(110 days)
Not Found
No
The device description mentions "on-board method-specific algorithms" for interpreting fluorescent signals, which is standard for many diagnostic instruments and does not indicate the use of AI or ML. There are no mentions of AI, ML, or related concepts like neural networks or deep learning in the document.
No
The device is described as an in vitro diagnostic test for the qualitative detection of Trichomonas vaginalis nucleic acids to aid in the diagnosis of trichomoniasis, which indicates it provides diagnostic information rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test... to aid in the diagnosis of trichomoniasis."
No
The device description clearly states that the assay is intended for use only with the Solana® instrument, which is a hardware device that performs amplification and detection. While the Solana instrument uses "on-board method-specific algorithms" (software) to interpret results, the overall system includes significant hardware components (the instrument itself, reaction tubes, lysis tubes, etc.) and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Solana® Trichomonas Assay is an in vitro diagnostic test..." This directly identifies the device as an IVD.
N/A
Intended Use / Indications for Use
The Solana® Trichomonas Assay is an in vitro diagnostic test, using isothermal amplification technology (helicase-dependent amplification, HDA), for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swabs and female urine specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The Solana® Trichomonas Assay is intended for use only with the Solana® Instrument.
Product codes (comma separated list FDA assigned to the subject device)
OUY
Device Description
The Solana® Trichomonas Assay amplifies and detects Trichomonas vaginalis nucleic acids present in clinician-collected vaginal swabs and urine specimens from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaqinalis DNA.
The vaginal swab is eluted in a swab lysis tube or a urine specimen is added to a urine lysis tube, and the cells in either specimen type are lysed by simple heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of the diluted sample is added to a reaction tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of T. vaginalis-specific target sequence. In Solana, the target sequence is amplified by T. vaginalis specific primers and detected by a T. vaginalis specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by T. vaginalis specific primers and detected by a PRC specific fluorescence probe.
The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to T. vaqinalis or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana instrument will then report the test results to the user on its display screen, and the results can be printed via a printer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, female genitourinary tract (for urine specimens)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision/Reproducibility:
Study Type: Blinded and randomized reproducibility study.
Sample Size:
Swab workflow: Each panel (moderate positive, low positive, high negative, negative) tested with 30 replicates per site for a total of 90 replicates across 3 sites.
Urine workflow: Each panel (moderate positive, low positive, high negative, negative) tested with 30 replicates per site for a total of 90 replicates across 3 sites.
Data Source: In-house laboratory and two (2) clinical sites.
Annotation Protocol: Not explicitly stated, but results were compared against expected outcomes (positive/negative).
Key Results:
Swab Workflow:
High Negative (1.89 trophozoites /mL): 69% overall agreement (62/90 expected results). 95% CI 58.7% to 77.5%.
Low Positive (102 trophozoites /mL): 100% overall agreement (90/90 expected results). 95% CI 95.9% to 100%.
Moderate Positive (306 trophozoites /mL): 100% overall agreement (90/90 expected results). 95% CI 95.9% to 100%.
Negative: 100% overall agreement (90/90 expected results). 95% CI 95.9% to 100%.
Positive Control: 100% overall agreement (90/90 expected results). 95% CI 95.9% to 100%.
Negative Control: 100% overall agreement (90/90 expected results). 95% CI 95.9% to 100%.
Urine Workflow:
High Negative (0.2 trophozoites /mL): 68% overall agreement (61/90 expected results). 95% CI 57.6% to 75.5%.
Low Positive (4 trophozoites /mL): 100% overall agreement (90/90 expected results). 95% CI 95.9% to 100%.
Moderate Positive (12 trophozoites /mL): 100% overall agreement (90/90 expected results). 95% CI 95.9% to 100%.
Negative: 100% overall agreement (90/90 expected results). 95% CI 95.9% to 100%.
Positive Control: 100% overall agreement (90/90 expected results). 95% CI 95.9% to 100%.
Negative Control: 100% overall agreement (90/90 expected results). 95% CI 95.9% to 100%.
Conclusion: Results suggest no significant differences between users, sites, or days for either workflow.
Clinical Sensitivity and Specificity (Multi-center study):
Study Type: Clinical study.
Sample Size: One thousand forty-four (1044) clinician-collected vaginal swab and urine specimens.
Data Source: Four (4) locations in the United States, November 2015 through March 2016.
Annotation Protocol: All sensitivity and specificity calculations based on a composite reference method of Wet Mount and InPouch TV culture. A specimen was considered positive if either test was positive. For discordant results, FDA-cleared molecular assay was used.
Vaginal Swab Specimens (1043 evaluable samples):
Combined Symptom Status:
Sensitivity: 99.2% (95% CI 95.4 to 99.9)
Specificity: 98.7% (95% CI 97.7 to 99.3)
PPV: 90.8% (95% CI 84.7 to 94.7)
NPV: 99.7% (95% CI 99.4 to 100)
Asymptomatic:
Sensitivity: 100% (95% CI 92.9 to 100)
Specificity: 98.9% (95% CI 97.4 to 99.5)
Symptomatic:
Sensitivity: 98.6% (95% CI 92.3 to 99.7)
Specificity: 98.5% (95% CI 97.0 to 99.3)
Urine Specimens (1044 evaluable samples):
Combined Symptom Status:
Sensitivity: 95.0% (95% CI 89.5 to 97.7)
Specificity: 98.2% (95% CI 97.1 to 98.8)
PPV: 87.0% (95% CI 80.2 to 91.7)
NPV: 99.3% (95% CI 98.6 to 99.7)
Asymptomatic:
Sensitivity: 98.0% (95% CI 89.5 to 99.6)
Specificity: 98.4% (95% CI 96.8 to 99.2)
Symptomatic:
Sensitivity: 92.9% (95% CI 84.3 to 96.9)
Specificity: 97.9% (95% CI 96.2 to 98.8)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Vaginal Swab Specimens (Combined Symptom Status):
Sensitivity: 99.2% (95% CI 95.4 to 99.9)
Specificity: 98.7% (95% CI 97.7 to 99.3)
PPV: 90.8% (95% CI 84.7 to 94.7)
NPV: 99.7% (95% CI 99.4 to 100)
Urine Specimens (Combined Symptom Status):
Sensitivity: 95.0% (95% CI 89.5 to 97.7)
Specificity: 98.2% (95% CI 97.1 to 98.8)
PPV: 87.0% (95% CI 80.2 to 91.7)
NPV: 99.3% (95% CI 98.6 to 99.7)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3860
Trichomonas vaginalis nucleic acid assay.(a)
Identification. ATrichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomoniasis in asymptomatic women. The detection of trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of trichomoniasis caused byTrichomonas vaginalis .(b)
Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection ofTrichomonas vaginalis; Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three overlapping profiles facing to the right.
