(112 days)
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.
Rapid Lateral Flow assay for the qualitative detection of human IgG class antibodies to HSV-2
Here's a breakdown of the acceptance criteria and study information for the HerpeSelect Express IgG device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the performance characteristics presented in comparison to the predicate device (HerpeSelect 1 and 2 Immunoblot IgG). The document does not explicitly state a pre-defined numerical "acceptance criteria" for sensitivity and specificity. Instead, it presents the device's performance, indicating that these achieved results were deemed acceptable for market clearance.
| Study Population & Sample Type | Criteria | Acceptance Criteria (Implied) | Reported Device Performance (HerpeSelect Express vs. Immunoblot) |
|---|---|---|---|
| Pregnant Women | |||
| Sera | Specificity | Not explicitly stated | 92.3% (108/117) |
| Sensitivity | Not explicitly stated | 96.1% (271/282) | |
| Venous Whole Blood | Specificity | Not explicitly stated | 93.2% (109/117) |
| Sensitivity | Not explicitly stated | 97.2% (274/282) | |
| Capillary Whole Blood | Specificity | Not explicitly stated | 94.9% (111/117) |
| Sensitivity | Not explicitly stated | 95.4% (269/282) | |
| Sexually Active Adults | |||
| Sera | Specificity | Not explicitly stated | 92.9% (210/226) |
| Sensitivity | Not explicitly stated | 91.8% (315/343) | |
| Venous Whole Blood | Specificity | Not explicitly stated | 93.4% (211/226) |
| Sensitivity | Not explicitly stated | 92.4% (317/343) | |
| Capillary Whole Blood | Specificity | Not explicitly stated | 93.8% (212/226) |
| Sensitivity | Not explicitly stated | 91.8% (315/343) | |
| Non-Sexually Active Adults (Low Prevalence) | |||
| Sera | Specificity | Not explicitly stated | 0% (0/2) * (This low sensitivity for positives with few samples is noted to indicate low prevalence)* |
| Sensitivity | Not explicitly stated | 100% (101/101) | |
| Venous Whole Blood | Specificity | Not explicitly stated | 0% (0/2) |
| Sensitivity | Not explicitly stated | 100% (101/101) | |
| Capillary Whole Blood | Specificity | Not explicitly stated | 0% (0/2) |
| Sensitivity | Not explicitly stated | 100% (101/101) | |
| CDC HSV/CMV Panel | |||
| Specificity | Not explicitly stated | 100% (35/35) | |
| Sensitivity | Not explicitly stated | 98.5% (64/65) | |
| Cross-reactivity | Overall Cross-reactivity | Not explicitly stated | 4.2% (9/213) |
| Inter-Lot Reproducibility | %CV | Not explicitly stated | <10% (for mean) |
| Inter-Operator & Inter-Site Reproducibility | %CV range | Not explicitly stated | <65.0% (for precision, one sample) |
| Intra-Operator Reproducibility | %CV | Not explicitly stated | <35.1% (for precision, one operator) |
| Intra-Site Reproducibility | %CV of positives | Not explicitly stated | <23.0% (for precision, one site) |
| Interference | No effect on sample results | No effect on sample results | No interference observed |
2. Sample Sizes Used for the Test Set and Data Provenance
- Pregnant Women: 401 samples (n=161 from Southeastern US, n=120 from Mid-Atlantic US, n=120 from Mid-Atlantic US). Prospective.
- Sexually Active Adults: 575 samples (n=195 from Southeastern US, n=190 from Rocky Mountain Region US, n=190 from Southeastern US). Prospective.
- Non-Sexually Active Adults (Low Prevalence): 104 samples (n=46 from Southeastern US, n=58 from Pacific Northwest US). Prospective.
- CDC HSV/CMV Panel: 100 samples (65 HSV-2 negative, 35 HSV-2 positive). Provenance is CDC (likely mixed origin, characterized serum panel).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the primary studies (Pregnant Women, Sexually Active Adults, Non-Sexually Active Adults) was established by the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG. This is a reference method/predicate device, not a panel of human experts. Therefore, the number and qualifications of experts are not applicable for establishing the ground truth directly for these studies as it refers to a laboratory assay.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth was based on a reference laboratory assay (Immunoblot) and not on expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on the performance of the device against a reference method and not on human reader performance with or without AI assistance. The "Inter-Operator & Inter-Site Reproducibility" section mentions different sites and operators, but this evaluates the device's consistency under various conditions, not the comparative effectiveness of human readers using the device versus not using it.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are for the standalone performance of the HerpeSelect Express IgG device. It is a rapid diagnostic test, and its performance (sensitivity and specificity) is reported independently against a reference method.
7. The Type of Ground Truth Used
The primary ground truth used for the sensitivity and specificity analysis was the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG, which is a reference laboratory method/predicate device. Additionally, agreement with the HerpeSelect 2 ELISA IgG (another cleared predicate device) was evaluated. For the CDC panel, the ground truth was a characterized serum panel from the CDC.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. The HerpeSelect Express IgG is an immunochromatographic test, meaning it's a biochemical assay, not an algorithm that requires a training set in the typical sense of AI/ML. The samples mentioned were for performance evaluation (test sets).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as the device is not an AI/ML algorithm requiring a training set with established ground truth in that manner.
