(155 days)
Not Found
Not Found
No
The device description outlines a standard immunoassay procedure with fluorescence measurement and comparison to a cut-off calibrator. There is no mention of AI/ML in the device description, intended use, or performance studies.
No.
The device is a qualitative diagnostic test for detecting antibodies to HSV-1 and HSV-2, aiding in diagnosis, not directly treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is intended for "aiding in the presumptive diagnosis of HSV-1 and HSV-2 infection," which is a diagnostic purpose.
No
The device description clearly outlines a multiplexed immunoassay that uses physical components like antigen beads and requires a three-step procedure involving incubation and measurement of fluorescence. This indicates a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera." This involves testing human specimens (sera) to obtain information about a person's health status (presence of antibodies indicating infection).
- Device Description: The description details a "multiplexed immunoassay" that uses "human sera" and involves a multi-step procedure to detect antibodies. This is a typical description of an in vitro diagnostic test.
- Performance Studies: The document includes detailed performance studies using human serum samples from different populations (expectant mothers, sexually active adults, CDC panel, low prevalence population, cross-reactivity samples) and compares the results to reference methods (Immunoblot and ELISA). This is a requirement for demonstrating the performance of an IVD.
- Key Metrics: The document reports key metrics relevant to the performance of a diagnostic test, such as agreement with positives and negatives, cross-reactivity, and reproducibility.
- Predicate and Reference Devices: The mention of predicate and reference devices (other IVD tests for HSV) further confirms its classification as an IVD.
The device is designed to be used in vitro (outside the body) to analyze a human specimen (serum) for diagnostic purposes (aiding in the presumptive diagnosis of HSV infection).
N/A
Intended Use / Indications for Use
Focus Diagnostics' Plexus™HerpeSelect®1 and 2 IgG is intended for qualitatively detecting the presence of human IgG class antibodies to HSV-1 and HSV-2 in human sera. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV-1 infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-2 infection. The performance of this assay has not been established for use in a pediative population, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment.
Product codes (comma separated list FDA assigned to the subject device)
MXJ, MYF
Device Description
The Focus Diagnostics Plexus™HerpeSelect®1 and 2 IgG is a multiplexed immunoassay for qualitatively detecting and differentiating human IgG antibodies to HSV-1 and 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
The test is indicated for testing sexually active adults or expectant mothers. The performance of this assay has not been established for use in a pediatric population.
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
Expectant Mothers (n = 300)
Sera from Expectant Mothers (n = 300) were assessed, with 150 samples processed by Focus and 150 by an external investigator (University laboratory in Northern California). The sera were sequentially submitted, archived, and masked, collected in the Pacific Northwestern United States. Results were compared against HerpeSelect 1 ELISA IgG and HerpeSelect 2 ELISA IgG, using Focus HerpeSelect 1 and 2 Immunoblot IgG as the reference method.
Sexually Active Adults (n = 300)
Sera from sexually active adults (n = 300) were assessed, with 150 samples processed by Focus and 150 by an external investigator (clinical laboratory in Southern California). The sera were sequentially submitted, archived, and masked, collected in the Pacific Northwestern United States. Results were compared against HerpeSelect 1 ELISA IgG and HerpeSelect 2 ELISA IgG, using Focus HerpeSelect 1 and 2 Immunoblot IgG as the reference method. One sample was not run on the Plexus device for HSV-1 reactivity analysis and one sample was not run on the Plexus device for HSV-2 reactivity analysis.
CDC Panel (n = 100)
A serum panel of 100 samples obtained from the CDC was tested by Focus Diagnostics. This panel contained duplicate samples of 50 test sera to test for reproducibility. It included 16 HSV-1 positive, 11 double-positive, and 16 double-negative sera, resulting in 54 HSV-1 positive and 36 HSV-2 positive specimens. The panel was masked.
Low Prevalence Population (n = 77)
Sera from patients aged 18 and 19 years (n = 77) from states with a history of low sexually transmitted disease prevalence were assessed by Focus. Samples were sourced from a clinical laboratory in Southern California. Sera submitted for other diseases, herpesvirus testing, or indicating immunocompromised patients were excluded. Samples were sequentially selected, archived, and masked. Results were compared against Focus HerpeSelect 1 and 2 Immunoblot IgG.
Cross-reactivity (n = 51)
Fifty-one samples were tested: a "HSV ELISA dual negative" group (n=37) and a "HSV ELISA mixed sero-reactivity" group (n=14). The dual negative group was sero-negative for HerpeSelect-1 ELISA IgG and HerpeSelect 2 ELISA IgG but positive for at least one of FDA cleared CMV ELISA IgG (n=18), home brew VZV ACIF (n=32), or FDA cleared EBV VCA IgG (n=31). The mixed reactivity group was sero-positive for either HerpeSelect-1 ELISA IgG or HerpeSelect 2 ELISA IgG, and positive for at least one of FDA cleared CMV ELISA IgG (HSV-1 neg n=2, HSV-2 neg n=9), home brew VZV ACIF (HSV-1 neg n=1, HSV-2 neg n=2), or FDA cleared EBV VCA IgG (HSV-1 neg n=1, HSV-2 neg n=0).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Agreement/Reactivity studies, Reproducibility
Expectant Mothers (n = 300)
- HSV-1 Reactivity:
- 96.5% (164/170) agreement with Immunoblot positives.