Public Health Service
August 15, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Quidel Corporation Ronald H. Lollar Senior Director, Clinical and Regulatory Affairs 2005 East State Street, Suite 100 Athens, OH 45701
Re: K161182
Trade/Device Name: Solana® Trichomonas Assay Regulation Number: 21 CFR 866.3860 Regulation Name: Trichomonas vaginalis nucleic acid assay Regulatory Class: II Product Code: OUY Dated: July 14, 2016 Received: July 15, 2016
Dear Mr. Lollar:
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 (QS) regulation (21 CFR Part 820); and if applicable, the
1
Page 2 - Mr. Lollar
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21CFR 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,
Steven R. Gitterman -S
for Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161182
Device Name Solana® Trichomonas Assay
Indications for Use (Describe)
The Solana® Trichomonas Assay is an in vitro diagnostic test, using isothermal amplification technology (helicasedependent amplification, HDA), for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swabs and female urine specimens obtained from symptomatic females to aid in the diagnosis of trichomoniasis. The Solana® Trichomonas Assay is intended for use only with the Solana® instrument.
| 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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3
Applicant:
Quidel Corporation 12544 High Bluff Drive, Suite 200 San Diego, California 92130 Telephone: 858-552-7910 Fax: 858-646-8045
Contact Information:
Ronald H. Lollar, Senior Director Clinical and Regulatory Affairs 2005 East State Street, Suite 100 Athens, Ohio 45701 740-589-3300 - Corporate number 740-589-3373 – Desk phone 858-552-6451—Fax Ron.Lollar@quidel.com
Date of preparation of 510(k) summary:
April 26, 2016
A. 510(k) Number:
B. Purpose for Submission:
To obtain substantial equivalence for the Solana Trichomonas Assay when performed on the Solana
C. Measurand:
Repeated DNA fragment located in T. vaginalis genome
D. Type of Test:
Helicase-dependent amplification (HDA)
4
E. Applicant:
Quidel Corporation
F. Proprietary and Established Names:
Solana Trichomonas Assay
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| OUY – | |||
| Trichomonas vaginalis nucleic | |||
| acid amplification | |||
| test system | Class II | 21 CFR 866.3860 Trichomonas vaginalis nucleic acid assay | Microbiology (83) |
H. Intended Use:
1. Intended Use(s):
The Solana® Trichomonas Assay is an in vitro diagnostic test, using isothermal amplification technology (helicase-dependent amplification, HDA), for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swabs and female urine specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The Solana® Trichomonas Assay is intended for use only with the Solana® Instrument.
2. Indication(s) for Use:
Same as Intended Use.
3. Special conditions for use statement(s):
- For in vitro diagnostic use only
- For prescription use only
-
- Special instrument requirements:
Solana® Instrument
5
l. Device Description:
The Solana® Trichomonas Assay amplifies and detects Trichomonas vaginalis nucleic acids present in clinician-collected vaginal swabs and urine specimens from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaqinalis DNA.
The vaginal swab is eluted in a swab lysis tube or a urine specimen is added to a urine lysis tube, and the cells in either specimen type are lysed by simple heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of the diluted sample is added to a reaction tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of T. vaginalis-specific target sequence. In Solana, the target sequence is amplified by T. vaginalis specific primers and detected by a T. vaginalis specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by T. vaginalis specific primers and detected by a PRC specific fluorescence probe.
The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to T. vaqinalis or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana instrument will then report the test results to the user on its display screen, and the results can be printed via a printer.
Materials Provided:
Solana® Trichomonas Assay Kit: M304.S for swab testing or M304.U for urine testing
| Solana® Trichomonas Assay Kit – M304.S | ||
|---|---|---|
| Component | Quantity | Storage |
| Lysis Buffer Tubes | 48 tubes/kit, 1.0 mL | 2° to 8°C |
| Dilution Tubes | 48 tubes/kit, 1.5 mL | 2° to 8°C |
| Reaction Tubes | 48 tubes/kit | 2° to 8°C |
| Solana® Trichomonas Assay Kit - M304.U | ||
| Component | Quantity | Storage |
| Lysis Buffer Tubes | 48 tubes/kit, 0.2 mL | 2° to 8°C |
| Dilution Tubes | 48 tubes/kit, 1.5 mL | 2° to 8°C |
| Reaction Tubes | 48 tubes/kit | 2° to 8°C |
48 Tests per kit
6
Materials required but not provided:
- External controls for Trichomonas vaginalis (e.g. Quidel Molecular Trichomonas Assay Control Kit: M119), which contains positive and negative controls. This positive control contains intact non-viable, trophozoites and has been titered to be near the limit of detection for the assay. This negative control is the same matrix as the positive control, but is trophozoite-free. These controls serve as an external processing and extraction control
- Sterile DNAse-free filter-blocked or positive displacement micropipettor tips
- Micropipettor
- BD BBL™ CultureSwab™ collection and transport device ●
- . Stopwatch or timer
- Scissors or a blade
- Micro tube tray
- Heat block capable of 95° C ± 2° C temperature ●
- Thermometer
- Solana Instrument ●
J. Substantial Equivalence Information:
-
- Predicate device name(s):
AmpliVue Trichomonas Assay
- Predicate device name(s):
-
- Predicate 510(k) number(s): K143329
3. Comparison with predicate:
| Similarities | ||
|---|---|---|
| Item | Solana® Trichomonas Assay | |
| (K161182) | AmpliVue® Trichomonas Assay | |
| (K143329) | ||
| Intended Use | The Solana® Trichomonas Assay is | |
| an in vitro diagnostic test, using | ||
