Who is the manufacturer of SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500?

Focus Diagnostics, Inc. filed the 510(k) submission for SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 (K100148).

What is the FDA product code for SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500?

OQW. It is classified under 21 CFR 866.3332 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500?

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

What are the predicate devices for SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500?

xTAG Respiratory Viral Panel - FluA (K091667, K081483, K063765); CDC Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (K080570).

Who can help prepare an FDA 510(k) submission like SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500?

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 INFLUENZA A H1N1 (2009) MODEL MOL2500

K100148 · Focus Diagnostics, Inc. · OQW · May 24, 2010 · Microbiology

Device Facts

Record ID	K100148
Device Name	SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
Applicant	Focus Diagnostics, Inc.
Product Code	OQW · Microbiology
Decision Date	May 24, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3332
Device Class	Class 2

Intended Use

The Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) assay is intended for use on the 3M Integrated Cycler as part of the Microfluidic Molecular System for the in vitro qualitative detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA in nasopharyngeal swabs (NS), and nasopharyngeal aspirates (NPA) from human patients with signs and symptoms of respiratory in conjunction with clinical and epidemiological risk factors. Neqative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2009-2010 influenza season when 2009 H1N1 influenza was the predominant influenza A virus 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™ Influenza A H1N1 (2009) is a nucleic acid amplification test; uses real-time RT-PCR to detect influenza A and 2009 H1N1 viral RNA. Input: nasopharyngeal swabs, nasal swabs, or nasopharyngeal aspirates. Process: RNA extraction followed by real-time PCR amplification on 3M Integrated Cycler; uses bi-functional fluorescent probe-primers; fluorescent signal generated upon probe binding to target RNA. Output: qualitative detection/differentiation of influenza A and 2009 H1N1. Used in clinical laboratories; operated by trained personnel. Results interpreted by healthcare providers to aid in diagnosis of respiratory infection; negative results do not rule out infection; results used alongside clinical/epidemiological data. Benefits: rapid identification of 2009 H1N1 influenza virus.

Clinical Evidence

Clinical performance evaluated using 299 prospective nasal/nasopharyngeal swabs and 112 nasopharyngeal aspirates, plus 214 retrospective swabs and 2 washes. Compared against a composite reference method (Luminex xTAG RVP, CDC validated PCR, and sequencing). For prospective swabs, H1N1 positive agreement was 100% (95% CI: 96.3-100%) and negative agreement 95.5% (95% CI: 91.4-97.7%). For prospective aspirates, H1N1 positive agreement was 100% (95% CI: 86.2-100%) and negative agreement 92.5% (95% CI: 84.6-96.5%). Influenza A performance also showed high agreement across specimen types.

Technological Characteristics

Nucleic acid amplification test using real-time RT-PCR. Employs bi-functional fluorescent probe-primers for target detection. Targets: matrix gene (Influenza A) and hemagglutinin gene (2009 H1N1). System includes 3M Integrated Cycler, disk media for sample processing, and Integrated Cycler Studio Software. Connectivity: external computer control. Extraction methods: Roche MagNA Pure LC or QIAGEN QIAamp Viral RNA Mini Kit.

Indications for Use

Indicated for qualitative detection and differentiation of influenza A and 2009 H1N1 viral RNA in nasopharyngeal swabs, nasal swabs, and nasopharyngeal aspirates from symptomatic patients. Prescription use only.

Regulatory Classification

Identification

Reagents for detection of specific novel influenza A viruses are devices that are intended for use in a nucleic acid amplification test to directly detect specific virus RNA in human respiratory specimens or viral cultures. Detection of specific virus RNA aids in the diagnosis of influenza caused by specific novel influenza A viruses in patients with clinical risk of infection with these viruses, and also aids in the presumptive laboratory identification of specific novel influenza A viruses to provide epidemiological information on influenza. These reagents include primers, probes, and specific influenza A virus controls.

Special Controls

The device is classified as Class II under regulation 21 CFR 866.3332 with special controls. The special control guidance document "Reagents for Detection of Specific Novel Influenza A viruses" will be available shortly.

*Classification.* Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses.” See § 866.1(e) for information on obtaining this document. (2) The distribution of these devices is limited to laboratories with experienced personnel who have training in standardized molecular testing procedures and expertise in viral diagnosis, and appropriate biosafety equipment and containment.

