Alinity m STI Assay

K202977 · Abbott Molecular, Inc. · QEP · Apr 29, 2022 · Microbiology

Device Facts

• Record ID: K202977
• Device Name: Alinity m STI Assay
• Applicant: Abbott Molecular, Inc.
• Product Code: QEP · Microbiology
• Decision Date: Apr 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3393
• Device Class: Class 2

Intended Use

The Alinity m STI Assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae (NG), ribosomal RNA from Trichomonas vaginalis (TV), and ribosomal RNA from Mycoplasma genitalium (MG), to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals for the following analytes: CT: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, male urine, oropharyngeal swabs, and rectal swabs NG: vaginal swabs (clinician-collected and self-collected in a clinical setting). endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, male urine, oropharyngeal swabs, and rectal swabs TV: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, and male urine MG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, and male urine A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated if M. genitalium infection is suspected.

Device Story

Alinity m STI Assay is a real-time PCR test for qualitative detection of CT (rRNA), NG (DNA), TV (rRNA), and MG (rRNA). Input: endocervical/vaginal/oropharyngeal/rectal swabs, urine, or PreservCyt specimens. Operation: automated on Alinity m System; magnetic microparticle-based nucleic acid extraction; RT-PCR assembly; amplification/detection; result calculation. Output: qualitative report of presence/absence of target organisms. Used in clinical laboratories; operated by trained technicians. Healthcare providers use results to guide STI diagnosis and treatment. Benefits: rapid, automated, high-throughput detection of multiple STI pathogens from diverse specimen types.

Clinical Evidence

Multicenter clinical study (N=7,099) evaluated urogenital specimens; extragenital study (N=2,373) evaluated oropharyngeal/rectal specimens. Performance compared to composite comparator/NAATs. Urogenital sensitivity/specificity generally >94%. Extragenital sensitivity/specificity generally >93%. Bench testing included LoD, inclusivity, cross-reactivity, interference, precision, and carryover.

Technological Characteristics

Real-time PCR assay. Targets: CT (rRNA), NG (DNA), TV (rRNA), MG (rRNA), human beta-globin (cellular control), exogenous internal control (armored RNA). Automated on Alinity m System using magnetic microparticle extraction. Reagents: lyophilized unit-dose amplification plates, liquid activation reagents. Connectivity: networked system. Software: automated result calculation.

Indications for Use

Indicated for symptomatic and asymptomatic individuals aged 14+ to aid in diagnosis of CT, NG, TV, and MG infections using urogenital (swabs, urine, PreservCyt) and extragenital (oropharyngeal, rectal) specimens.

Regulatory Classification

Identification

A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) and their associated resistance markers in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data. These devices do not provide confirmation of antibiotic susceptibility since mechanisms of resistance may exist that are not detected by the device.

Special Controls

A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) must comply with the following special controls: (1) The intended use for the 21 CFR 809.10 labeling must include a detailed description of targets the device detects, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended. (2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device: alternatively, the sample collection device must be cleared in a premarket submission as a part of this device. (3) The 21 CFR 809.10(b) labeling must include: (i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens; (ii) Detailed discussion of the performance characteristics of the device for all claimed specimen types based on analytical studies, including, but not limited to. Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, with-in lab precision, and reproducibility, as appropriate; (iii) Detailed descriptions of the test procedure, the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing. (iv) Limiting statements indicating that: (A)a negative test result does not preclude the possibility of infection; (B) the test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician; (C) reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe procedures in any one of these steps can lead to incorrect results; and (D)if appropriate (e.g., recommended by CDC, by current well-accepted clinical guidelines, or by published peer reviewed research), that the clinical performance is inferior in a specific clinical subpopulation or for a specific claimed specimen type. (v) If the device is intended to detect antimicrobial resistance markers, limiting statements, as appropriate, indicating that: (A)negative results for claimed resistance markers do not indicate susceptibility of detected microorganisms, as resistance markers not measured by the assay or other potential mechanisms of antibiotic resistance may be present; (B) detection of resistance markers cannot be definitively linked to specific microorganisms and the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora; (C) detection of antibiotic resistance markers may not correlate with phenotypic gene expression; and (D) therapeutic failure or success cannot be determined based on the assay results, since nucleic acid may persist following appropriate antimicrobial therapy. (4) Design verification and validation must include: (i) Detailed device description documentation, including, but not limited to, methodology from obtaining sample to result, design of primer/probe sequences, rationale for target sequence selection, and computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported result). (ii) Detailed documentation of analytical studies including but not limited to, Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, with-in lab precision, and reproducibility, as appropriate. (iii) Detailed documentation and performance results from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from FDA accepted comparator methods. Documentation from the clinical studies must include the clinical study protocol (including a predefined statistical analysis plan) study report, testing results, and results of all statistical analyses. (iv) A detailed description of the impact of any software, including, but not limited to, software applications and hardware-based devices that incorporate software, on the device's functions.