| isothermal amplification | ||
| technology (helicase-dependent | ||
| amplification, HDA), for the | ||
| qualitative detection of | ||
| Trichomonas vaginalis nucleic acids | The AmpliVue® Trichomonas | |
| Assay is an in vitro diagnostic | ||
| test, uses isothermal | ||
| amplification technology | ||
| (helicase-dependent | ||
| amplification, HDA) for the | ||
| qualitative detection of |
7
Solana® Trichomonas Assay 7/26/2016 Page 5 of 21
510(k) Summary
| Similarities | ||
|---|---|---|
| Item | Solana® Trichomonas Assay | |
| (K161182) | AmpliVue® Trichomonas Assay | |
| (K143329) | ||
| isolated from clinician-collected vaginal swabs and female urine specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The Solana® Trichomonas Assay is intended for use only with the Solana® instrument. | Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. | |
| Target | ||
| Sequence | ||
| Detected | Repeated DNA fragment located in T. vaginalis genome | Same |
| Amplification | ||
| Technology | Helicase-dependent amplification (HDA) | Same |
| Differences | ||
|---|---|---|
| Item | Solana® Trichomonas Assay | |
| (K161182) | AmpliVue® Trichomonas | |
| Assay (K143329) | ||
| Sample Types | Clinician-collected Vaginal | |
| Swabs, Female Urine | Clinician-collected Vaginal | |
| Swabs | ||
| Self-Contained | ||
| System Assay after | ||
| sample preparation | Yes | No |
| Detection Technique | Automated | Manual |
| Instrument | Solana | None |
| Performance | Clinician-collected Vaginal | |
| Specimens: Asymptomatic | Clinician-collected Vaginal | |
| Specimens: Asymptomatic |
8
| Differences | ||
|---|---|---|
| Item | Solana® Trichomonas Assay | |
| (K161182) | AmpliVue® Trichomonas | |
| Assay (K143329) | ||
| Characteristics | Sensitivity 100% (95% CI 92.9 – |
Specificity 98.9% (95% CI 97.4 –
99.5)
Symptomatic
Sensitivity 98.6% (95% CI 92.3 –
99.7)
Specificity 98.5% (95% CI 97.0 –
99.3)
Female Urine Specimens:
Asymptomatic
Sensitivity 98% (95% CI 89.5 –
99.6)
Specificity 98.4% (95% CI 96.8 –
99.2)
Symptomatic
Sensitivity 92.9% (95% CI 84.3 –
96.9)
Specificity 97.9% (95% CI 96.2 –
98.8) | Sensitivity 100% (95% CI
94.1 – 100)
Specificity 98.3% (95% CI
96.9 – 99.1)
Symptomatic
Sensitivity 100% (95% CI
93.9 – 100)
Specificity 97.9% (95% CI
95.5 – 99.0) |
K. Standard/Guidance Document Referenced (if applicable):
Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis
L. Test Principle:
The vaginal swab is eluted in a swab lysis tube or a urine specimen is added to a urine lysis tube, and the cells in either specimen type are lysed by simple heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of the diluted sample is added to a reaction tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of T. vaginalis-specific target sequence. In Solana, the target sequence is amplified by T. vaginalis specific primers
9
and detected by a T. vaqinalis specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by T. vaginalis specific primers and detected by a PRC specific fluorescence probe.
The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to T. vaqinalis or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana instrument will then report the test results to the user on its display screen, and the results can be printed via an attached printer.
M. Performance Characteristics:
1. Analytical performance:
a. Precision/Reproducibility:
Reproducibility
In order to confirm the reproducibility of the Solana Trichomonas Assay a blinded and randomized study consisting of the following four-member panel containing Trichomonas vaginalis positive and negative samples was performed: swab workflow - moderate positive (3x LoD), low positive (1x LoD), high negative (1/54x LoD), and a negative sample; urine workflow - moderate positive (3x LoD), low positive (1x LoD), high negative (1/27x LoD), and a negative sample. The testing was performed using appropriate swab or urine workflows at three (3) test sites (one inhouse laboratory and two (2) clinical sites). Each site tested a reproducibility panel and Assay Controls for five (5) days in triplicate. Testing was done by two (2) operators at each site. Each operator ran the panel once a day using one lot of Solana Trichomonas Assay. The testing was performed using both the swab and urine workflows.
| SITE | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Category | ||||||||||||
| Swab | ||||||||||||
| Workflow | Site #1 | Site #2 | Site #3 | Overall Percent | ||||||||
| Agreement | 95% | |||||||||||
| Confidence | ||||||||||||
| Interval | ||||||||||||
| #expected | ||||||||||||
| results/# | ||||||||||||
| tested | % | |||||||||||
| Agreement | 95% | |||||||||||
| Confidence | ||||||||||||
| Interval | #expected | |||||||||||
| results/# | ||||||||||||
| tested | % | |||||||||||
| Agreement | 95% | |||||||||||
| Confidence | ||||||||||||
| Interval | #expected | |||||||||||
| results/# | ||||||||||||
| tested | % | |||||||||||
| Agreement | 95% | |||||||||||
| Confidence | ||||||||||||
| Interval | ||||||||||||
| High Negative | ||||||||||||
| (1.89 | ||||||||||||
| trophozoites | ||||||||||||
| /mL) | 25/30 | 83% | 66.4% to | |||||||||
| 92.7% | 22/30 | 73% | 55.6% to | |||||||||
| 85.8% | 15/30 | 50% | 33.2% | |||||||||
| to | ||||||||||||
| 66.8% | 62/ | |||||||||||
| 90 | 69% | 58.7% to | ||||||||||
| 77.5% |
10
Solana® Trichomonas Assay 7/26/2016 Page 8 of 21
510(k) Summary
| | SITE | | | SITE | | | SITE | | | Overall Percent
Agreement | 95%
Confidence
Interval |
|------------------------------------------------------|----------------------------------|----------------|-------------------------------|----------------------------------|----------------|-------------------------------|----------------------------------|----------------|-------------------------------|------------------------------|-------------------------------|
| Category
Swab
Workflow | #expected
results/#
