(114 days)
The Focus Diagnostics Simplexa™ Flu A/B & RSV 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 during the 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.
The test is a real-time RT-PCR amplification system that utilizes a bi-functional fluorescent probe-primer for the detection and differentiation of human influenza A virus RNA, human influenza B virus RNA and respiratory syncytial virus RNA in nasopharyngeal swabs (NPS). The assay is composed of two principal steps: (1) extraction of RNA from patient specimens, (2) A bi-functional fluorescent probe-primer is used together with a reverse primer to amplify a specific target (for each analyte and the RNA internal control). 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 monitor the extraction process and to detect RT-PCR 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.
The Focus Diagnostics Simplexa™ Flu A/B & RSV assay is intended for the qualitative detection and discrimination of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as distinct numerical thresholds for PPA/NPA. Instead, it provides the clinical agreement percentages, which are implicitly the performance targets for demonstrating substantial equivalence. The table below summarizes the reported clinical agreement from the clinical agreement study for both prospective and retrospective samples.
| Category | Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|---|---|
| Influenza A | ||||
| - Prospective Samples | % Agreement (Detected) | High | 100% (25/25) | For Influenza A, Simplexa™ showed perfect agreement with the high-performance NAT for detected cases in prospective samples. |
| % Agreement (Not Detected) | High | 99.8% (527/528) | Very high agreement for not detected cases, with one discordant result. | |
| - Retrospective Samples | % Agreement (Detected) | High | 100% (79/79) | For Influenza A, Simplexa™ showed perfect agreement with the high-performance NAT for detected cases in retrospective samples. |
| % Agreement (Not Detected) | High | 99% (97/98) | High agreement for not detected cases, with one discordant result. | |
| Influenza B | ||||
| - Prospective Samples | % Agreement (Detected) | High | 50% (1/2) | Note: This is a very low agreement, but based on a very small sample size (only 2 detected samples by reference method). This would be a concern if not for the very small sample size and the fact the sample was "retested" and confirmed as a false negative. |
| % Agreement (Not Detected) | High | 99.8% (550/551) | Very high agreement for not detected cases, with one discordant result. | |
| - Retrospective Samples | % Agreement (Detected) | High | 100% (50/50) | For Influenza B, Simplexa™ showed perfect agreement with the high-performance NAT for detected cases in retrospective samples. |
| % Agreement (Not Detected) | High | 100% (127/127) | Perfect agreement for not detected cases. | |
| RSV | ||||
| - Prospective Samples | % Agreement (Detected) | High | 99.1% (110/111) | High agreement for detected cases. |
| % Agreement (Not Detected) | High | 99.5% (440/442) | High agreement for not detected cases. | |
| - Retrospective Samples | % Agreement (Detected) | High | 100% (22/22) | For RSV, Simplexa™ showed perfect agreement with NAT for detected cases in retrospective samples. |
| % Agreement (Not Detected) | High | 99.4% (154/155) | High agreement for not detected cases. |
2. Sample size used for the test set and the data provenance:
- Total Sample Size: 735 nasopharyngeal swabs (NPS).
- Provenance:
- Prospective Samples: 558 specimens, collected from patients with signs and symptoms of viral respiratory tract infection.
- Retrospective Samples: An unspecified number (the document mentions "banked specimens with signs and symptoms of viral respiratory tract infection," and the individual category summaries provide the counts for retrospective testing: 177 for Influenza A, 177 for Influenza B, and 177 for RSV). The combined numbers in the tables (e.g., 553 for prospective Flu A, 553 for prospective Flu B, etc.) indicate how the 558 prospective samples were distributed across the different analytes, and similarly for retrospective samples from the total of 735.
- Country of Origin: Not explicitly stated, but typically for FDA submissions, these studies are conducted in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The ground truth was established by laboratory methods, not expert visual assessment.
4. Adjudication method for the test set:
This information is not applicable as the ground truth was established by reference laboratory methods (high-performance NAT and culture/DFA), not by human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This study is for an in vitro diagnostic device (RT-PCR assay), not an imaging-based AI diagnostic that typically involves human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance were not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, this was effectively a standalone study. The Simplexa™ Flu A/B & RSV assay is an automated RT-PCR system. Its performance was compared directly against reference methods (high-performance NAT and culture/DFA) without human interpretation steps that would integrate with the device's output. The device itself is the "standalone algorithm/system."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Influenza A Virus: High performance FDA cleared nucleic acid test (NAT).
