(90 days)
No
The summary describes a standard in vitro diagnostic test system utilizing RT-PCR and automated processing on the Alinity m System. There is no mention of AI or ML in the device description, intended use, performance studies, or any other section. The focus is on the chemical and biological processes of the assay and the automated handling by the Alinity m system.
No.
This device is an in vitro diagnostic (IVD) test system designed for the detection and identification of specific sexually transmitted infection (STI) pathogens. It aids in the diagnosis of diseases by analyzing collected specimens, rather than directly treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the test system is intended "to aid in the diagnosis of disease(s) caused by infection from these organisms."
No
The device is a test system that includes physical collection kits (simpli-COLLECT Urine Collection Kit and simpli-COLLECT Swab Collection Kit) and relies on the Alinity m System hardware and associated reagents for laboratory testing. It is not solely software.
Based on the provided text, the simpli-COLLECT STI Test is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the simpli-COLLECT STI Test is a "test system intended for in vitro detection and identification" of specific pathogens. The term "in vitro" means "in glass" or "in a test tube," referring to tests performed outside of a living organism.
- Device Description: The description further clarifies that the system uses the Alinity m STI Assay for "real time RT-PCR to amplify and detect" genetic material from the target organisms. This process is performed in a laboratory setting using reagents and equipment, which is characteristic of an in vitro diagnostic test.
- Components: The kit includes components for specimen collection and transport, but the actual testing is performed in a clinical laboratory using the Alinity m System and associated reagents (Alinity m STI AMP Kit, Alinity m STI CTRL Kit, etc.). These are all integral parts of an in vitro diagnostic testing process.
- Regulatory Context: The mention of predicate devices with K numbers (DEN200070, K202977, K222379) indicates that this device is undergoing regulatory review, which is a requirement for IVDs.
In summary, the simpli-COLLECT STI Test is a system that facilitates the collection and transport of specimens for subsequent in vitro diagnostic testing in a laboratory setting. The core diagnostic process (detection and identification of pathogens) happens outside the body, making it an IVD.
N/A
Intended Use / Indications for Use
The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens. The specimens are shipped to a clinical laboratory for testing using the Alinity m STI Assay with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from CT, DNA from NG, ribosomal RNA from TV, and ribosomal RNA from MG, to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following self-collected specimens from symptomatic and asymptomatic individuals for the following analytes:
- · CT: vaginal swabs, female urine and male urine
- · NG: vaginal swabs, female urine, and male urine
- · TV: vaginal swabs, female urine and male urine
- · MG: vaginal swabs and male urine
The simpli-COLLECT STI Test contains all the necessary components for the self-collection and transport of urine from male and female patients (simpli-COLLECT Urine Collection Kit) or vaginal swabs from female patients (simpli-COLLECT Swab Collection Kit) in their home, or in similar environments. The simpli-COLLECT Collection Kits may also be used to self-collect specimens in a clinic.
Product codes
OYA
Device Description
The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens (simpli-COLLECT Urine Collection Kit [09N93001] and the simpli-COLLECT Swab Collection Kit [09R02-001]).
This test system uses the Alinity m STI Assay (cleared under K202977 and K222379) for real time RT-PCR to amplify and detect Chlamydia trachomatis (CT) ribosomal RNA sequences, Neisseria gonorrhoeae (NG) genomic DNA sequences, Trichomonas vaginalis (TV) ribosomal RNA sequences, Mycoplasma genitalium (MG) ribosomal RNA sequences, and human genomic DNA sequences that have been extracted from vaginal swab specimens or male and female urine specimens.
The Alinity m STI assay requires two separate assay-specific kits as follows:
-. Alinity m STI AMP Kit (09N17-095), which consists of multi-well amplification plates containing lyophilized, unit-dose RT-PCR amplification/detection reagents, and multi-well activator plates containing liquid, unit-dose activation reagents (MgC12. TMAC, and KC1). The intended storage condition for the Alinity m STI AMP Kit is 2°C to 8°C.
