Who is the manufacturer of Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack?

Focus Diagnostics filed the 510(k) submission for Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (K150962).

What is the FDA product code for Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack?

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

What is the regulatory pathway for Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack?

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

Who can help prepare an FDA 510(k) submission like Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack?

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.

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

Q: What are the predicate devices for Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack?

artus® HSV-1/2 QS-RGQ MDx Kit (K142738).

K150962 · Focus Diagnostics · OQO · Aug 28, 2015 · Microbiology

Device Facts

Record ID	K150962
Device Name	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
Applicant	Focus Diagnostics
Product Code	OQO · Microbiology
Decision Date	Aug 28, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3305
Device Class	Class 2

Intended Use

Simplexa™ HSV 1 & 2 Direct The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct assay is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of herpes simplex virus (HSV-1 and HSV-2) DNA present in genital lesion swabs samples from patients with signs and symptoms of HSV-1 or HSV-2 infection of the genitalia. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 genital infections. The assay is not intended for use as a screening test for the presence of HSV-1 and HSV-2 in blood or blood products. The assay is for professional use only. Simplexa™ HSV 1 & 2 Positive Control Pack The Simplexa™ HSV 1 & 2 Positive Control Pack is intended to be used as a control with the Simplexa™ HSV 1 & 2 Direct kit. This control is not intended for use with other assays or systems.

Device Story

Real-time PCR system for direct amplification, detection, and differentiation of HSV-1 and HSV-2 DNA from unprocessed genital lesion swabs; eliminates nucleic acid extraction step. System includes Simplexa™ HSV 1 & 2 Direct assay, 3M Integrated Cycler, Integrated Cycler Studio Software, and Direct Amplification Disc. Bi-functional fluorescent probe-primers target conserved regions of HSV-1 and HSV-2 DNA polymerase genes; internal control monitors for PCR failure/inhibition. Used in clinical settings by professionals. Software automatically calculates results (Detected, Not Detected, Invalid, EC500). Output aids differential diagnosis of genital HSV infections. Benefits include rapid, direct testing without separate extraction.

Clinical Evidence

Prospective study of 696 genital swab samples compared to a composite comparator (culture, bi-directional sequencing, and FDA-cleared NAAT). HSV-1 sensitivity 97.4%, specificity 98.2%. HSV-2 sensitivity 97.2%, specificity 97.8%. Retrospective study of 28 samples showed 100% PPA and 100% NPA for HSV-2, and 100% PPA and 92.9% NPA for HSV-1.

Technological Characteristics

Real-time PCR; direct amplification (no extraction); bi-functional fluorescent probe-primers; targets HSV-1 and HSV-2 DNA polymerase genes; internal control included. Instrument: 3M Integrated Cycler. Software: 3M Integrated Cycler Studio Software. Form factor: Direct Amplification Disc.

Indications for Use

Indicated for qualitative detection and differentiation of HSV-1 and HSV-2 DNA in genital lesion swabs from symptomatic patients. For professional use only. Not for blood/blood product screening.

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

artus® HSV-1/2 QS-RGQ MDx Kit (K142738)