- Influenza B Virus: High performance FDA cleared nucleic acid test (NAT).
- Respiratory Syncytial Virus (RSV): Culture/DFA (Direct Fluorescent Antibody).
8. The sample size for the training set:
The document does not explicitly mention a "training set" in the context of device development. This is typical for in vitro diagnostic assays like RT-PCR, where analytical performance (e.g., Limit of Detection, analytical reactivity, cross-reactivity) is established using characterized strains and then clinical performance is validated on clinical samples, rather than a machine learning training/validation split.
9. How the ground truth for the training set was established:
As no explicit "training set" or machine learning approach is described for the device, this information is not applicable. The analytical characteristics are determined using known concentrations of viral strains and the clinical performance is compared against established reference methods.
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Image /page/0/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features a stylized black swoosh shape on the left, followed by the word "FOCUS" in bold, uppercase letters. Below "FOCUS" is the word "Diagnostics" in a smaller, less bold font. The logo is simple and modern, with a focus on the company name.
Simplexa™ Flu A/B & RSV Catalog No. Prepared Date: November
| Applicant | Focus Diagnostics, Inc.11331 Valley View StreetCypress, California 90630USA | NOV 2 4 2010 |
|---|---|---|
| Establishment Registration No. | 2023365 | |
| Contact Person | Tara Vivianitel 714.822.2115fax 714.822.3898tviviani@focusdx.com | |
| Summary Date | November 12, 2010 | |
| Proprietary Name | Simplexa™ Flu A/B & RSV | |
| Generic Name | Respiratory Viral Panel | |
| Classification | Class II, Special Controls | |
| Predicate Devices | Prodesse, ProFlu+ Assay (K092500, K081030, K073029) |
Intended Use
The Focus Diagnostics Simplexa™ Flu A/B & RSV assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and discrimination 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 during the 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
The test is a real-time RT-PCR amplification system that utilizes a bi-functional fluorescent probe-primer for the detection and differentiation of human influenza A virus RNA, human influenza B virus RNA and respiratory syncytial virus RNA in nasopharyngeal swabs (NPS). The assay is composed of two principal steps: (1) extraction of RNA from patient specimens, (2) A bi-functional fluorescent probe-primer is used together with a reverse primer to amplify a specific target (for each analyte and the RNA internal control). 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
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Image /page/1/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. To the left of the word "FOCUS" is a curved, black shape that resembles a crescent or a stylized checkmark.
specimen. An RNA internal control is used to monitor the extraction process and to detect RT-PCR 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+ | Prodesse | K092500,K081030,K073029 | 08/20/200905/02/200801/04/2008 | Microbiology(83) | OCC |
Comparison to Predicate
| ItemName | Device | Predicate |
|---|---|---|
| Intended Use | The Focus Diagnostics Simplexa™Flu A/B & RSV assay is intended foruse on the 3M Integrated Cyclerinstrument for the in vitro qualitativedetection and discrimination ofinfluenza A virus, influenza B virus,and respiratory syncytial virus (RSV)RNA in nasopharyngeal swabs (NPS)from human patients with signs andsymptoms of respiratory tract infectionin conjunction with clinical andepidemiological risk factors. This testis intended for use as an aid in thedifferential diagnosis of influenza A,influenza B, and RSV viral infectionsin humans and is not intended todetect influenza C.Negative results do not precludeinfluenza virus or RSV infection andshould not be used as the sole basisfor treatment or other patientmanagement decisions.Performance characteristics forinfluenza A were established duringthe 2010 influenza season when 2009H1N1 influenza was the predominantinfluenza A virus in circulation. Whenother influenza A viruses are | The ProFlu™+ Assay is a multiplexReal-Time PCR (RT-PCR) in vitrodiagnostic test for the rapid andqualitative detection anddiscrimination of Influenza A Virus,Influenza B Virus, and RespiratorySyncytial Virus (RSV) nucleic acidsisolated and purified fromnasopharyngeal (NP) swab specimensobtained from symptomatic patients.This test is intended for use to aid inthe differential diagnosis of InfluenzaA, Influenza B and RSV viral infectionsin humans and is not intended todetect Influenza C.Negative results do not precludeinfluenza or RSV virus infection andshould not be used as the sole basisfor treatment or other managementdecisions. It is recommended thatnegative RSV results be confirmed byculture. Performance characteristicsfor Influenza A Virus were establishedwhen Influenza A/H3 and A/H1 werethe predominant Influenza A viruses incirculation. When other Influenza Aviruses are emerging, performancecharacteristics may vary. |
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Image /page/2/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 curved, black shape that resembles a crescent or a stylized checkmark.
