Who is the manufacturer of SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK?

Focus Diagnostics, Inc. filed the 510(k) submission for SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK (K120413).

What is the FDA product code for SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK?

OCC. It is classified under 21 CFR 866.3980 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK?

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

Who can help prepare an FDA 510(k) submission like SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV 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 FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK

Q: What are the predicate devices for SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK?

Prodesse, ProFlu+ Assay (K092500, K081030, K073029).

K120413 · Focus Diagnostics, Inc. · OCC · Jul 13, 2012 · Microbiology

Device Facts

Record ID	K120413
Device Name	SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
Applicant	Focus Diagnostics, Inc.
Product Code	OCC · Microbiology
Decision Date	Jul 13, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3980
Device Class	Class 2

Intended Use

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 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.

Device Story

Simplexa™ Flu A/B & RSV Direct is a real-time RT-PCR assay for qualitative detection/differentiation of Flu A, Flu B, and RSV RNA from unprocessed nasopharyngeal swabs. System includes assay reagents, 3M Integrated Cycler, and Direct Amplification Disc. Bi-functional fluorescent probe-primers amplify viral targets and internal control RNA. Instrument performs real-time fluorometric detection of targets within disc wells. Operated by laboratory personnel in clinical settings. Results aid clinicians in differential diagnosis of respiratory infections. Benefits include direct amplification without prior nucleic acid extraction, enabling rapid identification of viral pathogens to inform patient management.

Clinical Evidence

Prospective and retrospective clinical studies evaluated performance against viral culture. Prospective study (n=722) showed Flu A sensitivity 97.1%, specificity 97.9%; Flu B sensitivity 100%, specificity 99.9%; RSV sensitivity/specificity varied by site (90-100% sensitivity, 84.6-98.2% specificity). Retrospective study (n=223) showed Flu A PPA 96.2%, NPA 99.3%; Flu B PPA 97.6%, NPA 100%; RSV PPA 100%, NPA 98.6%. Analytical studies confirmed LoD, cross-reactivity, and lack of interference from common nasal substances.

Technological Characteristics

Real-time RT-PCR assay; utilizes bi-functional fluorescent probe-primers. System components: 3M Integrated Cycler, Direct Amplification Disc, and Integrated Cycler Studio Software. Direct amplification (no extraction). Multiplex detection using reporter dyes. Targets: Flu A (matrix gene), Flu B (matrix gene), RSV (M gene). Internal control included for RT-PCR inhibition monitoring.

Indications for Use

Indicated for symptomatic human patients requiring differential diagnosis of influenza A, influenza B, and RSV viral infections via nasopharyngeal swab specimens. For prescription use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Prodesse, ProFlu+ Assay (K092500, K081030, K073029)