Related Devices

K173798 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack · Diasorin Molecular, LLC · Mar 14, 2018
K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK · Focus Diagnostics · Jul 1, 2014
DEN130049 — SIMPLEXA HSV 1&2 DIRECT · Focus Diagnostics · Mar 21, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The text is in all caps and is evenly spaced around the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 28, 2015 FOCUS DIAGNOSTICS, INC. SHARON YOUNG SENIOR REGULATORY AFFAIRS SPECIALIST 11331 VALLEY VIEW STREET CYPRESS, CA 90630 Re: K150962 Trade/Device Name: Simplexa HSV 1 & 2 Direct, Simplexa HSV1 & 2 Positive Control Pack Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: II Product Code: OQO Dated: August 25, 2015 Received: August 26, 2015 Dear Ms. Young: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, ## Stephen J. Lovell -S for Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K150962 #### Device Name Simplexa™ HSV 1 & 2 Direct and Simplexa™ HSV 1 & 2 Positive Control Pack #### Indications for Use (Describe) Simplexa™ HSV 1 & 2 Direct The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct assay is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of herpes simples virus (HSV-2) DNA present in genital lesion swabs samples from patients with signs and symptoms of HSV-2 infection of the genitalia. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 genital infections. The assay is not intended for use as a screening test for the presence of HSV-2 in blood or blood products. The assay is for professional use only. Simplexa™ HSV 1 & 2 Positive Control Pack The Simplexa™ HSV 1 & 2 Positive Control Pack is intended to be used as a control with the Simplexa™ HSV 1 & 2 Direct kit. This control is not intended for use with other assays or systems. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/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 check mark or swoosh. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin black line. ### 510(k) Summary Simplexa™ HSV 1 & 2 Direct Catalog No. MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack Catalog No. MOL2160 August 20, 2015 Page 1 of 12 | Applicant | Focus Diagnostics, Inc. 11331 Valley View Street Cypress, California 90630 USA | |--------------------------------|-----------------------------------------------------------------------------------------| | Establishment Registration No. | 2023365 | | Contact Person | Sharon Young tel 562.240.6680 fax 562.240.6529 syoung@focusdx.com | | Summary Date | August 20, 2015 | | Proprietary Name | Simplexa™ HSV 1 & 2 Direct Simplexa™ HSV 1 & 2 Positive Control Pack | | Generic Name | Herpes Simplex Virus serological assays | | Classification | OQO | | Regulation | | | Product Code | | | Predicate Device | OQO - artus® HSV-1/2 QS-RGQ MDx Kit (K142738) | #### Intended Use Simplexa™ HSV 1 & 2 Direct The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct assay is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of herpes simples virus (HSV-1 and HSV-2) DNA present in genital lesion swabs samples from patients with signs and symptoms of HSV-1 or HSV-2 infection of the genitalia. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 genital infections. The assay is not intended for use as a screening test for the presence of HSV-1 and HSV-2 in blood or blood products. The assay is for professional use only. #### Simplexa™ HSV 1 & 2 Positive Control Pack The Simplexa™ HSV 1 & 2 Positive Control Pack is intended to be used as a control with the Simplexa™ HSV 1 & 2 Direct kit. This control is not intended for use with other assays or systems. #### Device Description The Simplexa™ HSV 1 & 2 Direct assay system is a real-time PCR that enables the direct amplification, detection and differentiation of HSV-1 and/or HSV-2 DNA from unprocessed genital swab specimens without nucleic acid extraction. The system consists of the Simplexa™ HSV 1 & 2 Direct assay, the 3M Integrated Cycler (with 3M Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories. In the Simplexa™ HSV 1 & 2 Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify HSV-1, HSV-2 and internal control targets. Well conserved regions of the HSV-1 and HSV-2 DNA polymerase genes are targeted to identify HSV-1 and HSV-2 DNA respectively in the specimen. An internal control is used to detect PCR failure and/or inhibition. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of a stylized swoosh shape on the left, followed by the word "FOCUS" in a bold, sans-serif font. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line. The entire logo is in black and white. ### 510(k) Summary Simplexa™ HSV 1 & 2 Direct Catalog No. MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack Catalog No. MOL2160 August 20, 2015 Page 2 of 12 ### Predicate Device Information #### Similarities | Name | Simplexa™ HSV 1 & 2 Direct | artus® HSV-1/2 QS-RGQ MDx Kit K142738 | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Simplexa™ HSV 1 & 2 Direct The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct assay is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of herpes simplex virus (HSV-1 and HSV-2) DNA present in genital lesion swabs samples from patients with signs and symptoms of HSV-1 or HSV-2 infection of the genitalia. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 genital infections. The assay is not intended for use as a screening test for the presence of HSV-1 and HSV-2 in blood or blood products. The assay is for professional use only. Simplexa™ HSV 1 & 2 Positive Control Pack The Simplexa™ HSV 1 & 2 Positive Control Pack is intended to be used as a control with the Simplexa™ HSV 1 & 2 Direct kit. This control is not intended for use with other assays or systems. | The artus HSV-1/2 QS-RGQ MDx Kit is an in vitro real-time PCR DNA amplification assay performed on the QIAsymphony RGQ MDx system for the direct qualitative detection and differentiation of herpes simplex virus (HSV-1 and HSV-2) DNA in genital or oral vesicular lesions from male and female patients suspected of HSV infection. The assay is intended for use as an aid in diagnosis of HSV infection in symptomatic patients. Warning: The artus HSV-1/2 QS-RGQ MDx Kit is not FDA-cleared for use with cerebrospinal fluid (CSF) or for prenatal screening. | | Assay Targets | HSV-1 and HSV-2 DNA | HSV-1 and HSV-2 DNA | | Detection Techniques | Multiplex assay using different reporter dyes for each target. | Multiplex assay using different reporter dyes for each target. | ### Differences | Name | Simplexa™ HSV 1 & 2 Direct | artus® HSV-1/2 QS-RGQ MDx Kit K142738 | |-------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sample Types | Genital herpetic lesion swab samples | Male and female genital or oral herpetic lesions. | | Assay Methodology | PCR-based system for detecting the presence / absence of viral DNA in clinical specimens | Amplification and detection are carried out using the artus HSV-1/2 QS-RGQ MDx Kit with the Rotor- Gene Q MDx (RGQ MDx) and Rotor-Gene Assay Manager software. | {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 a curved, swooping line above it. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line. ### 510(k) Summary Simplexa™ HSV 1 & 2 Direct Catalog No. MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack Catalog No. MOL2160 August 20, 2015 Page 3 of 12 #### REPRODUCIBILITY - Genital Swab Sample Type Reproducibility for the Simplexa™ HSV 1 & 2 Direct assay was evaluated. Three investigative sites assessed the device's inter-site, inter-day and inter/intra-assay reproducibility. Each of the laboratories tested the positive control and a panel of five contrived sample pools including a low (approximately 1-2 times LoD) and medium positive (approximately 2-4 times LoD) for each analyte and a high negative. The high negative sample contained a small amount of HSV-1 and it was designed to be neqative approximately 95% of the time. The assays were performed in triplicate on five different days. Each site had two operators; each operator assayed the entire sample panel and positive control once per day, for a total of two sets of data per day. Combined results for all sites are presented in the tables below. | | Sample | Site - 1 | | | Site - 2 | | | Site - 3 | | | Total % Agreement with Expected Results | 95% CI | |----------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------------------------|------------|--------------|-----------------------------------------------|------------|--------------|-----------------------------------------------|------------|--------------|-----------------------------------------------------|-------------------| | | | % Agreement with Expected Results | Avg. Ct | Total %CV | % Agreement with Expected Results | Avg. Ct | Total %CV | % Agreement with Expected Results | Avg. Ct | Total %CV | | | | | HSV-1 Low Positive | 100.0% (30/30) | 36.0 | 2.2 | 100.0% (30/30) | 36.1 | 2.6 | 100.0% (30/30) | 36.3 | 2.7 | 100.0% (90/90) | 95.9 to 100.0% | | HSV-1 Result | HSV-1 Medium Positive | 100.0% (30/30) | 34.4 | 1.7 | 100.0% (30/30) | 34.8 | 1.2 | 100.0% (30/30) | 34.6 | 1.9 | 100.0% (90/90) | 95.9 to 100.0% | | | HSV-2 Low Positive | 100.0% (30/30)a | NA | NA | 100.0% (30/30)a | NA | NA | 96.7% (29/30)a | NA | NA | 98.9% (89/90)a | 94.0 to 99.8% | | | HSV-2 Medium Positive | 100.0% (30/30)a | NA | NA | 96.7% (29/30)a | NA | NA | 100.0% (30/30)a | NA | NA | 98.9% (89/90)a | 94.0 to 99.8% | | | High Negative | 96.7% (29/30)a | 38.8 | 0.0 | 93.3% (28/30)a | 38.7 | 0.5 | 90.0% (27/30)a | 38.0 | 4.1 | 93.3% (84/90)a | 86.2 to 96.9% | | | Positive Control | 100.0% (30/30) | 29.9 | 0.8 | 100.0% (30/30) | 30.4 | 1.3 | 100.0% (29/29) | 29.9 | 2.8 | 100.0% (89/89) | 95.9 to 100.0% | | | Total Agreement | 99.4% (179/180) | | | 98.3% (177/180) | | | 