510(k) Summary Simplexa™ Flu A/B & RSV Catalog No. MOL2600 Prepared Date: November 23, 2010 Page 3 of 7
| ItemName | Device | Predicate |
|---|---|---|
| Simplexa™ Flu A/B & RSV | ProFlu+ | |
| 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. | 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. | |
| Assay Targets | Influenza A, Influenza B, RSV | Influenza A, Influenza B, RSV |
| Sample Types | NPS | NPS |
| ExtractionMethods | Roche MagNA Pure LC Total NucleicAcid Isolation Kit,Biomérieux NucliSENS easyMAG | Roche MagNA Pure LC Total NucleicAcid Isolation Kit,Biomérieux NucliSENS easyMAG |
| AssayMethodology | PCR-based system for detecting thepresence / absence of viral RNA inclinical specimens | PCR-based system for detecting thepresence / absence of viral DNA/RNAin clinical specimens |
| DetectionTechniques | Multiplex assay using differentreporter dyes for each target. | Multiplex assay using differentreporter dyes for each target. |
| Influenza AViral Target | Well conserved region of the matrixgene | Matrix gene |
| Influenza BViral Target | Well conserved region of the matrixgene | Non-structural NS1 and NS2 |
| RespiratorySyncytial ViralTarget | M gene | Polymerase |
Reproducibility:
Three investigative sites assessed the device's inter-laboratory reproducibility and interlintra-assay reproducibility. Each of the three laboratories tested eighteen samples, the Positive Control and the No Template Control, in triplicate on five different days. Each site had two operators who each ran the assay once per day, for a total of two runs per day. One site performed the extraction using the MagNA Pure LC Total Nucleic Acid Isolation Kit; two sites performed the extraction step using the Biomérieux NucliSENS easyMAG. Combined results for all sites are summarized below.
Influenza A = Total %CV of 0.8 to 2.1 Influenza B = Total %CV of 0.5 to 6.8 RSV = Total %CV of 2.1 to 4.5
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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. Above and to the left of the word "FOCUS" is a curved, black shape that resembles a swoosh or an abstract crescent. Below the word "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line.
1021
510(k) Summary Simplexa™ Flu A/B & RSV Catalog No. MOL2600 Prepared Date: November 23, 2010 Page 4 of 7
Limit of Detection
| Viral Strain | LoD MagNA Pureextraction (TCID50/mL) | LoD NucliSENS easyMAG.extraction (TCID50/mL) |
|---|---|---|
| Influenza A/PR/8/34 (H1N1) | $1.0 x10^{-2}$ | $1.0 x10^{-2}$ |
| Influenza A/Hong Kong/8/68 (H3N2) | $1.0 x10^{1}$ | $1.0 x10^{1}$ |
| Influenza B/Great Lakes/1739/54 | $1.0 x10^{0}$ | $5.0 x10^{0}$ |
| Influenza B/Malaysia/2506/2004 | $1.0 x10^{1}$ | $1.0 x10^{1}$ |
| RSV A2 | $1.0 x10^{0}$ | $1.0 x10^{0}$ |
| RSV B1 | $1.0 x10^{0}$ | $5.0 x10^{0}$ |
Analytical Reactivity
| Viral Strain | Lowest Concentration Detected (TCID50/mL) | Result |
|---|---|---|
| Influenza A/Wisconsin/67/05 H3 | $1.0 x10^2$ | Positive for FLU A |
| Influenza A/New Caledonia/10/07 H1N1 | $1.0 x10^2$ | Positive for FLU A |
| Influenza A/Brisbane/10/07 H3 | $1.0 x10^2$ | Positive for FLU A |
| Influenza A/Solomon Island/03/06 H1 | $1.0 x10^2$ | Positive for FLU A |
| Influenza A/Taiwan/42/06 H1N1 | $1.0 x10^2$ | Positive for FLU A |
| Influenza A/Brisbane/59/07 H1 | $1.0 x10^2$ | Positive for FLU A |
| Influenza A/Swine NY/02/2009 H1 | $1.0 x10^2$ | Positive for FLU A |
| Influenza A/WS/33 H1N1 | $1.0 x10^2$ | Positive for FLU A |
| Influenza A/Port Chalmers/1/73 H3N2 | $1.0 x10^2$ | Positive for FLU A |
| Influenza A/California/7/2009 NYMC X-179A | $1.0 x10^2$ | Positive for FLU A |
| Influenza B/Florida/02/06 | $1.0 x10^2$ | Positive for FLU B |
| Influenza B/Florida/04/06 | $2.0 x10^2$ | Positive for FLU B |
| Influenza B/Florida/07/04 | $1.0 x10^2$ | Positive for FLU B |
