(1094 days)
No
The summary describes a home collection kit for laboratory testing using a previously cleared assay. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Suitability Questionnaire" is mentioned, but there is no indication that its processing involves AI/ML.
No
The device is intended for in vitro detection and identification of C. trachomatis and/or N. gonorrhoeae, which is a diagnostic purpose, not a therapeutic one. The description explicitly states the information provided by this product should not be used to start, stop, or change any course of treatment unless advised by a healthcare provider.
Yes
The device is intended for the "in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC)," which directly relates to diagnosing infections.
No
The device description explicitly states that the Simple 2 Test is composed of physical collection kits (Simple 2 Urine Home Collection Kit and Simple 2 Swab Home Collection Kit) which are used to collect specimens. While there is an online portal and questionnaire, the core of the device involves physical components for specimen collection.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "intended for in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC)". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The device description details a system for collecting biological specimens (urine and vaginal swabs) and shipping them to a laboratory for testing. The testing itself is performed using the Aptima Combo 2 Assay, which is a previously cleared IVD.
- Testing Location: While the collection is done at home, the testing is performed in a clinical laboratory using an assay designed to detect specific analytes (CT and GC) in biological samples.
The Simple 2 Test is essentially a system that facilitates the collection of samples for an existing IVD test (the Aptima Combo 2 Assay). The collection kit itself is a component of the overall IVD process, enabling the in vitro diagnostic testing to occur.
N/A
Intended Use / Indications for Use
The Simple 2 Test is intended for in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home-collected specimens which are shipped to a clinical laboratory for testing using the Aptima Combo 2 Assay on the Panther System. This product is available over-the-counter (OTC) to consumers 18 years of age and older.
The Simple 2 Test contains all the necessary components to collect urine from male patients (Simple 2 Urine Home Collection Kit (Penile)) or vaginal swabs from female patients (Simple 2 Swab Home Collection Kit (Vaginal)) in their home, or in similar environments, without supervision from a healthcare provider.
The Simple 2 Test Collection Kits may also be used to self-collect specimens in a clinic.
The testing is performed, as determined to be appropriate, based on the results of LetsGetChecked Suitability Questionnaire.
This test system is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop, or change any course of treatment unless advised by your healthcare provider.
Testing is limited to the manufacturer, Priva Path laboratories (d.b.a. LetsGetChecked. Inc.).
Product codes (comma separated list FDA assigned to the subject device)
QYA
Device Description
The LetsGetChecked Simple 2 Test is composed of the Simple 2 Urine Home Collection Kit (Penile) and the Simple 2 Swab Home Collection Kit (Vaginal) and the samples are shipped to LetsGetChecked's Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory for processing using the Aptima Combo 2 Assay on the Panther System. The Aptima Combo 2 Assay was previously cleared for the qualitative in vitro detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) when used with male urine and self-collected vaginal swabs collected in clinical settings.
The home collection kits are intended to be distributed for purchase online without the need for prescription from a physician or healthcare professional (over-the-counter use). After purchase, the user activates the kit on LetsGetChecked's website and is requested to fill out the Suitability Questionnaire to determine whether this test is appropriate for this individual. The user follows detailed directions for self-collecting a urogenital specimen (male urine or female vaginal swab, as applicable), packaging and shipping it to the LetsGetChecked CLIA certified laboratory for testing (PrivaPath lab). The test results are delivered to the individual via LetsGetChecked online portal. Positive and invalid/inconclusive results are followed up with a call from the LetsGetChecked Care Team. If the patient received a positive chlamydia result, treatment options are discussed. Patients receiving a positive gonorrhea test result, will be advised to contact their healthcare provider to receive appropriate treatment. The LetsGetChecked Care Team will also contact all patients who test negative for chlamydia and gonorrhea, but do report symptoms, or concerns, or where further investigation is indicated. These patients are internally flagged for follow-up.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urine from male patients (Penile), vaginal swabs from female patients (Vaginal)
Indicated Patient Age Range
18 years of age and older
Intended User / Care Setting
Consumers (lay users) in their home, or in similar environments, without supervision from a healthcare provider. May also be used for self-collection in a clinic. Testing is limited to the manufacturer, Priva Path laboratories (d.b.a. LetsGetChecked, Inc.).