- 92.2% (118/128) agreement with Immunoblot negatives.
- The two Immunoblot HSV Common Antigen band positives were both negative in the Plexus.
- HSV-2 Reactivity:
- 94.3% (115/122) agreement with Immunoblot positives.
- 95.5% (168/176) agreement with Immunoblot negatives.
- The two Immunoblot HSV Common Antigen band positives were both negative in the Plexus.
Sexually Active Adults (n = 300)
- HSV-1 Reactivity:
- 91.0% (142/156) agreement with Immunoblot positives.
- 96.5% (137/142) agreement with Immunoblot negatives.
- HSV-2 Reactivity:
- 96.3% (105/109) agreement with Immunoblot positives.
- 97.4% (184/189) agreement with Immunoblot negatives.
CDC Panel (n = 100)
- Of the 54 HSV-1 positive samples, 100% (54/54) were correctly identified.
- Of the 36 HSV-2 positive samples, 100% (36/36) were correctly identified.
- Of the 22 double positive samples, 100% (22/22) were correctly identified.
- Of the 32 double negative samples, 100% (32/32) were correctly identified.
- CDC Panel Reproducibility: All paired sera were correctly identified:
- 16 out of 16 paired HSV-1 positive and HSV-2 negative (100%).
- 7 out of 7 paired HSV-1 negative (100%).
- 11 out of 11 paired double-positive (100%).
- 16 out of 16 paired double-negative (100%).
Low Prevalence Population (n = 77)
- HSV-1 Reactivity:
- 96.4% (27/28) agreement with Immunoblot positives (one HSV-1 Immunoblot positive was equivocal in the Plexus device).
- 97.9% (46/47) agreement with Immunoblot negatives (one HSV-1 Immunoblot negative was positive in the Plexus device).
- One Immunoblot HSV Common Antigen band positive was equivocal; the other was Plexus negative.
- HSV-2 Reactivity:
- 75.0% (3/4) agreement with Immunoblot positives (one HSV-1 Immunoblot positive was equivocal in the Plexus device).
- 100% (71/71) agreement with Immunoblot negatives (one HSV-1 Immunoblot negative in the Plexus device).
- Both Immunoblot HSV Common Antigen band positives were negative in the Plexus.
Cross-reactivity (n = 51)
- For HSV ELISA dual negatives:
- Plexus HerpeSelect®1 and 2 IgG was HSV-1 negative with all but one, and equivocal with one sample (CMV+ VZV+ EBV+).
- Plexus HerpeSelect®1 and 2 IgG was HSV-2 negative with all but one, and equivocal with one sample (CMV- VZV+ EBV+).
- For HSV ELISA mixed reactivity group:
- Plexus HerpeSelect®1 and 2 IgG was HSV-1 negative with all HSV-1 ELISA negatives.
- Plexus HerpeSelect®1 and 2 IgG was HSV-2 negative with all HSV-2 ELISA negatives.
- Overall cross-reactivity with CMV, EBV, and VZV: 0-5% for HSV-1 and 0-3% for HSV-2.
Reproducibility
- %CV of positives:
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in large, bold, sans-serif font, with the word "Diagnostics" in a smaller, thinner font underneath. A curved, swooping line extends from the left side of the word "FOCUS", creating a visual element that emphasizes the brand name.
510(k) Summary of Safety and Effectiveness Plexus "HerpeSelect®1 and 2 IgG Catalog No. MP0900G Prepared January 29, 2007 Page 1 of 10
| Applicant | Focus Diagnostics, Inc.
10703 Progress Way
Cypress, California 90630
USA |
|--------------------------------|-----------------------------------------------------------------------------------|
| Establishment Registration No. | 2023365 |
FEB - 1 2007
| Contact Person | Michael J. Wagner, Esq.
tel 714.220.1900
fax 714.995.6921
mwagner@focusdx.com |
|-------------------|------------------------------------------------------------------------------------------|
| Summary Date | January 29, 2007 |
| Proprietary Name | Plexus™HerpeSelect®1 and 2 IgG |
| Generic Name | Herpes Simplex Virus Types 1 and 2 Serological Assays |
| Classification | Class II |
| Predicate Devices | HerpeSelect 1 and 2 Immunoblot IgG
HerpeSelect-1 ELISA IgG
HerpeSelect-2 ELISA IgG |
Device Description
The Focus Diagnostics Plexus™HerpeSelect®1 and 2 IgG is a multiplexed immunoassay for qualitatively detecting and differentiating human IgG antibodies to HSV-1 and HSV-2.
Intended Use
Focus Diagnostics' Plexus™HerpeSelect®1 and 2 IgG is intended for qualitatively detecting the presence of human IgG class antibodies to HSV-1 and HSV-2 in human sera. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV-1 infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-2 infection. The performance of this assay has not been established for use in a pediative population, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment.
Test Principle
The Focus Diagnosics Plexus™HerpeSelect®1 and 2 IgG uses an Antigen Bead suspension that contains two distinct HSV antigen bead types that fluoresce at different wavelengths and/or intensities: gG-1 beads. The Focus Diagnostics Plexus 100 HerpeSelect®1 and 2 IgG is a three step procedure.
