Who is the manufacturer of HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G?

Focus Diagnostics, Inc. filed the 510(k) submission for HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G (K062543).

What is the FDA product code for HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G?

MXJ. It is classified under 21 CFR 866.3305 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G?

HerpeSelect 1 and 2 Immunoblot IgG; HerpeSelect-1 ELISA IgG; HerpeSelect-2 ELISA IgG.

Who can help prepare an FDA 510(k) submission like HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G

K062543 · Focus Diagnostics, Inc. · MXJ · Feb 1, 2007 · Microbiology

Device Facts

Record ID	K062543
Device Name	HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G
Applicant	Focus Diagnostics, Inc.
Product Code	MXJ · Microbiology
Decision Date	Feb 1, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3305
Device Class	Class 2

Intended Use

Focus Diagnostics' Plexus™HerpeSelect®1 and 2 IgG is intended 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.

Device Story

Multiplexed immunoassay for qualitative detection/differentiation of human IgG antibodies to HSV-1 and HSV-2 in human sera. Input: patient serum samples. Principle: Antigen bead suspension containing distinct HSV-1 and HSV-2 antigen beads; patient sera incubated with beads; phycoerythrin-conjugated goat anti-human IgG added to form sandwich; fluorescence measured at distinct wavelengths/intensities per bead type. Output: fluorescence intensity compared against cut-off calibrator to determine presence/absence of antibodies. Used in clinical laboratories; operated by laboratory technicians. Results aid clinicians in presumptive diagnosis of HSV infection. Benefits include simultaneous differentiation of HSV-1 and HSV-2 status.

Clinical Evidence

Clinical performance evaluated in 300 expectant mothers and 300 sexually active adults. Compared against HerpeSelect 1/2 Immunoblot IgG. Expectant mothers: HSV-1 agreement 96.5% (pos)/92.2% (neg); HSV-2 agreement 94.3% (pos)/95.5% (neg). Sexually active adults: HSV-1 agreement 91.0% (pos)/96.5% (neg); HSV-2 agreement 96.3% (pos)/97.4% (neg). CDC panel (n=100) showed 100% agreement. Reproducibility studies showed %CV ≤ 10%. Cross-reactivity with CMV, EBV, VZV was 0-5%.

Technological Characteristics

Multiplexed immunoassay using antigen bead suspension. Beads fluoresce at distinct wavelengths/intensities. Three-step procedure: incubation with patient sera, addition of phycoerythrin-conjugated goat anti-human IgG, and fluorescence measurement. Standalone laboratory assay; non-automated.

Indications for Use

Indicated for sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-1 and HSV-2 infection via qualitative detection of human IgG antibodies in serum. Not for pediatric use, neonatal screening, immunocompromised patients, point-of-care, or automated equipment.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

HerpeSelect 1 and 2 Immunoblot IgG
HerpeSelect-1 ELISA IgG
HerpeSelect-2 ELISA IgG

Related Devices

K090409 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM · Bio-Rad Laboratories · May 8, 2009
K071511 — PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G · Focus Diagnostics, Inc. · Oct 5, 2007
K120959 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT · Bio-Rad Laboratories · Jun 22, 2012
K072178 — ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM · Zeus Scientific, Inc. · May 30, 2008
K093784 — ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM · Zeus Scientific, Inc. · Jul 16, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ 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) 1. | 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 | {4}------------------------------------------------ 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ K062543 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) {8}------------------------------------------------ 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. {9}------------------------------------------------ K062543 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. {10}------------------------------------------------ ## 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