-. Alinity m STI CTRL Kit (09N17-085), which consists of negative controls and positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m STI Control Kit is -15°C to -25°C.
The steps of the Alinity m STI assay consist of sample preparation. RT-PCR assembly, amplification/detection, and result calculation and reporting. All stages of the Alinity m STI assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m STI assay in parallel with other Alinity m assays on the same instrument.
Nucleic acids from specimens are extracted automatically on-board the Alinity m System using the Alinity m Sample Prep Kit 1, Alinity m Lysis Solution, Alinity m Ethanol Solution or Alinity m Bottle for Ethanol Use filled with Ethanol supplied by customers, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash, and elution. The resulting purified nucleic acids are then combined with the liquid unit dose activator reagent, lyophilized unit-dose Alinity m STI amplification reagents, and Alinity m Vapor Barrier Solution, and transferred by the instrument to an amplification/detection module for reverse transcription, PCR amplification, and real-time fluorescence detection.
Assay controls are tested at or above an established minimum frequency to help ensure that instrument and reagent performance remain satisfactory. During each control event, a negative control and a positive control are processed through sample preparation and RT-PCR procedures that are identical to those used for specimens. Assay controls are used to demonstrate proper sample processing and assay validity. The CTRL kit configuration includes 12 vials at 0.47 mL of both the Alinity m STI Negative CTRL and Alinity m STI Positive CTRL.
The Alinity m STI amplification reagents include primers and probes that amplify and detect the single copy human gene, ß-globin. Amplification and detection of the ß-globin gene demonstrates proper sample processing and adequate sample input. In addition, an exogenous internal control (containing an armored RNA sequence) is included in the lyophilized Alinity m STI amplification reagents and is used to confirm that no PCR inhibitors are present in the sample. The ß-globin control and internal control are both used to demonstrate assay validity. The AMP kit configuration includes 4 trays (96 tests per tray) of both an AMP TRAY 1 and ACT TRAY 2. The AMP Kit provides sufficient reagents for 384 tests.
The simpli-COLLECT Urine Collection Kit is used to collect, stabilize, and transport male urine specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae. Trichomonas vaginalis, and Mycoplasma genitalium, and female urine specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Each kit can be used to collect 1 urine specimen. The collected specimens are intended for testing with the Alinity m STI assay. The simpli-COLLECT Urine Collection Kit contains the following components: 1 Abbott Sample Collection pack, which contains 1 Alinity m Sample Tube with Liguid Buffer and 1 Transfer Pipette, 1 Tube and Bag Label Sheet, 1 Urine Cup/Urine Collection Cup, 1 simpli-COLLECT Urine Collection Kit Patient Instructions For Use, 1 Biohazard Bag with Absorbent Pad, 1 Tube and Cap Holder, and 1 simpli-COLLECT Urine Collection Kit Box.
The simpli-COLLECT Swab Collection Kit is used to collect, stabilize, and transport vaginal swab specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Each kit can be used to collect 1 vaginal swab specimen. The collected specimens are intended for testing with the Alinity m STI assay. The simpli-COLLECT Swab Collection Kit contains the following components: 1 Abbott Swab Collection pack, which contains 1 Alinity m Sample Tube with Liguid Buffer and 1 Specimen Collection Swab, 1 Tube and Bag Label Sheet, 1 Biohazard Bag with Absorbent Pad, 1 Tube and Cap Holder, 1 simpli-COLLECT Swab Collection Kit Patient Instructions For Use, and 1 simpli-COLLECT Swab Collection Kit Box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urogenital
Indicated Patient Age Range
14 years and older
Intended User / Care Setting
Home collected specimens shipped to a clinical laboratory. The simpli-COLLECT Collection Kits may also be used to self-collect specimens in a clinic. Prescription use only.
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)
Specific Performance Characteristics
Precision (Repeatability/Reproducibility) studies were conducted previously to support the clearance of K202977. No further studies were needed as there were no changes to Alinity m STI reagents, sample processing, assay procedure, and data reduction.