- Patient sera are diluted, and the diluted sera are incubated with Antibodies are present, then the 1 . antibodies bind to the corresponding antigen beads.
- Phycoerythrin-conjugated goat anti-human IgG, (Conjugate) is added, and the Conjugate binds to the bound HSV 2. antibody (if present), and forms a Conjugate-HSV antibody-antigen bead sandwich.
- Fluorescence from each distinct HSV antigen bead type is measured and compared against a Cut-off Calibrator. 3.
1
Image /page/1/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of a stylized crescent shape on the left, followed by the word "FOCUS" in bold, sans-serif font. Below "FOCUS" is the word "Diagnostics" in a smaller, less bold font, underlined with a thin line.
K062543 510(k) Summary of Safety and Effectiveness Plexus™HerpeSelect®1 and 2 IgG Catalog No. MP0900G Prepared January 29, 2007 Page 2 of 10 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
.
Performance Characteristics
Summary of Studies (details below)
| Study | | Plexus
HerpeSelect 1 IgG
Results | Plexus
HerpeSelect 2 IgG
Results |
|-----------------------------------------------|--------------------------|----------------------------------------|----------------------------------------|
| Expectant Mothers (Indicated population) | Agreement with positives | 96.5% | 94.3% |
| | Agreement with negatives | 92.2% | 95.5% |
| Sexually Active Adults (Indicated population) | Agreement with positives | 91.0% | 96.3% |
| | Agreement with negatives | 96.5% | 97.4% |
| CDC HSV/CMV Panel | Agreement with positives | 100% | 100% |
| | Agreement with negatives | 100% | 100% |
| Low Prevalence Population | Agreement with negatives | 97.9% | 100% |
| Cross-reactivity with CMV, EBV and VZV. | Cross-reactivity | 0-5% | 0-3% |
| Reproducibility | %CV of positives | $\leq$ 10% | $\leq$ 10% |
2
Image /page/2/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of a stylized black swoosh above the word "FOCUS" in a bold, sans-serif font. Below "FOCUS" is the word "Diagnostics" in a smaller, less bold font, underlined with a thin black line. The overall design is simple and professional.
Reactivity with Expectant Mothers (n = 300)
Focus (n = 150) and an external investigator (n = 150) assessed the device's reactivity with sera from Expectant Mothers. The sera were sequentially submitted to the laboratory, archived, and masked. The external investigator was an University laboratory located in Northern California, and the sera were collected in the Pacific Northwestern United States. The HerpeSelect Plexus results were compared to the HerpeSelect 1 ELISA IgG and the HerpeSelect 2 ELISA IgG, using the Focus HerpeSelect 1 and 2 Immunoblot IgG as the reference method.
HSV-1 Reactivity
The Focus HerpeSelect 1 Immunoblot IgG was: HSV-1 positive for 170 samples, HSV-1 negative with 128 samples, and HSV Common Antigen band positive for two samples.
The Plexus HerpeSelect 1 agreed with: 96.5% (164/170) of Immunoblot positives, and 92.2% (118/128) of Immunoblot negatives. The two Immunoblot HSV Common Antigen band positives were both negative in the Plexus,
HSV-2 Reactivity
The Focus HerpeSelect 2 Immunoblot IgG was: HSV-2 positive for 122 samples, HSV-2 negative with 176 samples, and HSV Common Antigen band positive for two samples.
The Plexus HerpeSelect 2 agreed with: 94.3% (115/122) of Immunoblot positives, and 95.5% (168/176) of Immunoblot negatives. The two Immunoblot HSV Common Antigen band positives were both negative in the Plexus.
3
Image /page/3/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, uppercase letters, with a curved graphic element to the left of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, non-bold font, underlined with a thin line.
K062543
510(k) Summary of Safety and Effectiveness Plexus™HerpeSelect®1 and 2 IgG Catalog No. MP0900G
Prepared January 29, 2007
Page 4 of 10
Plexus HerpeSelect 1 IgG Reactivity with Expectant Mothers (n = 300)
| Lab | HerpeSelect
Immunoblot | n | Neg | Eqv | Pos | % Agreement | n | Neg | Eqv | Pos | % Agreement |
|---------------|---------------------------|-----|-----|-----|-----|-------------------------------------|-----|-----|-----|-----|-------------------------------------|
