(85 days)
The Focus Diagnostics Simplexa™ Group A Strep Direct assay is intended for use on the 3M Integrated Cycler for the in vitro qualitative detection of Group A Streptococcus (GAS) from throat swabs collected from human patients with signs and symptoms of pharyngitis, such as sore throat. This test is intended for use as an aid in the diagnosis of GAS infection. The assay is intended for use in hospital, reference, or state laboratory settings. The device is not intended for point-of-care use.
The Simplexa™ Group A Strep Direct assay system is a real-time PCR system that enables the direct amplification and qualitative detection of Group A Strep bacterial DNA from throat swabs that have not undergone a nucleic acid extraction. The system consists of the Simplexa™ Group A Strep Direct assay, the 3M Integrated Cycler (with Integrated Cycler Studio Software), the Direct Amplification Disc (DAD) and associated accessories.
In the Simplexa™ Group A Strep Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify Group A Strep bacterial DNA and the Internal Control (DNA IC). The assay targets a conserved region of Group A Strep (pyroqenic exotoxin B gene) to identify this bacteria in the specimen. The DNA IC is used to detect PCR failure and/or inhibition.
Here is a summary of the acceptance criteria and study information for the Simplexa™ Group A Strep Direct device, based on the provided text:
Acceptance Criteria and Device Performance for Simplexa™ Group A Strep Direct
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the clinical study's sensitivity and specificity. However, the performance characteristics of the device and its predicate device are compared. For the purpose of this response, we will consider the reported "Performance Characteristics" of the predicate device as a benchmark or implicit acceptance criteria, though the device has slightly lower specificity than the predicate.
| Metric | Predicate Device Performance / Benchmark (Simplexa™ Group A Strep Direct K133883) | Simplexa™ Group A Strep Direct Performance (Clinical Prospective Study) |
|---|---|---|
| Sensitivity | 96.5% (95% CI: 91.3% - 98.6%) | 97.4% (152/156) (95% CI: 93.6% to 99.0%) |
| Specificity | 98.0% (95% CI: 97.0% - 98.6%) | 95.2% (1139/1196) (95% CI: 93.9% to 96.3%) |
| Positive Predictive Value (PPV) | Not explicitly stated for predicate in comparison table. | 72.7% (152/209) (95% CI: 66.3% to 78.3%) |
| Negative Predictive Value (NPV) | Not explicitly stated for predicate in comparison table. | 99.7% (1139/1143) (95% CI: 99.1% to 99.9%) |
Note: The device's sensitivity (97.4%) is numerically higher than the predicate's (96.5%), and its specificity (95.2%) is numerically lower than the predicate's (98.0%). The FDA's substantial equivalence determination implies these results were acceptable.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 1352 evaluable samples.
- Data Provenance: Prospectively collected from four geographically diverse sites. The country of origin is not explicitly stated but can be inferred to be the USA given the FDA submission document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of "experts" in the traditional sense (e.g., radiologists) for establishing ground truth. Instead, for the clinical prospective study, the comparator culture method was used as the primary reference for ground truth, and discrepant results were further analyzed.
4. Adjudication Method for the Test Set
The primary comparison was against a "comparator culture method" performed at one central laboratory.
For discrepant analysis, a "validated bidirectional sequencing assay" was performed.
- 46 out of 57 samples where Simplexa™ was Positive and Culture was Not Detected were confirmed as Group A Strep Positive by sequencing.
- 2 out of 4 samples where Simplexa™ was Not Detected and Culture was Detected were confirmed as Group A Strep Positive by sequencing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a molecular diagnostic assay (PCR-based system) for the qualitative detection of Group A Streptococcus, not an imaging device requiring human reader interpretation. Therefore, the concept of improving human readers with AI assistance is not applicable here.
6. Standalone Performance Study
Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was performed. The entire clinical prospective study and analytical studies evaluate the device's performance independently. The device's results are compared directly against a culture method and a sequencing assay, not against human interpretation of the device's output.
7. Type of Ground Truth Used
- Primary Ground Truth: Comparator culture method.
- Confirmatory Ground Truth for Discrepancies: Validated bidirectional sequencing assay.