97.8% (175/179) | | | 98.5% (531/539) | 97.1 to 99.2% | | a) Expected Results of HSV-2 Low Positive, HSV-2 Medium Positive and High Negative samples are "Negative" for HSV-1. | | | | | | | | | | | | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, black letters. Above and to the left of the word "FOCUS" is a black swoosh design. Below the word "FOCUS" is the word "Diagnostics" in smaller, black letters with a line above it. ## 510(k) Summary Simplexa™ HSV 1 & 2 Direct Catalog No. MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack Catalog No. MOL2160 August 20, 2015 Page 4 of 12 | | Sample | Site - 1 | | | Site - 2 | | | Site - 3 | | | Total % Agreement with Expected Results | 95% CI | |-----------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|------------|-----------------|-----------------------------------------------|------------|-----------------|-----------------------------------------------|------------|--------------------|-----------------------------------------------------|-------------------| | | | % Agreement with Expected Results | Avg. Ct | Total %CV | % Agreement with Expected Results | Avg. Ct | Total %CV | % Agreement with Expected Results | Avg. Ct | Total %CV | | | | HSV-2 Result | HSV-1 Low Positive | 100.0% (30/30)b | NA | NA | 100.0% (30/30)b | NA | NA | 96.7% (29/30)b | 41.1 | 0.0 | 98.9% (89/90)b | 94.0 to 99.8% | | | HSV-1 Medium Positive | 100.0% (30/30)b | NA | NA | 100.0% (30/30)b | NA | NA | 100.0% (30/30)b | NA | NA | 100.0% (90/90)b | 95.9 to 100.0% | | | HSV-2 Low Positive | 100.0% (30/30) | 37.4 | 2.9 | 90.0% (27/30) | 37.5 | 3.5 | 93.3% (28/30) | 37.1 | 2.8 | 94.4% (85/90) | 87.6 to 97.6% | | | HSV-2 Medium Positive | 100.0% (30/30) | 35.5 | 1.9 | 100.0% (30/30) | 35.6 | 2.0 | 100.0% (30/30) | 35.3 | 1.6 | 100.0% (90/90) | 95.9 to 100.0% | | | High Negative | 96.7% (29/30)b | 39.5 | 0.0 | 86.7% (26/30)b | 38.6 | 2.9 | 100.0% (30/30)b | NA | NA | 94.4% (85/90)b | 87.6 to 97.6% | | | Positive Control | 100.0% (30/30) | 30.2 | 1.3 | 100.0% (30/30) | 30.1 | 0.6 | 100.0% (29/29) | 29.9 | 1.2 | 100.0% (89/89) | 95.9 to 100.0% | | | Total Agreement | 99.4% (179/180) | | 96.1% (173/180) | | | 98.9% (176/179) | | | 98.0% (528/539) | 96.4 to 98.9% | | | | b) Expected Results of HSV-1 Low Positive, HSV-1 Medium Positive and High Negative samples are "Negative" for HSV-2. | | | | | | | | | | | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, black letters. A curved black line extends from the top left of the "F" and curves over the word. Below "FOCUS" is the word "Diagnostics" in smaller, black letters with a line above it. ## 510(k) Summary Simplexa™ HSV 1 & 2 Direct Catalog No. MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack Catalog No. MOL2160 August 20, 2015 Page 5 of 12 | | Sample | Site - 1 | | Site - 2 | | Site - 3 | | | | | | | |---------------------|-----------------------------|-----------------------------------------------------------------------------------|------------|------------------|-----------------------------------------------------------------------------------|------------------|--------------|-----------------------------------------------------------------------------------|------------------|--------------|-----------------------------------------------------------------------------------------|-------------------| | | Sample | % Agreement with Expected Results | Avg. Ct | Total %CV | % Agreement with Expected Results | Avg. Ct | Total %CV | % Agreement with Expected Results | Avg. Ct | Total %CV | Total % Agreement with Expected Results | 95% CI | | DNA IC Result | HSV-1 Low Positive | 100.0% (30/30) | 29.6 | 0.7 | 100.0% (30/30) | 29.8 | 1.2 | 100.0% (30/30) | 29.7 | 1.0 | 100.0% (90/90) | 95.9 to 100.0% | | | HSV-1 Medium Positive | 100.0% (30/30) | 29.6 | 0.8 | 100.0% (30/30) | 29.8 | 1.4 | 100.0% (30/30) | 29.7 | 0.9 | 100.0% (90/90) | 95.9 to 100.0% | | | HSV-2 Low Positive | 100.0% (30/30) | 29.6 | 0.8 | 100.0% (30/30) | 29.8 | 1.2 | 100.0% (30/30) | 29.7 | 1.0 | 100.0% (90/90) | 95.9 to 100.0% | | | HSV-2 Medium Positive | 100.0% (30/30) | 29.5 | 0.6 | 100.0% (30/30) | 29.7 | 1.4 | 100.0% (30/30) | 29.8 | 1.4 | 100.0% (90/90) | 95.9 to 100.0% | | | High Negative | 100.0% (30/30) | 29.6 | 0.6 | 100.0% (30/30) | 29.8 | 1.2 | 100.0% (30/30) | 29.7 | 1.0 | 100.0% (90/90) | 95.9 to 100.0% | | | Positive Control | 100.0% (30/30) | 29.5 | 0.5 | 100.0% (30/30) | 29.7 | 1.4 | 100.0% (29/29) | 29.7 | 0.9 | 100.0% (89/89) | 95.9 to 100.0% | | | Total Agreement | 100.0% (180/180) | | 100.0% (180/180) | | 100.0% (179/179) | | 100.0% (539/539) | 96.4 to 98.9% | | | | #### ANALYTICAL SENSITIVITY/LIMIT OF DETECTION - Genital Swab Sample Type The Limit of Detection (LoD) was determined for the Simplexa™ HSV 1 & 2 Direct assay using quantified stocks of HSV-1 and HSV-2 serially diluted into negative genital swab ma genital swabs. LoD was determined to be the lowest