*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of targets the device detects, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended. (2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device. (3) The labeling required under § 809.10(b) of this chapter must include: (i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens; (ii) Detailed discussion of the performance characteristics of the device for all claimed specimen types based on analytical studies, including Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate; (iii) Detailed descriptions of the test procedure, the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing; (iv) Limiting statements indicating that: (A) A negative test result does not preclude the possibility of infection; (B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician; (C) Reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and (D) If appropriate ( *e.g.,* recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer reviewed research), that the clinical performance is inferior in a specific clinical subpopulation or for a specific claimed specimen type; and(v) If the device is intended to detect antimicrobial resistance markers, limiting statements, as appropriate, indicating that: (A) Negative results for claimed resistance markers do not indicate susceptibility of detected microorganisms, as resistance markers not measured by the assay or other potential mechanisms of antibiotic resistance may be present; (B) Detection of resistance markers cannot be definitively linked to specific microorganisms and the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora; (C) Detection of antibiotic resistance markers may not correlate with phenotypic gene expression; and (D) Therapeutic failure or success cannot be determined based on the assay results, since nucleic acid may persist following appropriate antimicrobial therapy. (4) Design verification and validation must include: (i) Detailed device description documentation, including methodology from obtaining sample to result, design of primer/probe sequences, rationale for target sequence selection, and computational path from collected raw data to reported result ( *e.g.,* how collected raw signals are converted into a reported result).(ii) Detailed documentation of analytical studies, including, Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate. (iii) Detailed documentation and performance results from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from FDA accepted comparator methods. Documentation from the clinical studies must include the clinical study protocol (including a predefined statistical analysis plan) study report, testing results, and results of all statistical analyses. (iv) A detailed description of the impact of any software, including software applications and hardware-based devices that incorporate software, on the device's functions.

Predicate Devices

• Abbott RealTime CT/NG (K140354)
• Aptima Combo 2 Assay (K190515)
• BD Max CT/GC/TV (K151589)
• Aptima Mycoplasma genitalium Assay (DEN180047)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 29, 2022

Abbott Molecular, Inc. Stacy Ferguson Associate Director Regulatory Affairs 1300 E. Touhy Des Plains, Illinois 60018

Re: K202977

Trade/Device Name: Alinity m STI Assay Regulation Number: 21 CFR 866.3393 Regulation Name: Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) Regulatory Class: Class II Product Code: QEP, MKZ, LSL, OUY, LIO, OOI Dated: February 11, 2022 Received: February 14, 2022

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 (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 located 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Himani Bisht, Ph.D. Assistant Director Viral Respiratory and HPV Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# Section 5: 510(k) Summary

## Table of Contents

| | | | | Page |
|-----|-----|----------------|-------------------------------------------------------------------|------|
| 5.0 | | 510(k) Summary | | |
| | 5.1 | | Submitter | |
| | 5.2 | | Device Information | |
| | 5.3 | | Predicate Devices | |
| | 5.4 | | Device Description | |
| | 5.5 | | Intended Use | |
| | 5.6 | | Similarities and Differences to Predicate Devices | |
| | 5.7 | | Performance Data | |
| | | 5.7.1 | Specific Performance Characteristics | |
| | | | 5.7.1.1 Analytical Sensitivity | |
| | | | 5.7.1.2 Inclusivity | |
| | | | 5.7.1.3 Evaluation of Potential Cross Reacting Microorganisms 14 | |
| | | | 5.7.1.4 Evaluation of Potential Interfering Substances 19 | |
| | | | 5.7.1.5 Competitive Interference Study | |
| | | | 5.7.1.6 Within Laboratory Precision | |
| | | | 5.7.1.7 Carryover | |
| | | | 5.7.1.8 Reproducibility Study | |
| | | 5.7.2 | Clinical Performance | |
| | | | 5.7.2.1 Clinical Study Results - Urogenital Specimens 35 | |
| | | | 5.7.2.2 Clinical Study Results - Extragenital Specimens 65 | |
| | 5.8 | | Conclusions Drawn from the Studies | |

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#### 5.0 510(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).

