(114 days)
Not Found
No
The device description and performance studies focus on standard real-time RT-PCR technology and data analysis, with no mention of AI or ML algorithms.
No.
This device is an in vitro diagnostic (IVD) device intended for the qualitative detection and discrimination of specific viral RNA, which aids in differential diagnosis, rather than providing therapy or treatment.
Yes.
The device is intended for the "in vitro qualitative detection and discrimination of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA" and "is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans." This clearly indicates its role in diagnosing medical conditions.
No
The device description clearly states it is a real-time RT-PCR amplification system that utilizes a bi-functional fluorescent probe-primer and is used with the 3M Integrated Cycler instrument, which is a hardware device. While software (Integrated Cycler Studio Software) is used to control the instrument, the core medical device is a combination of reagents and hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is intended for "in vitro qualitative detection and discrimination" of influenza A, influenza B, and RSV RNA in nasopharyngeal swabs. "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device analyzes "nasopharyngeal swabs from human patients," which are biological specimens taken from the body.
- Purpose: The test is used as an "aid in the differential diagnosis" of viral infections, providing information about a patient's health status.
- Device Description: The description details a "real-time RT-PCR amplification system" that analyzes RNA from patient specimens. This is a common technology used in IVD tests for detecting pathogens.
- Performance Studies: The document includes detailed performance studies (reproducibility, limit of detection, analytical reactivity, cross-reactivity, interference, clinical agreement) which are required for regulatory approval of IVD devices.
- Predicate Device(s): The mention of predicate devices (K numbers and names) indicates that this device is being compared to previously cleared IVDs.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
OCC
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal swabs (NPS)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Results:
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
Limit of Detection:
Determined using two extraction methods (MagNA Pure extraction and NucliSENS easyMAG extraction) against various viral strains.
Key Results (LoD in TCID50/mL):
Influenza A/PR/8/34 (H1N1): 1.0 x 10^-2 (MagNA Pure), 1.0 x 10^-2 (NucliSENS easyMAG)
Influenza A/Hong Kong/8/68 (H3N2): 1.0 x 10^1 (MagNA Pure), 1.0 x 10^1 (NucliSENS easyMAG)
Influenza B/Great Lakes/1739/54: 1.0 x 10^0 (MagNA Pure), 5.0 x 10^0 (NucliSENS easyMAG)
Influenza B/Malaysia/2506/2004: 1.0 x 10^1 (MagNA Pure), 1.0 x 10^1 (NucliSENS easyMAG)
RSV A2: 1.0 x 10^0 (MagNA Pure), 1.0 x 10^0 (NucliSENS easyMAG)
RSV B1: 1.0 x 10^0 (MagNA Pure), 5.0 x 10^0 (NucliSENS easyMAG)
Analytical Reactivity:
Evaluated the detection of various viral strains.
Key Results: All listed Influenza A, Influenza B, and RSV strains were detected and yielded positive results at the specified concentrations.
Cross-Reactivity:
No cross-reactivity was detected for Influenza A, Influenza B, or RSV with closely related organisms, those causing similar clinical symptoms, or normal flora.
Interference:
Evaluated with potentially interfering substances at specified concentrations (Influenza A/Hong Kong/8/68 and Influenza B/Malaysia/2506/2004 at 50 TCIDsdmL, RSV A2 at 5 TCIDsJmL).
Key Results: No evidence of interference.
Inhibition by Other Microorganisms:
Evaluated the ability of the assay to identify influenza A, influenza B, and RSV when potentially inhibitory organisms are present.
Key Results: No inhibitory effects were confirmed.
Clinical Agreement:
Three external testing sites participated. Reference methods: FDA cleared nucleic acid test (NAT) for influenza A and B, culture/DFA for RSV. Total of 735 nasopharyngeal swab specimens (558 prospectively collected, 177 retrospectively banked).
