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.

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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information for the Simplexa™ Flu A/B & RSV Direct device, based on the provided document:

Acceptance Criteria and Device Performance Study

The purpose of this Special 510(k) (K152408) is to expand the analytical reactivity of the Simplexa™ Flu A/B & RSV Direct assay to include 53 additional strains. Therefore, the primary acceptance criteria for this specific submission relate to the successful detection of these new strains.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the additional strains is detection by the Simplexa™ Flu A/B & RSV Direct assay. All tested strains were successfully detected.

Target Organism	Acceptance Criteria	Reported Device Performance
Influenza A Viruses (37 strains)	Flu A Detected	All 37 tested Influenza A strains were detected.
Influenza B Viruses (9 strains)	Flu B Detected	All 9 tested Influenza B strains were detected.
RSV Viruses (7 strains)	RSV Detected	All 7 tested RSV strains were detected.

Note: The document explicitly states: "Fifty-three strains met the established acceptance criteria and passed validation testing. Analytical Reactivity will be expanded to add 53 additional strains." This confirms that the acceptance criteria for these specific strains was successful detection.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: For each of the 53 additional strains, the testing was performed in triplicate. This means a total of 53 strains * 3 replicates = 159 individual tests were performed for this specific analytical reactivity study.
Data Provenance: The strains were sourced from various locations and historical periods, indicating a focus on analytical validity and strain diversity rather than clinical performance from a specific population or region. Examples include strains like "A/California/4/2009", "A/Massachusetts/15/2013", "A/Japan/305/57", "B/Brisbane/33/2008", and "ATCC-2012-10". The study itself is an analytical study conducted in a lab setting, not a direct clinical study. The document doesn't specify the country of origin where the testing took place, but it's likely a controlled lab environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This study focuses on analytical reactivity, where the "ground truth" is the presence and identification of a specific viral strain at a known concentration. This type of ground truth does not typically involve expert clinical adjudication. The ground truth (i.e., confirmation of the viral strain and its concentration) would have been established by standard laboratory methods for viral culture, quantification (e.g., TCID50/mL, CEID50/mL, PFU/mL), and characterization, prior to being used in the Simplexa™ assay. The document does not specify the number or qualifications of experts involved in establishing this initial ground truth, as it's a standard process in virology.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is described, as this is an analytical study evaluating device performance against known quantities of target analytes, not a clinical study requiring human interpretation or consensus for diagnosis. The "result" is the output of the RT-PCR system ("Flu A Detected," "Flu B Detected," "RSV Detected").

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done for this particular submission. This 510(k) is a "Special 510(k)" to expand analytical reactivity, not to re-evaluate or compare clinical effectiveness with human readers. The clinical performance characteristics were established in a previous submission (K142365).

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Yes, a standalone performance study was done for the analytical reactivity. The study evaluated the ability of the Simplexa™ Flu A/B & RSV Direct assay system (algorithm/device only) to detect the specified viral strains. The results presented ("Flu A Detected," "Flu B Detected," "RSV Detected") are direct outputs from the device, with no human intervention in the detection process itself.

7. Type of Ground Truth Used

The ground truth used for this analytical reactivity study was based on known quantified viral material. This means:

Viral Culture/Quantification: Viral samples were quantified using methods like TCID50/mL (Tissue Culture Infectious Dose 50%), CEID50/mL (Chicken Embryo Infectious Dose 50%), PFU/mL (Plaque Forming Units/mL), or using purified RNA at known concentrations (e.g., ng/µL, IU/mL).
Strain Identification: The specific identity and subtype of each viral strain were confirmed through standard virological methods.
These known viral materials were then spiked into a negative swab matrix to simulate clinical samples for testing.

8. Sample Size for the Training Set

The document does not provide details about the training set sample size. This submission (K152408) is an expansion of analytical reactivity and refers to the predicate device K142365 for most other performance characteristics, including clinical studies. RT-PCR assays typically do not have a "training set" in the machine learning sense, but rather a development and validation process during which assay parameters are optimized and locked.