#### Submitter 5.1

| Applicants Name and Address: | Abbott Molecular Inc.<br>1300 E. Touhy Ave<br>Abbott Molecular Inc. |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stacy Ferguson<br>Director Regulatory Affairs<br>Abbott Molecular, Inc.<br>1300 E. Touhy Avenue<br>Des Plaines, IL 60018<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | April 14, 2022 |

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| Trade Name | Regulation Name | Product<br>Code | Regulation<br>Number | Class |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------|-------|
| Alinity m STI Assay | Device to detect nucleic acids from<br>non-viral microorganism(s) causing<br>sexually transmitted infections and<br>associated resistance marker(s) | QEP | 866.3393 | II |

#### 5.2 Device Information

#### 5.3 Predicate Devices

| Device Name | Predicate Device | 510(k) | Cleared |
|------------------------------------|------------------------------------------------------------------|-----------|---------|
| Alinity m STI Assay | Abbott RealTime CT/NG<br>(Primary Predicate for CT/NG) | K140354 | 5/9/14 |
| Aptima Combo 2 Assay | Aptima Combo 2 Assay<br>(Primary Predicate for CT/NG) | K190515 | 5/23/19 |
| BD Max CT/GC/TV | BD Max CT/GC/TV<br>(Primary Predicate for TV) | K151589 | 9/6/16 |
| Aptima Mycoplasma genitalium Assay | Aptima Mycoplasma genitalium Assay<br>(Primary Predicate for MG) | DEN180047 | 1/23/19 |

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#### 5.4 Device Description

The Alinity m STI Assay is a real time polymerase chain reaction (PCR) assay for the amplification and detection of Chlamydia trachomatis (CT) ribosomal RNA sequences, Neisseria gonorrhea (NG) genomic DNA sequences, Trichomonas vaginalis (TV) ribosomal RNA sequences, Mycoplasma genitalium (MG) ribosomal RNA sequences, and human genomic DNA sequences. The assay can be used with endocervical swab specimens, vaginal swab specimens, male and female urine specimens, gynecological specimens in ThinPrep® PreservCyt® Solution, oropharyngeal swab specimens, and rectal swab specimens. Endocervical swab, vaginal swab, oropharyngeal swab, rectal swab and urine specimens are collected with the Alinity m multi-Collect Specimen Collection Kit. PreservCyt Solution specimens are transferred to an Alinity m Transport Tube for processing on the Alinity m System.

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.

The Alinity m STI Assay requires two separate assay specific kits as follows:

- . Alinity m STI AMP Kit, List No. 09N17-095 consisting of multi-well amplification plates containing lyophilized, unit-dose PCR amplification/detection reagents and multi-well activator plates containing liquid, unit-dose activation reagents (MgCl2, TMAC, and KCl). The intended storage condition for the Alinity m STI AMP Kit is 2℃ to 8℃.
- . Alinity m STI CTRL Kit, List No. 09N17-085 consisting 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.

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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, 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 of every 24 hours 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 controls do not indicate if bacterial cells have been adequately lysed.

The Alinity m STI amplification reagents include primers and a probe 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 to assess amplification efficiency and to confirm that no PCR inhibitors are present in the sample. The cellular control and internal control are both used to demonstrate assay validity.

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The Alinity m STI Assay also utilizes the following accessories:

- . Alinity m STI Assay Application Specification File, List No. 09N17-03A
- . Alinity m System and System Software, List No. 08N53-002
- Alinity m Sample Prep Kit 1, List No. 09N18-001 .
- Alinity m multi-Collect Specimen Collection Kit, List No. 09N19-010 .
- . Alinity m Tubes and Caps, List No. 09N49:
- Alinity m Transport Tubes Pierceable Capped, List No. 09N49-010 .
- . Alinity m Transport Tube, List No. 09N49-011
- Alinity m Pierceable Cap, List No. 09N49-012 .
- Alinity m System Solutions, List No. 09N20: .
- Alinity m Lysis Solution, List No. 09N20-001 .
- Alinity m Ethanol Solution, List No. 09N20-002 .
- Alinity m Diluent Solution, List No. 09N20-003
- Alinity m Vapor Barrier Solution, List No. 09N20-004 •

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#### 5.5 Intended Use

### Alinity m STI AMP Kit:

The Alinity m STI Assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae (NG), ribosomal RNA from Trichomonas vaginalis (TV), and ribosomal RNA from Mycoplasma genitalium (MG), to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals for the following analytes:

CT: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, male urine, oropharyngeal swabs, and rectal swabs

NG: vaginal swabs (clinician-collected and self-collected in a clinical setting). endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, male urine, oropharyngeal swabs, and rectal swabs

TV: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, and male urine

MG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, and male urine

A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated if M. genitalium infection is suspected.