Analytical Sensitivity/Detection Limit studies were conducted previously to support the clearance of K202977. No further studies were needed as there were no changes to Alinity m STI reagents, sample processing, assay procedure, and data reduction.
Analytical Specificity/Interference was evaluated previously for K202977. An additional study on potential hand contaminants was conducted for this submission. The potential for interference was assessed with 11 hand contaminants in swab and urine matrices (negative or positive for CT, NG, TV, and MG). No interference was observed with the tested substances and concentrations in Table 2. Interference may occur with Purell Advanced Hand Sanitizer, Germ X Advanced Moisturizing Hand Sanitizer with Aloe at concentrations > 0.1% v/v in urine and swab matrix, and Vaseline Intensive Care Deep Restore Lotion at concentrations > 0.5% v/v in urine matrix. Limitations are reflected in assay labeling.
Assay Cut-Off studies were conducted previously to support the clearance of K202977. No further studies were needed as there were no changes to Alinity m STI reagents, sample processing, assay procedure, and data reduction.
Clinical Performance
Clinical Study Results - Urogenital Specimens: Performance characteristics of the Alinity m STI assay with swab and urine specimens were established in a multicenter clinical study conducted in the United States to support the clearance of K202977 and K222379.
Human Factors Studies: A summative usability study was conducted to evaluate patient interaction with the simpli-COLLECT Urine Collection Kit and simpli-COLLECT Swab Collection Kit in a simulated home environment. 223 participants from six user groups (males and females ages 14-17, 18-64, and ≥65) were enrolled. Half had access only to paper IFU, the other half to paper IFU and an instructional video. Participants self-collected and packaged a sample, and difficulties were noted. Packaged samples were evaluated for errors based on laboratory accessioning criteria. A questionnaire assessed label comprehension. The study demonstrated that lay users are able to collect and ship urine and vaginal specimens with minimal error, and the labeling for both kits is easy to understand.
Conclusion Drawn from the Studies
The studies demonstrated that lay users can self-collect and prepare specimens for transport without additional risks of erroneous results, and that the devices perform comparably to the predicate device in the collection and transport of clinical specimens for nucleic acid testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
January 30th, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Abbott Molecular Stacy Ferguson Director Regulatory Affairs 1300 E Touhy Ave Des Plaines, Illinois 60018
Re: K243410
Trade/Device Name: simpli-COLLECT STI Test Regulation Number: 21 CFR 866.3385 Regulation Name: System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Sexually Transmitted Infections Using Home-Collected Specimens Regulatory Class: Class II Product Code: OYA Dated: October 31, 2024 Received: November 1, 2024
Dear Stacy Ferguson:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Himani Bisht -S
Himani Bisht, Ph.D. Assistant Director Viral Respiratory and HPV Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243410
Device Name
simpli-COLLECT STI Test
Indications for Use (Describe)
The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in homecollected specimens. The specimens are shipped to a clinical laboratory for testing using the Alinity m STI Assay with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from CT, DNA from NG, ribosomal RNA from TV, and ribosomal RNA from MG, to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following self-collected specimens from symptomatic and asymptomatic individuals for the following analytes:
- · CT: vaginal swabs, female urine and male urine
- · NG: vaginal swabs, female urine, and male urine
- · TV: vaginal swabs, female urine and male urine
- · MG: vaginal swabs and male urine
The simpli-COLLECT STI Test contains all the necessary components for the self-collection and transport of urine from male and female patients (simpli-COLLECT Urine Collection Kit) or vaginal swabs from female patients (simpli-COLLECT Swab Collection Kit) in their home, or in similar environments. The simpli-COLLECT Collection Kits may also be used to self-collect specimens in a clinic.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
Table of Contents
| 1.0 | 510(k) Summary | Page | 2 | |
|---|---|---|---|---|
| 1.1 | Submitter | 2 | ||
| 1.2 | Device Information | 3 | ||
| 1.3 | Predicate Devices | 3 | ||
| 1.4 | Device Description | 4 | ||
| 1.5 | Intended Use | 7 | ||
| 1.6 | Similarities and Differences to Predicate Device | 7 | ||
| 1.7 | Performance Data | 10 | ||
| 1.8 | Conclusion Drawn from the Studies | 13 |
5
1.0 510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR Section 807.92(c).