8. Sample Size for the Training Set
The document describes the performance of the device and does not explicitly mention a "training set" in the context of machine learning. The studies described are validation studies (e.g., Limit of Detection, Analytical Reactivity, Cross Reactivity, Interference, Clinical Prospective Study) that assess the device's performance characteristics. If the device's internal algorithms underwent a "training" phase during its development, the details are not provided in this regulatory summary.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is mentioned for an algorithm, the method for establishing its ground truth is not provided. The document focuses on the validation of the finalized device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
FOCUS DIAGNOSTICS, INC. SHARON YOUNG SENIOR REGULATORY AFFAIRS SPECIALIST 11331 VALLEY VIEW ST CYPRESS CA 90630
March 18. 2015
Re: K143651
Trade/Device Name: Simplexa™ Group A Strep Direct, Simplexa™ Group A Strep Positive Control Pack Regulation Number: 21 CFR 866.2680 Regulation Name: Streptococcus spp. nucleic acid-based assay Regulatory Class: II Product Code: PGX, OOI Dated: December 22, 2014 Received: December 23, 2014
Dear Ms. Young:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Uwe Scherf -S for
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143651
Device Name
Simplexa™ Group A Strep Direct and Simplexa™ Group A Strep Positive Control Pack
Indications for Use (Describe)
SimplexaTM Group A Strep Direct
The Focus Diagnostics Simplexa™ Group A Strep Direct assay is intended for use on the 3M Integrated Cycler for the in vitro qualitative detection of Group A Streptococcus (GAS) from throat swabs collected from human patients with signs and symptoms of pharyngitis, such as sore throat. This test is intended for use as an aid in the diagnosis of GAS infection. The assay is intended for use in hospital, reference, or state laboratory settings. The device is not intended for point-ofcare use.
Simplexa™ Group A Strep Positive Control Pack
Focus Diagnostics' Simplexa™ Group A Strep Positive Control Pack is intended to be used as a control with Simplexa™ Group A Strep Direct. This control is not intended for use with other assays or systems.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| -- | -- | -- | ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font. A curved, black shape is positioned to the left of the word, resembling a bracket or a stylized eye. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin, horizontal line.
510(k) Summary
Simplexa™ Group A Strep Direct Catalog No. MOL2850 Simplexa™ Group A Strep Positive Control Pack Catalog No. MOL2860 March 17, 2015 Page 1 of 10
| Applicant | Focus Diagnostics, Inc.11331 Valley View StreetCypress, California 90630USA |
|---|---|
| Establishment Registration No. | 2023365 |
| Contact Person | Sharon Youngtel 562.240.6680fax 562.240.6529syoung@focusdx.com |
| Summary Date | March 17, 2015 |
| Proprietary Name | Simplexa™ Group A Strep DirectSimplexa™ Group A Strep Positive Control Pack |
| Generic Name | Group A Streptococcus nucleic acid |
| ClassificationRegulationProduct Code | Class II21 CFR 866.2680PGX |
| Predicate Device | Lyra™ Direct Strep Assay K133883, |
Intended Use
Simplexa™ Group A Strep Direct
The Focus Diagnostics Simplexa™ Group A Strep Direct assay is intended for use on the 3M Integrated Cycler for the in vitro qualitative detection of Group A Streptococcus (GAS) from throat swabs collected from human patients with signs and symptoms of pharvnaitis, such as sore throat. This test is intended for use as an aid in the diagnosis of GAS infection. The assay is intended for use in hospital, reference, or state laboratory settings. The device is not intended for point-of-care use.
Simplexa™ Group A Strep Positive Control Pack
Focus Diagnostics' Simplexa™ Group A Strep Positive Control Pack is intended to be used as a control with Simplexa™ Group A Strep Direct. This control is not intended for use with other assays or systems.
Device Description
The Simplexa™ Group A Strep Direct assay system is a real-time PCR system that enables the direct amplification and qualitative detection of Group A Strep bacterial DNA from throat swabs that have not undergone a nucleic acid extraction. The system consists of the Simplexa™ Group A Strep Direct assay, the 3M Integrated Cycler (with Integrated Cycler Studio Software), the Direct Amplification Disc (DAD) and associated accessories.
In the Simplexa™ Group A Strep Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify Group A Strep bacterial DNA and the Internal Control (DNA IC). The assay targets a conserved region of Group A Strep (pyroqenic exotoxin B gene) to identify this bacteria in the specimen. The DNA IC is used to detect PCR failure and/or inhibition.
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Image /page/4/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, black letters. There is a curved, black shape to the left of the word. Below the word "FOCUS" is the word "Diagnostics" in smaller, black letters with a line above it.