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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 WayCypress, California 90630USA |
|---|---|
| Establishment Registration No. | 2023365 SEP 24 2007 |
| Contact Person | Constance Bridgestel 714.220.1900fax 714.995.6921cbridges@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 IgGHerpeSelect-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.
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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 ExpressIn Sera | HerpeSelect ExpressIn Venous Whole Blood | HerpeSelect ExpressIn Capillary Whole Blood | HerpeSelectImmunoblot |
| 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 ActiveAdults | (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 andSensitivity withHerpeSelectImmunoblot |
|---|---|---|
| Pregnant Women (Indicated population) in Serum | SpecificitySensitivity | 92.3% (108/117)96.1% (271/282) |
| Pregnant Women (Indicated population) in Venous Whole Blood | SpecificitySensitivity | 93.2% (109/117)97.2% (274/282) |
| Pregnant Women (Indicated population) in Capillary Whole Blood | SpecificitySensitivity | 94.9% (111/117)95.4% (269/282) |
| Sexually Active Adults (Indicated population) in Serum | SpecificitySensitivity | 92.9% (210/226)91.8% (315/343) |
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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 andSensitivity withHerpeSelectImmunoblot | |
|---|---|---|---|
| Sexually Active Adults (Indicated population) in Venous WholeBlood | SpecificitySensitivity | 93.4% (211/226)92.4% (317/343) | |
| Sexually Active Adults (Indicated population) in Capillary WholeBlood | SpecificitySensitivity | 93.4% (211/226)92.4% (317/343) | |
| Non-Sexually Active Adults (Low Prevalence Population) in Serum | SpecificitySensitivity | 0% (0/2)100% (101/101) | |
| Non-Sexually Active Adults (Low Prevalence Population) in VenousWhole Blood | SpecificitySensitivity | 0% (0/2)100% (101/101) | |
| Non-Sexually Active Adults (Low Prevalence Population) inCapillary Whole Blood | SpecificitySensitivity | 0% (0/2)100% (101/101) | |
| CDC HSV/CMV Panel | SpecificitySensitivity | 100% (35/35)98.5% (64/65) | |
| Cross-reactivity: | Overall Cross-reactivity | 4.2% (9/213) | |
| Inter-Lot Reproducibility | %CV | <10% | |
| Inter-Operator & Inter-Site Reproducibility | % CV range | < 65.0% | |
| Intra-Operator Reproducibility | % CV | < 35.1% | |
| Intra-Site Reproducibility | % CV of positives | < 23.0% | |
| Interference | No effect on sample results |
Sensitivity and Specificity with Pregnant Women (n = 401)
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. 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. 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. The Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG was the typing reference method for calculation of sensitivity and specificity.
Pregnant Women in Sera
The HerpeSelect Express showed 96.1% (271/282) agreement with Immunoblot negatives, and 92.3% (108/117) agreement with Immunoblot positives. Two samples were not tested in Immunoblot.
Of the 401 sera, the HerpeSelect Immunoblot IgG was negative with 117. Two samples were not tested in Immunoblot; one due to insufficient quantities and the other due to improper storage.
Of the 282 negative HerpeSelect Immunoblot sera, Express was negative with 96.1% (271/282), positive with 9, and invalid with 2.
Of the 117 positive HerpeSelect Immunoblot sera, Express was negative with 92.3% (108/17), and invalid with 3.
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Image /page/3/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with a curved, black shape resembling a crescent or a stylized checkmark to the left of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin, horizontal 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 4 of 13
| Immunoblot | n1 | Express | Specificity | Sensitivity | ||
|---|---|---|---|---|---|---|
| Positive | 117 | 108 | 6 | 3 | 92.3% (108/117)95%CI 85.9-96.4% | N/A |
| Negative | 282 | 9 | 271 | 2 | N/A | 96.1% (271/282)95%CI 93.1-98.0% |
| Equivocal | 0 | 0 | 0 | 0 | N/A | N/A |
unoblot with Pregnant Women in Sera (n = 401)
Two samples were not tested.
Pregnant Women in Venous Whole Blood
The HerpeSelect Express showed 97.2% (274/282) agreement with Immunoblot negatives, and 93.2% (109/117) agreement with Immunoblot positives.
Of the 401 samples, the HerpeSelect Immunoblot IgG was negative with 282 and positive with 117. Two samples were not tested; one due to insufficient quantity and one due to improper storage.
Of the 282 negative HerpeSelect Immunoblot samples, Express was negative with 97.2% (274/282), positive with 8, and invalid with 0.
Of the 117 positive HerpeSelect Immunoblot samples, Express was negative with 93.2% (109/117), and invalid with 0.
HerpeSelect Express compared to Immunoblot with Pregnant Women in Venous Whole Blood (n = 401)
| Immunoblot | n1 | Express | Specificity | Sensitivity | ||
|---|---|---|---|---|---|---|
| Positive | 117 | 109 | 8 | 0 | 93.2% (109/117)95%CI 87.0-97.0% | N/A |
| Negative | 282 | 8 | 274 | 0 | N/A | 97.2% (274/282)95%CI 94.5-98.8% |
| Equivocal | 0 | 0 | 0 | 0 | N/A | N/A |
Two samples were not tested.
Pregnant Women in Capillary Whole Blood
The HerpeSelect Express showed 95.4% (269/282) agreement with Immunoblot negatives, and 94.9% (11/117) agreement with Immunoblot positives.