1.1 Submitter
| Applicants Name and Address: | Abbott Molecular Inc.
1300 E. Touhy Ave
Des Plaines, IL 60018 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stacy Ferguson
Director Regulatory Affairs
Abbott Molecular, Inc.
1300 E. Touhy Avenue
Des Plaines, IL 60018
Phone: 224-361-7449
Fax: 224-361-7269 |
| Date Prepared: | January 29, 2025 |
6
| Trade Name | Regulation Name | Product
Code | Regulation
Number | Class |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------|-------|
| simpli-COLLECT STI Test | System for detection of nucleic
acid from non-viral
microorganism(s) causing STIs
using specimens collected at
home | QYA | 866.3385 | II |
1.2 Device Information
1.3 Predicate Devices
| Predicate Device Name | 510(k) | Date Cleared |
|---|---|---|
| Simple Test 2 | DEN200070 | 11/15/2023 |
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1.4 Device Description
1.4.1 simpli-COLLECT STI Test
The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens (simpli-COLLECT Urine Collection Kit [09N93001] and the simpli-COLLECT Swab Collection Kit [09R02-001]).
This test system uses the Alinity m STI Assay (cleared under K202977 and K222379) for real time RT-PCR to amplify and detect Chlamydia trachomatis (CT) ribosomal RNA sequences, Neisseria gonorrhoeae (NG) genomic DNA sequences, Trichomonas vaginalis (TV) ribosomal RNA sequences, Mycoplasma genitalium (MG) ribosomal RNA sequences, and human genomic DNA sequences that have been extracted from vaginal swab specimens or male and female urine specimens.
The Alinity m STI assay requires two separate assay-specific kits as follows:
- . Alinity m STI AMP Kit (09N17-095), which consists of multi-well amplification plates containing lyophilized, unit-dose RT-PCR amplification/detection reagents, and multi-well activator plates containing liquid, unit-dose activation reagents (MgC12. TMAC, and KC1). The intended storage condition for the Alinity m STI AMP Kit is 2°C to 8°C.
- . Alinity m STI CTRL Kit (09N17-085), which consists of negative controls and positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m STI Control Kit is -15°C to -25°C.
The steps of the Alinity m STI assay consist of sample preparation. RT-PCR assembly, amplification/detection, and result calculation and reporting. All stages of the Alinity m STI assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m STI assay in parallel with other Alinity m assays on the same instrument.
8
Nucleic acids from specimens are extracted automatically on-board the Alinity m System using the Alinity m Sample Prep Kit 1, Alinity m Lysis Solution, Alinity m Ethanol Solution or Alinity m Bottle for Ethanol Use filled with Ethanol supplied by customers, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash, and elution. The resulting purified nucleic acids are then combined with the liquid unit dose activator reagent, lyophilized unit-dose Alinity m STI amplification reagents, and Alinity m Vapor Barrier Solution, and transferred by the instrument to an amplification/detection module for reverse transcription, PCR amplification, and real-time fluorescence detection.
Assay controls are tested at or above an established minimum frequency to help ensure that instrument and reagent performance remain satisfactory. During each control event, a negative control and a positive control are processed through sample preparation and RT-PCR procedures that are identical to those used for specimens. Assay controls are used to demonstrate proper sample processing and assay validity. The CTRL kit configuration includes 12 vials at 0.47 mL of both the Alinity m STI Negative CTRL and Alinity m STI Positive CTRL.
The Alinity m STI amplification reagents include primers and probes that amplify and detect the single copy human gene, ß-globin. Amplification and detection of the ß-globin gene demonstrates proper sample processing and adequate sample input. In addition, an exogenous internal control (containing an armored RNA sequence) is included in the lyophilized Alinity m STI amplification reagents and is used to confirm that no PCR inhibitors are present in the sample. The ß-globin control and internal control are both used to demonstrate assay validity. The AMP kit configuration includes 4 trays (96 tests per tray) of both an AMP TRAY 1 and ACT TRAY 2. The AMP Kit provides sufficient reagents for 384 tests.
