(27 days)
Not Found
No
The device description and performance studies focus on real-time RT-PCR technology for viral detection, with no mention of AI or ML.
No
The device is described as an "in vitro qualitative detection and differentiation" assay, meaning it diagnoses diseases rather than treating them.
Yes
The device is described as "intended for the in vitro qualitative detection and differentiation of influenza B virus, and respiratory syncytial virus (RSV) RNA" and "intended for use as an aid in the differential diagnosis of influenza B, and RSV viral infections in humans". This directly indicates its role in diagnosing medical conditions.
No
The device description explicitly states that the system consists of the Simplexa™ Flu A/B & RSV Direct assay, the 3M Integrated Cycler (with Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories. This indicates the device includes hardware components (the 3M Integrated Cycler and Direct Amplification Disc) in addition to software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is intended for "in vitro qualitative detection and differentiation of influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients". The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of the living body.
- Sample Type: The test uses "nasopharyngeal swabs (NPS) from human patients," which are biological specimens collected from a human.
- Purpose: The test is used "as an aid in the differential diagnosis of influenza B, and RSV viral infections in humans," indicating its role in providing information for clinical decision-making.
- Device Description: The "Device Description" further clarifies that it's a "real-time RT-PCR system" that analyzes RNA from these specimens.
All of these characteristics align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
Simplexa™ Flu A/B & RSV Direct REF MOL2650
The Focus Diagnostics Simplexa™ Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other patient management decisions.
Performance characteristics for influenza A were established with clinical specimens collected during the 2010/2011 influenza season when 2009 H1N1 influenza and H3N2 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to the state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Simplexa™ Flu A/B & RSV Positive Control Pack REF MOL2660
Focus Diagnostics' Simplexa™ Flu A/B & RSV Positive Control Pack is intended to be used as a control with the Simplexa™ Flu A/B & RSV Direct kit. This control is not intended for use with other assays or systems.
Product codes (comma separated list FDA assigned to the subject device)
OCC, OOI
Device Description
The Simplexa™ Flu AB & RSV Direct assay system is a real-time RT-PCR system that enables the direct amplification, detection and differentiation of human influenza A (Flu A) virus RNA, human influenza B (Flu B) virus RNA and RSV RNA from unprocessed nasopharyngeal swabs that have not undergone nucleic acid extraction. The system consists of the Simplexa™ Flu A/B & RSV Direct assay, the 3M Integrated Cycler (with Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories.
In the Simplexa™ Flu A/B & RSV Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify Flu A, Flu B, RSV and internal control RNA. The assay provides three results; conserved regions of influenza A viruses (matrix gene), influenza B viruses (matrix gene) and RSV (M gene) are targeted to identify these viruses in the specimen. An RNA internal control is used to detect RT-PCR failure and/or inhibition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal swabs (NPS)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The purpose of this Special 510(k) is to expand the analytical reactivity to add 53 additional strains.
Analytical Reactivity - Simplexa™ Flu A/B & RSV Direct:
Multiple strains of influenza A (H1, H2, H3, H5 and H9 subtypes), avian influenza A (H1, H3, H4, H7, H10, H11, H12, H13 and H16 subtypes), swine influenza A (H1 and H3 subtypes), influenza B (Victoria and Yamagata lineages) and RSV (A subtypes) were evaluated. The most recent strains and geographically diverse strains were chosen. Quantified viral material was spiked into negative swab matrix at a single dilution at the concentrations below. Each was assayed in triplicate. The Ct values obtained indicate all viral strains were detected at the concentrations tested.
Results:
All 53 additional influenza strains were detected.
Influenza A (37 Strains) were detected.
Influenza B (9 Strains) were detected.
RSV (7 Strains) were detected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.
(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.
0
Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2015
Focus Diagnostics, Inc. Irene Guzman Senior Regulatory Affairs Specialist 11331 Valley View Street Cypress, CA 90630
Re: K152408
Trade/Device Name: Simplexa™ Flu A/B & RSV Direct and Simplexa™ Flu A/B & RSV Positive Control Pack Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OCC Dated: August 24, 2015 Received: August 25, 2015
Dear Ms. Guzman:
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,
Tamara V. Feldblyum for ഗ
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) K152408
Device Name
Simplexa™ Flu A/B & RSV Direct REF MOL2650 and Simplexa™ Flu A/B & RSV Positive Control Pack REF MOL2660
Indications for Use (Describe)
Simplexa™ Flu A/B & RSV Direct REF MOL2650
The Focus Diagnostics Simplexa™ Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other patient management decisions.