| Influenza B/Lee/40 | $1.0 x10^2$ | Positive for FLU B |
| Influenza B/Maryland/1/59 | $1.0 x10^2$ | Positive for FLU B |
| Influenza B/Hong Kong/5/72 | $1.0 x10^2$ | Positive for FLU B |
| Influenza B/Allen/45 | $1.0 x10^2$ | Positive for FLU B |
| Influenza B/Taiwan/2/62 | $2.0 x10^2$ | Positive for FLU B |
| Influenza B/Panama/45/90 | $2.0 x10^2$ | Positive for FLU B |
| RSV A-Long | $1.0 x10^2$ | Positive for RSV |
| RSV B-Wash/18537/62 | $1.0 x10^2$ | Positive for RSV |
| RSV B-WV/14617/85 | $1.0 x10^2$ | Positive for RSV |
| RSV B-9320 | $1.0 x10^2$ | Positive for RSV |
Cross-Reactivity
No cross reactivity was detected for Influenza A, Influenza B or RSV to organisms that are closely related to influenza or RSV, or cause similar clinical symptoms as influenza or RSV, or present as normal flora in the specimen types of interest.
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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, non-bold font underneath. To the left of the word "FOCUS" is a curved, black shape that resembles a stylized check mark or swoosh.
Interference
The performance of this assay was evaluated with potentially interfering substances that may be present in nasopharyngeal swabs. The potentially interfering substances were evaluated in influenza A/Hong Kong/8/68), and influenza B (influenza B/Malaysia/2506/2004) at a concentration of 50 TCIDsdmL and RSV A2 at a concentration of 5 TCIDsJmL. There was no evidence of interference caused by the substances tested.
Inhibition by Other Microorganisms
The Simplexa™ assay was evaluated by testing the ability to identify influenza B virus, influenza B virus and RSV when potentially inhibitory organisms are present. No inhibitory effects were confirmed for influenza A, influenza B or RSV.
Clinical Agreement
Three external testing sites participated in the Clinical Agreement Study. Reference results for influenza A and influenza B viruses were generated using a high performance FDA cleared nucleic acid test (NAT). Reference results for RSV were generated using culture/DFA. Culture/DFA results were carried forward from the results obtained at the time of sample collection or banking. A total of 735 nasopharyngeal swabs specimens were obtained from a combination of prospectively collected specimens (n = 558) from patients with signs and symptoms of viral respiratory tract infection and retrospectively banked specimens with signs and symptoms of viral respiratory tract infection.
| *High Perf.NAT¹ | Simplexa | |||
|---|---|---|---|---|
| n | Detected | NotDetected | % Agreement | |
| Detected | 25 | 25 | 0 | 100%(25/25)95% CI:86.7-100% |
| NotDetected | 528 | 1 | 527 | 99.8%(527/528)95% CI:98.9-100% |
Influenza A Clinical Agreement Summary - Prospective Samples
| Culture/DFA | Simplexa | |||
|---|---|---|---|---|
| n | Detected | NotDetected | Sensitivity /Specificity | |
| Detected | 22 | 22 | 0 | 100%(22/22)95% CI:85.1-100% |
| NotDetected | 534 | 4 | 530 | 99.3%(530/534)95% CI:98.1-99.7% |
Influenza B Clinical Agreement Summary - Prospective Samples
| *High Perf.NAT | Simplexa | |||
|---|---|---|---|---|
| n | Detected | NotDetected | % Agreement | |
| Detected | 2 | 1 | 1 | 50%(1/2)95% CI:9.5-90.5% |
| NotDetected | 551 | 1 | 550 | 99.8%(550/551)95% CI:99-100% |
| Culture/DFA | Simplexa | |||
|---|---|---|---|---|
| n | Detected | Not Detected | Sensitivity /Specificity | |
| Detected | 1 | 1 | 0 | 100%(1/1)95% CI:20.7-100% |
| NotDetected | 555 | 1 | 554 | 99.8%(554/555)95% CI:99-100% |
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Image /page/5/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with a curved, crescent-shaped graphic to the left of the word. Below the word "FOCUS" is the word "Diagnostics" in a smaller, non-bold font, underlined with a thin line.