concentration that could be detected positive > 95% of the time. | Virus Strain | LoD Concentration (TCID50/mL) | Qualitative Results (#Detected/#Total) | Mean Ct ± SD (from Detected Replicates only) | |----------------|----------------------------------|----------------------------------------------|----------------------------------------------------| | HSV-1 McIntyre | 4 | 32/32 | 36.4 ± 1.16 | | HSV-1 HF | 160 | 32/32 | 35.2 ± 1.03 | | HSV-2 G | 2 | 32/32 | 37.5 ± 1.08 | | HSV-2 MS | 10 | 31/32 | 37.9 ± 1.15 | {8}------------------------------------------------ Image /page/8/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 swoosh or a stylized checkmark. ### 510(k) Summary Simplexa™ HSV 1 & 2 Direct Catalog No. MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack Catalog No. MOL2160 August 20, 2015 Page 6 of 12 #### ANALYTICAL REACTIVITY/ CROSS REACTIVITY #### Analytical Reactivity -Genital Swab Sample Type The analytical reactivity of the Simplexa™ HSV 1 & 2 Direct assay was evaluated using different strains of HSV-1 and HSV-2 that were not used in the determination of the limit of detection (LoD) for the assay. Quantified viral material was spiked into negative genital swab matrix containing male and female genital swabs using a single dilution and assayed in triplicate. The Simplexa™ HSV 1 & 2 Direct assay was able to detect other strains of HSV-1 and HSV-2 viruses. | HSV Strain/Isolate | Spiked Concentration [TCID50/mL] | Qualitative Result (#Detected/#Total) | | |-----------------------|-------------------------------------|------------------------------------------|-------| | | | HSV-1 | HSV-2 | | HSV-1 KOS | 16 | 3/3 | 0/3 | | HSV-1 F | 32 | 3/3 | 0/3 | | HSV-2 Isolate 1 | 8 | 0/3 | 3/3 | | HSV-2 Isolate 2 | 8 | 0/3 | 3/3 | | HSV-2 Isolate 3 | 8 | 0/3 | 3/3 | #### Cross-Reactivity (Analytical Specificity) - Genital Swab Sample Type The Simplexa™ HSV 1 & 2 Direct assay's analytical specificity was evaluated by testing the ability to exclusively identify HSV-1 and HSV-2 viruses with no cross-reactivity to organisms that are closely related, or cause similar clinical symptoms or may be present on swabs of the genital region. Thirty six (36) potential cross-reactants were spiked into negative genital swab matrix containing male and female genital swabs and assayed in triplicate. No cross-reactivity was observed. | No. | Potential Cross-Reactants | Tested Concentration | Qualitative Result (#Detected/#Total) | | |-----|------------------------------|----------------------|------------------------------------------|----------------| | | | | HSV-1 | HSV-2 | | 1 | None (Baseline) | Not Applicable | 0/15 | 0/15 | | 2 | Bacteroides fragilis | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 3 | Bacteroides ureolyticus* | Not Applicable | Not Applicable | Not Applicable | | 4 | Candida albicans | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 5 | Chlamydia trachomatis | 1.00 X 106 IFU/mL | 0/3 | 0/3 | | 6 | Clostridium sordellii | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 7 | Corynebacterium genitalium | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 8 | Cytomegalovirus AD169 strain | 1.00 X 105 TCID50/mL | 0/3 | 0/3 | | 9 | Enterococcus faecalis vanB | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 10 | Enterovirus 71 | 1.00 X 105 TCID50/mL | 0/8 | 1/8 | | 11 | Epstein Barr Virus (B95-8) | 1.00 X 105 copies/mL | 0/3 | 0/3 | | 12 | Escherichia coli O157H7 | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 13 | Gardnerella vaginalis | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 14 | Hepatitis B | 1.00 X 105 IU/mL | 0/3 | 0/3 | | 15 | Hepatitis C | 1.00 X 105 IU/mL | 0/3 | 0/3 | | 16 | HHV-6 (Z29 Strain) | 1.00 X 105 TCID50/mL | 0/3 | 0/3 | | 17 | HHV-7 SB | 1.00 X 105 TCID50/mL | 0/3 | 0/3 | | 18 | HIV-1 IIIB | 1.00 X 105 copies/mL | 0/3 | 0/3 | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in large, bold, black letters. To the left of the word is a curved, black shape that resembles a stylized check mark or swoosh. Below the word "FOCUS" is the word "Diagnostics" in a smaller font, underlined with a thin black line. ## 510(k) Summary Simplexa™ HSV 1 & 2 Direct Catalog No. MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack Catalog No. MOL2160 August 20, 2015 Page 7 of 12 | No. | Potential Cross-Reactants | Tested Concentration | Qualitative Result (#Detected/#Total) | | |-----|--------------------------------------------------|----------------------------|------------------------------------------|----------------| | | | | HSV-1 | HSV-2 | | 19 | HIV-2 NIHZ** | Not Available | 0/3 | 0/3 | | 20 | HPV18 Recombinant | 1.00 X 105 pfu/mL | 0/3 | 0/3 | | 21 | Lactobacillus acidophilus | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 22 | Mobiluncus mulieris | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 23 | Mycoplasma genitalium** | Not Applicable | Not