Performance characteristics for influenza A were established with clinical specimens collected during the 2010/2011 influenza season when 2009 H1N1 influenza and H3N2 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to the state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Simplexa™ Flu A/B & RSV Positive Control Pack REF MOL2660
Focus Diagnostics' Simplexa™ Flu A/B & RSV Positive Control Pack is intended to be used as a control with the Simplexa™ Flu A/B & RSV Direct kit. This control is not intended for use with other assays or systems.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ 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 logo consists of the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, crescent-shaped graphic is positioned to the left of the word "FOCUS", creating a visual element that emphasizes the brand name.
olk) Sum
Simplexa" Flu A/B & RSV Direct REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack |REF|MOL2660 Prepared Date: September 18, 2015
Page 1 of 7
| Applicant | Focus Diagnostics, Inc.
11331 Valley View Street
Cypress, California 90630
USA |
|--------------------------------|--------------------------------------------------------------------------------------------------------------|
| Establishment Registration No. | 2023365 |
| Contact Person | Irene M. Guzman
tel 562.240.6133
fax 562.240.6530
iguzman@focusdx.com |
| Summary Date | August 24, 2015 |
| Proprietary Name | Simplexa™ Flu A/B & RSV Direct and Simplexa™ Flu A/B & RSV
Positive Control Pack |
| Generic Name | Respiratory viral panel nucleic acid |
| Classification | Class II |
| US Product Code | OCC - Respiratory Viral Panel Nucleic Acid Assay System
OOI - Real Time Nucleic Acid Amplification System |
| Regulation Number | 21 CFR § 866.3980 |
| Predicate Device | K142365 Simplexa™ Flu A/B & RSV Direct and Simplexa™ Flu A/B
& RSV Positive Control Pack |
510(k) SUBMISSION PURPOSE
The purpose of this Special 510(k) is to expand the analytical reactivity to add 53 additional strains.
INTENDED USE
Simplexa™ Flu A/B & RSV Direct REF MOL2650
The Focus Diagnostics Simplexa™ Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other patient management decisions.
Performance characteristics for influenza A were established with clinical specimens collected during the 2010/2011 influenza season when 2009 H1N1 influenza and H3N2 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to the state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facilable to receive and culture specimens.
Simplexa" Flu A/B & RSV Positive Control Pack REF MOL2660
Focus Diagnostics' Simplexa™ Flu A/B & RSV Positive Control Pack is intended to be used as a control with the Simplexa™ Flu A/B & RSV Direct kit. This control is not intended for use with other assays or systems.
4
Image /page/4/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. A curved, swooping line is placed to the left of the word "FOCUS", adding a dynamic element to the design. The logo is simple, clean, and professional.
152408
510(k) Summary
Simplexa™ Flu A/B & RSV Direct REF MOL2650 Simplexa" Flu A/B & RSV Positive Control Pack |REF|MOL2660 Prepared Date: September 18, 2015 Page 2 of 7
DEVICE DESCRIPTION
The Simplexa™ Flu AB & RSV Direct assay system is a real-time RT-PCR system that enables the direct amplification, detection and differentiation of human influenza A (Flu A) virus RNA, human influenza B (Flu B) virus RNA and RSV RNA from unprocessed nasopharyngeal swabs that have not undergone nucleic acid extraction. The system consists of the Simplexa™ Flu A/B & RSV Direct assay, the 3M Integrated Cycler (with Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories.
In the Simplexa™ Flu A/B & RSV Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify Flu A, Flu B, RSV and internal control RNA. The assay provides three results; conserved regions of influenza A viruses (matrix gene), influenza B viruses (matrix gene) and RSV (M gene) are targeted to identify these viruses in the specimen. An RNA internal control is used to detect RT-PCR failure and/or inhibition.
COMPARISON TO PREDICATE
Similarities
| Feature | Predicate K142365 | Proposed Product |
|---|---|---|
| Intended Use | Simplexa™ Flu A/B & RSV Direct REF MOL2650 | |
| The Focus Diagnostics Simplexa™ Flu A/B & RSV Direct assay | ||
| is intended for use on the 3M Integrated Cycler instrument for | ||
| the in vitro qualitative detection and differentiation of influenza A | ||
| virus, influenza B virus, and respiratory syncytial virus (RSV) | ||
| RNA in nasopharyngeal swabs (NPS) from human patients with | ||
| signs and symptoms of respiratory tract infection in conjunction | ||
| with clinical and epidemiological risk factors. This test is | ||
| intended for use as an aid in the differential diagnosis of | ||
| influenza A, influenza B, and RSV viral infections in humans and | ||
| is not intended to detect influenza C. |
Negative results do not preclude influenza virus or RSV infection
and should not be used as the sole basis for treatment or other
patient management decisions.