510(k) Summary
Simplexa™ Group A Strep Direct Catalog No. MOL2850 Simplexa™ Group A Strep Positive Control Pack Catalog No. MOL2860 March 17, 2015 Page 2 of 10
Predicate Device Information
| Item | Device | Predicate |
|---|---|---|
| Name | Simplexa™ Group A Strep Direct | Lyra™ Direct Strep AssayK133883 |
| Intended Use | Simplexa™ Group A Strep DirectThe Focus Diagnostics Simplexa™ Group A Strep Direct assay is intended for use on the 3M Integrated Cycler for the in vitroqualitative detection of Group AStreptococcus (GAS) from throat swabscollected from human patients with signs andsymptoms of pharyngitis, such as sore throat.This test is intended for use as an aid in thediagnosis of GAS infection. This test isintended for use as an aid in the diagnosis ofGAS infection. The assay is intended for usein hospital, reference, or state laboratorysettings. The device is not intended for point-of-care use.Simplexa™ Group A Strep Positive Control PackFocus Diagnostics' Simplexa™ Group AStrep Positive Control Pack is intended to beused as a control with Simplexa™ Group AStrep Direct. This control is not intended foruse with other assays or systems. | The Lyra Direct Strep Assay is a Real-Time PCR in vitro diagnostic test for the qualitative detection and differentiation of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) and pyogenic Group C and G β-hemolytic Streptococcus nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as a sore throat. The assay does not differentiate between pyogenic Groups C and G β-hemolytic Streptococcus.All negative test results should be confirmed by bacterial culture, because negative results do not preclude Group A, C or G Strep infection and should not be used as the sole basis for treatment.The assay is intended for use in hospital, reference, or state laboratory settings. The device is not intended for point-of-care use. |
| Assay Targets | Group A streptococcus – Streptococcus pyogenes | Group A streptococcus – Streptococcus pyogenes |
| Assay Type | Qualitative | Qualitative |
| Sample Types | Throat swab | Throat Swab |
| ExtractionMethods | Self-contained and automated | Manual |
| AssayMethodology | PCR-based system for detecting the presence / absence of bacterial DNA in clinical specimens | PCR-based system for detecting the presence / absence of bacterial DNA in clinical specimens |
| DetectionTechniques | Singleplex assay using different reporter dyes for each target. | Triplex assay using different reporter dyes for each target. |
| Group A StrepBacterialTarget | Well conserved region of the exotoxin B gene (speB) | Group A – 99bp product in the putative competence (comX1.1) geneGroups C/G – 188bp product in the tagatose-6-phosphate kinase (lacC) gene |
| Instrumentation | 3M Integrated Cycler | ABI 7500 Fast DX Thermocycler |
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Image /page/5/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of a stylized black swoosh on the left, followed by the word "FOCUS" in bold, black capital letters. Below "FOCUS" is the word "Diagnostics" in a smaller, non-bold font, underlined with a thin black line.
510(k) Summary
Simplexa™ Group A Strep Direct Catalog No. MOL2850 Simplexa™ Group A Strep Positive Control Pack Catalog No. MOL2860 March 17, 2015 Page 3 of 10
| ltem | Device | Predicate | |||
|---|---|---|---|---|---|
| Name | Simplexa™ Group A Strep Direct | Lyra™ Direct Strep AssayK133883 | |||
| PerformanceCharacteristics | Sensitivity: 97.4% (152/156) (95% Cl: 93.6%to 99.0%)Specificity: 95.2% (1139/1196) (95% Cl:93.9% to 96.3%) | GAS Sensitivity:96.5% (95% Cl: 91.3% - 98.6%)GAS Specificity:98.0% (95% Cl: 97.0% - 98.6%)Pyo GCS/GGS Sensitivity:95.7% (95% Cl: 88.1% - 98.5%)Pyo GCS/GGS Specificity:98.3% (95% Cl: 97.4% - 98.9%) |
REPRODUCIBILITY
Three (3) investigative sites assessed the device's inter-site, inter-day and interlintra-assay reproducibility. Each of the laboratories tested a panel of six (6) members that included contrived samples at low positive, (approximately 1 X LoD) and moderately positive sample (approximately 3 X LoD) for M1 and M3 serotypes of Group A Streptococus, a positive and negative control were also included in the panel. The assays were performed in triplicate (3) on five (5) different days. Each site had two (2) operators who each assayed the sample panel once (1) per day, for a total of two (2) sets of data per day. Combined results for all sites are presented in the tables below.