1.4.2 simpli-COLLECT Collection Kits
The simpli-COLLECT Urine Collection Kit is used to collect, stabilize, and transport male urine specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae. Trichomonas vaginalis, and Mycoplasma genitalium, and female urine
9
specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Each kit can be used to collect 1 urine specimen. The collected specimens are intended for testing with the Alinity m STI assay. The simpli-COLLECT Urine Collection Kit contains the following components: 1 Abbott Sample Collection pack, which contains 1 Alinity m Sample Tube with Liguid Buffer and 1 Transfer Pipette, 1 Tube and Bag Label Sheet, 1 Urine Cup/Urine Collection Cup, 1 simpli-COLLECT Urine Collection Kit Patient Instructions For Use, 1 Biohazard Bag with Absorbent Pad, 1 Tube and Cap Holder, and 1 simpli-COLLECT Urine Collection Kit Box.
The simpli-COLLECT Swab Collection Kit is used to collect, stabilize, and transport vaginal swab specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Each kit can be used to collect 1 vaginal swab specimen. The collected specimens are intended for testing with the Alinity m STI assay. The simpli-COLLECT Swab Collection Kit contains the following components: 1 Abbott Swab Collection pack, which contains 1 Alinity m Sample Tube with Liguid Buffer and 1 Specimen Collection Swab, 1 Tube and Bag Label Sheet, 1 Biohazard Bag with Absorbent Pad, 1 Tube and Cap Holder, 1 simpli-COLLECT Swab Collection Kit Patient Instructions For Use, and 1 simpli-COLLECT Swab Collection Kit Box.
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1.5 Intended Use
The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens. The specimens are shipped to a clinical laboratory for testing using the Alinity m STI Assay with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from CT, DNA from NG, ribosomal RNA from TV, and ribosomal RNA from MG, to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following self-collected specimens from symptomatic and asymptomatic individuals for the following analytes:
- · CT: vaginal swabs, female urine and male urine .
- NG: vaginal swabs, female urine, and male urine .
- . · TV: vaginal swabs, female urine and male urine
- . • MG: vaginal swabs and male urine
The simpli-COLLECT STI Test contains all the necessary components for the selfcollection and transport of urine from male and female patients (simpli-COLLECT Urine Collection Kit) or vaginal swabs from female patients (simpli-COLLECT Swab Collection Kit) in their home, or in similar environments. The simpli-COLLECT Collection Kits may also be used to self-collect specimens in a clinic.
1.6 Similarities and Differences to Predicate Device
1.6.1 Alinity m STI Assay
There are no technological differences between the simpli-COLLECT STI Test and the predicate device. The similarities and differences between the simpli-COLLECT STI Test and the predicate device are shown in Table 1; The differences are shown in underlined italics.