Performance characteristics for influenza A were established
with clinical specimens collected during the 2010/2011 influenza
season when 2009 H1N1 influenza and H3N2 were the
predominant influenza A viruses in circulation. When other
influenza A viruses are emerging, performance characteristics
may vary.
If infection with a novel Influenza A virus is suspected based on
current clinical and epidemiological screening criteria
recommended by public health authorities, specimens should be
collected with appropriate infection control precautions for novel
virulent Influenza viruses and sent to the state or local health
department for testing. Viral culture should not be attempted in
these cases unless a BSL 3+ facility is available to receive and
culture specimens.
Simplexa™ Flu A/B & RSV Positive Control Pack
REF MOL2660
Focus Diagnostics' Simplexa™ Flu A/B & RSV Positive Control
Pack is intended to be used as a control with the Simplexa™ Flu
A/B & RSV Direct kit. This control is not intended for use with
other assays or systems. | Same |
5
Image /page/5/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, sans-serif font, with a curved shape above it. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line. The logo is in black and white.
K152408
510(k) Summary
Simplexa™ Flu A/B & RSV Direct REF MOL2650 Simplexa"" Flu A/B & RSV Positive Control Pack [REF] MOL2660 Prepared Date: September 18, 2015
Page 3 of 7
| Feature | Predicate K142365 | Proposed Product |
|---|---|---|
| Technology | The Simplexa™ Flu A/B & RSV Direct assay system is a real-time RT-PCR system that enables the direct amplification, detection and differentiation of human influenza A (Flu A) virus RNA, human influenza B (Flu B) virus RNA and RSV RNA from unprocessed nasopharyngeal swabs that have not undergone nucleic acid extraction. The system consists of the Simplexa™ Flu A/B & RSV Direct assay, the 3M Integrated Cycler (with Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories. |
In the Simplexa™ Flu A/B & RSV Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify Flu A, Flu B, RSV and internal control RNA. The assay provides three results; conserved regions of influenza A viruses (matrix gene), influenza B viruses (matrix gene) and RSV (M gene) are targeted to identify these viruses in the specimen. An RNA internal control is used to detect RT-PCR failure and/or inhibition. | Same |
| Instrument | 3M Integrated Cycler | Same |
| Specimen
Type | Unprocessed nasopharyngeal swabs that have not undergone nucleic acid extraction | Same |
| Influenza A
Viral Target | Well conserved region of the matrix gene | Same |
| Influenza B
Viral Target | Well conserved region of the matrix gene | Same |
| Respiratory
Syncytial
Viral Target | M gene | Same |
| Assay Type | Qualitative | Same |
6
Image /page/6/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font. A curved line extends from the top left 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™ Flu A/B & RSV Direct REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack |REF MOL2660 Prepared Date: September 18, 2015
Page 4 of 7
Differences
| Subject Device | |
|---|---|
| Add 53 additional | |
| influenza strains to | |
| Analytical Reactivity. | Fifty (53) additional influenza strains were tested and included in the analytical reactivity table. |
| Thirty-seven (37) | |
| Strains of Influenza A | Influenza A (37 Strains) |
| (H1N1) pdm09 - A/California/4/2009, (H1N1) pdm09 - A/Massachusetts/15/2013, | |