| Site 1 | Pos | 84 | 6 | 0 | 78 | 92.9% (78/84)
95%CI 85.1-97.3% | 84 | 5 | 1 | 78 | 92.9% (78/84)
95%CI 85.1-97.3% |
| Focus | Pos | 86 | 0 | 0 | 86 | 100% (86/86)
95%CI 95.8-100% | 86 | 0 | 0 | 86 | 100% (86/86)
95%CI 95.8-100% |
| Combined Labs | Pos | 170 | 6 | 0 | 164 | 96.5% (164/170)
95%CI 92.5-98.7% | 170 | 5 | 1 | 164 | 96.5% (164/170)
95%CI 92.5-98.7% |
| Site 1 | Neg | 66 | 61 | 1 | 4 | 92.4% (61/66)
95%CI 83.2-97.5% | 66 | 59 | 2 | 5 | 89.4% (59/66)
95%CI 79.4-95.6% |
| Focus | Neg | 62 | 57 | 2 | 3 | 91.9% (57/62)
95%CI 82.2-97.3% | 62 | 59 | 1 | 2 | 95.2% (59/62)
95%CI 86.5-99.0% |
| Combined Labs | Neg | 128 | 118 | 3 | 7 | 92.2% (118/128)
95%CI 86.1-96.2% | 128 | 118 | 3 | 7 | 92.2% (118/128)
95%CI 86.1-96.2% |
| Site 1 | Com | 0 | 0 | 0 | 0 | NA | 0 | 0 | 0 | 0 | NA |
| Focus | Com | 2 | 2 | 0 | 0 | NA | 2 | 2 | 0 | 0 | NA |
| Combined Labs | Com | 2 | 2 | 0 | 0 | NA | 2 | 2 | 0 | 0 | NA |
Plexus HerpeSelect 2 IgG Reactivity with Expectant Mothers (n = 300)
| Lab | Herpe-Select
Immunoblot | Plexus HerpeSelect-2 | | | | | HerpeSelect-2 ELISA | | | | |
|---------------|----------------------------|----------------------|-----|-----|-----|-------------------------------------|---------------------|-----|-----|-----|-------------------------------------|
| | | n | Neg | Eqv | Pos | % Agreement | n | Neg | Eqv | Pos | % Agreement |
| Site I | Pos | 60 | 3 | 1 | 56 | 93.3% (56/60)
95%CI 83.8-98.2% | 60 | 2 | 0 | 58 | 96.7% (58/60)
95%CI 88.5-99.6% |
| Focus | Pos | 62 | 2 | 1 | 59 | 95.2% (59/62)
95%CI 86.5-99.0% | 62 | 1 | 0 | 61 | 98.4% (61/62)
95%CI 91.3-100% |
| Combined Labs | Pos | 122 | 5 | 2 | 115 | 94.3% (115/122)
95%CI 88.5-97.7% | 122 | 3 | 0 | 119 | 97.5% (119/122)
95%CI 93.0-99.5% |
| Site 1 | Neg | 90 | 88 | 0 | 2 | 97.8% (88/90)
95%CI 92.2-99.7% | 90 | 86 | 0 | 4 | 95.6% (86/90)
95%CI 89.0-98.8% |
| Focus | Neg | 86 | 80 | 3 | 3 | 93.0% (80/86)
95%CI 85.4-97.4% | 86 | 80 | 1 | 5 | 93.0% (80/86)
95%CI 85.4-97.4% |
| Combined Labs | Neg | 176 | 168 | 3 | 5 | 95.5% (168/176)
95%CI 91.2-98.0% | 176 | 166 | 1 | 9 | 94.3% (166/176)
95%CI 89.8-97.2% |
| Site 1 | Com | 0 | 0 | 0 | 0 | NA | 0 | 0 | 0 | 0 | NA |
| Focus | Com | 2 | 2 | 0 | 0 | NA | 2 | 2 | 0 | 0 | NA |
| Combined Labs | Com | 2 | 2 | 0 | 0 | NA | 2 | 2 | 0 | 0 | NA |
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Image /page/4/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in large, bold, sans-serif font. Below "FOCUS" is the word "Diagnostics" in a smaller, thinner font with a line above it. To the left of the word "FOCUS" is a curved, crescent-shaped graphic element.
Page 5 of 10
Reactivity with Sexually Active Adults (n = 300)
Focus (n = 150) and an external investigator (n = 150) assessed the device's reactivity with sera from sexually active adults. The sera were sequentially submitted to the laboratory, archived, and masked. The external investigator was a clinical laboratory located in Southern California, and the sera were collected in the Pacific Northwestern United States. The HerpeSelect Plexus results were compared to the HerpeSelect 1 ELISA IgG and the HerpeSelect 2 ELISA IgG, using the Focus HerpeSelect 1 and 2 Immunoblot IgG as the reference method.
HSV-1 Reactivity
The Focus HerpeSelect 1 Immunoblot IgG was: HSV-1 positive for 157 samples, HSV-1 negative with 142 samples, and HSV Common Antigen band positive for one sample.
The Plexus HerpeSelect 1 agreed with: 91.0% (142/156) of Immunoblot positives (one sample was not run on the Plexus device), and 96.5% (137/142) of Immunoblot negatives.
HSV-2 Reactivity The Focus HerpeSelect 2 Immunoblot IgG was: HSV-2 positive for 109 samples, HSV-2 negative with 190 samples, and HSV Common Antigen band positive for one sample.
The Plexus HerpeSelect 2 agreed with: 96.3% (105/109) of Immunoblot positives, and 97.4% (184/189) of Immunoblot negatives (one sample was not run on the Plexus device).
5
Image /page/5/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller, serif font underneath. A curved, black shape is positioned to the left of the word "FOCUS", creating a visual element that complements the text.