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| Table 1. Similarities and Differences Between Alinity m STI and Predicate Device | ||
|---|---|---|
| Feature | Current Submission | Predicate Device |
| simpli-COLLECT STI Test | Simple 2 Test (DEN00070) | |
| Conditions for use | For prescription use only | OTC-Over the Counter |
| Assay Type | Same | Qualitative |
| Intended Use | The simpli-COLLECT STI Test is a test system intended | |
| for in vitro detection and identification of Chlamydia | ||
| trachomatis (CT), Neisseria gonorrhoeae (NG), | ||
| Trichomonas vaginalis (TV), and Mycoplasma genitalium | ||
| (MG) in home-collected specimens. The specimens are | ||
| shipped to a clinical laboratory for testing using the | ||
| Alinity m STI Assay with the automated Alinity m | ||
| System for the direct, qualitative detection and | ||
| differentiation of ribosomal RNA from CT, DNA from | ||
| NG, ribosomal RNA from TV, and ribosomal RNA from | ||
| MG, to aid in the diagnosis of disease(s) caused by | ||
| infection from these organisms. The assay may be used to | ||
| test the following self-collected specimens from | ||
| symptomatic and asymptomatic individuals for the | ||
| following analytes: | ||
| •CT: vaginal swabs, female urine, and male urine | ||
| •NG: vaginal swabs, female urine, and male urine | ||
| •TV: vaginal swabs, female urine, and male urine | ||
| •MG: vaginal swabs and male urine | ||
| The simpli-COLLECT STI Test contains all the necessary | ||
| components for the self-collection and transport of urine | ||
| from male and female patients (simpli-COLLECT Urine | ||
| Collection Kit) or vaginal swabs from female patients | ||
| (simpli-COLLECT Swab Collection Kit) in their home, or | ||
| in similar environments. The simpli-COLLECT | ||
| Collection Kits may also be used to self-collect specimens | ||
| in a clinic. | 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. | ||
| Table 1. Similarities and Differences Between Alinity m STI and Predicate Device | ||
| Feature | Current Submission | Predicate Device |
| Specimen Collection and Trasport | simpli-COLLECT STI Test | |
| simpli-COLLECT Urine Collection Kit | ||
| Simpli-COLLECT Swab Collection Kit | Simple 2 Test (DEN00070) | |
| Simple Test 2 (Simple 2 Urine Home Collection Kit (Penile)) | ||
| Simple 2 Test Simple 2 Swab Home Collection Kit (Vaginal) | ||
| Minimum Age of Users | 14 years | 18 years |
| Assay Targets | CT ribosomal RNA | |
| NG genomic DNA | ||
| TV ribosomal RNA | ||
| MG ribosomal RNA | CT ribosomal RNA | |
| NG genomic DNA | ||
| Technology/Dectection | Real-Time Reverse Transcription-Polymerate Chain Reaction (RT-PCR) | Target Capture (TC), Transcription-mediated Amplification (TMA), Dual Kinetic Assay (DKA) |
| Instrument System | Alinity m System | Panther System |
| Assay Controls | Internal Control (IC) | |
| Negative Control | ||
| Positive Control | CT Positive/NG Negative Control | |
| CT Negative/NG Positive Control | ||
| Results Reporting | Positive, negative, and invalid. | |
| Initial invalid require retest. | Positive, negative, equivocal, and invalid. | |
| Initial equivocal and invalid require retest. |
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1.7 Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1.7.1 Specific Performance Characteristics
1.7.1.1 Precision (Repeatability/Reproducibility)
Precision studies were conducted previously to support the clearance of K202977. There are no changes to Alinity m STI reagents, sample processing, assay procedure, and data reduction; therefore, further precision studies were not necessary.
1.7.1.2 Analytical Sensitivity/Detection Limit
Analytical Sensitivity/Detection Limit studies were conducted previously to support the clearance of K202977. There are no changes to Alinity m STI reagents, sample processing, assay procedure, and data reduction; therefore, further Analytical Sensitivity/Detection Limit studies were not necessary.
1.7.1.3 Analytical Specificity/Interference
Evaluation of Potential Interfering Substances was conducted previously to support the clearance of K202977. Please refer to decision summary of K202977.
An additional study evaluating the potential for interference by hand contaminants was conducted for this submission. Please refer to Section 1.7.1.3.1.
1.7.1.3.1 Potentially Interfering Hand Contaminants
The potential for interference in the Alinity m STI assay was assessed with 11 potential hand contaminants (see Table 2). Hand contaminants were diluted into swab and urine matrices that were negative or positive for CT, NG, TV, and MG.
No interference was observed in the presence of the substances and concentrations listed in Table 2. Assay interference may be observed in the presence of Purell Advanced Hand Sanitizer at concentrations greater than 0.1% v/v in urine and swab matrix, Germ X
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Advanced Moisturizing Hand Sanitizer with Aloe at concentrations greater than 0.1% v/v in urine and swab matrix, and Vasoline Intensive Care Deep Restore Lotion at concentrations greater than 0.5% v/v in urine matrix.