| (H1N1) pdm09 - A/Mexico/4108/2009, (H1N1) pdm09 - A/New York/18/2009, | |
| H1N1 - A/Hawaii/15/2001, H2N2 - A/Japan/305/57, H3N2 - A/California/02/2014, | |
| H3N2 - A/New York/55/2004, H3N2 - A/Rhode Island/01/2010, | |
| H3N2 - A/Santiago/7981/2006, H3N2 - A/Switzerland/9715293/2013, | |
| H5N1 - A/Egypt/N03072/2010(H5N1)-PR8-IDCDC-RG29, | |
| H5N1 - A/Hubei/1/2010(H5N1)-PR8-IDCDC-RG30, | |
| H5N1 - A/India/NIV/2006(H5N1)-PR8-IBCDC-RG7, | |
| H9N2 - A/Hong Kong/33982/2009(H9N2)-PR8-IDCDC_RG26 | |
| Avian Influenza A Viruses | |
| H1N3 - A/shorebird/Delaware Bay/211/1994, | |
| H1N8 - A/red knot/Delaware Bay/240/1994, H3N6 - A/redhead/Alberta/192/2002, | |
| H3N8 - A/duck/Chabarovsk/1610/1972, H4N6 - A/duck/Czechoslovakia/1956, | |
| H4N6 - A/red knot/Delaware/541/1988, | |
| H5N1 - A/chicken/Vietnam/NCVD-016/2008(H5N1)-PR8-IDCDC-RG12, | |
| H5N2 - A/pheasant/New Jersey/1355/1998(H5N2)-PR8-IBCDC-4, | |
| H6N2 - A/turkey/Massachusetts/3740/1965, | |
| H7N2 - A/turkey/Virginia/4529/2002 (H7N2)xPR8-IBCDC-5, | |
| H7N7 - A/mallard/Netherlands/12/2000(H7N7)/PR8-IBCDC-1, | |
| H10N1 - A/mallard/Wisconsin/4230/2009, H10N7 - A/chicken/Germany/N/49, H10N7 - | |
| A/mallard/Illinois/10OS4334/2010, | |
| H10N8 - A/quail/Italy/1117/1965, | |
| H11N9 - A/American green-winged teal/Mississippi/300/2010, | |
| H12N5 - A/mallard/Wisconsin/4218/2009, H12N6 -A/duck/Wisconsin/480/1979, | |
| H13N6 - A/black-legged kittiwake/Quebec/02838-1/2009, | |
| H16N3 - A/shorebird/Delaware/172/2006, | |
| Swine Influenza A Viruses | |
| H1N2 - A/swine/Ohio/09SW1477/2009, H3N2 - A/swine/Ohio/09SW83E/2009 | |
| Nine (9) Strains of | |
| Influenza B | Influenza B (9 Strains) |
| Victoria - B/Brisbane/33/2008, Yamagata - B/Christchurch/33/2004, | |
| Yamagata-B/Guangdong-Liwan/1133/2014, Yamagata - B/Massachusetts/2/2012, | |
| Victoria - B/Nevada/03/2011, Yamagata - B/Phuket/3073/2013, | |
| Victoria - B/Texas/02/2013, Yamagata - B/Utah/9/2014, | |
| Victoria - B/Victoria/304/2006 | |
| Seven (7) strains of | |
| RSV | RSV (7 Strains) |
| ATCC-2012-10, A 1997/12-35, A 1998/12-21, A 1998/3-2, A 2000/3-4, | |
| A 2001/2-20, A 2001/3-12 |
CLINICAL AGREEMENT - PROSPECTIVE STUDY
No Change. Refer to K142365.
CLINICAL AGREEMENT - RETROSPECTIVE STUDY
No Change. Refer to K142365.
REPRODUCIBILITY
No Change. Refer to K142365.
ANALYTICAL SENSITIVITY / LIMIT OF DETECTION
No Change. Refer to K142365.
7
Image /page/7/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 above and to the left of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin black line. The logo is in black and white.
52408
510(k) Summary
Simplexa™ Flu A/B & RSV Direct REF MOL2650 Simplexa"" Flu A/B & RSV Positive Control Pack [REF] MOL2660 Prepared Date: September 18, 2015 Page 5 of 7
ANALYTICAL REACTIVITY/ CROSS REACTIVITY
Analytical Reactivity - Simplexa™ Flu A/B & RSV Direct
Multiple strains of influenza A (H1, H2, H3, H5 and H9 subtypes), avian influenza A (H1, H3, H4, H7, H10, H11, H12, H13 and H16 subtypes), swine influenza A (H1 and H3 subtypes), influenza B (Victoria and Yamagata lineages) and RSV (A subtypes) were evaluated. The most recent strains and geographically diverse strains were chosen. Quantified viral material was spiked into negative swab matrix at a single dilution at the concentrations below. Each was assayed in triplicate. The Ct values obtained indicate all viral strains were detected at the concentrations tested.
