually active adult and pregnant women populations in different geographic areas may produce different frequency distributions from the table above. Each laboratory should establish frequency distributions for their specific patient populations.
PERFORMANCE CHARACTERISTICS
Summary of Studies
| Study | Criteria | Specificity and
Sensitivity with
HerpeSelect
Immunoblot |
|----------------------------------------------------------------|----------------------------|------------------------------------------------------------------|
| Pregnant Women (Indicated population) in Serum | Specificity
Sensitivity | 92.3% (108/117)
96.1% (271/282) |
| Pregnant Women (Indicated population) in Venous Whole Blood | Specificity
Sensitivity | 93.2% (109/117)
97.2% (274/282) |
| Pregnant Women (Indicated population) in Capillary Whole Blood | Specificity
Sensitivity | 94.9% (111/117)
95.4% (269/282) |
| Sexually Active Adults (Indicated population) in Serum | Specificity
Sensitivity | 92.9% (210/226)
91.8% (315/343) |
2
Image /page/2/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, uppercase letters, with a curved, swooping shape to the left of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, non-bold font, underlined with a thin line. The logo is simple and professional, likely representing a company in the medical or scientific field.
510(k) Summary of Safety and Effectiveness HerpeSelect 1 and 2 Plexus IgG Catalog No. RT0920G Prepared May 31, 2007 Revised September 21, 2007 Page 3 of 13
| Study | Criteria | Specificity and
Sensitivity with
HerpeSelect
Immunoblot | |
|------------------------------------------------------------------------------------|------------------------------|------------------------------------------------------------------|--|
| Sexually Active Adults (Indicated population) in Venous Whole
Blood | Specificity
Sensitivity | 93.4% (211/226)
92.4% (317/343) | |
| Sexually Active Adults (Indicated population) in Capillary Whole
Blood | Specificity
Sensitivity | 93.4% (211/226)
92.4% (317/343) | |
| Non-Sexually Active Adults (Low Prevalence Population) in Serum | Specificity
Sensitivity | 0% (0/2)
100% (101/101) | |
| Non-Sexually Active Adults (Low Prevalence Population) in Venous
Whole Blood | Specificity
Sensitivity | 0% (0/2)
100% (101/101) | |
| Non-Sexually Active Adults (Low Prevalence Population) in
Capillary Whole Blood | Specificity
Sensitivity | 0% (0/2)
100% (101/101) | |
| CDC HSV/CMV Panel | Specificity
Sensitivity | 100% (35/35)
98.5% (64/65) | |
| Cross-reactivity: | Overall Cross-
reactivity | 4.2% (9/213) | |
| Inter-Lot Reproducibility | %CV |