tested | %
Agreement | 95%
Confidence
Interval | #expected
results/#
tested | %
Agreement | 95%
Confidence
Interval | #expected
results/#
tested | %
Agreement | 95%
Confidence
Interval | | |
| Low Positive
(102
trophozoites
/mL) | 30/30 | 100% | 88.6% to
100% | 30/30 | 100% | 88.6% to
100% | 30/30 | 100% | 88.6%
to
100% | 90/
90 | 95.9% to
100% |
| Moderate
Positive
(306
trophozoites
/mL) | 30/30 | 100% | 88.6% to
100% | 30/30 | 100% | 88.6% to
100% | 30/30 | 100% | 88.6%
to
100% | 90/
90 | 95.9% to
100% |
| Negative | 30/30 | 100% | 88.6% to
100% | 30/30 | 100% | 88.6% to
100% | 30/30 | 100% | 88.6%
to
100% | 90/
90 | 95.9% to
100% |
| Positive
Control | 30/30 | 100% | 88.6% to
100% | 30/30 | 100% | 88.6% to
100% | 30/30 | 100% | 88.6%
to
100% | 90/
90 | 95.9% to
100% |
| Negative
Control | 30/30 | 100% | 88.6% to
100% | 30/30 | 100% | 88.6% to
100% | 30/30 | 100% | 88.6%
to
100% | 90/
90 | 95.9% to
100% |
| SITE | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Category | ||||||||||||
| Urine | ||||||||||||
| Workflow | #expected | |||||||||||
| results/# | ||||||||||||
| tested | % | |||||||||||
| Agreement | 95% | |||||||||||
| Confidence | ||||||||||||
| Interval | #expected | |||||||||||
| results/# | ||||||||||||
| tested | % | |||||||||||
| Agreement | 95% | |||||||||||
| Confidence | ||||||||||||
| Interval | #expected | |||||||||||
| results/# | ||||||||||||
| tested | % | |||||||||||
| Agreement | 95% | |||||||||||
| Confidence | ||||||||||||
| Interval | Overall Percent | |||||||||||
| Agreement | 95% | |||||||||||
| Confidence | ||||||||||||
| Interval | ||||||||||||
| High Negative | ||||||||||||
| (0.2 | ||||||||||||
| trophozoites | ||||||||||||
| /mL) | 20/30 | 67% | 48.8% to | |||||||||
| 80.8% | 19/30 | 63% | 45.5% to | |||||||||
| 78.1% | 22/30 | 73% | 55.6% to | |||||||||
| 85.8% | 61/ | |||||||||||
| 90 | 68% | 57.6% to | ||||||||||
| 75.5% | ||||||||||||
| Low Positive | ||||||||||||
| (4 trophozoites | ||||||||||||
| /mL) | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 90/ | |||||||||||
| 90 | 100% | 95.9% to | ||||||||||
| 100% | ||||||||||||
| Moderate | ||||||||||||
| Positive | ||||||||||||
| (12 | ||||||||||||
| trophozoites | ||||||||||||
| /mL) | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 90/ | |||||||||||
| 90 | 100% | 95.9% to | ||||||||||
| 100% | ||||||||||||
| Negative | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 90/ | |||||||||||
| 90 | 100% | 95.9% to | ||||||||||
| 100% | ||||||||||||
| Positive | ||||||||||||
| Control | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 90/ | |||||||||||
| 90 | 100% | 95.9% to | ||||||||||
| 100% | ||||||||||||
| Negative | ||||||||||||
| Control | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 30/30 | 100% | 88.6% to | |||||||||
| 100% | 90/ | |||||||||||
| 90 | 100% | 95.9% to | ||||||||||
| 100% |
11
The results suggest that there are no significant differences between different users and different sites on different days using either the swab or the urine workflow. Reproducibility studies are acceptable.
-
b. Linearity/assay reportable range:
Not applicable - This assay is qualitative. -
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability:
Not applicable. This assay is qualitative.
Specimen Stability:
A study was performed to determine the stability of swab and urine samples when stored at 2 to 8°C or 30°C ± 2°C. Contrived positive swab and urine samples (2x LoD) were prepared. The testing time points for the specimens stored at 2° to 8°C were 0, 24, 48, 72, 73 hours, 5, 7, 8 days. The testing time points for the specimens stored at 30°C ± 2°C were 0, 2.5, 6.5, 24, 25, 27, 48, and 49 hours.
Based on the data generated by this study, swab specimens may be stored between 2° to 8°C for up to 7 days prior to testing. Swab specimens may be stored at up to 48-hours at 30°C ± 2°C or below prior to testing.
Based on the data generated by this study, urine specimens may be stored between 2° to 8°C for up to 7 days prior to testing. Urine specimens may be stored at up to 24-hours at 30°C ± 2°C or below prior to testing.
Controls:
Controls (Quidel Molecular Trichomonas Control Set #M119, which contains positive and negative controls, serves as an external processing and extraction control) were run on the Solana * Trichomonas Assay each day of testing. These controls are described as follows:
- a. The internal control is used to detect HDA inhibitory specimens and to confirm the integrity of assay reagents and the operation of the Solana instrument. The internal control is included in the lysis tube.
12
- b. External assay positive control (e.g. Quidel Molecular Trichomonas Control Set (M119)) serves as the assay positive control. Transfer 50 µL of positive control into a labeled lysis buffer tube and proceed with processing. The external assay positive control is intended to monitor substantial reagent and instrument failure.
- External assay negative control (e.g. Quidel Molecular Trichomonas Control ﻥ Set (M119)) serves as the assay negative control. Transfer 50 µL of negative control into a labeled lysis buffer tube and proceed with processing. The external assay negative control is intended to detect reagent or environment contamination or carry-over by either T. vaginalis DNA or amplicons.
- d. Detection limit:
The analytical sensitivity (limit of detection or LoD) of the Solana Trichomonas Assay was determined using quantified (trophozoite/mL) strains of two (2) T. vaginalis strains, one metronidazole-susceptible G3 and one metronidazole-resistant CDC888 serially diluted in negative clinical matrix. The LOD is defined as the lowest concentration at which 95% of all replicates tested positive.
The strains were freshly grown and quantified using a hemocytometer. The cells were serially diluted in negative clinical matrix to three (3) concentrations at 3×, 1×, and 1/3× in the preliminary LOD determination study.