| Influenza A Viruses | ||||
|---|---|---|---|---|
| Subtype | Organism | Concentration | ||
| Tested | Result | |||
| (H1N1) pdm09 | A/California/4/2009 | 100 TCID50/mL | Flu A Detected | |
| (H1N1) pdm09 | A/Massachusetts/15/2013 | 1000 CEID50/mL² | Flu A Detected | |
| (H1N1) pdm09 | A/Mexico/4108/2009 | 100 CEID50/mL² | Flu A Detected | |
| (H1N1) pdm09 | A/New York/18/2009 | 100 CEID50/mL2 | Flu A Detected | |
| H1N1 | A/Hawaii/15/2001 | 100 CEID50/mL2 | Flu A Detected | |
| H2N2 | A/Japan/305/57 | 3.26E-01 ng/μL3 | Flu A Detected | |
| H3N2 | A/California/02/2014 | 100 TCID50/mL | Flu A Detected | |
| H3N2 | A/New York/55/2004 | 100 CEID50/mL² | Flu A Detected | |
| H3N2 | A/Rhode Island/01/2010 | 400 CEID50/mL2 | Flu A Detected | |
| H3N2 | A/Santiago/7981/2006 | 100 CEID50/mL² | Flu A Detected | |
| H3N2 | A/Switzerland/9715293/2013 | 200 CEID50/mL² | Flu A Detected | |
| HENT | A/Egypt/N03072/2010(H5N1)-PR8-IDCDC-RG29 | 1:100,000ª | Flu A Detected | |
| HENT | A/Hubei/1/2010(H5N1)-PR8-IDCDC-RG30 | 1:100,0004 | Flu A Detected | |
| H5N1 | A/India/NIV/2006(H5N1)-PR8-IBCDC-RG7 | 1:100,0004 | Flu A Detected | |
| H9N2 | A/Hong Kong/33982/2009(H9N2)-PR8-IDCDC_RG26 | 100 CEID50/mL² | Flu A Detected |
Infectious Units/mL
2CEID50/mL: Chicken Embryo Infectious Dose
31xTE was used for dilution. Japan/305/57 (H2N2) is purified RNA, not virus like the rest of the panel.
4 Inactivated virus was diluted and tested
్ EID50/mL: Egg Infectious Dose
| Avian Influenza A Viruses | |||
|---|---|---|---|
| Subtype | Organism | Concentration | |
| Tested | Result | ||
| H1N3 | A/shorebird/Delaware Bay/211/1994 | 100 CEID50/mL1 | Flu A Detected |
| H1N8 | A/red knot/Delaware Bay/240/1994 | 200 CEID50/mL1 | Flu A Detected |
| H3N6 | A/redhead/Alberta/192/2002 | 100 CEID50/mL1 | Flu A Detected |
| H3N8 | A/duck/Chabarovsk/1610/1972 | 400 CEID50/mL1 | Flu A Detected |
| H4N6 | A/duck/Czechoslovakia/1956 | 100 CEID50/mL1 | Flu A Detected |
| H4N6 | A/red knot/Delaware/541/1988 | 100 CEID50/mL1 | Flu A Detected |
| H5N1 | A/chicken/Vietnam/NCVD-016/2008(H5N1)-PR8-IDCDC-RG12 | 1:100,0002 | Flu A Detected |
| H5N2 | A/pheasant/New Jersey/1355/1998(H5N2)-PR8-IBCDC-4 | 1:100,0002 | Flu A Detected |
8
Image /page/8/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, black letters. To the left of the word is a curved, black swoosh. Below the word "FOCUS" is the word "Diagnostics" in smaller, black letters with a line above it.