| NAT | Simplexa | |||
|---|---|---|---|---|
| n | Detected | NotDetected | % Agreement | |
| Detected | 111 | 110 | 1 | 99.1%(110/111)95% CI:95.1-99.8% |
| NotDetected | 442 | 2 | 440 | 99.5%(440/442)95% CI:98.4-99.9% |
| RSV Clinical Agreement Summary - Prospective Samples | |
|---|---|
| *Culture/DFA | n | Simplexa | NotDetected | Sensitivity /Specificity |
|---|---|---|---|---|
| Detected | 100 | 98 | 2 | 98%(98/100)95% CI:93-99.4% |
| NotDetected | 455 | 14 | 441 | 96.9%(441/455)95% CI:94.9-98.2% |
Influenza A Clinical Agreement Summary - Retrospective Samples
| *High Perf.NAT | Simplexa | |||
|---|---|---|---|---|
| n | Detected | NotDetected | % Agreement | |
| Detected | 79 | 79 | 0 | 100%(79/79)95% CI:95.4-100% |
| NotDetected | 98 | 1 | 97 | 99%(97/98)95% CI:94.4-99.8% |
| Culture/DFA | n | Simplexa | NotDetected | Sensitivity /Specificity |
|---|---|---|---|---|
| Detected | 80 | 80 | 0 | 100%(80/80)95% CI:95.4-100% |
| NotDetected | 50 | 0 | 50 | 100%(50/50)95% CI:92.9-100% |
Influenza B Clinical Agreement Summary - Retrospective Samples
| *High Perf.NAT | Simplexa | Culture/DFA | Simplexa | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| n | Detected | NotDetected | % Agreement | n | Detected | NotDetected | Sensitivity /Specificity | |||
| Detected | 50 | 50 | 0 | 100%(50/50)95% CI:92.9-100% | Detected | 50 | 50 | 0 | 100%(50/50)95% CI:92.9-100% | |
| NotDetected | 127 | 0 | 127 | 100%(127/127)95% CI:97.1-100% | NotDetected | 93 | 0 | 93 | 100%(93/93)95% CI:96-100% |
RSV Clinical Agreement Summary - Retrospective Samples
| NAT | Simplexa | *Culture | ||||
|---|---|---|---|---|---|---|
| n | Detected | Not Detected | ||||
| Detected | 22 | 22 | 0 | Detected | ||
| NotDetected | 155 | 1 | 154 | % Agreement100%(22/22)95% CI:85.1-100% | ||
| 99.4%(154/155)95% CI:96.4-99.9% | NotDetected |
| *Culture/DFA | n | Simplexa | Sensitivity /Specificity | |
|---|---|---|---|---|
| Detected | Not Detected | |||
| Detected | 22 | 22 | 0 | 100%(22/22)95% CI:85.1-100% |
| NotDetected | 25 | 1 | 24 | 96%(24/25)95% CI:80.5-99.3% |
1High Perf. NAT = High Performance Nucleic Acid Test
*Reference method for clinical performance evaluation for 510(k) clearance.
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Image /page/6/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of a stylized, curved shape on the left, resembling a check mark or swoosh. To the right of this shape is the word "FOCUS" in bold, sans-serif capital letters. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined.
Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Focus Diagnostics, Inc. c/o Tara Viviani Regulatory Affairs Project Manager 11331 Valley View St. Cypress, California 90630
NOV 2 4 2010
Re: K102170
Simplexa™ Flu A/B & RSV Trade/Device Name: Regulation Number: 21 CFR §866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: Class II Product Code: OCC Dated: November 11, 2010 Received: November 12, 2010
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. Drue, 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 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); 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
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Page 2 - Tara Viviani
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.
Vallyatym
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
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Indications for Use
510(k) Number (if known): K102170
NOV 2 4 2010
Simplexa™ Flu A/B & RSV Device Name:
Indications for Use:
The Focus Diagnostics Simplexa™ Flu A/B & RSV 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 during the 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.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)
Concurrence of CDRH, Office of InVitro Diagnostics (OIVD)
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§ 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.