LoD was confirmed by testing each reference strain with 20 replicates on three reagent lots in the negative vaginal swab and negative urine matrixes.
| Trichomonas vaginalis
| reference strain | Swab Workflow LoD | Urine Workflow LoD |
|---|---|---|
| G3 | 102 trophozoite /mL | 4 trophozoite /mL |
| CDC888 | 306 trophozoite /mL | 108 trophozoite /mL |
- e. Analytical specificity:
Cross Reactivity:
A study was performed to evaluate the cross-reactivity of the Solana® Trichomonas Assay in the presence of forty-seven (47) microorganisms (37 bacteria, 4 yeast, 4 viruses, 2 parasite) potentially found in specimens collected to test for Trichomonas
13
vaginalis infection. Each microorganism was diluted in either swab negative matrix or negative urine matrix to the desired concentration (10° or higher CFU/mL or copies/mL for bacteria, yeast or DNA/RNA and 105 or higher pfu/mL or TCID50/mL for viruses). The strains included in the cross-reactive study are shown in the table below.
| Microorganism | Stock Concentration | Microorganism | Stock Concentration |
|---|---|---|---|
| Acinetobacter Iwoffi | 1.0×106 CFU/mL | Herpes simplex virus I | 1.0×105 TCID50/mL |
| Actinomyces israelii | 1.0×106 CFU/mL | Herpes simplex virus II | 1.0×105 TCID50/mL |
| Atopobium vaginae | 1.0×106 CFU/mL | Klebsiella oxytoca | 1.0×106 CFU/mL |
| Bacteroides fragilis | 1.0×106 CFU/mL | Lactobacillus acidophilus | 1.0×106 CFU/mL |
| Bifidobacterium adolescentis | 1.0×106 CFU/mL | Lactobacillus jensenii | 1.0×106 CFU/mL |
| Campylobacter jejuni | 1.0×106 CFU/mL | Lactobacillus vaginalis | 1.0×106 CFU/mL |
| Candida albicans | 1.0×106 CFU/mL | Listeria monocytogenes | 1.0×106 CFU/mL |
| Candida glabrata | 1.0×106 CFU/mL | Mobiluncus curtisii | 1.0×106 CFU/mL |
| Candida parapsilosis | 1.0×106 CFU/mL | Mycoplasma hominis | 1.0×106 CFU/mL |
| Candida tropicalis | 1.0×106 CFU/mL | Neisseria gonorrhoeae | 1.0×106 CFU/mL |
| Chlamydia trachomatis | 1.0×106 CFU/mL | Pentatrichomonas hominis | 1.0×106 CFU/mL |
| Clostridium difficile | 1.0×106 CFU/mL | Prevotella bivia | 1.0×106 CFU/mL |
| Clostridium perfingens | 1.0×106 CFU/mL | Propionibacterium acnes | 1.0×106 CFU/mL |
| Corynebacterium genitalium | 1.0×106 CFU/mL | Proteus mirabilis | 1.0×106 CFU/mL |
| Cryptococcus neoformans | 1.0×106 CFU/mL | Pseudomonas aeruginosa | 1.0×106 CFU/mL |
| Enterobacter aerogenes | 1.0×106 CFU/mL | Staphylococcus aureus (MRSA) | 1.0×106 CFU/mL |
| Enterococcus faecalis | 1.0×106 CFU/mL | Staphylococcus epidermidis | 1.0×106 CFU/mL |
| Escherichia coli | 1.0×106 CFU/mL | Streptococcus pyogenes | 1.0×106 CFU/mL |
| Fusobacterium nucleatum | 1.0×106 CFU/mL | Streptococcus agalactiae | 1.0×106 CFU/mL |
| Gardnerella vaginalis | 1.0×106 CFU/mL | Trichomonas tenax | 1.0×106 CFU/mL |
| Microorganism | Stock | ||
| Concentration | Microorganism | Stock | |
| Concentration | |||
| Haemophilus ducreyi | 1.0×106 copies/mL | Enterobacter cloacae | 1.0×106 CFU/mL |
| HIV-1 Subtype B RNA | 1.0×105 RNA | ||
| copies/mL | HPV 16 (SiHa) | 1.0×105 copies/mL | |
| Peptostreptococcus anaerobius | 1.0×106 copies/mL | Ureaplasma urealyticum DNA | 1.23 x108 cp/mL |
| Synthetic Mycoplasma genitalium DNA* | 1.0×106 copies/mL |
14
- Preparation includes fragments from the 16S gene, mgpA, and gap.
No cross-reactivity was seen with the Solana "Trichomonas Assay with any of fortyseven (47) microorganisms (37 bacteria, 4 yeast, 4 viruses, 2 parasite) tested.
Interference:
Vaginal Swab Specimens
A study was conducted to determine if the Solana "Trichomonas assay is inhibited in the presence of a panel of fourteen (14) substances potentially present in vaginal swab specimens collected to test for Trichomonas vaginalis infection. Each of the potential interfering substances was tested in three (3) replicates in the presence and absence of near LOD (2x) levels of two (2) strains of Trichomonas vaginalis in the Solana Trichomonas Assay. Substances were introduced into the assay at concentrations which were medically relevant.
| Class | Substances | Concentration Tested |
|---|---|---|
| Blood | Whole blood with EDTA | 10% (v/v) |
| Seminal fluid | Seminal fluid | 1% (v/v) |
| Mucus | Mucin from Porcine Stomach | 1% (w/v) |
| Over the counter | ||
| (OTC) vaginal | ||
| products and | ||
| contraceptives | K-Y Personal Lubricant Jelly | 1% (w/v) |
| Ortho Options Gynol II Extra Strength Vaginal Contraceptive Jelly | 1% (w/v) | |
| Summer's Eve Ultra Extra Strength Feminine Deodorant Spray | 1% (w/v) | |
| Vagisil Creme Maximum Strength | 1% (w/v) |
15
| Class | Substances | Concentration Tested |
|---|---|---|
| CVS Vinegar & Water Extra Cleansing | ||
| Disposable Douche (Glacial acetic acid) | 1% (v/v) | |
| Summer's Eve Douche, Medicated | 1% (v/v) | |
| Intravaginal | ||
| Hormones | Estradiol | 1% (w/v) |
| Hemerrhoidal Cream | Preparation H | 1% (w/v) |
| Leukocytes | Leukocytes | 106 cells/mL |
| Prescription vaginal | ||
| treatments | Acyclovir (Acycloguanosine) | 0.05% (w/v) (1% of active |
| ingredient of Zovirax | ||
| cream with Acyclovir at | ||
| 5%) | ||
| Metronidazole | 0.0075% (w/v) (1% of | |
| active ingredient of | ||
| Vandazole gel with | ||
| Metronidazole at 0.75%) |
None of the substances tested interfered with the detection of either strain of 2x LoD Trichomonas vaginalis, or the detection of the internal control in negative specimens.