152408
510(k) Summary
Simplexa™ Flu A/B & RSV Direct REF MOL2650 Simplexa"" Flu A/B & RSV Positive Control Pack |REF|MOL2660 Prepared Date: September 18, 2015 Page 6 of 7
| Avian Influenza A Viruses (Continued) | |||
|---|---|---|---|
| Subtype | Organism | Concentration | |
| Tested | Result | ||
| H6N2 | A/turkey/Massachusetts/3740/1965 | 200 CEID50/mL1 | Flu A Detected |
| H7N2 | A/turkey/Virginia/4529/2002 (H7N2)xPR8-IBCDC-5 | 1:100,0002 | Flu A Detected |
| H7N7 | A/mallard/Netherlands/12/2000(H7N7)/PR8-IBCDC-1 | 1:100,0002 | Flu A Detected |
| H10N1 | A/mallard/Wisconsin/4230/2009 | 100 CEID50/mL1 | Flu A Detected |
| H10N7 | A/chicken/Germany/N/49 | 100 CEID50/mL1 | Flu A Detected |
| H10N7 | A/mallard/Illinois/10OS4334/2010 | 100 CEID50/mL1 | Flu A Detected |
| H10N8 | A/quail/Italy/1117/1965 | 100 CEID50/mL1 | Flu A Detected |
| H11N9 | A/American green-winged teal/Mississippi/300/2010 | 100 CEID50/mL1 | Flu A Detected |
| H12N5 | A/mallard/Wisconsin/4218/2009 | 100 CEID50/mL1 | Flu A Detected |
| H12N6 | A/duck/Wisconsin/480/1979 | 100 CEID50/mL1 | Flu A Detected |
| H13N6 | A/black-legged kittiwake/Quebec/02838-1/2009 | 200 CEID50/mL1 | Flu A Detected |
| H16N3 | A/shorebird/Delaware/172/2006 | 400 CEID50/mL1 | Flu A Detected |
'CEID50/mL: Chicken Embryo Infectious Dose
²Inactivated virus was diluted and tested
NOTE: Although this test has been shown to detect novel avian influenza A (H7N9) and H3N2v cultured viruses, the performance characteristics of this device with clinical specimens that are positive for novel avian influenza A (H7N9) and H3N2v influenza viruses have not been established.
| Swine Influenza A Viruses | |||
|---|---|---|---|
| Subtype | Organism | Concentration | |
| Tested | Result | ||
| H1N2 | A/swine/Ohio/09SW1477/2009 | 100 TCID50/mL | Flu A Detected |
| H3N2 | A/swine/Ohio/09SW83E/2009 | 400 CEID50/mL1 | Flu A Detected |
1CEID50/mL: Chicken Embryo Infectious Dose
| Influenza B Viruses | |||
|---|---|---|---|
| Lineage | Organism | Concentration | |
| Tested | Result | ||
| Victoria | B/Brisbane/33/2008 | 20 CEID50/mL1 | Flu B Detected |
| Victoria | B/Nevada/03/2011 | 100 CEID50/mL1 | Flu B Detected |
| Victoria | B/Texas/02/2013 | 100 TCID50/mL | Flu B Detected |
| Victoria | B/Victoria/304/2006 | 20 CEID50/mL1 | Flu B Detected |
| Yamagata | B/Christchurch/33/2004 | 100 TCID50/mL | Flu B Detected |
| Yamagata | B/Guangdong-Liwan/1133/2014 | 400 CEID50/mL1 | Flu B Detected |
| Yamagata | B/Massachusetts/2/2012 | 100 IU/mL2 | Flu B Detected |
| Yamagata | B/Phuket/3073/2013 | 100 CEID50/mL1 | Flu B Detected |
| Yamagata | B/Utah/9/2014 | 100 CEID50/mL1 | Flu B Detected |
1CEID50/mL: Chicken Embryo Infectious Dose 2Infectious Units/mL
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. A curved, black swoosh is positioned to the left of the word "FOCUS", adding a dynamic element to the design. The overall design is simple, clean, and professional.
510(k) Sui Simplexa™ Flu A/B & RSV Direct REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack |REF|MOL2660 Prepared Date: September 18, 2015 Page 7 of 7
| RSV | |||
|---|---|---|---|
| Subtype | Organism | Concentration | |
| Tested | Result | ||
| N/A | ATCC-2012-10 | 100 PFU/mL | RSV Detected |
| A | A 1997/12-35 | 100 TCID50/mL | RSV Detected |
| A | A 1998/12-21 | 100 TCID50/mL | RSV Detected |
| A | A 1998/3-2 | 100 TCID50/mL | RSV Detected |
| A | A 2000/3-4 | 100 TCID50/mL | RSV Detected |
| A | A 2001/2-20 | 100 TCID50/mL | RSV Detected |
| A | A 2001/3-12 | 100 TCID50/mL | RSV Detected |
CROSS REACTIVITY (Analytical Specificity)
No Change. Refer to K142365.
INTERFERENCE
No Change. Refer to K142365.
COMPETITIVE INTERFERENCE
No Change. Refer to K142365.
INHIBITION BY OTHER MICROORGANISMS
No Change. Refer to K142365.
ADDITIONAL PERFORMANCE STUDIES
Please refer to the previously FDA cleared 510(k) K142365 for additional information.
CONCLUSION
Fifty-three strains met the established acceptance criteria and passed validation testing. Analytical Reactivity will be expanded to add 53 additional strains.