Of the 401 samples, the HerpeSelect Immunoblot IgG was negative with 282 and positive with 117. Two samples were not tested in Immunoblot due to insufficient quantities.
Of the 282 negative HerpeSelect Immunoblot samples, Express was negative with 95.4% (269/282), positive with 12, and invalid with 1.
Of the 117 positive HerpeSelect Immunoblot samples, Express was negative with 94.9% (11/117), and invalid with 0.
HerpeSelect Express compared to Immunoblot with Pregnant Women in Capillary Whole Blood (n = 401)
| Immunoblot | n1 | Express | Specificity | Sensitivity | ||
|---|---|---|---|---|---|---|
| Positive | Negative | Invalid | ||||
| Positive | 117 | 111 | 6 | 0 | 94.9% (111/117)95%CI 89.2-98.1% | N/A |
| Negative | 282 | 12 | 269 | 1 | N/A | 95.4% (269/282)95%CI 92.2-97.5% |
| Equivocal | 0 | 0 | 0 | 0 | N/A | N/A |
Two samples were not tested.
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Image /page/4/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 and centered. A curved, crescent-shaped graphic is positioned to the left of the word "FOCUS", visually emphasizing the brand name.
510(k) Summary of Safety and Effectiveness HerpeSelect 1 and 2 Plexus IgG Catalog No. RT0920G Prepared Mav 31, 2007 Revised September 21, 2007 Page 5 of 13
HerpeSelect Express Percent Negative and Positive Agreement with HerpeSelect 2 (ELISA) in Pregnant Women (n = 401)
The gold-standard reference method was the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG for calculation of sensitivity and specificity. The device was also evaluated with the HerpeSelect2 ELISA IgG a cleared predicate device which is not required for regulatory clearance for typing assay.
HerpeSelect Express Agreement with ELISA in Sera with Pregnant Women
The HerpeSelect Express showed 96.7% (267/276) agreement with ELISA negatives in sera, and 91.7% (11/121). agreement with ELISA positives. Two ELISA equivocals were excluded. One sample was not tested due to improper storage.
Of the 401 sera, the HerpeSelect 2 ELISA IgG was negative with 121, and equivocal with 2. One sample was not tested due to improper storage.
Of the 276 negative HerpeSelect 2 ELISA sera, Express was negative with 96.7% (267/276), positive with 7, and invalid with 2.
Of the 121 positive HerpeSelect 2 ELISA sera, the Express was negative with 91.7% (11/121), and invalid with 3.
Express Agreement with ELISA in Sera with Pregnant Women (n = 401)
| ELISA | n1 | HerpeSelect Express | % Agreement | ||
|---|---|---|---|---|---|
| Positive | Negative | Invalid | |||
| Positive | 121 | 111 | 7 | 3 | 91.7% (111/121)95%CI 85.3-96.0% |
| Negative | 276 | 7 | 267 | 2 | 96.7% (267/276)95%CI 93.9-98.5% |
| Equivocal | 2 | 0 | 2 | 0 | N/A |
One sample was not tested in ELISA.
HerpeSelect Express Agreement with ELISA in Venous Whole Blood with Pregnant Women
The HerpeSelect Express showed 97.8% (271/277) agreement with ELISA negatives in samples, and 92.6% (112/121) agreement with ELISA positives. Two ELISA equivocals were excluded and one sample was not tested due to improper storage.
Of the 401 samples, the HerpeSelect 2 ELISA IgG was negative with 121, and equivocal with 3. One sample was not tested due to improper storage.
Of the 277 negative HerpeSelect 2 ELISA samples, Express was negative with 97.8% (271/277), positive with 6. and invalid with 0.
Of the 121 positive HerpeSelect 2 ELISA samples, the Express was negative with 92.6% (112/121), and invalid with 0.
Express Agreement with ELISA in Venous Whole Blood with Pregnant Women (n = 401)
| ELISA | n1 | HerpeSelect Express | % Agreement | ||
|---|---|---|---|---|---|
| Positive | Negative | Invalid | |||
| Positive | 121 | 112 | 9 | 0 | 92.6% (112/121)95%CI 86.4-96.5% |
| Negative | 277 | 6 | 271 | 0 | 97.8% (271/277)95%CI 95.3-99.2% |
| Equivocal | 3 | 0 | 3 | 0 | N/A |
One sample was not tested in ELISA
HerpeSelect Express Agreement with ELISA in Capillary Whole Blood with Pregnant Women
The HerpeSelect Express showed 96.4% (266/276) agreement with ELISA negatives in samples, and 94.2% (114/121), agreement with ELISA positives. Two ELISA equivocals were excluded.
Of the 401 samples, the HerpeSelect 2 ELISA IgG was negative with 121, and equivocal with 3. One sample was not tested due to improper storage.
Of the 121 positive HerpeSelect 2 ELISA samples, the Express was negative with 94.2% (114/121), and invalid with 0.
Of the 276 negative HerpeSelect 2 ELISA samples, Express was negative with 96.4% (266/276), positive with 9, and invalid with 1.
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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, non-bold font underneath. To the left of the word "FOCUS" is a curved, black shape that resembles a crescent or a stylized checkmark.