Urine Specimens
A study was conducted to determine if the Solana Trichomonas assay is inhibited in the presence of a panel of seventeen (17) substances potentially present in urine specimens collected to test for Trichomonas vaginalis infection. Each of the potential interfering substances was tested in three (3) replicates in the presence and absence of near LoD (2x) levels of two (2) strains of Trichomonas vaginalis in the Solana "Trichomonas Assay. Substances were introduced into the assay at concentrations which were medically relevant.
| Class | Substances | Concentration Tested |
|---|---|---|
| Blood | Whole blood with EDTA | 1% (v/v) |
| Seminal fluid | Seminal fluid | 5% (v/v) |
| Mucus | Mucin from Porcine Stomach | 1% (w/v) |
| AZO Standard Urinary Relief Tablets | ||
| (Phenazopyridine Hydrochloride) | 1.0 mg/mL |
16
| Class | Substances | Concentration Tested |
|---|---|---|
| Analgesics & | ||
| Antibiotics | Acetylsalicylic Acid | 8 mg/mL |
| Acetaminophen | 3.2 mg/mL | |
| Azithromycin | 1.0 mg/mL | |
| Doxycycline | 0.5 mg/mL | |
| Over the counter | ||
| deodorant spray and | ||
| powder | Summer's Eve Feminine Deodorant | |
| Powder | 1% (w/v) | |
| Summer's Eve Feminine Deodorant Spray | 1% (w/v) | |
| Albumin | Human Albumin | 10 mg/ml |
| Glucose | Glucose | 10 mg/ml |
| Bilirubin | Bilirubin | 1 mg/ml |
| Acidic Urine (pH 4.0) | Urine + N-Acetyl-L-Cysteine | pH 4.0 |
| Alkaline Urine (pH 9.0) | Urine + Ammonium Citrate & Sodium | |
| hydroxide | pH 9.0 | |
| Leukocytes | Leukocytes | $10^6$ cells/mL |
| Intravaginal | ||
| Hormones | Estradiol | 1% (w/v) |
None of the substances tested interfered with the detection of either strain of 2x LOD Trichomonas vaginalis, or the detection of the internal control in negative specimens.
Analytical Reactivity (Inclusivity):
A study was performed to verify the in silico inclusivity results with functional testing of the Solana Trichomonas Assay using twenty (20) additional strains of Trichomonas vaginalis tested in triplicate at concentrations at or near the 1x LoD levels of the assay in both the swab and urine workflows.
| Bacterial Strain | Strain Detected
(Yes/No) | Strain Detected
(Yes/No) |
|------------------|-----------------------------|-----------------------------|
| CDC899 | Yes | Yes |
| CDC938 | Yes | Yes |
| CDC963 | Yes | Yes |
| CDC1031 | Yes | Yes |
17
| Bacterial Strain | Strain Detected
(Yes/No) | Strain Detected
(Yes/No) |
|------------------|-----------------------------|-----------------------------|
| CDC1256 | Yes | Yes |
| PMGH25 | Yes | Yes |
| BUSH20 | Yes | Yes |
| CDC911 | Yes | Yes |
| MOR31 | Yes | Yes |
| CDC1080 | Yes | Yes |
| B7708/1839 | Yes | Yes |
| F1623 | Yes | Yes |
| CDC1095 | Yes | Yes |
| SD1 | Yes | Yes |
| SA-384 | Yes | Yes |
| CDC948 | Yes | Yes |
| SD10 | Yes | Yes |
| SA-A53 | Yes | Yes |
| CDC1230 | Yes | Yes |
| SA-A19 | Yes | Yes |
The twenty (20) additional strains of Trichomonas vaginalis tested in triplicate at concentrations near the LoD levels of the assay were detected in both the swab and urine workflows of the Solana Trichomonas assay.
-
f. Assay cut-off:
Not applicable. -
- Comparison studies:
- a. Method comparison with predicate device:
Not applicable
-
b. Matrix comparison:
Not applicable -
- Clinical studies:
18
Clinical Sensitivity: a.
A multi-center study was performed to evaluate Solana Trichomonas Assay using one thousand forty-four (1044) clinician-collected vaginal swab and urine specimens obtained from asymptomatic (n=501) or symptomatic (n=543) patients. The clinician categorized the patients as symptomatic or asymptomatic at the of specimen collection. The study was performed November 2015 through March 2016 at four (4) locations in the United States. Specimens were obtained from each subject after informed consent was obtained. The study was conducted in accord with the Health Insurance Portability and Accountability Act (HIPAA).
Vaginal Swab
For each subject, three (3) vaginal specimens were collected using polyester or rayon Swabs w/ liquid Stuart's, and one (1) vaginal specimen was collected with a collection swab from a FDA-cleared molecular device. The four (4) clinician collected vaginal swabs were used for reference and Solana testing. The first two (2) polyester/rayon swabs were randomized, one swab was tested for the Wet Mount (reference method) and the other swab was used for the InPouch TV Culture (reference method). The third swab was used for testing the Solana Trichomonas Assay. The FDA-cleared molecular device collection swab was used for discordant testing.
All sensitivity and specificity calculations were based on a composite reference method of Wet Mount and InPouch TV culture. A specimen was considered positive if either test was positive.
One thousand forty-four (1044) clinician-collected vaginal swab specimens obtained from asymptomatic (n=501) or symptomatic (n=543) patients were tested by the composite reference method and the Solana Trichomonas Assay. Ten (10) specimens generated invalid results upon initial testing with the Solana Trichomonas Assay (0.96%). These specimens were re-tested according to the instructions provided in the package insert. Nine (9) of these specimens generated valid results upon re-testing (6 negative and 3 positive results), and one (1) specimen generated a second invalid result (0.1%). The table below shows the sensitivity, specificity, PPV, and NPV of the Solana Trichomonas Assay and the prevalence of T. vaginalis (by asymptomatic, symptomatic clinician designations and combined) for the remaining one thousand forty-three (1043) subjects.