Influenza A Clinical Agreement Summary - Prospective Samples:
Reference: High Perf. NAT (n=553)
Detected: Simplexa 25/25 (100%), Not Detected: Simplexa 527/528 (99.8%)
Reference: Culture/DFA (n=556)
Sensitivity: 22/22 (100%), Specificity: 530/534 (99.3%)
Influenza B Clinical Agreement Summary - Prospective Samples:
Reference: High Perf. NAT (n=553)
Detected: Simplexa 1/2 (50%), Not Detected: Simplexa 550/551 (99.8%)
Reference: Culture/DFA (n=556)
Sensitivity: 1/1 (100%), Specificity: 554/555 (99.8%)
RSV Clinical Agreement Summary - Prospective Samples:
Reference: NAT (n=553)
Detected: Simplexa 110/111 (99.1%), Not Detected: Simplexa 440/442 (99.5%)
Reference: Culture/DFA (n=555)
Sensitivity: 98/100 (98%), Specificity: 441/455 (96.9%)
Influenza A Clinical Agreement Summary - Retrospective Samples:
Reference: High Perf. NAT (n=177)
Detected: Simplexa 79/79 (100%), Not Detected: Simplexa 97/98 (99%)
Reference: Culture/DFA (n=130)
Sensitivity: 80/80 (100%), Specificity: 50/50 (100%)
Influenza B Clinical Agreement Summary - Retrospective Samples:
Reference: High Perf. NAT (n=177)
Detected: Simplexa 50/50 (100%), Not Detected: Simplexa 127/127 (100%)
Reference: Culture/DFA (n=143)
Sensitivity: 50/50 (100%), Specificity: 93/93 (100%)
RSV Clinical Agreement Summary - Retrospective Samples:
Reference: NAT (n=177)
Detected: Simplexa 22/22 (100%), Not Detected: Simplexa 154/155 (99.4%)
Reference: Culture/DFA (n=47)
Sensitivity: 22/22 (100%), Specificity: 24/25 (96%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Prospective Samples:
Influenza A (vs. High Perf. NAT):
% Agreement (Detected): 100%(25/25)
% Agreement (Not Detected): 99.8%(527/528)
Influenza A (vs. Culture/DFA):
Sensitivity: 100%(22/22)
Specificity: 99.3%(530/534)
Influenza B (vs. High Perf. NAT):
% Agreement (Detected): 50%(1/2)
% Agreement (Not Detected): 99.8%(550/551)
Influenza B (vs. Culture/DFA):
Sensitivity: 100%(1/1)
Specificity: 99.8%(554/555)
RSV (vs. NAT):
% Agreement (Detected): 99.1%(110/111)
% Agreement (Not Detected): 99.5%(440/442)
RSV (vs. Culture/DFA):
Sensitivity: 98%(98/100)
Specificity: 96.9%(441/455)
Retrospective Samples:
Influenza A (vs. High Perf. NAT):
% Agreement (Detected): 100%(79/79)
% Agreement (Not Detected): 99%(97/98)
Influenza A (vs. Culture/DFA):
Sensitivity: 100%(80/80)
Specificity: 100%(50/50)
Influenza B (vs. High Perf. NAT):
% Agreement (Detected): 100%(50/50)
% Agreement (Not Detected): 100%(127/127)
Influenza B (vs. Culture/DFA):
Sensitivity: 100%(50/50)
Specificity: 100%(93/93)
RSV (vs. NAT):
% Agreement (Detected): 100%(22/22)
% Agreement (Not Detected): 99.4%(154/155)
RSV (vs. Culture/DFA):
Sensitivity: 100%(22/22)
Specificity: 96%(24/25)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.
(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.