| Testing Site 1 | Testing Site 2 | Testing Site 3 | Overall | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| SamplePanelMember | %AgreementwithExpectedResults | Avg.Ct | %CV | %AgreementwithExpectedResults | Avg.Ct | %CV | %AgreementwithExpectedResults | Avg.Ct | %CV | Total % | 95% CI |
| Negative | 100.0%(30/30) | NA | NA | 96.7%(29/30) | 41.9 | NA | 100.0%(30/30) | NA | NA | 98.9%(89/90) | 94.0 to99.8% |
| PositiveControl(PC) | 100.0%(30/30) | 29.5 | 1.4 | 100.0%(30/30) | 29.5 | 3 | 100.0%(30/30) | 30 | 1.2 | 100.0%(90/90) | 95.9 to100.0% |
| Group AStrep M1SerotypeLowPositive | 100.0%(30/30) | 38.6 | 4.4 | 83.3%(25/30) | 39.4 | 5.6 | 96.7%(29/30) | 38 | 3.5 | 93.3%(84/90) | 86.2 to96.9% |
| Group AStrep M1SerotypeModeratePositive | 100.0%(30/30) | 35.9 | 2.6 | 93.3%(28/30) | 36.3 | 4.8 | 100.0%(30/30) | 36 | 1.8 | 97.8%(88/90) | 92.3 to99.4% |
| Group AStrep M3SerotypeLowPositive | 96.7%(29/30) | 38.5 | 2.9 | 90.0%(27/30) | 39.2 | 4.8 | 96.7%(29/30) | 39 | 4.5 | 94.4%(85/90) | 87.6 to97.6% |
| Group AStrep M3SerotypeModeratePositive | 100.0%(30/30) | 36.3 | 2.6 | 90.0%(27/30) | 36.7 | 3.2 | 100.0%(30/30) | 37 | 2.7 | 96.7%(87/90) | 90.7 to98.9% |
| All | 99.4% (179/180) | NA | NA | 92.2% (166/180) | NA | NA | 98.9% (178/180) | NA | NA | 96.9%(523/540) | 95.0 to98.0% |
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Image /page/6/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, black letters, with the word "Diagnostics" in a smaller font size underneath. A curved, black shape is positioned to the left of the word "FOCUS", creating a visual element that draws the eye to the brand name.
510(k) Summary
Simplexa™ Group A Strep Direct Catalog No. MOL2850 Simplexa™ Group A Strep Positive Control Pack Catalog No. MOL2860 March 17, 2015 Page 4 of 10
ANALYTICAL SENSITIVITY/LIMIT OF DETECTION
The Limit of Detection (LoD) was determined for the Simplexa™ Group A Strep Direct by performing a dilution series. The LoD samples used for the study were contrived using two (2) serotypes of Group A Streptococcus; M1 and M3 that were verified (re-grown and re-titered) bacterial stock. For each serotype, eight (8) different concentrations were spiked in simulated matrix from the verified bacterial and confirmed using thirty two (32) replicates. The Limit of Detection (LoD) was determined to be the following;
| Simplexa™ Group A Strep Direct - Limit of Detection | |||||
|---|---|---|---|---|---|
| Group A Strep Serotype | Concentration (cfu/mL) | ||||
| M1 | 682 | ||||
| M3 | 2350 |
ANALYTICAL REACTIVITY / CROSS REACTIVITY
Analytical Reactivity
Analytical Reactivity was assessed for the ability of Simplexa™ Group A Strep Direct to detect sixty (60) Group A Streptococus strains not present in the LoD study. Analytical Reactivity was observed in testing of twenty one (21) strains. All were detected as positive for Group A Strep at or below 5000 cfu/mL. Analytical Reactivity was tested using in silico NCBI BLAST sequence analysis methods for thirty nine (39) GAS strains distinct from the wet tested strains.
| Streptococcus pyogenesSerotype | Concentration (cfu/mL) | Simplexa™ Group A StrepDirect Qualitative Result% Detection |
|---|---|---|
| M2 | 1.50 X 103 | 100% (3/3) |
| M4 | 1.50X 103 | 100% (3/3) |
| M5 | 1.50 X 103 | 100% (3/3) |
| M6 | 1.50 X 103 | 100% (3/3) |
| M9 | 3.00 X 103 | 100% (3/3) |
| M12 | 1.50 X 103 | 100% (3/3) |
| M13 | 1.50 X 103 | 100% (3/3) |
| M14 | 1.50 X 103 | 100% (3/3) |
| M18 | 5.00 X 103 | 100% (3/3) |
| M22 | 1.50 X 103 | 100% (3/3) |
| M27 | 3.00 X 103 | 100% (3/3) |
| M28 | 1.50 X 103 | 100% (3/3) |
| M29 | 1.50 X 103 | 100% (3/3) |
| M49 | 1.50 X 103 | 100% (3/3) |
| M73 | 3.00 X 103 | 100% (3/3) |
| M75 | 3.00 X 103 | 100% (3/3) |
| M77 | 3.00 X 103 | 100% (3/3) |
| M78 | 1.50 X 103 | 100% (3/3) |
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Image /page/7/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font. Below "FOCUS" is the word "Diagnostics" in a smaller, less bold font. A curved, black shape is on the left side of the word "FOCUS", adding a design element to the logo.