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### Alinity m multi-Collect Specimen Collection Kit:

The Alinity m multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female urine specimens, endocervical swab specimens, vaginal swab specimens, oropharyngeal swab specimens, and rectal swab specimens to stabilize nucleic acid for testing with the Alinity m STI Assay. Refer to the Alinity m STI Assay package insert for additional information.

The Alinity m multi-Collect Specimen Collection Kit is not intended for home use.

#### 5.6 Similarities and Differences to Predicate Devices

The primary functional components of the Alinity m STI Assay are substantially equivalent to other legally marketed nucleic acid amplification tests (NAAT) intended for the qualitative detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG).

The Alinity m STI Assay has the same general intended use as the predicate devices. Although there are some technological differences between the Alinity m STI Assay and the predicate devices, these differences do not raise new types of safety or effectiveness questions.

These devices are similar in that they are designed to prepare nucleic acids for amplification, amplify specific CT, NG, TV, and MG sequences, detect the amplified products, and report qualitative results.

The primary similarities and differences between the Alinity m STI Assay and the NAAT predicate devices are shown in Table 1. The primary similarities and differences between the Alinity m multi-Collect Specimen Collection Kit and the predicate device are shown in .

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| Table 1. Similarities and Differences Between Alinity m STI Assay and Nucleic Acid Amplification Tests-Predicate Devices | | | | | |
|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Current Application | Predicate Devices | | | |
| | Alinity m STI Assay | Abbott RealTime CT/NG<br>(Predicate for CT/NG) | Aptima Combo 2 Assay<br>(Predicate for CT/NG) | Becton Dickinson<br>MAX CT/GC/TV<br>(Predicate for TV) | Aptima Mycoplasma genitalium<br>Assay<br>(Predicate for MG) |
| Intended Use | The Alinity m STI Assay is an in<br>vitro polymerase chain reaction<br>(PCR) assay for use with the<br>automated Alinity m System for<br>the direct, qualitative detection<br>and differentiation of ribosomal<br>RNA from Chlamydia<br>trachomatis (CT), DNA from<br>Neisseria gonorrhoeae (NG),<br>ribosomal RNA from<br>Trichomonas vaginalis (TV), and<br>ribosomal RNA from<br>Mycoplasma genitalium (MG) to<br>aid in the diagnosis of urogenital<br>disease(s) caused by infection<br>from these organisms. The assay<br>may be used to test the following<br>specimens from symptomatic and<br>asymptomatic individuals for the<br>following analytes:<br>CT: vaginal swabs (clinician-<br>collected and self-collected in a<br>clinical settings), endocervical<br>swabs, male urine, oropharyngeal<br>swabs, and rectal swabs<br>NG: vaginal swabs (clinician-<br>collected and self-collected in a<br>clinical settings), endocervical<br>swabs, gynecological specimens<br>in ThinPrep PreservCyt Solution,<br>male urine, oropharyngeal swabs,<br>and rectal swabs<br>TV: vaginal swabs (clinician-<br>collected and self-collected in a | The Abbott RealTime CT/NG assay<br>is an in vitro polymerase chain<br>reaction (PCR) assay for the direct,<br>qualitative detection of the plasmid<br>DNA of Chlamydia trachomatis<br>and the genomic DNA of Neisseria<br>gonorrhoeae. The assay may be<br>used to test the following<br>specimens from symptomatic<br>individuals: female endocervical<br>swab, clinician-collected vaginal<br>swab, patient-collected vaginal<br>swab specimens; male urethral<br>swab specimens; and female and<br>male urine specimens. The assay<br>may be used to test the following<br>specimens from asymptomatic<br>individuals: clinician-collected<br>vaginal swab and patient-collected<br>vaginal swab specimens; female<br>and male urine specimens. | The Aptima Combo 2 Assay is a<br>target amplification nucleic acid<br>probe test that utilizes target capture<br>for the in vitro qualitative detection<br>and differentiation of ribosomal<br>RNA (rRNA) from Chlamydia<br>trachomatis (CT) and/or Neisseria<br>gonorrhoeae (GC) to aid in the<br>diagnosis of chlamydial and/or<br>gonococcal disease using the Panther<br>System as specified.