Limitations for assay use with Purell Advanced Hand Sanitizer Sanitizing Gel, Germ X advanced Moisturizing Hand Sanitizer with Aloe in swab and urine samples, and Vaseline Intensive Care Deep Restore Lotion in urine samples are reflected in assay labeling.
| Hand contaminants | Matrix | Highest concentration
Tested with No
Interference |
|-------------------------------------------------------|-------------|---------------------------------------------------------|
| Purell Advanced Hand Sanitizer Sanitizing Gel | Swab, Urine | 0.1% v/v |
| Germ·X Advanced Moisturizing Hand Sanitizer with Aloe | Swab, Urine | 0.1% v/v |
| Tap Water | Swab, Urine | 1.0% v/v |
| Touchland Glow Mist | Swab, Urine | 1.0% v/v |
| Honest Hand Sanitizer Spray | Swab, Urine | 1.0% v/v |
| Meyer's Clean Day Hand Sanitizer | Swab, Urine | 1.0% v/v |
| Vaseline Intensive Care Deep Restore Lotion | Swab | 1.0% v/v |
| | Urine | 0.5% v/v |
| CeraVe Daily Moisturizing Lotion | Swab, Urine | 1.0% v/v |
| Aveeno Daily moisturizing body lotion | Swab, Urine | 1.0% v/v |
| Palmolive Fresh & Clean Dish Liquid | Swab, Urine | 1.0% v/v |
| Softsoap, Aquarium | Swab, Urine | 1.0% v/v |
Table 2. Potentially Interfering Hand Contaminants Evaluated in Swab and Urine matrices.
1.7.1.4 Assay Cut-Off
Assay cut-off studies were conducted previously to support the clearance of K202977.
There are no changes to Alinity m STI reagents, sample processing, assay procedure, and data reduction; therefore, further assay cut-off studies were not necessary.
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1.7.2 Clinical Performance
Clinical Study Results - Urogenital Specimens 1.7.2.1
Performance characteristics of the Alinity m STI assay with swab and urine specimens were established in a multicenter clinical study conducted in the United States to support the clearance of K202977 and K222379.
1.7.2.2 Human Factors Studies
A human factors summative usability study, to evaluate patient interaction with the simpli-COLLECT Urine Collection Kit and simpli-COLLECT Swab Collection Kit in a simulated home environment, was conducted. Kit usability and user label comprehension were evaluated through simulated use, knowledge-based questions, and subjective feedback in individual, in-person sessions. The study enrolled 223 participants from across six user groups: males and females ages 14 - 17, ages 18 - 64, and ages ≥65. Approximately half of the participants in each user group had access only to the paper Instructions For Use (IFU) that comes in the kit. The other half of the participants had access to both the paper IFU and an instructional video. No training was provided to any of the participants since end users are expected to use the collection kits without formalized training. Participants were observed while collecting and packaging a sample and difficulties were noted. The packaged samples were then evaluated for errors according to the laboratory accessioning criteria. At the end of the study, a questionnaire, aimed at evaluating users' ability to locate and understand key communication messages found in the labeling, was issued to all study participants.
The results of the usability study demonstrated that lay users are able to collect and ship a urine specimen using the simpli-Collect Urine Collection Kit (List No. 09N93-001) and a vaginal specimen using the simpli-COLLECT Swab Collection Kit (List No. 09R02-001) with minimal error. The results of the user label comprehension (i.e., the questionnaire) demonstrated that the labeling for both kits is easy to understand by lay users.
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1.8 Conclusion Drawn from the Studies
The studies conducted for this submission demonstrate that the simpli-COLLECT Urine Collection Kit and simpli-COLLECT Swab Collection Kit devices, used with the Alinity m STI assay on the Alinity m System, perform comparably to the predicate device in the collection and transport of clinical specimens for nucleic acid testing and support a substantial equivalence decision. The studies demonstrated that lay users can self-collect and prepare specimens for transport without additional risks of erroneous results.