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 6 of 13
| Express Agreement with ELISA in Capillary Whole Blood with Pregnant Women (n = 401) | |||||
|---|---|---|---|---|---|
| ELISA | n1 | HerpeSelect ExpressPositive | Negative | Invalid | % Agreement |
| Positive | 121 | 114 | 7 | 0 | 94.2% (114/121)95%CI 88.4-97.6% |
| Negative | 276 | 9 | 266 | 1 | 96.4% (266/276)95%CI 93.4-98.3% |
| Equivocal | 3 | 1 | 2 | 0 | N/A |
' One sample was not tested in ELISA
Sensitivity and Specificity with Sexually Active Adults (n = 575)
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. 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. 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. The Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG was the typing reference method for calculation of sensitivity and specificity.
Sexually Active Adults in Sera
The HerpeSelect Express showed 91.8% (315/343) agreement with Immunoblot negatives, and 92.9% (210/226) agreement with Immunoblot positives.
Of the 575 sera, the HerpeSelect Immunoblot IgG was negative with 226, and equivocal with 1. Five samples were not tested in Immunoblot. Two samples were lost between the Investigator and the Focus Laboratory, and three were not tested due to insufficient quantities.
Of the 343 negative HerpeSelect Immunoblot sera, Express was negative with 91.8% (315/343), positive with 28, and invalid with 0.
Of the 226 positive HerpeSelect Immunoblot sera, Express was negative with 14, positive with 92.9% (210/226), and invalid with 2.
| Immunoblot | n' | Express | Specificity | Sensitivity | ||
|---|---|---|---|---|---|---|
| Positive | 226 | 210 | 14 | 2 | 92.9% (210/226)95% CI 88.8-95.9% | N/A |
| Negative | 343 | 28 | 315 | 0 | N/A | 91.8% (315/343)95% CI 88.4-94.5% |
| Equivocal | 1 | 0 | 1 | 0 | N/A | N/A |
HerpeSelect Express compared to Immunoblot with Sexually Active Adult in Sera (n = 575)
Five samples were not tested.
Sexually Active Adults in Venous Whole Blood
The HerpeSelect Express showed 92.4% (317/343) agreement with Immunoblot negatives, and 93.4% (211/226) agreement with Immunoblot positives.
Of the 575 samples, the HerpeSelect Immunoblot IgG was negative with 343 and positive with 226. Five samples were not tested in Immunoblot. Two samples were lost between the Investigator and the Focus Laboratory, and three were not tested due to insufficient quantities.
Of the 343 negative HerpeSelect Immunoblot samples, Express was negative with 92.4% (317/343), positive with 26, and invalid with 0.
Of the 226 positive HerpeSelect Immunoblot samples, Express was negative with 15, positive with 93,4% (211/226), and invalid with 0.
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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. To the left of the word "FOCUS" is a curved, crescent-shaped graphic element that appears to be embracing the word.
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 7 of 13
HerpeSelect Express compared to Immunoblot with Sexually Active Adult in Venous Whole Blood (n = 575)
| Immunoblot | n' | Express | Specificity | Sensitivity | ||
|---|---|---|---|---|---|---|
| Positive | 226 | 211 | 15 | 0 | 93.4% (211/226)95% CI 89.3-96.2% | N/A |
| Negative | 343 | 26 | 317 | 0 | N/A | 92.4% (317/343)95% CI 89.1-95.0% |
| Equivocal | 1 | 0 | 1 | 0 | N/A | N/A |
Five samples were not tested.
Sexually Active Adults in Capillary Whole Blood
The HerpeSelect Express showed 91.8% (315/343) agreement with ELISA negatives, and 93.8% (212/226) agreement with Immunoblot positives.
Of the 575 samples, the HerpeSelect Immunoblot IgG was negative with 343 and positive with 226. Five samples were not tested in Immunoblot. Two samples were lost between the Investigator and the Focus Laboratory, and three were not tested due to insufficient quantities
Of the 343 negative HerpeSelect Immunoblot samples, Express was negative with 91.8% (315/343), positive with 28, and invalid with 0.
Of the 226 positive HerpeSelect Immunoblot samples, Express was negative with 14, positive with 93.8% (212/226), and invalid with 0.
| HerpeSelect Express compared to Immunoblot with Sexually Active Adult in Capillary Whole Blood |
|---|
| ------------------------------------------------------------------------------------------------ |
| Immunoblot | n1 | Express | Specificity | Sensitivity | ||
|---|---|---|---|---|---|---|
| Positive | 226 | 212 | 14 | 0 | 93.8% (212/226)95% CI 89.8-96.6% | N/A |
| Negative | 343 | 28 | 315 | 0 | N/A | 91.8% (315/343)95% CI 88.4-94.5% |
| Equivocal | 1 | 0 | 1 | 0 | N/A | N/A |
Five samples were not tested.
HerpeSelect Express Percent Agreement with HerpeSelect 2 (ELISA) in Sexually Active Adults (n = 575)
The gold-standard reference method was the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG for calculation of sensitivity and specificity. The device was also evaluated with the HerpeSelect2 ELISA IgG a cleared predicate device which is not required for regulatory clearance for typing assay.
HerpeSelect Express Agreement with ELISA in Sera with Sexually Active Adults
The HerpeSelect Express showed 98.8% (323/327) agreement with ELISA negatives in sera, and 97.1% (236/243) agreement with ELISA positives. Three ELISA equivocals were excluded.