| Performance Characteristics of the Solana Trichomonas Assay with Vaginal Swabs by Symptom Status compared to the Composite Reference Method | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site Number | Symptom Status | N | TP | FP | TN | FN | Prev% | Sensitivity% | |||
| (95% CI) | Specificity% | ||||||||||
| (95% CI) | PPV % | ||||||||||
| (95% CI) | NPV % | ||||||||||
| (95% CI) |
19
Solana Trichomonas Assay 7/26/2016 Page 17 of 21
510(k) Summary
| Site Number | Symptom Status | N | TP | FP | TN | FN | Prev% | Sensitivity% (95% CI) | Specificity% (95% CI) | PPV % (95% CI) | NPV % (95% CI) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Combined | Asymptomatic | 501 | 50 | 5 | 446 | 0 | 10.0 | 100 (92.9 to 100) | 98.9 (97.4 to 99.5) | 90.9 (80.4 to 96.1) | 100 (99.1 to 100) |
| Symptomatic | 542 | 69 | 7 | 465 | 1 | 12.9 | 98.6 (92.3 to 99.7) | 98.5 (97.0 to 99.3) | 90.8 (82.2 to 95.5) | 99.8 (98.8 to 100) | |
| All | 1043 | 119 | 12* | 911 | 1* | 11.5 | 99.2 (95.4 to 99.9) | 98.7 (97.7 to 99.3) | 90.8 (84.7 to 94.7) | 99.7 (99.4 to 100) | |
| Site 1 | Asymptomatic | 77 | 7 | 0 | 70 | 0 | 9.1 | 100 (64.6 to 100) | 100 (94.8 to 100) | 100 (64.6 to 100) | 100 (94.8 to 100) |
| Symptomatic | 27 | 2 | 1 | 24 | 0 | 7.4 | 100 (34.2 to 100) | 96.0 (80.5 to 99.3) | 66.7 (20.8 to 93.9) | 100 (86.2 to 100) | |
| All | 104 | 9 | 1 | 94 | 0 | 8.7 | 100 (70.1 to 100) | 98.9 (94.3 to 99.8) | 90.0 (59.6 to 98.2) | 100 (96.1 to 100) | |
| Site 2 | Asymptomatic | 108 | 13 | 0 | 95 | 0 | 12.0 | 100 (77.2 to 100) | 100 (96.1 to 100) | 100 (77.2 to 100) | 100 (96.1 to 100) |
| Symptomatic | 213 | 37 | 2 | 174 | 0 | 17.4 | 100 (90.6 to 100) | 98.9 (80.5 to 99.3) | 94.9 (83.1 to 98.6) | 100 (97.8 to 100) | |
| All | 321 | 50 | 2 | 269 | 0 | 15.6 | 100 (92.9 to 100) | 99.3 (97.3 to 99.8) | 96.2 (87.0 to 98.9) | 100 (98.6 to 100) | |
| Site 3 | Asymptomatic | 146 | 19 | 1 | 126 | 0 | 13.0 | 100 (83.2 to 100) | 99.2 (95.7 to 99.9) | 95.0 (76.4 to 99.1) | 100 (97.0 to 100) |
| Symptomatic | 67 | 9 | 1 | 57 | 0 | 13.4 | 100 (70.1 to 100) | 98.3 (90.9 to 99.7) | 90.0 (59.6 to 98.2) | 100 (93.7 to 100) | |
| All | 213 | 28 | 2 | 183 | 0 | 13.1 | 100 (87.9 to 100) | 98.9 (96.1 to 99.7) | 85.9 (76.0 to 92.2) | 100 (99.3 to 100) | |
| Site 4 | Asymptomatic | 170 | 11 | 4 | 155 | 0 | 6.5 | 100 (74.1 to 100) | 97.5 (93.7 to 99.0) | 73.3 (48.0 to 89.1) | 100 (97.6 to 100) |
| Symptomatic | 235 | 21 | 3 | 210 | 1 | 9.4 | 95.5 (78.2 to 99.2) | 98.6 (95.9 to 99.5) | 87.5 (69.0 to 95.7) | 99.5 (97.4 to 99.9) | |
| All | 405 | 32 | 7 | 365 | 1 | 8.1 | 97.0 (84.7 to 99.5) | 98.1 (96.2 to 99.1) | 82.1 (67.3 to 91.0) | 99.7 (98.5 to 100) |
*Of the one thousand forty-three 1043 specimens evaluated a total of thirteen (13) specimens were discordant. Of the twelve (12) discordant (Solana Positive/Composite Reference Method Negative) specimens, four (4) were positive by a FDA-cleared Trichomonas vaginalis molecular assay. The one (1) discordant (Solana Negative/Composite Reference Method Positive) specimen was negative by a FDA-cleared Trichomonas vaginalis molecular assay.
Urine
One thousand forty-four (1044) first catch urine specimens obtained from asymptomatic (n=501) or symptomatic (n=543) patients were tested by the Solana Trichomonas Assay. Five (5) specimens generated invalid results upon initial testing with the Solana Trichomonas Assay (0.5%). These specimens were re-tested according to the instructions provided in the package insert. All five (5) of these specimens generated valid results upon re-testing (four (4) negative and one (1) positive result). The table below shows the sensitivity, specificity, PPV, and NPV of the Solana Trichomonas Assay and the prevalence of T. vaginalis (by asymptomatic, symptomatic clinician designations and combined) for the one thousand forty-four (1044) subjects when compared to the corresponding Wet Mount and the InPouch TV Culture results.