Applicable | Not Applicable | | 24 | Mycoplasma hominis | 1.00 X 106 CCU/mL | 0/3 | 0/3 | | 25 | Neisseria gonorrhoeae | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 26 | Proteus vulgaris | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 27 | Rubella | 1.00 X 105 TCID50/mL | 0/3 | 0/3 | | 28 | Staphylococcus aureus (MRSA), ATCC 700699 | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 29 | Staphylococcus epidermidis (MRSE), ATCC 29887 | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 30 | Staphylococcus saprophyticus | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 31 | Streptococcus mitis | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 32 | Streptococcus pyogenes, M1 | 1.00 X 106 cfu/mL | 0/3 | 0/3 | | 33 | Toxoplasma gondii | 1.00 X 106 tachyzooites/mL | 0/3 | 0/3 | | 34 | Treponema pallidum** | Not Applicable | Not Applicable | Not Applicable | | 35 | Trichomonas vaginalis | 1.00 X 106 trophozoites/ml | 0/3 | 0/3 | | 36 | Ureaplasma urealyticum | 1.00 X 106 CCU/mL | 0/3 | 0/3 | | 37 | VZV | 1.00 X 105 copies/mL | 0/3 | 0/3 | " Microorganism was not available for testing therefore in-silico NCBI BLAST analysis was performed and found no predicted cross reactivity. ** Quantified material was not available to test; instead the vendor provided a culture fluid with a known Ct value. The site was directed to dilute the stock to a relevant Ct value; 1:50 dilution factor. #### INTERFERENCE - Genital Swab Sample Type The performance of the Simplexa™ HSV 1 & 2 Direct assay was evaluated with potentially interfering substances that may be present on swabs of the genital region at the concentrations indicated in the table below. A total of five (26) potentially interfering substances were tested in a low positive HSV-1 and HSV-2 sample (4 times LoD) in negative genital swab matrix containing male and female genital swabs and assayed in triplicate. No interference was observed. | Potential Interferent | Interferent Concentration | #Detected/#Total | | | |-----------------------------------|---------------------------|------------------|-------|-----| | | | HSV-1 | HSV-2 | IC | | Abreva cold sore treatment | 7% w/v | 3/3 | 3/3 | 3/3 | | Acyclovir | 2.5 mg/mL | 3/3 | 3/3 | 3/3 | | Acyclovir Cream* | 7% w/v | 8/8 | 5/8 | 8/8 | | Albumin | 10 mg/mL | 3/3 | 3/3 | 3/3 | | Balneol Hygienic Cleansing lotion | 7% w/v | 3/3 | 3/3 | 3/3 | | Casein | 10 mg/mL | 3/3 | 3/3 | 3/3 | | Cidofovir | 2.5 mg/mL | 3/3 | 3/3 | 3/3 | | Clotrimazole vaginal cream | 7% w/v | 3/3 | 3/3 | 3/3 | | Denavir | 2.5 mg/mL | 3/3 | 3/3 | 3/3 | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, uppercase letters. A curved line extends from the left side of the "F", arching over the word. Below "FOCUS" is the word "Diagnostics" in a smaller, non-bold font, underlined with a thin line. ### 510(k) Summary Simplexa™ HSV 1 & 2 Direct Catalog No. MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack Catalog No. MOL2160 August 20, 2015 Page 8 of 12 | | | #Detected/#Total | | | |-----------------------------------------------------------------------------------------------------------------------|---------------------------|------------------|-------|-----| | Potential Interferent | Interferent Concentration | HSV-1 | HSV-2 | IC | | Douche | 7% w/v | 3/3 | 3/3 | 3/3 | | Famciclovir | 2.5 mg/mL | 3/3 | 3/3 | 3/3 | | Feces | 2.5 mg/mL | 3/3 | 3/3 | 3/3 | | Gynol II (Contraceptive jelly) | 7% w/v | 3/3 | 3/3 | 3/3 | | KY Jelly | 5% v/v | 3/3 | 3/3 | 3/3 | | Monistat 1 | 7% w/v | 3/3 | 3/3 | 3/3 | | Monistat 3 | 7% w/v | 3/3 | 3/3 | 3/3 | | Mucin | 7% w/v | 3/3 | 3/3 | 3/3 | | Preparation H Hemorrhoid cream | 7% w/v | 3/3 | 3/3 | 3/3 | | Releev cold sore treatment | 7% w/v | 3/3 | 3/3 | 3/3 | | Urine | 10% v/v | 3/3 | 3/3 | 3/3 | | Vagicaine Anti-Itch Cream | 7% w/v | 3/3 | 3/3 | 3/3 | | Vagisil creme | 7% w/v | 3/3 | 3/3 | 3/3 | | VagiStat 1 | 7% w/v | 3/3 | 3/3 | 3/3 | | Valacyclovir | 2.5 mg/mL | 3/3 | 3/3 | 3/3 | | Whole Blood | 10% v/v | 3/3 | 3/3 | 3/3 | | YeastGard Suppositories | 7% w/v | 3/3 | 3/3 | 3/3 | | * One out of three (1/3) initial replicates and two out of five (2/5) confirmation replicates were negative for HSV-2 | | | | | #### CLINICAL AGREEMENT - Genital Swab Sample Type #### Prospective Study A total of 718 genital swab samples were prospectively collected from patients with signs and symptoms of genital herpes simplex virus (HSV) infection from 6 geographically diverse locations. Of the 718 samples collected. 