Predicate Devices

xTAG Respiratory Viral Panel - FluA (K091667, K081483, K063765)
CDC Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (K080570)

Related Devices

K101564 — CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL · Centers for Disease Control and Prevention · Jun 22, 2010
K230236 — Lyra Influenza A+B Assay · Quidel Corporation · Mar 3, 2023
K132237 — PRODESSE PROFAST+ ASSAY · Gen-Probe Prodesse, Inc. · Aug 26, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in large, bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, black shape is positioned to the left of the word "FOCUS", adding a visual element to the logo. 510(k) Summary of Safety and Effectiveness Simplexa™ Influenza A H1N1 (2009) Catalog No. MOL2500 Prepared Date: May 18, 2010 Page 1 of 9 | Applicant | Focus Diagnostics, Inc. 11331 Valley View Street Cypress, California 90630 USA | | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Establishment Registration No. | 2023365 | | | Contact Person | Tara Viviani tel 714.822.2115 fax 714.822.3898 tviviani@focusdx.com | MAY 24 2010 | | Summary Date | May 18, 2010 | | | Proprietary Name | Simplexa™ Influenza A H1N1 (2009) | | | Generic Name | Influenza A H1N1 2009 Real Time RT-PCR | | | Classification | Class II, Special Controls Luminex Diagnostics XTAG RESPIRATORY VIRAL PANEL (K091667, K081483, K063765) CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel (K080570) | | ### Intended Use The Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) assay is intended for use on the 3M Integrated Cycler as part of the Microfluidic Molecular System for the in vitro qualitative detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA in nasopharyngeal swabs (NS), and nasopharyngeal aspirates (NPA) from human patients with signs and symptoms of respiratory in conjunction with clinical and epidemiological risk factors. Neqative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2009-2010 influenza season when 2009 H1N1 influenza was the predominant influenza A virus 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 Description Simplexa™ Influenza A H1N1 (2009) test kit is a nucleic acid amplification test that uses real-time reverse transcriptase polymerase chain reaction (RT-PCR) amplification to enable simultaneous and distinct detection of influenza A and 2009 H1N1 influenza in a single reaction from nasophayngeal swabs (NPS), nasal swabs (NS), and nasopharyngeal aspirates (NPA). The assay combines real-time PCR amplification with fluorescent signal detection technology. A bi-functional fluorescent probe-primer is used together with a reverse primer to amplify a specific target (for each analyte and internal control). A fluorescent signal is generated after the separation of the fluorophore from the quencher as a result of the binding of a probe element to the extended RNA fragment synthesized during amplification. 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. Together, the instrument, software and test kit are referred to as the "Microfluidic Molecular System." {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features a stylized, curved shape resembling a crescent or a checkmark above the word "FOCUS" in bold, sans-serif font. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line. 510(k) Summary of Safety and Effectiveness Simplexa™ Influenza A H1N1 (2009) Catalog No. MOL2500 Prepared Date: May 18, 2010 Page 2 of 9 Predicate Device Information | Trade Name / Method | 510(k) submitter | 510(k) number | Decision Date | Panel | Product Code(s) | |-------------------------------------------------------------------------------------------|-----------------------------------------------------|-------------------------------|----------------------------------------|----------------------|-----------------------| | XTAG Respiratory Viral Panel - FluA | Luminex | K091667 K081483 K063765 | 06/25/2009 06/25/2008 11/30/2007 | Microbiology (83) | OCC, OEM, OEP | | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel | Centers for Disease Control and Prevention | K080570 | 09/30/2008 | Microbiology (83) | NXD, OEP, OCC, NSU | | Item Name | Device | Predicate | | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Simplexa™ Influenza A H1N1 (2009) | xTAG Respiratory Viral Panel - FLUA | CDC Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel | | Intended Use | The Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) assay is intended for use on the 3M Integrated Cycler as part of the Microfluidic Molecular System for the in vitro qualitative detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA in nasopharyngeal swabs (NPS), nasal swabs (NS), and nasopharyngeal aspirates (NPA) from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2009- 2010 influenza season when 2009 H1N1 influenza was 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 | The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections. The following virus types and subtypes are identified using RVP: Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza B, Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection if used in conjunction with other | The Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) is intended for use in Real- time RT-PCR assays on an ABI 7500 Fast Dx Real- time PCR instrument in conjunction with clinical and epidemiological information: * for qualitative detection of influenza virus type A or B in symptomatic patients from viral RNA in nasopharyngeal and/or nasal swab