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
Simple 2 Urine Home Collection Kit (Penile) Usability and Comprehension Studies:
- Initial Study: 89 male participants. Demographics provided in Table 1 (Age Group: 18-25: 8%, 26-35: 28%, 36-45: 19%, 46-55: 22%, 56-65: 16%, >65: 7%. Education: High school/Some College: 47%, Bachelor's degree or higher: 53%. Race/Ethnicity: Caucasian: 62%, Asian: 8%, Hispanic/Latin American: 10%, Black/African American: 12%, Mixed/Unknown/Other: 8%).
- Final Study: 32 male participants. Demographics provided in Table 2 (Age Group: 18-25: 16%, 26-35: 31%, 36-45: 19%, 46-55: 9%, 56-65: 16%, >65: 9%. Education: 65: 1%. Education: 65: 3%. Education: 95% positive results at 0 LoD). Integrity maintained despite temperature extremes.
- Simple 2 Swab Home Collection Kit (Vaginal):
- Test Samples: Negative vaginal swabs in transport medium and positive vaginal swabs in transport medium (spiked with live CT or GC at LoD (low) and 10/4 LoD (moderate)) after exposure to Summer and Winter Shipping Temperature Cycles (Tables 15 and 17). 10(4) low positive, " | | high positive, and 10 negative samples.
- Key Results (Tables 19 and 20): Expected results for all samples tested under both Summer and Winter Shipping Temperature Cycles. Integrity maintained despite temperature extremes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not explicitly stated for the Simple 2 Test, but analytical performance (Precision/Reproducibility, Linearity, Analytical Specificity/Interference, Assay Reportable Range, Traceability/Stability/Expected Values, Detection Limit, Assay Cut-Off, Instrument Accuracy, Carry-Over) and clinical performance (Clinical Sensitivity, Clinical Specificity) for the Aptima Combo 2 Assay were previously reviewed and described in predicate device summaries (K111409, K132251, K180681, and K200866).
Specific metrics from the flex studies include:
- Urine volume flex study (Table 9): Agreement with expected result (CT: 0% to 100%, GC: 20% to 100% for positive samples; 100% for negative samples).
- Transport media volume flex study (Table 11): Agreement with expected result (CT: 100%, GC: 0% to 100% for positive samples; 100% for negative samples).
- Delay of urine transfer study (Table 12): Agreement with expected result (CT: 60% to 100%, GC: 0% to 100% for positive samples; 100% for negative samples).
- Interfering substances in urine study (Table 13): Agreement with expected result (CT: 100%, GC: 0% to 100% for positive samples; 100% for negative samples).
- Interfering substances in vaginal swab study (Table 14): Agreement with expected result (CT: 100%, GC: 100% for positive samples; 100% for negative samples).
- Sample Shipping Stability studies (Tables 16, 18, 19, 20): Number positive/tested and number negative/tested for CT, GC, and CT/GC.
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.
Not Found (Cleared via De Novo pathway).
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.
K111409, K132251, K180681, K200866
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
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine. The text is written in a clear, sans-serif font, with "FDA" in a blue box.
EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR Simple 2 Test DECISION SUMMARY
I Background Information:
- A De Novo Number
DEN200070
B Applicant
LetsGetChecked Inc. (formerly PrivaPath Diagnostics Inc.)
C Proprietary and Established Names
Simple 2 Test
D Regulatory Information
| Product
Code(s) | Classification | Regulation
Section | Panel |
|--------------------|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| QYA | Class II | 21 CFR 866.3385 - System for detection of
nucleic acid from non-viral microorganism(s)
causing sexually transmitted infections using
home-collected specimens | MI - Microbiology |
Submission/Device Overview: II
A Purpose for Submission:
De Novo request for evaluation of automatic class III designation for the Simple 2 Test.
B Measurand:
Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) ribosomal RNA (rRNA)
C Type of Test:
Nucleic acid amplification assay
III Indications for Use:
A Intended Use(s):
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov
1
See Indications for Use below.