K062543 10(k) Summary of Safety and Effectiveness Plexus™HerpeSelect®1 and 2 IgG Catalog No. MP0900G Prepared January 29, 2007
Page 6 of 10
Plexus HerpeSelect 1 IgG Reactivity with Sexually Active Adults (n = 300)
| Lab | HerpeSelect
Immunoblot | n | Neg | Eqv | Pos | % Agreement | n | Neg | Eqv | Pos | % Agreement |
|---------------|---------------------------|-----|-----|-----|-----|-------------------------------------|-----|-----|-----|-----|-------------------------------------|
| Site 2 | Pos | 71 | 4 | 2 | 65 | 91.5% (65/71)
95%CI 82.5-96.8% | 71 | 3 | 0 | 68 | 95.8% (68/71)
95%CI 88.1-99.1% |
| Focus | Pos | 85* | 5 | 3 | 77 | 90.6% (77/85)
95%CI 82.3-95.9% | 86 | 4 | 2 | 80 | 93.0% (80/86)
95%CI 85.4-97.4% |
| Combined Labs | Pos | 156 | 9 | 5 | 142 | 91.0% (142/156)
95%CI 85.4-95.0% | 157 | 7 | 2 | 147 | 93.6% (147/157)
95%CI 88.6-96.9% |
| Site 2 | Neg | 79 | 78 | 1 | 0 | 98.7% (78/79)
95%CI 93.1-100% | 79 | 77 | 1 | 1 | 97.5% (77/79)
95%CI 91.2-99.7% |
| Focus | Neg | 63 | 59 | 2 | 2 | 93.7% (59/63)
95%CI 84.5-98.2% | 63 | 60 | 0 | 3 | 95.2% (60/63)
95%CI 86.7-99.0% |
| Combined Labs | Neg | 142 | 137 | 3 | 2 | 96.5% (137/142)
95%CI 92.0-98.9% | 142 | 137 | 1 | 4 | 96.5% (137/142)
95%CI 92.0-98.9% |
| Site 2 | Com | 0 | 0 | 0 | 0 | NA | 0 | 0 | 0 | 0 | NA |
| Focus | Com | 1 | 1 | 0 | 0 | NA | 1 | 1 | 0 | 0 | NA |
| Combined Labs | Com | 1 | 1 | 0 | 0 | NA | 1 | 1 | 0 | 0 | NA |
- One of 300 samples was not run in the Plexus HerpeSelect, and that one sample was HSV-1 negative/HSV-2 positive in the Immunoble.
Plexus HerpeSelect 2 IgG Reactivity with Sexually Active Adults (n = 300)
| Lab | HerpeSelect
Immunoblot | n | Neg | Eqv | Pos | % Agreement | n | Neg | Eqv | Pos | % Agreement |
|---------------|---------------------------|-----|-----|-----|-----|-------------------------------------|-----|-----|-----|-----|-------------------------------------|
| Site 2 | Pos | 47 | 3 | 1 | 43 | 91.5% (43/47)
95%CI 79.6-97.6% | 47 | 1 | 0 | 46 | 97.9% (46/47)
95%CI 88.7-99.9% |
| Focus | Pos | 62 | 0 | 0 | 62 | 100%(62/62)
95%CI 94.2-100% | 62 | 0 | 1 | 61 | 98.4%(61/62)
95%CI 91.3-100% |
| Combined Labs | Pos | 109 | 3 | 1 | 105 | 96.3% (105/109)
95%CI 90.9-99.0% | 109 | 1 | 1 | 107 | 98.2% (107/109)
95%CI 93.5-99.8% |
| Site 2 | Neg | 103 | 100 | 1 | 2 | 97.1% (100/103)
95%CI 91.7-99.4% | 103 | 102 | 0 | 1 | 99.0% (102/103)
95%CI 94.7-100% |
| Focus | Neg | 86* | 84 | 0 | 2 | 97.7% (84/86)
95%CI 91.8-99.7% | 87 | 84 | 1 | 2 | 96.6% (84/87)
95%CI 90.3-99.3% |
| Combined Labs | Neg | 189 | 184 | 1 | 4 | 97.4% (184/189)
95%CI 93.9-99.1% | 190 | 186 | 1 | 3 | 97.9% (186/190)
95%CI 94.7-99.4% |
| Site 2 | Com | 0 | 0 | 0 | 0 | NA | 0 | 0 | 0 | 0 | NA |
| Focus | Com | 1 | 1 | 0 | 0 | NA | 1 | 1 | 0 | 0 | NA |
| Combined Labs | Com | 1 | 1 | 0 | 0 | NA | 1 | 1 | 0 | 0 | NA |
*One of 300 samples was not run in the Plexus HerpeSelect, and that one sample was HSV-1 negative in the Immunoblot.
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Image /page/6/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in large, bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, crescent-shaped graphic is positioned to the left and above the word "FOCUS", adding a visual element to the logo. A horizontal line is placed above the word "Diagnostics".
Agreement with CDC Panel (n = 100)
The following information is from a serum panel obtained from the CDC and tested by Focus Diagnostics. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.
The test panel consists of 100 samples. This panel contains duplicate samples of 50 test sera. The duplicates serve to test for reproducibility, There are 16 HSV-1 positive, 11 double-positive and 16 double-negative sera resulting in 54 HSV-1 positive and 36 HSV-2 positive specimens.