Related Devices

K152408 — Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack · Focus Diagnostics, Inc. · Sep 21, 2015
K142365 — Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack · Focus Diagnostics · Dec 5, 2014
K102170 — SIMPLEXA FLU A/B & RSV · Focus Diagnostics, Inc. · Nov 24, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in large, bold, sans-serif font. A curved, swooping line extends from the left side of the "F", arcing over the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line. 510(k) Summary Simplexa™ Flu A/B & RSV Direct - REF MOL2650 implexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.July.2012 Page 1 of 7 | Applicant | Focus Diagnostics, Inc. 11331 Valley View Street Cypress, California 90630 USA | |--------------------------------|-----------------------------------------------------------------------------------------| | Establishment Registration No. | 2023365 | | | JUL 13 2012 | | Contact Person | Tara Viviani tel 562.240.6115 fax 562.240.6530 tviviani@focusdx.com | | Summary Date | May 18, 2012 | | Proprietary Name | Simplexa™ Flu A/B & RSV Direct Simplexa™ Flu A/B & RSV Positive Control Pack | | Generic Name | Respiratory Viral Panel | | Classification | Class II, Special Controls | | Regulation | § 21 CFR 866.3980 - respiratory viral panel multiplex nucleic acid assay | | Product Code | OCC - respiratory virus panel nucleic acid assay system | | Predicate Devices | Prodesse, ProFlu+ Assay (K092500, K081030, K073029) | | INTENDED USE | | 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 coniunction 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 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 enideria 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. ### INTENDED USE 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 A/B & RSV Direct assay system is a real-time RT-PCR system that enables the direct amplification, delection 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) {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, uppercase letters, with a curved graphic element to the left. 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: 12.July.2012 Page 2 of 7 K120413 are targeted to identify these viruses in the specimen. An RNA internal control is used to detect RT-PCR failure and/or inhibition. The 3M Integrated Cycler is a rapid real-time Polymerase Chain Reaction thermocycler used for the identification of nucleic acid from prepared biological samples. The instrument utilizes disk media to contain and to process samples. The instrument uses real time flourometric detection to identify targets within the sample wells. The instrument is controlled by an external computer running the Integrated Cycler Studio software. ### Predicate Device Information | Trade Name / Method | 510(k) submitter | 510(k) number | Decision Date | Panel | Product Code(s) | |---------------------|------------------------|---------------------------------|----------------------------------------|----------------------|--------------------| | ProFlu+ | GenProbe (Prodesse) | K092500, K081030, K073029 | 08/20/2009 05/02/2008 01/04/2008 | Microbiology (83) | OCC | ## Comparison to Predicate Device | | Device | Predicate | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item Name | Simplexa™ Flu A/B & RSV Direct | ProFlu+ | | Intended Use | 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 discrimination 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. | The ProFlu™+ Assay is a multiplex Real-Time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from symptomatic patients. This test is intended for use to 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 or RSV virus infection and should not be used as the sole basis for treatment or other management decisions. It is recommended that negative RSV results be confirmed by culture. Performance characteristics for Influenza A Virus were established when Influenza A/H3 and A/H1 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 | | | Device | Predicate | | Item Name | Simplexa™ Flu A/B & RSV Direct | ProFlu+ | | | 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 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. | viruses and sent to 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. | | Assay Targets | Influenza A, Influenza B, RSV | Influenza A, Influenza B, RSV | | Sample Types | NPS | NPS | | Extraction Methods | None | Roche MagNA Pure LC Total Nucleic Acid Isolation Kit, Biomérieux NucliSENS easyMAG | | Assay Methodology | PCR-based system for detecting the presence / absence of viral RNA in clinical specimens | PCR-based system for detecting the presence / absence of viral DNA/RNA in clinical specimens | | Detection Techniques | Multiplex assay using different reporter dyes for each target. | Multiplex assay using different reporter dyes for each target. | | Influenza A Viral