Of the 575 sera, the HerpeSelect 2 ELISA IgG was negative with 243, and equivocal with 3. Two samples were not tested in ELISA. The samples were lost between the Investigator and the Focus Laboratory.
Of the 327 negative HerpeSelect 2 ELISA sera, Express was negative with 98.8% (323/327), positive with 4, and invalid with 0.
Of the 243 positive HerpeSelect 2 ELISA sera, the Express was negative with 97.1% (236/243), and invalid with 2.
Express Agreement with ELISA in Sera with Sexually Active Patients (n = 575)
| ELISA | n1 | HerpeSelect Express | % Agreement | ||
|---|---|---|---|---|---|
| Positive | Negative | Invalid | |||
| Positive | 243 | 236 | 5 | 2 | 97.1% (236/243)95% CI 94.1-98.8% |
| Negative | 327 | 4 | 323 | 0 | 98.8% (323/327)95% CI 96.9-99.7% |
| Equivocal | 3 | 1 | 2 | 0 | N/A |
Two samples were not tested in ELISA
{7}------------------------------------------------
Image /page/7/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 underneath. A curved, crescent-shaped graphic is positioned to the left of the word "FOCUS", adding a visual element to the logo.
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 8 of 13
HerpeSelect Express Agreement with ELISA in Venous Whole Blood with Sexually Active Adults
The HerpeSelect Express showed 98.8% (322/327) agreement with ELISA negatives in samples, and 97.1% (236/243), agreement with ELISA positives. Three ELISA equivocals were excluded.
Of the 575 samples, the HerpeSelect 2 ELISA IgG was negative with 243, and equivocal with 3. Two samples were not tested in ELISA. The samples were lost between the Investigator and the Focus Laboratory. Of the 327 negative HerpeSelect 2 ELISA samples, Express was negative with 98.8% (323/327), positive with 4,
and invalid with 0.
Of the 243 positive HerpeSelect 2 ELISA samples, the Express was negative with 7, positive with 97.1% (236/243), and invalid with 0.
Express Agreement with ELISA in Venous Whole Blood with Sexually Active Patients (n = 575)
| ELISA | n¹ | HerpeSelect Express | |||
|---|---|---|---|---|---|
| Positive | Negative | Invalid | % Agreement | ||
| Positive | 243 | 236 | 7 | 0 | 97.1% (236/243)95%CI 94.1-98.8% |
| Negative | 327 | 4 | 323 | 0 | 98.8% (323/327)95% CI 96.9-99.7% |
| Equivocal | 3 | 0 | 3 | 0 | N/A |
Two samples were not tested in ELISA
Express in Capillary Whole Blood Agreement with ELISA
The HerpeSelect Express showed 98.5% (322/327) agreement with ELISA negatives in samples, and 97.5% (237/243) agreement with ELISA positives. Three ELISA equivocals were excluded.
Of the 575 samples, the HerpeSelect 2 ELISA IgG was negative with 243, and equivocal with 3. Two samples were not tested in ELISA. The samples were lost between the Investigator and the Focus Labratory, Of the 327 negative HerpeSelect 2 ELISA samples, Express was negative with 98.5% (322/327), positive with 5, and invalid with 0.
Of the 243 positive HerpeSelect 2 ELISA samples, the Express was negative with 6, positive with 97.5% (237/243). and invalid with 0.
Express Agreement with ELISA in Capillary Whole Blood with Sexually Active Patients (n = 575)
| ELISA | n1 | HerpeSelect Express | |||
|---|---|---|---|---|---|
| Positive | Negative | Invalid | % Agreement | ||
| Positive | 243 | 237 | 6 | 0 | 97.5% (237/243)95% CI 94.7-99.1% |
| Negative | 327 | 5 | 322 | 0 | 98.5% (322/327)95% CI 96.5-99.5% |
| Equivocal | 3 | 1 | 2 | 0 | N/A |
T Two samples were not tested in ELISA
Sensitivity and Specificity with Non-Sexually Active Adults {Low Prevalence} (n =104)
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. 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. External investigator I was a medical school clinic in Southeastern United States: External investigator II was an STD clinic located in the Pacific Northwest. 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) in Sera
The HerpeSelect Express showed 100.0% (101/101) agreement with Immunoblot negatives, and 0.0% (0/2) agreement with Immunoblot positives.
Of the 104 sera, the HerpeSelect Immunoblot IgG was negative with 2. One sample was not tested in Immunoblot due to insufficient quantities.
Of the 101 negative HerpeSelect Immunoblot sera, Express was negative with 100.0% (101/101), positive with 0, and invalid with 0.
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with a curved, swooping shape to the left of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line. The overall design is simple and professional.
Of the 2 positive HerpeSelect Immunoblot sera, Express was positive with 0.0% (0/2), negative with 2, and invalid with 0.
HerpeSelect Express compared to Immunoblot with Non-Sexually Active Adults (Low Prevalence) in Sera (n =104)
| Immunoblot | n' | Express | Specificity | Sensitivity | ||
|---|---|---|---|---|---|---|
| Positive | Negative | Invalid | ||||
| Positive | 2 | 0 | 2 | 0 | 0% (0/2) | N/A |
| Negative | 101 | 0 | 101 | 0 | N/A | 100% (101/101)95% CI 96.4-100 |
| Equivocal | 0 | 0 | 0 | 0 | N/A | N/A |
One sample was not tested.