Determination of positive and negative samples
Of the 54 HSV-1 positive samples, the HerpeSelect® Plexus IgG correctly identified 100% (54/54). Of the 36 HSV-2 positive samples, the HerpeSelect® Plexus IgG correctly identified 100% (36/36). Of the 22 double positive samples, the HerpeSelect® Plexus IgG correctly identified 100% (22/22). Of the 32 double negative samples, the HerpeSelect® Plexus IgG correctly identified 100% (32/32).
| Sample
Type | CDC Result | n | HerpeSelect-1 Plexus Results | HerpeSelect-2 Plexus Results | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
HSV1 | HSV2 | Neg | Eqv | Pos | % Agreement | Neg | Eqv | Pos | % Agreement | ||
HSV-1 | |||||||||||
Positive | Pos | Neg | 32 | 0 | 0 | 32 | 100% (32/32) | ||||
95%CI 89.1-100% | 32 | 0 | 0 | 100% (32/32) | |||||||
95%CI 89.1-100% | |||||||||||
HSV-2 | |||||||||||
Positive | Neg | Pos | 14 | 14 | 0 | 0 | 100% (14/14) | ||||
95%CI 76.8-100% | 0 | 0 | 14 | 100% (14/14) | |||||||
95%CI 76.8-100% | |||||||||||
Dual | |||||||||||
Positive | Pos | Pos | 22 | 0 | 0 | 22 | 100% (22/22) | ||||
95%CI 84.6-100% | 0 | 0 | 22 | 100% (22/22) | |||||||
95%CI 84.6-100% | |||||||||||
Dual | |||||||||||
Negative | Neg | Neg | 32 | 32 | 0 | 0 | 100% (32/32) | ||||
95%CI 89.1-100% | 32 | 0 | 0 | 100% (32/32) | |||||||
95%CI 89.1-100% |
Agreement with CDC Panel (n = 100)
CDC Panel Reproducibility
All paired sera were correctly identified: The Focus Diagnostics HerpeSelect® 1 and 2 Plexus IgG identified 16 out of 16 paired HSV-1 positive and HSV-2 negative (100%), 7 out of 7 paired HSV-1 negative (100%), 11 out of 11 paired double-positive (100%) and 16 out of 16 paired double-negative (100%) samples.
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Image /page/7/Picture/1 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 a crescent moon or a stylized checkmark to the left of the word. Below the word "FOCUS" is the word "Diagnostics" in a smaller, non-bold font, underlined by a thin line.
Plexus "HerpeSelect®1 and 2 IgG Catalog No. MP0900G Prepared January 29, 2007
Page 8 of 10
Reactivity with a Low Prevalence Population (n = 77)
Focus (n = 77) assessed the device's reactivity with sera from a low prevalence population. Focus selected sera from patients aged 18 and 19 years, and that had been submitted to a clinical laboratory in Southern California from states having a history of low sexually transmitted disease prevalence. Focus excluded sera that were submitted diseases, herpesvirus testing, and tests indicating the patient may be immunocompromised. The sera were sequentially selected, archived and masked. The HereSelect Plexus results were compared to the Focus HerpeSelect 1 and 2 Immunoblot IgG.
HSV-1 Reactivity
The Focus HerpeSelect 1 Immunoblot IgG was: HSV-1 positive for 28 samples, HSV-1 negative with 47 samples, and HSV Common Antigen band positive for two samples.
The Plexus HerpeSelect 1 agreed with: 96.4% (27/28) of Immunoblot positives (one HSV-1 Immunoblot positive was equivocal in the Plexus device), and 97.9% (46/47) of Immunoblot negatives (one HSV-1 Immunoblot negative was positive in the Plexus device).
One Immunoblot HSV Common Antigen band positive was equivocal in the other sample was Plexus negative.
HSV-2 Reactivity
The Focus HerpeSclect 2 Immunoblot IgG was: HSV-2 positive for four samples, HSV-2 negative with 71 samples, and HSV Common Antigen band positive for two samples.
The Plexus HerpeSelect 2 agreed with: 75.0% (3/4) of Immunoblot positives (one HSV-1 Immunoblot positive was equivocal in the Plexus device), and 100% (71/71) of Immunoblot negatives (one HSV-1 Immunoblot negative in the Plexus device). Both Immunoblot HSV Common Antigen band positives were negative in the Plexus.
| HerpeSelect
Immunoblot | n | Plexus HerpeSelect-1 | % Agreement | Plexus HerpeSelect-2 | % Agreement | |||||
---|---|---|---|---|---|---|---|---|---|---|
Neg | Eqv | Pos | Neg | Eqv | Pos | |||||
Pos | 28 | 0 | 1 | 27 | 96.4% (27/28) | |||||
95%CI 81.6-99.9% | 0 | 1 | 3 | 75.0% (3/4) | ||||||
95%CI 19.4-99.4% | ||||||||||
Neg | 47 | 46 | 0 | 1 | 97.9% (46/47) | |||||
95%CI 88.7-99.9% | 71 | 0 | 0 | 100% (71/71) | ||||||
95%CI 94.9-100% | ||||||||||
Com | 2 | 1 | 1 | 0 | NA | 2 | 0 | 0 | NA |
Reactivity with Low Prevalence Population (n = 77)
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Image /page/8/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of a stylized black swoosh shape on the left, followed by the word "FOCUS" in bold, sans-serif font. Below "FOCUS" is a horizontal line, and below that line is the word "Diagnostics" in a smaller, sans-serif font.
Cross-reactivity (n = 51)
Focus assessed cross-reactivity with two groups of samples: a "HSV ELISA dual negative" group (n=37), and a "HSV ELISA mixed sero-reactivity" group (n=14).