510(k) Summary
Simplexa™ Group A Strep Direct Catalog No. MOL2850 Simplexa™ Group A Strep Positive Control Pack Catalog No. MOL2860 March 17, 2015 Page 5 of 10
| Streptococcus pyogenesSerotype | Concentration (cfu/mL) | Simplexa™ Group A StrepDirect Qualitative Result% Detection |
|---|---|---|
| M82 | $1.50 X 10^3$ | 100% (3/3) |
| M87 | $1.50 X 10^3$ | 100% (3/3) |
| M89 | $3.00 X 10^3$ | 100% (3/3) |
Cross Reactivity (Analytical Specificity)
Analytical reactivity was evaluated for the Simplexa™ Group A Strep the ability to exclusively identify Group A Streptococcus with no cross reactivity to organisms that are closely related, or cause similar clinical symptoms, or present as normal flora in the pharynx. Negative specimens were spiked with potentially cross-reactive organisms at known concentrations. Spiked specimens were examined for reactivity with the Group A Strep Direct. Sixty four (64) organisms were tested. Bacteroides ovalis and Tremella fuciformis were not available for testing therefore data from In-Silico NCBI BLAST sequence analysis was performed. No cross reactivity was found
| Cross Reactant | Tested Concentration | Simplexa™ Group A Strep DirectQualitative Results: %Detection(# Detected/#Tested) |
|---|---|---|
| Baseline1 | Not Applicable | 0.0% (0/5) |
| Baseline2 | Not Applicable | 0.0% (0/5) |
| Adenovirus 1 | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Adenovirus 7A | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Arcanobacterium haemolyticum | 1.00 X 106 TCID50/mL | 0.0% (0/3) |
| Bacillus cereus | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Bacteroides ovatus | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Bordetella pertussis | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Burkholderia cepacia | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Campylobacter rectus | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Candida albicans | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Chlamydia pneumoniae | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Coronavirus 229E | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Corynebacterium diphtheriae | 1.00 X 106 TCID50/mL | 0.0% (0/3) |
| Cytomegalovirus (CMV) | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Enterococcus faecalis vanB | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Enterovirus 71 | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Epstein-Barr virus (B95-8) | 1.00 X 105 copies/mL | 0.0% (0/3) |
| Escherichia coli | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Fusobacterium necrophorum | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Haemophilus influenzae | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Cross Reactant | Tested Concentration | Simplexa™ Group A Strep DirectQualitative Results: %Detection(# Detected/#Tested) |
| HSV-1 McIntyre | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| HSV-2 G | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Influenza A/Hong Kong/8/68 H3N2 | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Influenza B/Panama/45/90 | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Klebsiella pneumoniae | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Lactobacillus acidophilus | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Legionella pneumophila | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Metapneumovirus-9 | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Moraxella catarrhalis | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Mycoplasma pneumoniae | 1.00 X 106 CCU/ml | 0.0% (0/3) |
| Neisseria gonorrhoeae | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Neisseria meningitidis | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Parainfluenza 1 | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Parainfluenza 2 | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Parainfluenza 3 | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Peptostreptococcus micros | 1.00 X 106 cfu/mL | 0.0% (0/6) |
| Pseudomonas aeruginosa | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Rhinovirus 1A | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| RSV-B 9320 | 1.00 X 105 TCID50/mL | 0.0% (0/3) |
| Staphylococcus aureus (MRSA), ATCC43300 | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Staphylococcus epidermidis (MRSE), ATCC29887 | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Stenotrophomonas maltophilia | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus agalactiae | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus anginosus | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus canis | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus constellatus subsp.constellatus | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus cristatus | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus dysgalactiae | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus equi subsp. zooepidemicus | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus equinus | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus gallolyticus | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus gordonii | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus intermedius | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus mitis | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Cross Reactant | Tested Concentration | Simplexa™ Group A Strep DirectQualitative Results: %Detection(# Detected/#Tested) |
| Streptococcus mutans | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus oralis | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus parasanguinis | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus pneumoniae | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus salivarius | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus sanguinis | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus sobrinus | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus uberis | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Streptococcus vestibularis | 1.00 X 106 cfu/mL | 0.0% (0/3) |
| Treponema denticola | 1.00 X 106 spirochetes/mL | 0.0% (0/3) |
| Veillonella parvula | 1.00 X 106 cfu/mL | 0.0% (0/3) |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, sans-serif font. A curved, swooping line extends from the top left of the "F" and arches over the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font with a line above it.