Non-Sexually Active Adults (Low Prevalence) in Venous Whole Blood
The HerpeSelect Express showed 100.0% (101/101) agreement with Immunoblot negatives, and 0.0% (0/2) agreement with Immunoblot positives.
Of the 104 sera, the HerpeSelect Immunoblot IgG was negative with 2. One sample was not tested in Immunoblot due to insufficient quantities.
Of the 101 negative HerpeSelect Immunoblot sera, Express was negative with 100.0% (101/101), positive with 0. and invalid with 0.
Of the 2 positive HerpeSelect Immunoblot sera, Express was positive with 0.0% (0/2), negative with 2, and invalid with 0.
HerpeSelect Express compared to Immunoblot with Non-Sexually Active Adults (Low Prevalence) in Venous Whole Blood (n =104)
| Immunoblot | n1 | Express | Specificity | Sensitivity | ||
|---|---|---|---|---|---|---|
| Positive | 2 | 0 | 2 | 0 | 0% (0/2) | N/A |
| Negative | 101 | 0 | 101 | 0 | N/A | 100% (101/101)95% CI 96.4-100 |
| Equivocal | 0 | 0 | 0 | 0 | N/A | N/A |
One sample was not tested.
Non-Sexually Active Adults (Low Prevalence) in Capillary Whole Blood
The HerpeSelect Express showed 100.0% (101/101) agreement with Immunoblot negatives, and 0.0% (0/2) agreement with Immunoblot positives.
Of the 104 sera, the HerpeSelect Immunoblot IgG was negative with 101 and positive with 2. One sample was not tested in Immunoblot due to insufficient quantities.
Of the 101 negative HerpeSelect Immunoblot sera, Express was negative with 100.0% (101/101), positive with 0, and invalid with 0.
Of the 2 positive HerpeSelect Immunoblot sera, Express was positive with 0.0% (0/2), negative with 2, and invalid with 0.
HerpeSelect Express compared to Immunoblot with Non-Sexually Active Adults (Low Prevalence) in Capillary Whole Blood (n = 104)
| Immunoblot | n1 | Positive | Negative | Invalid | Specificity | Sensitivity |
|---|---|---|---|---|---|---|
| Positive | 2 | 0 | 2 | 0 | 0% (0/2) | N/A |
| Negative | 101 | 0 | 101 | 0 | N/A | 100% (101/101)95% CI 96.4-100 |
| Equivocal | 0 | 0 | 0 | 0 | N/A | N/A |
'One sample was not tested.
{9}------------------------------------------------
Image /page/9/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 font size underneath. To the left of the word "FOCUS" is a curved, black shape that resembles a crescent or a stylized checkmark.
HerpeSelect Express Percent Agreement with Focus Diagnostics HerpeSelect 2 (ELISA) with Non-Sexually Active Adults {Low Prevalence} (n =104)
The gold-standard reference method was the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG for calculation of sensitivity and specificity. The device was also evaluated with the HerpeSelect2 ELISA IgG a cleared predicate device which is not required for regulatory clearance for typing assay.
HerpeSelect Express in Sera Agreement with ELISA
The HerpeSelect Express showed 100.0% (102/102) agreement with ELISA negatives in sera, and, 0.0% (0/1) agreement with ELISA positives. One ELISA equivocal was excluded.
Of the 104 sera, the HerpeSelect 2 ELISA IgG was negative with 1, and equivocal with 1,
Of the 102 negative HerpeSelect 2 ELISA sera, the Express was negative with 100.0% (102/102), positive with 0, and invalid with 0.
Of the 1 positive HerpeSelect 2 ELISA sera, Express was negative with 0.0% (0/1), and invalid with 0.
Express Agreement with ELISA in Sera with Non-Sexually Active Adults{Low Prevalence} (n = 104)
| ELISA | n | HerpeSelect Express | % Agreement | ||
|---|---|---|---|---|---|
| Positive | Negative | Invalid | |||
| Positive | 1 | 0 | 1 | 0 | 0% (0/1) |
| Negative | 102 | 0 | 102 | 0 | 100% (102/102)95% CI 96.4-100% |
| Equivocal | 1 | 0 | 1 | 0 | N/A |
HerpeSelect Express in Venous Whole Blood Agreement with ELISA
The HerpeSelect Express showed 100.0% (102/102) agreement with ELISA negatives in sera, and, 0.0% (0/1) agreement with ELISA positives. One ELISA equivocal was excluded.
Of the 104 sera, the HerpeSelect 2 ELISA IgG was negative with 1, and equivocal with 1,
Of the 102 negative HerpeSelect 2 ELISA sera, the Express was negative with 100.0% (102/102), positive with 0, and invalid with 0.
Of the 1 positive HerpeSelect 2 ELISA sera, Express was negative with 0.0% (0/1), and invalid with 0.