0
Image /page/0/Picture/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 Street
Cypress, California 90630
USA | NOV 2 4 2010 |
|--------------------------------|-----------------------------------------------------------------------------------------|--------------|
| Establishment Registration No. | 2023365 | |
| Contact Person | Tara Viviani
tel 714.822.2115
fax 714.822.3898
tviviani@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
1
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 | 08/20/2009 | ||||
| 05/02/2008 | |||||
| 01/04/2008 | Microbiology | ||||
| (83) | OCC |
Comparison to Predicate
| Item
| Name | Device | Predicate |
|---|---|---|
| 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 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 | 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. |
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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
| Item
| Name | 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 |
| Extraction | ||
| Methods | Roche MagNA Pure LC Total Nucleic | |
| Acid Isolation Kit, | ||
| Biomérieux NucliSENS easyMAG | 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 |
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 Pure
extraction (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 | Not | ||
| Detected | % Agreement | |||
| Detected | 25 | 25 | 0 | 100%(25/25) |
| 95% CI:86.7-100% | ||||
| Not | ||||
| Detected | 528 | 1 | 527 | 99.8%(527/528) |
| 95% CI:98.9-100% |
Influenza A Clinical Agreement Summary - Prospective Samples
| Culture/DFA | Simplexa | |||
|---|---|---|---|---|
| n | Detected | Not | ||
| Detected | Sensitivity / | |||
| Specificity | ||||
| Detected | 22 | 22 | 0 | 100%(22/22) |
| 95% CI:85.1-100% | ||||
| Not | ||||
| Detected | 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 | Not | ||
| Detected | % Agreement | |||
| Detected | 2 | 1 | 1 | 50%(1/2) |
| 95% CI:9.5-90.5% | ||||
| Not | ||||
| Detected | 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% | ||||
| Not | ||||
| Detected | 555 | 1 | 554 | 99.8%(554/555) |
| 95% CI:99-100% |
5
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 | Not | ||
| Detected | % Agreement | |||
| Detected | 111 | 110 | 1 | 99.1%(110/111) |
| 95% CI:95.1-99.8% | ||||
| Not | ||||
| Detected | 442 | 2 | 440 | 99.5%(440/442) |
| 95% CI:98.4-99.9% |
| RSV Clinical Agreement Summary - Prospective Samples | |
|---|---|
| *Culture/DFA | n | Simplexa | Not
Detected | Sensitivity /
Specificity |
|-----------------|-----|----------|-----------------|-------------------------------------|
| Detected | 100 | 98 | 2 | 98%(98/100)
95% CI:93-99.4% |
| Not
Detected | 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 | Not | ||
| Detected | % Agreement | |||
| Detected | 79 | 79 | 0 | 100%(79/79) |
| 95% CI:95.4-100% | ||||
| Not | ||||
| Detected | 98 | 1 | 97 | 99%(97/98) |
| 95% CI:94.4-99.8% |
| Culture/DFA | n | Simplexa | Not
Detected | Sensitivity /
Specificity |
|-----------------|----|----------|-----------------|---------------------------------|
| Detected | 80 | 80 | 0 | 100%(80/80)
95% CI:95.4-100% |
| Not
Detected | 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 | Not | ||||||||
| Detected | % Agreement | n | Detected | Not | ||||||
| Detected | 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% | ||||||||||
| Not | ||||||||||
| Detected | 127 | 0 | 127 | 100%(127/127) | ||||||
| 95% CI:97.1-100% | Not | |||||||||
| Detected | 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 | ||
| Not | ||||||
| Detected | 155 | 1 | 154 | % Agreement | ||
| 100%(22/22) | ||||||
| 95% CI:85.1-100% | ||||||
| 99.4%(154/155) | ||||||
| 95% CI:96.4-99.9% | Not | |||||
| Detected |
| *Culture/DFA | n | Simplexa | | Sensitivity /
Specificity |
|-----------------|----|----------|--------------|---------------------------------|
| | | Detected | Not Detected | |
| Detected | 22 | 22 | 0 | 100%(22/22)
95% CI:85.1-100% |
| Not
Detected | 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.
7
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a single bar. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The logo is black and white.
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
8
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
9
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)
| Uve Sch | |
|---|---|
| Division Sign-Off |
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | k 102 170 |
|---|---|
| -------- | ----------- |
510(k)_
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