510(k) Summary
Simplexa™ Group A Strep Direct Catalog No. MOL2850 Simplexa™ Group A Strep Positive Control Pack Catalog No. MOL2860 March 17, 2015 Page 6 of 10
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Image /page/9/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font. A curved line extends from the left side of the "F", arching over the word. Below "FOCUS" is the word "Diagnostics" in a smaller, non-bold font, underlined with a thin line.
510(k) Summary
Simplexa™ Group A Strep Direct Catalog No. MOL2850 Simplexa™ Group A Strep Positive Control Pack Catalog No. MOL2860 March 17, 2015 Page 7 of 10
INTERFERENCE
The performance of Simplexa™ Group A Strep Direct was evaluated with potentially interfering substances that may be present in pharynx. The potentially interfering substances were evaluated in a contrived sample that contained Group A Streptococus at low positive concentrations (approximately 1 X LoD) and moderate positive concentrations (approximately 3 X LoD) of Group A Streptococus serotypes M1 and M3. There was no evidence of interference caused by the substances at the concentrations tested.
| Potential Interferent | Active Ingredient | InterferentConcentration | GAS BacterialSerotype | Simplexa™ GroupA Strep DirectQualitative Result(# Detected/#Tested) |
|---|---|---|---|---|
| Baseline | Not Applicable | Not Applicable | M1 | 100.0%(5/5) |
| Baseline | Not Applicable | Not Applicable | M3 | 100.0%(5/5) |
| Afrin nasal Spray | OxymetazolineHydrochloride | 15% v/v | M1 | 100.0%(3/3) |
| Afrin nasal Spray | OxymetazolineHydrochloride | 15% v/v | M3 | 100.0%(3/3) |
| Antibiotic | Amoxicillin | 0.5 mg/mL | M1 | 100.0%(3/3) |
| Antibiotic | Amoxicillin | 0.5 mg/mL | M3 | 100.0%(3/3) |
| Antibiotic | Cephalexin | 0.04 mg/mL | M1 | 100.0%(3/3) |
| Antibiotic | Cephalexin | 0.04 mg/mL | M3 | 100.0%(3/3) |
| Antibiotic | Clindamycin | 0.06 mg/mL | M1 | 100.0%(5/5) |
| Antibiotic | Clindamycin | 0.06 mg/mL | M3 | 100.0%(3/3) |
| Antibiotic | Erythromycin | 1 mg/mL | M1 | 100.0%(3/3) |
| Antibiotic | Erythromycin | 1 mg/mL | M3 | 100.0%(3/3) |
| Antibiotic | Penicillin | 1200 U/mL | M1 | 100.0%(3/3) |
| Antibiotic | Penicillin | 1200 U/mL | M3 | 100.0%(3/3) |
| Aspirin | Aspirin | 0.62 mg/mL | M1 | 100.0%(3/3) |
| Potential Interferent | Active Ingredient | InterferentConcentration | GAS BacterialSerotype | Simplexa™ GroupA Strep DirectQualitative Result(# Detected/#Tested) |
| Aspirin | Aspirin | 0.62 mg/mL | M3 | 100.0%(3/3) |
| Benadryl | DiphenhydramineHCl | 10 µL/swab | M1 | 100.0%(3/3) |
| Benadryl | DiphenhydramineHCl | 10 µL/swab | M3 | 100.0%(3/3) |
| Blood | Blood | 10% v/v | M1 | 100.0%(3/3) |
| Blood | Blood | 10% v/v | M3 | 100.0%(3/3) |
| Chloraseptic Sore ThroatSpray | Phenol | 10% v/v | M1 | 100.0%(3/3) |
| Chloraseptic Sore ThroatSpray | Phenol | 10% v/v | M3 | 100.0%(3/3) |
| Contac Cold + Flu tablet | AcetaminophenChlorpheniramineMaleatePhenylephrine HCI | 16.2 mg/mL0.06 mg/mL0.16 mg/mL | M1 | 100.0%(3/3) |
| Contac Cold + Flu tablet | AcetaminophenChlorpheniramineMaleatePhenylephrine HCI | 16.2 mg/mL0.06 mg/mL0.16 mg/mL | M3 | 100.0%(3/3) |
| Corticosterone | Corticosterone | 4 mg/swab | M1 | 100.0%(3/3) |
| Corticosterone | Corticosterone | 4 mg/swab | M3 | 100.0%(3/3) |
| Crest CompleteToothpaste | Sodium Fluoride | 0.1 mg/mL | M1 | 100.0%(3/3) |