Express Agreement with ELISA in Venous Whole Blood with Non-Sexually Active Adults {Low Prevalence} (n = 104)
| ELISA | n | HerpeSelect Express | % Agreement | ||
|---|---|---|---|---|---|
| Positive | Negative | Invalid | |||
| Positive | 1 | 0 | 1 | 0 | 0% (0/1) |
| Negative | 102 | 0 | 102 | 0 | 100% (102/102)95% CI 96.4-100 |
| Equivocal | 1 | 0 | 1 | 0 | N/A |
Express in Capillary Whole Blood Agreement with ELISA
The HerpeSelect Express showed 100.0% (102/102) agreement with ELISA negatives in sera, and, 0.0% (0/1) agreement with ELISA positives. One ELISA equivocal was excluded.
Of the 104 sera, the HerpeSelect 2 ELISA IgG was negative with 1, and equivocal with 1,
Of the 102 negative HerpeSelect 2 ELISA sera, the Express was negative with 100.0% (102/102), positive with 0, and invalid with 0.
Of the 1 positive HerpeSelect 2 ELISA sera, Express was negative with 0.0% (0/1), and invalid with 0.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of a stylized black swoosh on the left, followed by the word "FOCUS" in bold, sans-serif font. Below "FOCUS" is the word "Diagnostics" in a smaller, non-bold, sans-serif font, underlined by a thin black line. The overall design is simple and professional.
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 11 of 13
Express Agreement with ELISA in Capillary Whole Blood with Non-Sexually Active Adults
| {Low Prevalenc |
|---|
| ---------------- |
| {Low Prevalence} | (n = 104) | ||||
|---|---|---|---|---|---|
| ELISA | n | Positive | HerpeSelect Express | % Agreement | |
| Positive | Negative | Invalid | |||
| Positive | 1 | 0 | 1 | 0 | 0% (0/1) |
| Negative | 102 | 0 | 102 | 0 | 100% (102/102)95% CI 96.4-100% |
| Equivocal | 1 | 0 | 1 | 0 | N/A |
Agreement with CDC Panel (n = 100)
The following information is from a serum panel obtained from the CDC and tested by Focus Diagnostics. 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. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel and do not imply an endorsement of the assay by the CDC.
The test panel consists of 100 samples. There are 65 HSV-2 negative and 35 HSV-2 positive specimens.
Determination of positive and negative samples
Of the 65 HSV-2 negative samples, the HerpeSelect® Express IgG correctly identified 98.5% (64/65). Of the 35 HSV-2 positive samples, the HerpeSelect® Express IgG correctly identified 100% (35/35).
| Agreement with CDC Panel (n = 100) | |||||
|---|---|---|---|---|---|
| CDC HSV2 | n | HerpeSelect® Express Positive | HerpeSelect® Express Negative | HerpeSelect® Express Invalid | % Agreement |
| Positive | 35 | 35 | 0 | 0 | 100% (35/35) 95% CI 90.0-100.0% |
| Negative | 65 | 1 | 64 | 0 | 98.5% (64/65) 95% CI 91.7 -100.0% |
Agreement with CDC Panel (n = 100)
Cross-Reactivity (n = 213)
Focus assessed cross-reactivity with samples that were sero-negative and sero-positive by at least one of
- (n= 25) Herpes Simplex 1 Virus (HSV-1) ●
- . (n= 25) Rubella virus
- . (n= 42) Varicella-Zoster virus, (VZV)
- . (n= 25) Epstein-Barr virus (EBV)
- . (n= 32) Cytomegalovirus (CMV)
- . (n= 33) Rheumatoid Factor (RF)
- . (n= 31) Anti-nuclear Antibodies (ANA)
Express Reactivity with Cross-Reactants
The HerpeSelect Express showed 4.2% (9/213) overall cross-reactivity.
With the HSV-1 IgG positives the Express was positive with 0.0% (0/25), negative with 25, and invalid with 0. With the Rubella virus positives the Express was positive with 4.0% (1/25), negative with 24, and invalid with 0. With the VZV IgG positives the Express was positive with 9.5% (4/42), negative with 38, and invalid with 0. With the EBV IgG positives the Express was positive with 4.0% (1/25), negative with 24, and invalid with 0. With the CMV IgG positives the Express was positive with 3.1% (1/32), negative with 31, and invalid with 0. With the RF positives the Express was positive with 3.0% (1/33), negative with 32, and invalid with 0. With the ANA positives the Express was positive with 3.2% (1/31), negative with 30, and invalid with 0.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller, non-bold font underneath. To the left of the word "FOCUS" is a curved, black graphic element that resembles a swoosh or a stylized checkmark.
510(k) Summary of Safety and Effectiveness HerpeSelect 1 and 2 Piexus IgG Catalog No. RT0920G Prepared May 31, 2007 Revised September 21, 2007 Page 12 of 13
| Cross-reactant | n | Positive | HerpeSelect ExpressNegative | Invalid | % Cross-Reactivity |
|---|---|---|---|---|---|
| HSV-1 IgG + | 25 | 0 | 25 | 0 | 0.0% (0/25)95%CI 0.0-13.7% |
| Rubella + | 25 | 1 | 24 | 0 | 4.0% (1/25)95%CI 0.0-20.4% |
| VZV IgG + | 42 | 4 | 38 | 0 | 9.5% (4/42)95%CI 2.7-22.6% |
| EBV IgG + | 25 | 1 | 24 | 0 | 4.0% (1/25)95%CI 0.0-20.4% |
| CMV IgG + | 32 | 1 | 31 | 0 | 3.1% (1/32)95%CI 0.0-16.2% |
| RF + | 33 | 1 | 32 | 0 | 3.0% (1/33)95%CI 0.0-15.8% |
| ANA + | 31 | 1 | 30 | 0 | 3.2% (1/31)95%CI 0.0-15.8% |
| Combined Cross-reactants | 213 | 9 | 204 | 0 | 4.2% (9/213)95%CI 1.9.0-7.8% |
Interference
The device performance was evaluated with the presence of interferents. Two subjects were drawn: one positive for herpes simplex virus-2 and negative for herpes simplex virus-1 and one negative for both herpes simplex virus 1 and herpes simplex virus 2 by HerpeSelect ELISA IgG. Baseline levels for triglycerides, albumin, bilirubin, and hemoglobin were established for each subject. The remaining serum was spiked with purchased interferents at levels which exceeded the expected human range. The spiked samples were tested again in the assay to determine if the elevated levels of interferents affected the assay. No interference was observed for any of the interferents in either the positive or negative sample.