9 samples were removed from the analysis because they were either not tested or had invalid results on the 3 assays (Simplexa™ HSV 1 & 2 Direct, Culture or bi-directional sequencing). Of the 709 remaining samples, 13 samples were removed from the analysis because they were not tested on the tests included in the comparator method sufficient to generate a final comparator result. A total of 696 samples were used for the analysis. The clinical performance of the Simplexa HSV 1 & HSV 2 assay was evaluated by comparing the positive and negative percent agreement to a composite comparator algorithm consisting of; culture, bi-directional sequencing and an FDA cleared NAAT. A positive result for HSV-1 and/or HSV-2 was determined by a positive test result in either the culture or the bi-directional sequencing. If both the culture and the bi-directional sequencing yielded positive results but disagreed in the differentiation of HSV-1 versus HSV-2, the results of the FDA cleared NAAT were used and a 2 out of 3 rule was followed to determine the type of the virus (e.g. if two of the methods were positive for HSV-1, the final comparator result was HSV-1 positive). All sites collected the genital swab samples on the Simplexa™ HSV-1 and HSV-2 Direct and sent samples to a central lab for culture testing. For culture, each sample was tested for HSV- 2 first and if positive for HSV-2 no further testing was performed. Samples that were HSV-2 culture negative were further tested for HSV-1 culture positivity. Dual positives could not be identified in the culture assay. The available retained samples were sent to Focus Diagnostics and tested in a validated bi-directional sequencing assay. Of the 24 discordant samples that were positive for HSV-2 by the culture method but positive for HSV-1 by the bi-directional sequencing assay, 18 samples had valid results and 1 sample had an invalid result when tested on an FDA cleared NAAT. There were 5 samples that were not tested on the FDA cleared NAAT due to insufficient volume and therefore 6 out of 24 samples were excluded from the {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, sans-serif font. A curved, swooping shape is to the left of the word. Below the word "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line. ## 510(k) Summary Simplexa™ HSV 1 & 2 Direct Catalog No. MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack Catalog No. MOL2160 August 20, 2015 Page 9 of 12 analysis. There were 2 samples that were positive for HSV-1 by the culture method but positive for HSV-2 by the bi-directional sequencing assay that were not tested on the FDA cleared NAAT for insufficient volume and therefore were excluded from analysis. Results for Simplexa™ HSV 1 & 2 Direct compared to the composite comparator algorithm are presented in the following tables. #### Simplexa™ HSV 1 & 2 Direct Compared to Composite Comparator Result (HSV-1) | Simplexa™ HSV 1 & 2 Direct Results HSV-1 | Composite Comparator Result (HSV-1) | | | |---------------------------------------------|------------------------------------------|--------------|------------------------------------------| | | Detected | Not Detected | Total | | Detected | 111 | 10 | 121 | | Not Detected | 3 | 560 | 563 | | Total | 114 | 570 | 684 | | | | | | | Sensitivity | 97.4%(111/114) 95% CI: 92.5% to 99.1% | Specificity | 98.2%(560/570) 95% CI: 96.8% to 99.0% | | PPV | 91.7%(111/121) 95% CI: 85.5% to 95.4% | NPV | 99.5%(560/563) 95% CI: 98.4% to 99.8% | #### Simplexa™ HSV 1 & 2 Direct Compared to Composite Comparator Result (HSV-2) | Simplexa™ HSV 1 & 2 Direct | Composite Comparator Result (HSV-2) | | | |----------------------------|------------------------------------------|--------------|------------------------------------------| | Results HSV-2 | Detected | Not Detected | Total | | Detected | 175 | 11 | 186 | | Not Detected | 5 | 497 | 502 | | Total | 180 | 508 | 688 | | | | | | | Sensitivity | 97.2%(175/180) 95% Cl: 93.7% to 98.8% | Specificity | 97.8%(497/508) 95% CI: 96.2% to 98.8% | | PPV | 94.1%(175/186) 95% Cl: 89.7% to 96.7% | NPV | 99.0%(497/502) 95% CI: 97.7% to 99.6% | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, black letters. Above and to the left of the word is a curved, black shape. Below the word "FOCUS" is a horizontal line, and below that line is the word "Diagnostics" in a smaller font. ### 510(k) Summary Simplexa™ HSV 1 & 2 Direct Catalog No. MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack Catalog No. MOL2160 August 20, 2015 Page 10 of 12 #### Retrospective Study A total of 28 genital swab samples (14 positive HSV-1 and 14 positive HSV-2) were retrospectively collected from male patients with signs and symptoms of genital herpes simplex virus (HSV) infection and contained preselected positive and negative samples were tested at Focus Diagnostics using the SimplexaTM HSV 1 & 2 Direct and a validated bi-directional sequencing assay. #### HSV-1 Validated Bi-Directional Sequencing Assay Results | Simplexa™ HSV 1 & 2 Direct Results | Composite Comparator Result (HSV-1) | | | |---------------------------------------|-------------------------------------|--------------|-------------------------| | | Detected | Not Detected | Total | | Detected | 14 | 1 | 15 | | Not Detected | 0 | 13 | 13 | | Total | 14 | 14 | 28 | | | | | | | PPA | 100.0%(14/14) | NPA | 92.9%(13/14) | | | 95% CI: 78.5% to 100.0% | | 95% CI: 68.5% to 98.7% | | PPV | 93.3%(14/15) | NPV | 100.0%(13/13) | | | 95% CI: 70.2% to 98.8% | | 95% CI: 77.2% to 100.0% | #### HSV-2 Validated Bi-Directional Sequencing Assay Results | Simplexa™ HSV 1 & 2 Direct Results | Composite Comparator Result (HSV-2) | | | |---------------------------------------|------------------------------------------|--------------|------------------------------------------| | Results | Detected | Not Detected | Total | | Detected | 14 | 0 | 14 | | Not Detected | 0 | 14 | 14 | | Total | 14 | 14 | 28 | | | | | | | PPA | 100.0%(14/14) 95% CI: 78.5% to 100.0% | NPA | 100.0%(14/14) 95% CI: 78.5% to 100.0% | | PPV | 100.0%(14/14) 95% CI: 78.5% to 100.0% | NPV | 100.0%(14/14) 95% CI: 78.5% to 100.0% | {13}------------------------------------------------ Image /page/13/Picture/0 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 below it. A curved, black shape is to the left of the word "FOCUS", which gives the logo a modern and professional look. The logo is simple, clean, and easy to read. ### 510(k) Summary Simplexa™ HSV 1 & 2 Direct Catalog No. MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack Catalog No. MOL2160 August 20, 2015 Page 11 of 12 #### EXPECTED VALUES - Genital Swab Sample Type The observed expected values using the Simplexa™ HSV 1 & 2 Direct assay are presented below for patients 17 years of age or older from the prospective study population. The data is stratified by age, and gender and collection sites. | | | | Sample Demographics by Simplexa™ HSV 1 & 2 Direct Assay | | | | | |--------|------------------------------------------|-----|---------------------------------------------------------|-------------------------------------------|-------------------------------------------|--------------------------------|----------------| | Gender | Age Group | | Simplexa™ HSV 1 & 2 Direct Result | | | | | | | | All | HSV-1 & HSV-2 Not Detected | HSV-1 Detected & HSV-2 Not Detected | HSV-1 Not Detected & HSV-2 Detected | HSV-1 & HSV-2 Dual Positive | Not-Evaluable | | Female | 17 Years of age to 21 Years of age | 98 | 41.8% (41/98) | 25.5% (25/98) | 30.6% (30/98) | 0.0% (0/98) | 2.0% (2/98) | | | More than 21 Years of age | 503 | 54.3% (273/503) | 16.9% (85/503) | 25.8% (130/503) | 0.8% (4/503) | 2.2% (11/503) | | | All | 601 | 52.2% (314/601) | 18.3% (110/601) | 26.6% (160/601) | 0.7% (4/601) | 2.2% (13/601) | | Male | 17 Years of age to 21 Years of age | 14 | 42.9% (6/14) | 21.4% (3/14) | 35.7% (5/14) | 0.0% (0/14) | 0.0% (0/14) | | | More than 21 Years of age | 66 | 68.2% (45/66) | 10.6% (7/66) | 18.2% (12/66) | 1.5% (1/66) | 1.5% (1/66) | | | All | 80 | 63.8% (51/80) | 12.5% (10/80) | 21.3% (17/80) | 1.3% (1/80) | 1.3% (1/80) | | All | | 681 | 53.6% (365/681) | 17.6% (120/681) | 26.0% (177/681) | 0.7% (5/681) | 0.7% (5/681)** | volume, daily PC/NTC failure, ** Excluded from this table are 35 samples from 17 years of age and 2 samples where the age of the patient was not t available. | Hypothetical Prevalence | HSV-1 | | HSV-2 | | |-------------------------|-------|--------|-------|--------| | | PPV* | NPV** | PPV* | NPV** | | 1.0% | 35.3% | 100.0% | 30.9% | 100.0% | | 2.0% | 52.5% | 99.9% | 47.4% | 99.9% | | 3.0% | 62.6% | 99.9% | 57.7% | 99.9% | | 5.0% | 74.0% | 99.9% | 69.9% | 99.8% | | 10.0% | 85.7% | 99.7% | 83.1% | 99.7% | | 15.0% | 90.5% | 99.5% | 88.6% | 99.5% | | 20.0% | 93.1% | 99.3% | 91.7% | 99.3% | | 30.0% | 95.9% | 98.9% | 95.0% | 98.8% | | 50.0% | 98.2% | 97.4% | 97.8% | 97.2% | *Positive Predictive Value (PPV) was calculated using: (Sensitivity x Prevalence)/(Sensitivity x Prevalence + [1 - Specificity] x [1 - Prevalence]). **Negative Predictive Value (NPV ) was calculated using: (Specificity x [1 - Prevalence])/([1 - Sensitivity] x Prevalence + Specificity x [1 - Prevalence]). {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, black letters. A curved black line extends from the top left of the "F" and curves around the word. Below "FOCUS" is the word "Diagnostics" in smaller, black letters, underlined with a thin black line. ### 510(k) Summary Simplexa™ HSV 1 & 2 Direct Catalog No. MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack Catalog No. MOL2160 August 20, 2015 Page 12 of 12 #### FRESH VS FROZEN STUDY Storage conditions were validated using the following transport media types BD VTM, M4, M4RT, M5, M6, and UTM by spiking media with organism at concentrations ranging from 3 times LoD to 50 times LoD and at different storage temperatures and durations. Samples should be transported on ice and stored at 2 to 8°C for up to 7 days post collection. If there is a greater than 7 day delay before processing of the sample, store the sample at -70° C. #### CONCLUSION The conclusions drawn from the nonclinical tests demonstrate the device is as safe and effective as the legally marketed device identified above.