Target | Well conserved region of the matrix gene | Matrix gene | | Influenza B Viral Target | Well conserved region of the matrix gene | Non-structural NS1 and NS2 | | Respiratory Syncytial Viral Target | M gene. | Polymerase | | LoD | Analytical sensitivity (LoD) as defined as the lowest concentration at which ≥ 95% of all replicates tested positive, ranges from 102 - 10-3 TCID50/mL. | Analytical sensitivity (LoD) as defined as the lowest concentration at which ≥ 95% of all replicates tested positive, ranges from 102 - 10-1 TCID50/mL. | | Reproducibility | Influenza A = %CV of 0.4 to 1.5 Influenza B = %CV of 0.5 to 3.6 RSV = %CV of 1.2 to 3.3 | Influenza A = %CV of 1.4 to 5.3 Influenza B = %CV of 0.7 to 3.1 RSV = %CV of 1.5 to 8.3 | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features a stylized swoosh shape on the left, followed by the word "FOCUS" in bold, sans-serif font. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font with a line above it. # K120413 510(k) Summary Simplexa™ Flu A/B & RSV Direct - REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.July.2012 Page 3 of 7 ### PERFORMANCE CHARACTERISTICS ## CLINICAL AGREEMENT - PROSPECTIVE STUDY Three external testing sites and one internal site participated in a prospective clinical study. Reference results for influenza A, influenza B viruses and respiratory syncytial virus were generated using culture. Culture results were carried forward from the results obtained at the time of sample collection. A total of 722 nasopharyngeal swabs {3}------------------------------------------------ # 1204' 510(k) Summary Simplexa™ Flu A/B & RSV Direct - REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.July.2012 Page 4 of 7 specimens were obtained from prospectively collected specimens with signs and symptoms of viral respiratory tract infection. Prospective samples were collected in Eastern United States from 10-November-2010 to 11-March-2011; the Mid-Western United States from 08-January-2011 and in Australia from 17-August-2010 to 20-October-2010. Of the 722 specimens were collected from female patients and 397 specimens were collected from male patents. A total of 327 specimens were from patients <5 years of age, 223 specimens were from patients between 5-22 years of age, 158 specimens were from patients between 22 to 60 years of age and 14 specimens were from patients >60 years of age, One (1) sample was excluded from the prospective analysis due to Invalid result for Flu A, three (3) samples were excluded due to an invalid result for Flu B and one (1) sample were excluded due to an invalid result for RSV. During the study the percentage of specimens with invalid results was 0.4% (3/722) with a 95% Cl of 0.1% to 1.2%. ### Clinical Agreement - Flu A (Prospective - All sites combined) | Culture Result | Simplexa™ Results - Flu A | | Sensitivity/Specificity | | |----------------|---------------------------|----------|-------------------------|------------------------------------------------------| | | n | Detected | Not Detected | 95% CI | | Detected | 68 | 66 | 2 | Sensitivity: 97.1%(66/68) 95% CI: 89.9 to 99.2% | | Not Detected | 653 | 14 | 639 | Specificity: 97.9%(639/653) 95% CI: 96.4 to 98.7% | ### Clinical Agreement - Flu B (Prospective - All sites combined) | Culture Result | N | Simplexa™ Results - FluB | | Sensitivity/Specificity 95% CI | |----------------|-----|--------------------------|--------------|-------------------------------------------------------| | | | Detected | Not Detected | | | Detected | 21 | 21 | 0 | Sensitivity: 100.0%(21/21) 95% CI: 84.5 to 100.0% | | Not Detected | 698 | 1 | 697 | Specificity: 99.9%(697/698) 95% CI: 99.2 to 100.0% | ### Clinical Agreement - RSV (Prospective - Site 1) | Culture Result | | Simplexa™ Results - RSV | | Sensitivity/Specificity | | |----------------|-----|-------------------------|--------------|------------------------------------------------------|--| | | | Detected | Not Detected | 95% Cl ÷ | | | Detected | | | | Sensitivity: 100.0%(1/1) 95% Cl: 20.7 to 100.0% | | | Not Detected | 329 | | 323 | Specificity: 98.2%(323/329) 95% CI: 96.1 to 99.2% | | a) 4/6 samples were confirmed as RSV positive by an FDA cleared NAT | Clinical Agreement - RSV (Prospective - Site 2) | | | |-------------------------------------------------|--|--| | | | | | Culture Result | N | Simplexa™ Results – RSV | | Sensitivity/Specificity | |----------------|-----|-------------------------|--------------|------------------------------------------------------| | | | Detected | Not Detected | 95% CI | | Detected | 73 | 72 | 1a | Sensitivity: 98.6%(72/73) 95% CI: 92.6 to 99.8% | | Not Detected | 172 | 18b | 154 | Specificity: 89.5%(154/172) 95% CI: 84.1 to 93.3% | a) 1/1 sample confirmed as RSV positive by an FDA cleared DFA b) 11/18 samples confirmed as RSV positive by an FDA cleared DFA {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, non-bold