The HSV ELISA dual negative group (n=37) included samples that were sero-negative with both the HerpeSelect-1 ELISA IgG and HerpeSelect 2 ELISA IgG, and were sero-positive by at least one of
a FDA cleared CMV ELISA IgG (n = 18),
a home brerw VZV ACIF (n=32),
a FDA cleared EBV VCA IgG (n=31).
The Plexus HerpeSelect®1 and 2 IgG was HSV-1 negative with all but one of the HSV ELISA dual negatives, and equivocal with one sample (the one sample was CMV+ VZV+ and EBV+).
The Plexus HerpeSelect®1 and 2 IgG was HSV-2 negative with all but one of the HSV ELISA dual negatives, and equivocal with one sample (the one sample was CMV- VZV+ and EBV+).
The HSV ELISA mixed reactivity group (n=14) included samples that were sero-positive with either the HerpeSelect-1 ELISA IgG or HerpeSelect 2 ELISA IgG, and were sero-positive by at least one of
a FDA cleared CMV ELISA IgG (HSV-1 neg n = 2, HSV-2 neg n = 9),
a home brew VZV ACIF (HSV-1 neg n = 1, HSV-2 neg n = 2),
a FDA cleared EBV VCA IgG (HSV-1 neg n = 1, HSV-2 neg n = 0).
The Plexus HerpeSelect®1 and 2 IgG was HSV-1 negative with all of the HSV-1 ELISA negatives in the mixed reactivity group.
The Plexus HerpeSelect®1 and 2 1gG was HSV-2 negative with all of the HSV-2 ELISA negatives in the mixed reactivity group.
| Cross-reactant | HSV
ELISAs | n | HerpeSelect-1 Plexus | | | | n | HerpeSelect-2 Plexus | | | |
|----------------|---------------|----|----------------------|------|-----|--------------------------------|----|----------------------|------|-----|--------------------------------|
| | | | Neg | Eqv* | Pos | %Pos | | Neg | Eqv† | Pos | %Pos |
| CMV IgG + | Dual Neg | 18 | 17 | 1 | 0 | 5.6% (1/18)
95%CI 0.1-27.3% | 18 | 18 | 0 | 0 | 0.0% (0/18)
95%CI 0.0-18.5% |
| | +/- or -/+ | 2 | 2 | 0 | 0 | 0.0% (0/2)
95%CI 0.0-84.2% | 9 | 9 | 0 | 0 | 0.0% (0/9)
95%CI 0.0-33.6% |
| | Total | 20 | 19 | 1 | 0 | 5.0% (1/20)
95%CI 0.1-24.9% | 27 | 27 | 0 | 0 | 0.0% (0/27)
95%CI 0.0-12.8% |
| VZV IgG + | Dual Neg | 32 | 31 | 1 | 0 | 3.1% (1/32)
95%CI 0.1-16.2% | 32 | 31 | 1 | 0 | 3.1% (1/32)
95%CI 0.1-16.2% |
| | +/- or -/+ | 1 | 1 | 0 | 0 | 0.0% (0/1)
na | 2 | 2 | 0 | 0 | 0.0% (0/2)
95%CI 0.0-84.2% |
| | Total | 33 | 32 | 1 | 0 | 3.0% (1/33)
95%CI 0.1-15.8% | 34 | 33 | 1 | 0 | 2.9% (1/34)
95%CI 0.1-15.3% |
| EBV IgG + | Dual Neg | 31 | 30 | 1 | 0 | 3.2% (1/31)
95%CI 0.1-16.7% | 31 | 30 | 1 | 0 | 3.2% (1/31)
95%CI 0.1-16.7% |
| | +/- or -/+ | 1 | 1 | 0 | 0 | 0.0% (0/1)
na | 0 | 0 | 0 | 0 | na |
| | Total | 32 | 31 | 1 | 0 | 3.1% (1/32)
95%CI 0.1-16.2% | 31 | 30 | 1 | 0 | 3.2% (1/31)
95%CI 0.1-16.7% |
Cross-reactivity (n = 51)
-
The HerpeSelect-1 Plexus was equivocal with one sample was IgG positive for CMV, VZV and EBV,
-
The HerpeSelect -2 Plexus was equivocal with one sample was IgG positive for VZV and EBV.
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Image /page/9/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in a bold, sans-serif font, with the word "Diagnostics" in a smaller font underneath. A curved, black shape is to the left of the word "FOCUS", which appears to be a stylized eye or lens.
510(k) Summary of Safety and Effectiveness
Plexus THerpeSelect®1 and 2 IgG Catalog No. MP0900G
Prepared January 29, 2007
Page 10 of 10
Inter-laboratory Reproducibility and Inter/Intra-assay Reproducibility
Focus, a clinical laboratory located in Southern California, and a university located in Northern California assessed the device's inter-laboratory reproducibility and interlintra-assay reproducibility. Each of the three laboratories tested eleven samples in triplicate on five different days.