B Indication(s) for Use:
The Simple 2 Test is intended for in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home-collected specimens which are shipped to a clinical laboratory for testing using the Aptima Combo 2 Assay on the Panther System. This product is available over-the-counter (OTC) to consumers 18 years of age and older.
The Simple 2 Test contains all the necessary components to collect urine from male patients (Simple 2 Urine Home Collection Kit (Penile)) or vaginal swabs from female patients (Simple 2 Swab Home Collection Kit (Vaginal)) in their home, or in similar environments, without supervision from a healthcare provider.
The Simple 2 Test Collection Kits may also be used to self-collect specimens in a clinic.
The testing is performed, as determined to be appropriate, based on the results of LetsGetChecked Suitability Questionnaire.
This test system is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop, or change any course of treatment unless advised by your healthcare provider.
Testing is limited to the manufacturer, Priva Path laboratories (d.b.a. LetsGetChecked. Inc.).
C Special Conditions for Use Statement(s):
OTC - Over the Counter
D Special Instrument Requirements:
Panther System
IV Device/System Characteristics:
A Device Description:
The LetsGetChecked Simple 2 Test is composed of the Simple 2 Urine Home Collection Kit (Penile) and the Simple 2 Swab Home Collection Kit (Vaginal) and the samples are shipped to LetsGetChecked's Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory for processing using the Aptima Combo 2 Assay on the Panther System. The Aptima Combo 2 Assay was previously cleared for the qualitative in vitro detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) when used with male urine and self-collected vaginal swabs collected in clinical settings.
The home collection kits are intended to be distributed for purchase online without the need for prescription from a physician or healthcare professional (over-the-counter use). After purchase, the user activates the kit on LetsGetChecked's website and is requested to fill out the Suitability Questionnaire to determine whether this test is appropriate for this individual. The user follows detailed directions for self-collecting a urogenital specimen (male urine or female vaginal swab,
2
as applicable), packaging and shipping it to the LetsGetChecked CLIA certified laboratory for testing (PrivaPath lab). The test results are delivered to the individual via LetsGetChecked online portal. Positive and invalid/inconclusive results are followed up with a call from the LetsGetChecked Care Team. If the patient received a positive chlamydia result, treatment options are discussed. Patients receiving a positive gonorrhea test result, will be advised to contact their healthcare provider to receive appropriate treatment. The LetsGetChecked Care Team will also contact all patients who test negative for chlamydia and gonorrhea, but do report symptoms, or concerns, or where further investigation is indicated. These patients are internally flagged for follow-up.
Simple 2 Urine Home Collection Kit (Penile)
Each Simple 2 Urine Home Collection Kit (Penile) includes a urine collection cup with indicated urine fill area, one Aptima Urine Specimen Transport Tube, a graduated transfer pipette, a biohazard bag, home specimen collection and shipping instructions, and Frequently Asked Questions (FAQs) sheets with information about CT/GC infections and test results. All components are included in the box which is also used for shipping of the sample to the laboratory for testing.
Simple 2 Swab Home Collection Kit (Vaginal)
Each Simple 2 Swab Home Collection Kit (Vaginal) includes Aptima Multitest Swab Specimen Collection Kit, which includes sterile vaginal swab and Sample Transport Tube. The kit also includes a biohazard bag, home specimen collection and shipping instructions, and Frequently Asked Questions (FAQs) sheets with information about CT/GC infections and test results. All components are included in the box which is also used for shipping of the sample to the laboratory for testing.
B Principle of Operation
The Aptima Combo 2 Assay utilizes target capture, transcription-mediated amplification, hybridization protection assay, and dual kinetic assay for specimen processing to amplify target rRNA and detect the amplicon, respectively. Please refer to the decision summaries of K111409, K132251, K180681, and K200866.
C Instrument Description Information
-
- Instrument Name:
Panther System
- Instrument Name:
-
- Calibration:
3
Refer to K111409, K132251, K180681, and K200866
V Standards/Guidance Documents Referenced:
Not applicable.
VI Performance Characteristics:
A Analytical Performance:
-
- Linearity:
Not Applicable; this is a qualitative assay.
- Linearity:
-
- Assay Reportable Range:
Not Applicable; this is a qualitative assay.