font underneath. To the left of the word "FOCUS" is a black, curved shape that resembles a crescent or a stylized checkmark. # 510(k) Summarv Simplexa™ Flu A/B & RSV Direct - REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.July.2012 Page 5 of 7 | Clinical Agreement - RSV (Prospective - Site 3) | | | | | | |-------------------------------------------------|-----|-------------------------|--------------|------------------------------------------------------|--| | Culture Result | | Simplexa™ Results - RSV | | Sensitivity/Specificity | | | | N | Detected | Not Detected | 95% CI | | | Detected | 10 | 9 | 1 | Sensitivity: 90.0%(9/10) 95% CI: 59.6 to 98.2% | | | Not Detected | 136 | 21a | 115 | Specificity: 84.6%(115/136) 95% CI: 77.5 to 89.7% | | a) 20/21 samples confirmed as RSV positive by an FDA cleared NAT ### CLINICAL AGREEMENT - RETROSPECTIVE STUDY Three external testing sites participated in a retrospective clinical study. Reference results for influenza B viruses and respiratory syncytial virus were generated using culture. Culture results were carried forward from the results obtained at the time of sample banking. A total of 223 nasopharyngeal swabs specimens were obtained from retrospectively banked specimens from patients with signs and symptoms of viral respiratory tract infection. | Culture Result | n | Simplexa™ Results – Flu A | | PPA/NPA* | |----------------|-----|---------------------------|--------------|-----------------------------------------------| | | | Detected | Not Detected | 95% CI | | Detected | 79 | 76 | 3 | PPA: 96.2% (76/79) 95% CI: 89.4 to 98.7% | | Not Detected | 144 | 1 | 143 | NPA: 99.3% (143/144) 95% CI: 96.2 to 99.9% | ### Clinical Agreement - Flu A (Retrospective - All sites combined) * PPA = Positive Percent Agreement, NPA = Negative Percent Agreement ### Clinical Agreement - Flu B (Retrospective - All sites combined) | Culture Result | N | Simplexa™ Results - Flu B | | PPA/NPA* | |----------------|-----|---------------------------|--------------|-------------------------------------------------| | | | Detected | Not Detected | 95% CI | | Detected | 41 | 40 | 1 | PPA: 97.6% (40/41) 95% CI: 87.4 to 99.6% | | Not Detected | 182 | 0 | 182 | NPA: 100.0% (182/182) 95% CI: 97.9 to 100.0% | * PPA = Positive Percent Agreement, NPA = Negative Percent Agreement ### Clinical Agreement - RSV (Retrospective - All sites combined) | Culture Result . " | | Simplexa™ Results - RSV | | PPA/NPA* | | |--------------------|-----|-------------------------|--------------|----------------------------------------------|--| | | | Detected | Not Detected | 95% Cl | | | Detected | 12 | 17 | | PPA: 100.0%(12/12) 95% Cl: 75.7 to 100.0% | | | Not Detected | 211 | | 208 | NPA: 98.6%(208/211) 95% CI: 95.9 to 99.5% | | * PPA = Positive Percent Agreement, NPA = Negative Percent Agreement ### ANALYTICAL SENSITIVITY/LIMIT OF DETECTION The Limit of Detection (LoD) was determined for the Simplexa™ Flu AJB & RSV Direct assay using quantified stocks of influenza A, influenza B and RSV virus strains serially diluted in negative swab matrix. The lowest concentration with ≥95% detection (at least 19 out of 20 replicates) was determined to be the limit of detection for each assay, {5}------------------------------------------------ Image /page/5/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 letter "F", arching over the word. Below "FOCUS" is the word "Diagnostics" in a smaller, non-bold font, underlined with a thin line. # Simplexa™ Flu A/B & RSV Direct - REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.Julv.2012 Page 6 of 7 | Simplexa TM Flu A/B & RSV Direct Limit of Detection | | |-----------------------------------------------------------------|-----------------| | Viral Strain | LoD (TCID50/mL) | | Influenza A/PR/8/34 (H1N1) | 0.005 | | Influenza A/Hong Kong/8/68 (H3N2) | 10 | | Influenza A/Swine NY/02/2009 (H1N1) | 0.1 | | Influenza B/Great Lakes/1739/54 | 2 | | Influenza B/Malaysia/2506/2004 | 20 | | RSV A2 | 1 | | RSV B CH93-18(18) | 3 | ### ANALYTICAL REACTIVITY / CROSS REACTIVITY ### Analytical Reactivity Different strains of influenza A including H1 and H3 subtypes, influenza B and RSV including A and B subtypes were evaluated. The most recent strains and geographically diverse strains were chosen. Quantified viral material was spiked into negative swab matrix at a sindle dilution with a concentration of approximately 1.0 x10 x10 x10 x10 TCIDsoml and assayed in triplicate. Ct values obtained during testing indicate all viral strains were tested near the LoD. All strains tested were appropriately detected. ### Cross Reactivity (Analytical Specificity) The Simplexa™ assay's analytical specificity was evaluated by testing the ability to exclusively identify influenza A virus and/or influenza B virus and/or RSV with no cross reactivity to organisms that are closely related, or cause