specimens, * for determination of the subtype of seasonal human influenza A virus, as seasonal A/HI or A/H3, if present, from viral RNA in nasopharyngeal and/or nasal swab specimens, * for presumptive identification of virus in patients who may be infected with influenza A subtype A/H5 (Asian lineage) from viral RNA in human respiratory specimens and viral culture in conjunction with clinical | | Item Name | Device | Predicate | | | | Simplexa™ Influenza A H1N1 (2009) | xTAG Respiratory Viral Panel - FLUA | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel | | | 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. | clinical and laboratory findings. It is recommended that specimens found to be negative for Influenza B, Respiratory Syncytial Virus subtype A and B, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3 and Adenovirus, after examination using RVP be confirmed by cell culture. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Positive results do not rule out bacterial infection, or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Due to seasonal prevalence, performance characteristics for Influenza A/H1 were established primarily with retrospective specimens. The RVP assay cannot adequately detect Adenovirus species C, or serotypes 7a and 41. The RVP primers for detection of rhinovirus cross-react with enterovirus. A rhinovirus reactive result | and epidemiological risk factors. * to provide epidemiologic information for surveillance for influenza viruses. Performance characteristics for influenza A 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. Testing with the influenza H5a and H5b primer and probe sets should not be performed unless the patient meets the most current U.S. Department of Health and Human Services (DHHS) clinical and epidemiologic criteria for testing suspect A/H5 specimens. The definitive identification of influenza A/H5 (Asian lineage) either directly from patient specimens or from virus cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. All users, analysts, and any person reporting diagnostic results from use of this device should be trained to | | Item Name | Device | Predicate | | | | Simplexa™ Influenza A H1N1 (2009) | xTAG Respiratory Viral Panel - FLUA | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel | | | | should be confirmed by an alternate method (e.g. cell 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 infections with a 2009 H1N1 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 2009 H1N1 virulent Influenza viruses and sent to a 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. | perform and interpret the results from this procedure by a CDC instructor or designee prior to use. CDC Influenza Division will limit the distribution of this device to only those users who have successfully completed training provided by CDC instructors or designees. | | Assay Targets | Influenza A 2009 H1N1 Influenza | Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza B, Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus. | Influenza A/H1 Influenza A/H3 Influenza A/H5 (asian lineage) Influenza B | | Item Name | Device | Predicate | | | | Simplexa™ Influenza A H1N1 (2009) | xTAG Respiratory Viral Panel - FLUA | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel | | Extraction Methods | Roche MagNA Pure LC Total Nucleic Acid Isolation Kit, QIAGEN QIAamp Viral RNA Mini Kit | QIAGEN QIAamp Mini Elute Biomérieux EasyMag, Biomérieux MiniMag | QIAamp® Viral RNA Mini Kit. Qiagen RNeasy® Mini Kit, MagNA Pure LC RNA Isolation Kit II Roche MagNA Pure LC Total Nucleic Acid Isolation Kit, | | 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 | PCR-based system for detecting the presence / absence of viral RNA in clinical specimens | | Detection Techniques | Multiplex assay using different reporter dyes for each target. | Multiplex assay using a combination of color coded beads and different reporter dyes. | A panel of oligonucleotide primers and dual-labeled hydrolysis (TaqMan®) probes for the qualitative detection and differentiation of influenza virus type and subtype target sequences. | | Influenza A Viral Target | Well conserved region of the matrix gene | Well conserved region of the matrix gene | Well conserved region of the matrix gene | | H1N1 (2009) Viral Target | Well conserved region of the hemagglutinin gene specific for H1N1 (2009) | n/a | n/a | | LoD | Influenza A Strains TCID50/mL in a range of $1x10^{-1}$ to $2.7x10^{1}$ 2009 H1N1 TCID50/mL in a range of $1x10^{-1}$ to $2.7x10^{1}$ Please refer to detailed table below. | Influenza A A/PR/8/34 (TCID50/mL = $8x10^{-1}$ ) A/Victoria/3/75 (TCID50/mL = $1x10^{2}$ ) | Influenza A A/New Caledonia/20/1999 (TCID50/mL = $10^{1.2}$ ) A/Hawaii/15/2001 (TCID50/mL = $10^{1.5}$ ) A/New York/55/2004 (TCID50/mL = $10^{2.2}$ ) A/Wisconsin/67/2005 (TCID50/mL = $10^{1.2}$ ) | | Reproducibility | FLUA Inter-Assay Total %CV range 0.0 to 4.8 FLUA Intra-Assay Total %CV range 0.0 to 6.6 H1N1 Inter-Assay Total %CV range 0.0 to 1.8 H1N1 Intra-Assay Total %CV range 0.0 to 4.7 | Influenza A - low positive %CV range 29.41 to 60.22 Influenza A - medium titer %CV range 5.6 to 35.6 | Influenza A - 1:10 of low positive %CV range 1.94 to 7.09 Influenza A - low positive %CV range 2.12 to 7.89…

SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

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SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

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