- Assay Reportable Range:
4
8. Accuracy (Instrument):
Instrument accuracy was previously reviewed and described in K111409, K132251, K180681, and K200866.
B Comparison Studies:
-
- Method Comparison:
Not applicable.
- Method Comparison:
-
- Matrix Comparison:
Not applicable.
- Matrix Comparison:
C Clinical Studies:
-
- Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
- Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
D Clinical Cut-Off:
Not applicable.
Expected Values/Reference Range: E .
Expected Values/Reference Range was previously reviewed and described in K111409, K132251, K180681, and K200866.
F Other Supportive Performance Characteristics Data:
1. USABILITY AND COMPREHENSION
5
A. Simple 2 Urine Home Collection Kit (Penile)
Two usability and comprehension studies with lay users were conducted to evaluate the ease of use of the collection kit, ability to interpret the test results and comprehension of the educational materials included in the Simple 2 Urine Home Collection Kit (Penile). The first study was conducted with 89 male participants. The summary of demographics of participants included in this study is presented in Table 1.
| Participants | N | % |
|---|---|---|
| Male | 89 | 100% |
| Age Group | ||
| 18-25 | 7 | 8% |
| 26-35 | 25 | 28% |
| 36-45 | 17 | 19% |
| 46-55 | 20 | 22% |
| 56-65 | 14 | 16% |
| > 65 | 6 | 7% |
| Education | ||
| 65 | 3 | 9% |
| Education | ||
| 65 | 1 | 1% |
| Education | ||
| 65 | 1 | 3% |
| Education | ||
| 95%) positive results were generated at [0] LoD. The data demonstrate that the urine sample integrity is maintained even when exposed to extremes of temperature during shipping. |
| Temperature | Cycle Period | Cycle Period (Hours) | Total Time (Hours) |
|---|---|---|---|
| (b)(4) | |||
18
| (b)(4) | ||
|---|---|---|
| -- | -------- | -- |
Table 16. Summary Results for the Summer Shipping Temperature Cycle.
| Concentration/
Organism | CT
positive/#tested | GC
positive/#tested | CT/GC
#negatives/#tested |
|----------------------------|--------------------------|--------------------------|-----------------------------|
| (b)(4) | | | |
Table 17. Winter Shipping Temperature Cycle.
| Temperature | Cycle Period | Cycle Period (Hours) | Total Time (Hours) |
|---|---|---|---|
| (b)(4) |
Table 18. Summary Results for the Winter Shipping Temperature Cycle.
| Concentration/
Organism | CT
positive/#tested | GC
positive/#tested | CT/GC
#negatives/#tested |
|----------------------------|--------------------------|--------------------------|-----------------------------|
| | (b)(4) | | |
B. Simple 2 Swab Home Collection Kit (Vaginal)
The stability of the collected vaginal specimens under shipping conditions was evaluated by testing negative vaginal swabs in transport medium and positive vaginal swabs in transport medium (spiked with live CT or GC at (1) LoD (low positive) and 10/4) LoD (moderate positive)) after exposure to the Summer and Winter Shipping Temperature Cycles, as indicated in Tables 15 and 17, respectively. 10(4) |low positive, " | |high positive, and 10 negative samples were subjected to the extended Summer and Winter shipping profiles, as indicated in Tables 15 and 17 above. The results are presented in Tables 19 and 20 below. The expected results were generated for all samples tested under both Summer and Winter Shipping Temperature Cycles. The study results demonstrate that the vaginal swab sample integrity is maintained even when exposed to extremes of temperature during shipping.
Table 19. Summary Results for the Summer Shipping Temperature Cycle.
| Concentration/
Organism | CT
positive/#tested | GC
positive/#tested | CT/GC
#negatives/#tested |
|----------------------------|--------------------------|--------------------------|-----------------------------|
| (b)(4) | | | |
19
(D)(4)
Table 20. Summary Results for the Winter Shipping Temperature Cycle.
VII Proposed Labeling:
The labeling supports the decision to grant the De Novo request for this device.