| Crest CompleteToothpaste | Sodium Fluoride | 0.1 mg/mL | M3 | 100.0%(3/3) |
| Finafta Oral Anesthetic /Analgesics | Ethyl AlcoholSalicylic AcidBenzocaine | 1/10X dilution | M1 | 100.0%(3/3) |
| Finafta Oral Anesthetic /Analgesics | Ethyl AlcoholSalicylic AcidBenzocaine | 1/10X dilution | M3 | 100.0%(3/3) |
| Listerine | EucalyptolMentholMethyl SalicylateThymol | 10 µL/swab | M1 | 100.0%(3/3) |
| Listerine | EucalyptolMentholMethyl SalicylateThymol | 10 µL/swab | M3 | 100.0%(3/3) |
| Mucin | Purified MucinProtein | 60 µg/mL | M1 | 100.0%(3/3) |
| Mucin | Purified MucinProtein | 60 µg/mL | M3 | 100.0%(3/3) |
| Neo-Synephrine | Phenylephrine HCI | 15% v/v | M1 | 100.0%(3/3) |
| Neo-Synephrine | Phenylephrine HCI | 15% v/v | M3 | 100.0%(3/3) |
| Potential Interferent | Active Ingredient | InterferentConcentration | GAS BacterialSerotype | Simplexa™ GroupA Strep DirectQualitative Result(# Detected/#Tested) |
| Nyquil | DextromethorphanHydrobromideDoxylamineSuccinate | 1/200 X dilution | M1 | 100.0%(3/3) |
| Nyquil | DextromethorphanHydrobromideDoxylamineSuccinate | 1/200 X dilution | M3 | 100.0%(3/3) |
| Pain Medication | NSAID | 0.1 mg/mL | M1 | 100.0%(3/3) |
| Pain Medication | NSAID | 0.1 mg/mL | M3 | 100.0%(3/3) |
| Pain Medication | Tylenol | 1 mg/mL | M1 | 100.0%(3/3) |
| Pain Medication | Tylenol | 1 mg/mL | M3 | 100.0%(3/3) |
| Robitussin Cough / ChestCongestion Cough Syrup | DextromethorphanHBrGuaifenesin | 2.0 mg/mL | M1 | 100.0%(3/3) |
| Robitussin Cough / ChestCongestion Cough Syrup | DextromethorphanHBrGuaifenesin | 2.0 mg/mL | M3 | 100.0%(3/3) |
| Saline Nasal Spray | Sodium Chloridewith Preservatives | 15% v/v | M1 | 100.0%(3/3) |
| Saline Nasal Spray | Sodium Chloridewith Preservatives | 15% v/v | M3 | 100.0%(3/3) |
| Saliva | Water, Electrolytes,Mucus, Etc. | 50 µL/swab | M1 | 100.0%(3/3) |
| Saliva | Water, Electrolytes,Mucus, Etc. | 50 µL/swab | M3 | 100.0%(3/3) |
| Scope | GlycerinSodium SaccharinSodium BenzoateCetylpyridinumChlorideBenzoic AcidBlue 1Yellow 5 | 10 µL/swab | M1 | 100.0%(3/3) |
| Scope | GlycerinSodium SaccharinSodium BenzoateCetylpyridinumChlorideBenzoic AcidBlue 1Yellow 5 | 10 µL/swab | M3 | 100.0%(3/3) |
| Sore Throat Lozenge | Menthol | 1.7 mg/mL | M1 | 100.0%(3/3) |
| Sore Throat Lozenge | Menthol | 1.7 mg/mL | M3 | 100.0%(3/3) |
| Sore Throat Lozenge | Pectin | 0.34 mg/mL | M1 | 100.0%(3/3) |
| Sore Throat Lozenge | Pectin | 0.34 mg/mL | M3 | 100.0%(3/3) |
| Potential Interferent | Active Ingredient | InterferentConcentration | GAS BacterialSerotype | Simplexa™ GroupA Strep DirectQualitative Result(# Detected/#Tested) |
| Sore Throat Lozenge | Zinc Gluconate Glycine | 0.1 mg/mL | M1 | 100.0%(3/3) |
| Sore Throat Lozenge | Zinc Gluconate Glycine | 0.1 mg/mL | M3 | 100.0%(3/3) |
| Thymol | Thymol | 400 mg/swab | M1 | 100.0%(3/3) |
| Thymol | Thymol | 400 mg/swab | M3 | 100.0%(3/3) |
| Zicam Oral Mist | Zincum Aceticum Zincum Gluonicum | 0.625% v/v | M1 | 100.0%(3/3) |
| Zicam Oral Mist | Zincum Aceticum Zincum Gluonicum | 0.625% v/v | M3 | 100.0%(3/3) |
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Image /page/10/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font. A curved line extends from the left side of the "F", arching over the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line.