similar clinical symptoms, or present as normal flora in the specimen types of interest. The panel of thirty-two (32) potential cross reactants were into a swab matrix at clinically relevant concentrations. The unspiked matrix was also tested to serve as a baseline. Samples were tested in triplicate to screen for cross reactivity. If signal was detected in any detection channel (Flu A, Flu B, RSV) in any of the three replicates, an additional 5 replicates were tested for confirmation. No cross reactivity was detected for Flu A, Flu B or RSV. ### INTERFERENCE The performance of this assay was evaluated with potentially interfering substances that may be present in nasopharyngeal swabs at the concentrations indicated in the table below. The potentially interfering substances were evaluated in a contrived sample that contained influenza A/PR/8/34 H1N1) at a concentration of 0.01 TCIDsomL and influenza B (influenza B/Malaysia/2506/2004) at a concentration of 40 TC/Ds/mL and RSV A2 at a concentration of 4 TCIDsomL. All strains were tested at two to four times the LoD. There was no evidence of interference caused by the substances tested. | Potential Interferents | Active Ingredient | Interferent Concentration | |---------------------------------------|----------------------------------------|------------------------------| | Afrin Nasal Spray | Oxymetazoline | 15% (v/v) | | Antibacterial, systemic | Tobramycin | 4 µg/mL | | Antibiotic, nasal ointment | Mupirocin | 6.6 mg/mL | | Blood | N/A | 2%(v/v) | | Purified Mucin Protein | Bovine Submaxillary Gland Type I- S | 60 µg/mL | | Nasal Corticosteroid - Beconase AQ | Beclomethasone | 5% (v/v) | | Nasal Corticosteroid - Fluticasone | Fluticasone | 5% (v/v) | | Relenza Antiviral Drug | Zanamivir | 3.3 mg/mL | | Tamiflu Antiviral Drug | Oseltamivir | 1 μΜ | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in large, 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 line. # 20413 510(k) Summary Simplexa™ Flu A/B & RSV Direct - REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.July.2012 Page 7 of 7 | Potential Interferents | Active Ingredient | Interferent Concentration | |------------------------|----------------------------------------------------------------------|------------------------------| | Zicam Nasal Gel | Luffa Opperculata, Galphimia glauca, histaminum hydrochloricum | 5% (v/v) | ### INHIBITION BY OTHER MICROORGANISMS The Simplexa™ assay was evaluated by testing the ability to identify influenza B virus, and RSV when potentially inhibitory organisms are present. The panel of thirty two (32) potentially inhibitory organisms was individually spiked into a low concentration (approximately 2 times LoD) of influenza A/PR/8/34 H1N1), influenza B (Influenza B/Malaysia/2506/2004) and RSV (A2). Samples were tested in triplicate to screen for inhibition. If signal was not detected in any detection channel (Flu A, Flu B, RSV) in any of the three replicates, an additional 5 replicates were tested for confirmation. No inhibitory effects were confirmed for influenza A, influenza B, or RSV at the concentrations tested. ### CARRY-OVER CONTAMINATION An internal carry-over study searched for the presence of contamination in negative samples. The study was designed by alternately placing a high positive and a negative sample on each disc. The carryover effect was evaluated by comparing the observed negative rate for the negative sample with the expected rate under normal reproducibility conditions. No cary-over contamination effect was seen in the Flu A, Flu B or RSV channels. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. ### Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 JUL 1 3 2012 Focus Diagnostics, Inc. c/o Tara Viviani Regulatory Affairs Project Manager 11331 Valley View Street Cypress, California 90630 Re: K120413 Trade/Device Name: Simplexa™Flu A/B & RSV Direct Simplexa "Flu A/B & RSV Positive Control Pack Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel nucleic acid assay system Regulatory Class: Class II Product Code: OCC, OOI Dated: May 18, 2012 Received: May 21, 2012 Dear Ms. Viviani: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any is 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 {8}------------------------------------------------ ## Page 2 - Tara Viviani CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Jóááym. Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ # Indications for Use Statement ### 510(k) Number (if known): k120413 #### Simplexa™ Flu A/B & RSV Direct Device Name: Simplexa™ Flu A/B & RSV Positive Control Pack 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 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 HINI 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. X And/Or Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Tamara Feldhuhn Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K 120413