<br>On the Panther System, the assay<br>may be used to test the following<br>specimens from symptomatic and<br>asymptomatic individuals: clinician-<br>collected endocervical, vaginal,<br>throat, rectal, and male urethral swab<br>specimens, clinician-collected<br>gynecological specimens collected in<br>the PreservCyt Solution, patient-<br>collected vaginal swab specimens,1<br>and female and male urine<br>specimens.<br>Patient-collected vaginal swab<br>specimens are an option for<br>screening women when a pelvic<br>exam is not otherwise indicated. The<br>Aptima Multitest Swab Specimen<br>Collection kit has not been evaluated<br>for home use. | The BD MAX CT/GC/TV assay, as<br>performed using the BD MAX<br>System incorporates automated<br>DNA extraction and real-time<br>polymerase chain reaction (PCR)<br>for the direct, qualitative detection<br>of DNA from Chlamydia<br>trachomatis (CT), Neisseria<br>gonorrhoeae (GC) and/or<br>Trichomonas vaginalis (TV). The<br>assay may be used for detection of<br>CT and/or GC DNA in male urine<br>specimens, and the detection of CT,<br>GC and/or TV DNA in female<br>urine specimens, clinician-collected<br>female endocervical swab<br>specimens and patient-collected<br>vaginal swab specimens (in a<br>clinical setting). The assay is<br>indicated for use to aid in the<br>diagnosis of chlamydial urogenital<br>disease, gonococcal urogenital<br>disease and/or trichomoniasis in<br>asymptomatic and symptomatic<br>individuals. | The Aptima Mycoplasma genitalium<br>assay is an in vitro nucleic acid<br>amplification test (NAAT) for the<br>qualitative detection of ribosomal<br>RNA (rRNA) from Mycoplasma<br>genitalium on the fully automated<br>Panther system. It is intended for use<br>as an aid in the diagnosis of M.<br>genitalium urogenital infections in<br>male and female patients suspected of<br>M. genitalium infection.<br>The assay may be used to test the<br>following specimens: clinician-<br>collected and self-collected vaginal<br>swabs (in a clinical setting), clinician-<br>collected endocervical swabs, female<br>and male urine, clinician-collected<br>male urethral swabs, and self-<br>collected penile meatal swabs (in a<br>clinical setting).<br>For females, a vaginal swab is the<br>preferred specimen type due to higher<br>clinical sensitivity for detecting M.<br>genitalium than other specimen types;<br>however, female urine or clinician-<br>collected endocervical swabs may be<br>used as alternative specimens when<br>vaginal swab specimens are not<br>available. If female urine or clinician-<br>collected endocervical swab<br>specimens test negative, testing with a<br>vaginal swab may be indicated, if M.<br>genitalium infection is suspected. |
| Feature | Current Application | Predicate Devices | | | |
| | Alinity m STI Assay | Abbott RealTime CT/NG<br>(Predicate for CT/NG) | Aptima Combo 2 Assay<br>(Predicate for CT/NG) | Becton Dickinson<br>MAX CT/GC/TV<br>(Predicate for TV) | Aptima Mycoplasma genitalium<br>Assay<br>(Predicate for MG) |
| | clinical settings), endocervical<br>swabs, gynecological specimens<br>in ThinPrep PreservCyt Solution,<br>female urine, and male urine | | | | |
| | <i>MG</i> : vaginal swabs (clinician<br>collected and self-collected in a<br>clinical settings), endocervical<br>swabs, and male urine | | | | |
| | A vaginal swab (self-collected or<br>clinician-collected) is the<br>preferred specimen type for <i>MG</i><br>testing in females due to higher<br>clinical sensitivity compared to<br>endocervical swabs. If<br>endocervical swab specimens test<br>negative, testing with a vaginal<br>swab may be indicated if <i>M.</i><br><i>genitalium</i> infection is suspected. | | | | |
| Table 1. Similarities and Differences Between Alinity m STI Assay and Nucleic Acid Amplification Tests-Predicate Devices | | | | | |
| Feature | Current Application | Predicate Devices | | |…