20
| Site Number | Symptom Status | N | TP | FP | TN | FN | Prev% | Sensitivity%
(95% CI) | Specificity%
(95% CI) | PPV %
(95% CI) | NPV %
(95% CI) |
|-------------|----------------|------|-----|----|-----|----|-------|--------------------------|--------------------------|------------------------|------------------------|
| Combined | Asymptomatic | 501 | 49 | 7 | 444 | 1 | 10.0 | 98.0
(89.5 to 99.6) | 98.4
(96.8 to 99.2) | 87.5
(76.4 to 93.8) | 99.8
(98.7 to 100) |
| | Symptomatic | 543 | 65 | 10 | 463 | 5 | 12.9 | 92.9
(84.3 to 96.9) | 97.9
(96.2 to 98.8) | 86.7
(77.2 to 92.6) | 98.9
(97.5 to 99.5) |
| | All | 1044 | 114 | 17 | 907 | 6 | 11.5 | 95.0
(89.5 to 97.7) | 98.2
(97.1 to 98.8) | 87.0
(80.2 to 91.7) | 99.3
(98.6 to 99.7) |
| Site 1 | Asymptomatic | 77 | 6 | 0 | 70 | 1 | 9.1 | 85.7
(48.7 to 97.4) | 100
(94.8 to 100) | 100
(61.0 to 100) | 98.6
(92.4 to 99.8) |
| | Symptomatic | 27 | 2 | 3 | 22 | 0 | 7.4 | 100
(34.2 to 100) | 88.0
(70.0 to 95.8) | 40.0
(11.8 t 76.9) | 100
(85.1 to 100) |
| | All | 104 | 8 | 3 | 92 | 1 | 8.7 | 88.9
(56.5 to 98.0) | 96.6
(91.1 to 98.9) | 72.7
(43.4 to 90.3) | 98.9
(94.2 to99.8) |
| Site 2 | Asymptomatic | 108 | 13 | 0 | 95 | 0 | 12.0 | 100
(77.2 to 100) | 100
(96.1 to 100) | 100
(77.2 to 100) | 100
(96.1 to 100) |
| | Symptomatic | 214 | 35 | 4 | 173 | 2 | 17.3 | 94.6
(82.3 to 98.5) | 97.7
(94.3 to 99.1) | 89.7
(76.4 to 95.9) | 98.9
(95.9 to 99.7) |
| | All | 322 | 48 | 4 | 268 | 2 | 15.5 | 96.0
(86.5 to 98.9) | 98.5
(96.3 to 99.4) | 92.3
(81.8 to 97.0) | 99.3
(97.3 to 99.8) |
| Site 3 | Asymptomatic | 146 | 19 | 1 | 126 | 0 | 13.0 | 100
(83.2 to 100) | 99.2
(95.7 to 99.9) | 95.0
(76.4 to 99.1) | 100
(97.0 to 100) |
| | Symptomatic | 67 | 9 | 0 | 58 | 0 | 13.4 | 100
(70.1 to 100) | 100
(93.8 to 100) | 100
(70.1 to 100) | 100
(93.8 to 100) |
| | All | 213 | 28 | 1 | 184 | 0 | 13.1 | 100
(87.9 to 100) | 99.5
(97.0 to 99.9) | 96.6
(82.8 to 99.4) | 100
(97.9 to 100) |
| Site 4 | Asymptomatic | 170 | 11 | 6 | 153 | 0 | 6.5 | 100
(74.1 to 100) | 96.2
(92.0 to 98.3) | 64.7
(41.3 to 82.7) | 100
(97.6 to 100) |
| | Symptomatic | 235 | 19 | 3 | 210 | 3 | 9.4 | 86.4
(66.7 to 95.3) | 98.6
(95.9 to 99.5) | 86.4
(66.7 to 95.3) | 99.5
(97.4 to 99.9) |
| | All | 405 | 30 | 9 | 363 | 3 | 8.1 | 90.9
(76.4 to 96.9) | 97.6
(95.5 to 98.7) | 76.9
(61.7 to 87.4) | 99.2
(97.6 to 99.7) |
b. Clinical specificity:
See Section 3a.
Other clinical supportive data (when a. and b. are not applicable): C.
Not applicable
4. Clinical cut-off:
Not applicable
-
- Expected values:
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The prevalence of T. vaginalis (by asymptomatic clinician designations and combined) detected by the Solana Trichomonas Assay in the multi-center study was calculated and is provided in the table below.
| Study Prevalence | |||||
|---|---|---|---|---|---|
| Swab specimens | |||||
| Symptom Status | Combined | Site 1 | Site 2 | Site 3 | Site 4 |
| Asymptomatic | 10.0% | 9.1% | 12.0% | 13.0% | 6.5% |
| Symptomatic | 12.9% | 7.4% | 17.4% | 13.4% | 9.4% |
| Combined | 11.5% | 8.7% | 15.6% | 13.1% | 8.1% |
| Urine specimens | |||||
| Symptom Status | Combined | Site 1 | Site 2 | Site 3 | Site 4 |
| Asymptomatic | 10.0% | 9.1% | 12.0% | 13.0% | 6.5% |
| Symptomatic | 12.9% | 7.4% | 17.3% | 13.4% | 9.4% |
| Combined | 11.5% | 8.7% | 15.5% | 13.1% | 8.1% |
Positive and Negative Predictive Values
The estimated positive predictive value (PPV) and negative predictive value (NPV) of the Solana Trichomonas Assay across different hypothetical prevalence rates are shown in the table below. These calculations are based on the overall estimated sensitivity and specificity for clinician-collected vaginal swab specimens in the Solana Trichomonas Assay clinical study.
| Hypothetical PPV and NPV of the Solana Trichomonas Assay with clinician-
| collected vaginal swab specimens | ||
|---|---|---|
| Prevalence % | PPV (%) | NPV (%) |
| 1 | 43.5 | 100 |
| 2 | 60.9 | 100 |
| 5 | 80.1 | 100 |
| 10 | 89.5 | 99.9 |
| 15 | 93.1 | 99.9 |
| 20 | 95.0 | 99.8 |
| 25 | 96.2 | 99.7 |
The estimated positive predictive value (PPV) and negative predictive value (NPV) of the Solana Trichomonas Assay across different hypothetical prevalence rates are shown in the table below. These calculations are based on the overall estimated sensitivity and specificity for urine specimens in the Solana Trichomonas Assay clinical study.
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| Hypothetical PPV and NPV of the Solana Trichomonas Assay with Urine
| specimens | ||
|---|---|---|
| Prevalence % | PPV (%) | NPV (%) |
| 1 | 38.0 | 100 |
| 2 | 55.1 | 100 |
| 5 | 76.6 | 99.9 |
| 10 | 86.6 | 99.8 |
| 15 | 91.7 | 99.6 |
| 20 | 94.0 | 99.5 |
| 25 | 95.4 | 99.3 |
N. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
Instrument: Solana Instrument
O. System Descriptions:
1. Modes of Operation:
The Solana instrument heats each reaction tube to 64°C. If present, the target sequence is amplified by T. vaginalis specific primers and detected by a T. vaginalis specific fluorescence probe included in the Reaction Tube. The target probes are labeled with a quencher on one end and a fluorophore on the other end. In addition, the target probes carry a ribonucleic acid. Upon annealing to T. vaqinalis amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. The Solana instrument measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana instrument will then report the test results to the user on its display screen, and the results can be printed via a printer.
2. Software:
FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:
Yes No
P. Proposed Labeling:
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The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10, 21 CFR 801.109, and the special controls.