510(k) Summary
Simplexa™ Group A Strep Direct Catalog No. MOL2850 Simplexa™ Group A Strep Positive Control Pack Catalog No. MOL2860 March 17, 2015 Page 8 of 10
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Image /page/11/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, sans-serif font. There is a curved line above and to the left of the word. Below the word "FOCUS" is a horizontal line, and below that is the word "Diagnostics" in a smaller font.
510(k) Summary
Simplexa™ Group A Strep Direct Catalog No. MOL2850 Simplexa™ Group A Strep Positive Control Pack Catalog No. MOL2860 March 17, 2015 Page 9 of 10
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Image /page/12/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, swooping line extends from the left side of the image, arching over the word "FOCUS", creating a visual element that emphasizes the brand name.
510(k) Summary
Simplexa™ Group A Strep Direct Catalog No. MOL2850 Simplexa™ Group A Strep Positive Control Pack Catalog No. MOL2860 March 17, 2015 Page 10 of 10
CLINICAL PROSPECTIVE STUDY
One thousand three hundred and ninety seven (1397) samples that were prospectively collected from four (4) geographically diverse sites between May 6, 2014 from patients with signs and symptoms of Group A Strep infections of the pharynx. One thousand three hundred and fifty two (1352) samples were evaluable on Simplexa™ Group A Strep Direct and the comparator culture method. Samples were tested on Simplexa™ Group A Strep Direct at the collection sites and comparator culture method was performed at one (1) central laboratory. The invalid rate of the clinical prospective study using Simplexa™ Group A Strep Direct was 0.57% (eight out of one thousand three hundred and ninety six 8/1396 samples). Discrepant analysis was performed using a validated bidirectional sequencing assay.
| Clinical Prospective Study: (Overall) | |||
|---|---|---|---|
| Simplexa™Group A StrepDirect Result | Culture MethodDetected | Not Detected | Total |
| Detected | 152 | 57a | 209 |
| Not Detected | 4b | 1139 | 1143 |
| Total | 156 | 1196 | 1352 |
| %Sensitivity | 97.4%(152/156)95% CI: 93.6% to99.0% | %Specificity | 95.2%(1139/1196)95% CI: 93.9% to96.3% |
| % PositivePredictive Value(PPV) | 72.7%(152/209)95% CI: 66.3% to78.3% | %Negative PredictiveValue (NPV) | 99.7%(1139/1143)95% CI: 99.1% to99.9% |
| a46/57 discrepant samples were Group A Strep Positive, 9/57 were "Group A StrepNegative and 2/57 were Indeterminate when tested using a validated bidirectionalsequencing assay.b2/ 4 discrepant samples were Group A Strep Positive and 2/4 were Group A StrepNegative when tested using a validated bidirectional sequencing assay. |
CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate the device is as safe and effective as the legally marketed device identified above.
§ 866.2680
Streptococcus spp. nucleic acid-based assay.(a)
Identification. AStreptococcus spp. nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify variousStreptococcus spp. nucleic acids extracted directly from clinical specimens. The device detects specific nucleic acid sequences for organism identification. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology including primer/probe sequence, design, and rationale for sequence selection.
(2) Premarket notification submissions must include detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (Limit of Detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carry-over, and cross contamination.
(3) Premarket notification submissions must include detailed documentation from a clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted reference methods.
(4) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, software applications and hardware-based devices that incorporate software.
(5) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols, as appropriate.
(6) The device labeling must include limitations regarding the need for culture confirmation of negative specimens, as appropriate.
(7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.
(8) Premarket notification submissions must include details on an end user device training program that will be offered while marketing the device, as appropriate.