Matrix Comparison
Focus compared the device's relative reactivity with serum with venous whole blood by spiking a HerpeSelect 2 ELISA positive serum into negative venous whole blood, serially diluting the spiked serum and whole blood, and testing the diluted serum and blood with the device in triplicates. Two of three of the serum replicates end-pointed at 1:4. Three of three whole blood replicates end-pointed at 1:4.
Reproducibility
Focus, a clinical laboratory located in Southern California, a public health clinic located in the Rocky Mountain Region of the United States; a student health clinic in the Southeastern United States, and an STD clinic located in the Pacific Northwest assessed the device's Inter-lot, Inter/Intra-operator reproducibility and Inter/Intra-site reproducibility. Each of the sites tested at ten samples in singlicate on three different days.
| Inter-Lot Reproducibility | Inter-Operator | Inter-Site | |||||||
|---|---|---|---|---|---|---|---|---|---|
| ELISARange | SampleID | Mean | %CV | Accuracy | Precision | %CV | Accuracy | Precision | %CV |
| High Negative | HSV-1 | 100.0% | 0.0% | 100.0% | 100.0% | 0.0% | 100.0% | 100.0% | 0.0% |
| Borderline | HSV-2 | 100.0% | 0.0% | 98.8% | 96.3% | 3.7% | 98.8% | 97.8% | 2.2% |
| Negative | HSV-11 | 100.0% | 0.0% | 97.5% | 92.4% | 7.6% | 97.5% | 95.6% | 4.4% |
| High Positive | HSV-12 | 100.0% | 0.0% | 100.0% | 100.0% | 0.0% | 100.0% | 100.0% | 0.0% |
| Positive | HSV-13 | 100.0% | 0.0% | 97.5% | 92.4% | 7.6% | 97.5% | 95.6% | 4.4% |
| Low Positive | HSV-14 | 100.0% | 0.0% | 59.3% | 35.0% | 65.0% | 59.3% | 65.2% | 34.8% |
| Negative | HSV-15 | 77.8% | 24.7% | 82.7% | 71.4% | 28.6% | 82.7% | 83.0% | 17.0% |
| Positive | HSV-26 | 100.0% | 0.0% | 97.5% | 95.0% | 5.0% | 97.5% | 97.8% | 2.2% |
| Negative | HSV-27 | 100.0% | 0.0% | 100.0% | 100.0% | 0.0% | 100.0% | 100.0% | 0.0% |
| Positive | HSV-28 | 100.0% | 0.0% | 98.8% | 96.3% | 3.7% | 98.8% | 97.8% | 2.2% |
{12}------------------------------------------------
Image /page/12/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, partially surrounding it. Below "FOCUS" is the word "Diagnostics" in a smaller, 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
HerpeSelect 1 and 2 Plexus IgG Catalog No. RT0920G
Prepared May 31, 2007 Revised September 21, 2007 Page 13 of 13
| Intra-Operator | |||
|---|---|---|---|
| Operator | Accuracy | Precision | %CV |
| 1 | 96.7% | 89.1% | 10.9% |
| 2 | 97.8% | 95.2% | 4.8% |
| 3 | 90.0% | 64.9% | 35.1% |
| 4 | 98.9% | 96.4% | 3.6% |
| 5 | 87.8% | 70.5% | 29.5% |
| 6 | 96.7% | 89.1% | 10.9% |
| 7 | 87.8% | 86.1% | 13.9% |
| 8 | 92.2% | 77.2% | 22.8% |
| 9 | 91.1% | 69.1% | 30.9% |
| Intra-Site | |||
| Site | Accuracy | Precision | %CV |
| 1 | 94.8% | 87.6% | 12.4% |
| 2 | 94.4% | 87.3% | 12.7% |
| 3 | 90.4% | 79.0% | 21.0% |
{13}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Constance Bridges Director, Regulatory and Compliance Focus Diagnostics, Inc. 10703 Progress Way Cypress, CA 90630
SEP 2 4 2007
K071510 Re: Trade/Device Name: HerpeSelect® Express IgG Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological reagents Regulatory Class: Class II Product Code: MYF Dated: May 31, 2007 Received: June 4, 2007
Dear Ms. Bridges:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{14}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ' (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Sally attagrista
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
{15}------------------------------------------------
510(k) Number (if known): K071510
Device Name:
HerpeSelect Express IgG
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.
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)
Uhe Schaf
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
40715 10 510(k).
§ 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).