9. How the Ground Truth for the Training Set Was Established

Similar to point 8, the document does not specifically detail how a "training set ground truth" was established, as it's not a machine learning algorithm in the typical sense that would require a distinct training phase with labeled data in the way, for example, an image recognition AI would. The development of an RT-PCR assay involves optimization and validation studies using characterized viral isolates and clinical samples, where the "ground truth" for these samples is derived from:

Reference Methods: Such as viral culture, sequencing, or other FDA-cleared assays.
Expert Consensus: For clinical samples, expert microbiologists or virologists would confirm the presence/absence of target viruses using gold standard methods.

The current document focuses singularly on the analytical reactivity towards an expanded panel of viral strains, relying on the already established methodologies from the predicate device (K142365) for other aspects of performance.

Summary

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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.

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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

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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

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.

Simplexa™ Flu A/B & RSV Positive Control Pack REF MOL2660

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.

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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 StreetCypress, California 90630USA
Establishment Registration No.	2023365
Contact Person	Irene M. Guzmantel 562.240.6133fax 562.240.6530iguzman@focusdx.com
Summary Date	August 24, 2015
Proprietary Name	Simplexa™ Flu A/B & RSV Direct and Simplexa™ Flu A/B & RSVPositive Control Pack
Generic Name	Respiratory viral panel nucleic acid
Classification	Class II
US Product Code	OCC - Respiratory Viral Panel Nucleic Acid Assay SystemOOI - 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.

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

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Image /page/4/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in 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

COMPARISON TO PREDICATE

Similarities

Feature	Predicate K142365	Proposed Product
Intended Use	Simplexa™ Flu A/B & RSV Direct REF MOL2650The Focus Diagnostics Simplexa™ Flu A/B & RSV Direct assayis intended for use on the 3M Integrated Cycler instrument forthe in vitro qualitative detection and differentiation of influenza Avirus, influenza B virus, and respiratory syncytial virus (RSV)RNA in nasopharyngeal swabs (NPS) from human patients withsigns and symptoms of respiratory tract infection in conjunctionwith clinical and epidemiological risk factors. This test isintended for use as an aid in the differential diagnosis ofinfluenza A, influenza B, and RSV viral infections in humans andis not intended to detect influenza C.Negative results do not preclude influenza virus or RSV infectionand should not be used as the sole basis for treatment or otherpatient management decisions.Performance characteristics for influenza A were establishedwith clinical specimens collected during the 2010/2011 influenzaseason when 2009 H1N1 influenza and H3N2 were thepredominant influenza A viruses in circulation. When otherinfluenza A viruses are emerging, performance characteristicsmay vary.If infection with a novel Influenza A virus is suspected based oncurrent clinical and epidemiological screening criteriarecommended by public health authorities, specimens should becollected with appropriate infection control precautions for novelvirulent Influenza viruses and sent to the state or local healthdepartment for testing. Viral culture should not be attempted inthese cases unless a BSL 3+ facility is available to receive andculture specimens.Simplexa™ Flu A/B & RSV Positive Control PackREF MOL2660Focus Diagnostics' Simplexa™ Flu A/B & RSV Positive ControlPack is intended to be used as a control with the Simplexa™ FluA/B & RSV Direct kit. This control is not intended for use withother assays or systems.	Same

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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
SpecimenType	Unprocessed nasopharyngeal swabs that have not undergone nucleic acid extraction	Same
Influenza AViral Target	Well conserved region of the matrix gene	Same
Influenza BViral Target	Well conserved region of the matrix gene	Same
RespiratorySyncytialViral Target	M gene	Same
Assay Type	Qualitative	Same

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Image /page/6/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in 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 additionalinfluenza strains toAnalytical 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_RG26Avian Influenza A VirusesH1N3 - 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 VirusesH1N2 - A/swine/Ohio/09SW1477/2009, H3N2 - A/swine/Ohio/09SW83E/2009
Nine (9) Strains ofInfluenza 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 ofRSV	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.

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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.

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510(k) Summary

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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	ConcentrationTested	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	ConcentrationTested	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

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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

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Avian Influenza A Viruses (Continued)
Subtype	Organism	ConcentrationTested	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	ConcentrationTested	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	ConcentrationTested	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}------------------------------------------------

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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	ConcentrationTested	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.

Regulation Number and Section

§ 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.