Inter-laboratory Reproducibility and Inter/Intra-assay Reproducibilitya | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
HerpeSelect 1 Plexus IgG Results | HerpeSelect 2 Plexus IgG Results | |||||||||
Intra- and Inter-assay | Inter-Lab | Intra- and Inter-assay | Inter-Lab | |||||||
Sample | Mean Index | Intra-assay % CV | Inter-assay % CV | Mean Index | % CV | Mean Index | Intra-assay % CV | Inter-assay % CV | Mean Index | % CV |
9 | 4.93 | 3.6 | 10.3 | 4.94 | 3.7 | 3.88 | 3.4 | 10.0 | 3.87 | 2.5 |
6 | 4.24 | 3.8 | 8.7 | 4.22 | 3.3 | 4.90 | 2.6 | 8.5 | 4.89 | 2.1 |
2 | 3.87 | 4.8 | 7.9 | 3.86 | 1.3 | 3.36 | 4.3 | 7.7 | 3.35 | 2.0 |
8 | 3.27 | 4.9 | 9.1 | 3.25 | 3.0 | 4.56 | 3.1 | 8.3 | 4.55 | 1.5 |
4 | 3.24 | 4.9 | 7.4 | 3.22 | 2.1 | 2.55 | 4.5 | 8.9 | 2.54 | 5.8 |
1 | 3.04 | 4.3 | 8.9 | 3.02 | 2.3 | 2.71 | 3.8 | 9.3 | 2.70 | 2.1 |
12b | 2.13 | 7.9 | 8.7 | 2.13 | 4.1 | 1.87 | 7.2 | 8.8 | 1.87 | 3.4 |
3 | 0.34 | 9.1 | 14.9 | 0.34 | 6.8 | 0.06 | 8.7 | 28.3 | 0.06 | 22.6 |
10c | 0.19 | 9.9 | 213.1 | 0.19 | 59.0 | 0.12 | 11.4 | 334.2 | 0.40 | 103.8 |
10d | 0.13 | 10.0 | 15.8 | 0.12 | 1.9 | 0.06 | 11.5 | 41.7 | 0.06 | 38.3 |
7 | 0.18 | 8.3 | 16.3 | 0.17 | 9.4 | 0.06 | 8.1 | 23.7 | 0.06 | 17.3 |
5 | 0.14 | 9.0 | 16.0 | 0.14 | 2.7 | 0.06 | 8.3 | 39.8 | 0.06 | 38.1 |
d Inter/Intro ossov Reproducibility"
a. Excludes two runs at one site that were invalide Control index was beyond the acceptable QC criteria (it appears that the Positive Control was run in those wells since the indices were about 1.9 for both gG1 and gG2)
b. Samples 12 (inter-lab reproducibility) and 14 (inter-lot reporters, but they were made with the same sera Samples 11 did not have sufficient volume to be sent to investigators.
c. This includes all cata for Sample 10, including one run at Lab 2, where it appears that Sample 1 may have been run instead since the indices were about 2.7 for both gG1 and gG2.
d. This line includes all dual for Sample 10, except for one run at Lab 2, where it appears that Sample 1 may have the indices were about 2.7 for both gG1 and gG2.
Inter-Lot Reproducibility
Focus assessed the device's Inter-lot Reproducibility by testing eleven samples with three separate lots. The samples were run in triplicate. Each lot had a different set of gG-1 and gG2 beads, a different lot of conjugate (made from 2 different stock conjugates), and a different lot of calibrator (made from 2 different combinations of positive and negative sera). The results of the studies are summarized in the tables below:
Inter-lot Reproducibility | ||||
---|---|---|---|---|
Sample | HSV-1 | HSV-2 | ||
Mean Index | Inter-Lot %CV | Mean Index | Inter-Lot %CV | |
9 | 5.20 | 7.4 | 3.90 | 12.8 |
6 | 4.36 | 8.5 | 4.76 | 9.2 |
2 | 3.60 | 7.3 | 3.19 | 9.3 |
4 | 3.29 | 7.9 | 2.54 | 6.4 |
8 | 3.23 | 11.3 | 4.45 | 9.4 |
1 | 3.14 | 5.8 | 2.73 | 4.8 |
12/14* | 2.22 | 10.5 | 1.86 | 7.8 |
3 | 0.31 | 17.0 | 0.11 | 50.9 |
7 | 0.15 | 31.3 | 0.08 | 21.8 |
5 | 0.10 | 45.6 | 0.06 | 24.9 |
10 | 0.09 | 50.6 | 0.06 | 26.9 |
- Sumples 12 (inter-lab reproducibility) were separate sumples, but they were made with the same ser. Samples 11 and 13 did not have sufficient volume to be sent to investigators.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image shows a logo with a stylized bird figure on the right and text on the left. The bird figure is composed of three curved lines that suggest wings and a head. The text on the left is arranged in a circular fashion, following the curve of the logo. The logo appears to be a symbol of a government or public health organization.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Michael J. Wagner, Esq. Regulatory Counsel Focus Diagnostics, Inc. 10703 Progress Way Cypress, CA 90630
FEB - 1 2007
Re: K062543
Trade/Device Name: HerpeSelect 1 and 2 Plexus IgG Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological reagents Regulatory Class: Class II Product Code: MXJ. MYF Dated: January 15, 2007 Received: January 17, 2007
Dear Mr. Wagner:
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 indicetions 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, Ilsting 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),
11
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally, axtom
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
12
510(k) Number (if known): K062543
Device Name:
Plexus™HerpeSelect®1 and 2 IgG
Focus Diagnostics' Plexus "HerpeSelect®1 and 2 IgG is intended Indications for Use: for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV-1 and HSV-2 infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2 infection. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Nallard
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
Page 1 of 1
510(k) K062543