VIII Identified Risks and Mitigations:
| Identified Risks to Health | Mitigation Measures |
|---|---|
| Risk of false results | Certain labeling information including limitations, |
| device descriptions, performance information, and | |
| explanations of procedures. | |
| Use of certain specimen collection devices. | |
| Certain design verification and validation including | |
| documentation of device descriptions, certain analytical | |
| studies and clinical studies, risk analysis strategies. | |
| Failure to correctly interpret test | |
| results | Certain labeling information including limitations, |
| device descriptions, performance information, and | |
| explanations of procedures. | |
| Certain design verification and validation including | |
| documentation of device descriptions, certain analytical | |
| studies and clinical studies, risk analysis strategies. | |
| Failure to correctly operate the | |
| device | Certain labeling information including limitations, |
| device descriptions, performance information, and | |
| explanations of procedures. | |
| Certain design verification and validation including | |
| documentation of device descriptions, certain analytical | |
| studies and clinical studies, risk analysis strategies. |
IX Benefit/Risk Assessment:
A Summary of the Assessment of Benefit:
The Simple 2 Test is the first over-the counter device for detection of chlamydia and gonorhea that allows for self-collection of specimens in the privacy of one's home (home collection). It is probable that the wide availability of this test without prescription will increase testing for STIs in patients who cannot or chose not to visit a healthcare provider, and who would not be tested otherwise. Because infections with Chlamydia trachomatis and Neisseria gonorrhoeae are often
20
asymptomatic. opening the access to testing at home will likely help curb the spread of these infections. Further, home collection of specimens for testing for sexually transmitted infections is desirable to patients, facilitating access to information about their sexual health without the need for a visit to a physician. Additionally, identification of these infections early in the course of disease will lead to more effective or more timely treatments and a reduction in the morbidity in sexually active individuals. The data submitted in this De Novo application demonstrates that lay users can effectively collect samples at home without compromising the performance of the test results provided by the Aptima Combo 2 assay.
B Summary of the Assessment of Risk:
The risks associated with the test are mainly the possibility of false positive and false negative test results. False negative test results can cause delays to effective treatment, progression to disseminated disease, and spread of infection to other persons throughout the community. According to the CDC guidelines, patients with known exposure to either gonorrhea or chlamydia (e.g., a sexual partner with positive diagnosis), should be empirically treated with antibiotics, regardless of the test result. Thus, a false negative result obtained by persons with known exposures to gonorrhea or chlamydia using this test may lead to delays or lost opportunities for treatment. A false negative result may also be obtained if the test is used within a short time after exposure. False positive results when using this test could lead to an incorrect diagnosis and unnecessary treatment for chlamvdia and gonorrhea. Additionally, false positive results may lead to risk of side effects from unnecessary treatments, as well as psychological distress. Further, the risks associated with the device are failure to correctly interpret test results and failure to correctly operate the device. These risks are mitigated by the special controls, mainly required analytical and clinical performance and required information in the labeling and educational information about CT and GC infections contained in the enclosed FAQ pamphlet.
C Summary of the Assessment of Benefit-Risk:
In conclusion, given the available information above, for the following indication statement:
The Simple 2 Test is intended for in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home-collected specimens which are shipped to a CLIA compliant laboratory for testing using the Aptima Combo 2 Assay on the Panther System. This product is available over-the-counter (OTC) to consumers 18 years of age and older.
The Simple 2 Test contains all the necessary components to collect urine from male patients (Simple 2 Urine Home Collection Kit (Penile)) or vaginal swabs from female patients (Simple 2 Swab Home Collection Kit (Vaginal)) in their home, or in similar environments, without supervision from a healthcare provider.
The Simple 2 Test Collection Kits may also be used to self-collect specimens in a clinic.
The testing is performed, as determined to be appropriate, based on the results of LetsGetChecked Suitability Questionnaire.
This test system is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop, or change any course of treatment unless advised by your healthcare provider.
21
Testing is limited to the manufacturer, Priva Path laboratories (d.b.a. LetsGetChecked, Inc.).
The probable benefits outweigh the probable risks for the Simple 2 Test. The device provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls.
X Conclusion:
The De Novo request is granted and the device is classified under the following and subject to the special controls identified in the letter granting the De Novo request:
Product Code: QYA Device Type: System for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens.
Class: II Regulation: 21 CFR 866.3385