Alinity m STI Assay

K222379 · Abbott Molecular, Inc. · QEP · Mar 3, 2023 · Microbiology

Device Facts

• Record ID: K222379
• Device Name: Alinity m STI Assay
• Applicant: Abbott Molecular, Inc.
• Product Code: QEP · Microbiology
• Decision Date: Mar 3, 2023
• 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, gynecological specimens in ThinPrep PreservCyt Solution, female urine, 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, female urine, 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 the 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

The Alinity m STI Assay is an automated, in vitro, real-time PCR assay performed on the Alinity m System. It detects and differentiates CT (rRNA), NG (DNA), TV (rRNA), and MG (rRNA) from clinical specimens including swabs (vaginal, endocervical, oropharyngeal, rectal) and urine. The system automates sample preparation, RT-PCR assembly, amplification, detection, and result reporting. It uses magnetic microparticle technology for nucleic acid extraction. The assay includes an internal control (armored RNA) and a human gene (beta-globin) control to ensure sample processing and assay validity. The device is used in clinical laboratories by trained personnel. Results aid clinicians in diagnosing STI infections. The assay is a random-access analyzer allowing parallel processing of multiple assays.

Clinical Evidence

Prospective clinical study (N=2785) evaluated CT/NG in female urine; archived samples (N=2784) evaluated CT in PreservCyt. Performance assessed via composite comparator algorithm (CCA) using two/three NAATs. CT in urine: 96.7% PPA, 99.8% NPA. NG in urine: 98.0% PPA, 99.9% NPA. CT in PreservCyt: 98.3% PPA, 99.6% NPA.

Technological Characteristics

Real-time PCR assay; automated nucleic acid extraction via magnetic microparticles. Reagents: lyophilized unit-dose RT-PCR plates and liquid activator plates. Targets: CT (rRNA), NG (DNA), TV (rRNA), MG (rRNA), and human beta-globin (internal control). Connectivity: Integrated with Alinity m System. Storage: 2-8°C (AMP kit), -25 to -15°C (CTRL kit).

Indications for Use

Indicated for symptomatic and asymptomatic individuals to aid in the diagnosis of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) infections using various urogenital and extragenital specimen types.

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

• Alinity m STI Assay (K202977)

Submission Summary (Full Text)

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March 3, 2023

Image /page/0/Picture/1 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.

Abbott Molecular Inc. Paul Matushek Associate Director Regulatory Affairs 1300 E Touhy Ave Des Plaines, Illinois 60018

# Re: K222379

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, OUY, LSL, MKZ Dated: August 4, 2022 Received: August 5, 2022

# Dear Paul Matushek:

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.

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

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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 -S

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) K222379

Device Name Alinity m STI Assay

## Indications for Use (Describe)

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 (CT), DNA from Neisseria gonorthoeae (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 individuals for the following analytes:

· CT: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gyneoological specimens in ThinPrep PreservCyt Solution, female urine, oropharyngeal swabs, and rectal swabs

· NG: vaginal swabs (clinician-collected in a clinical setting), endocervical swabs, gyneological specimens in ThinPrep PreservCyt Solution, female 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 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 the 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.

Type of Use (Select one or both, as applicable)

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Section 5: 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 Device | | 3 |
| | 1.4 | Device Description | | 4 |
| | | 1.4.1 Alinity m STI Assay | | 4 |
| | 1.5 | Intended Use | | 7 |
| | 1.6 | Similarities and Differences to Predicate Devices | | 8 |
| | 1.7 | Performance Data | | 12 |
| | | 1.7.1 Specific Performance Characteristics | | 12 |
| | | 1.7.2 Clinical Performance | | 13 |
| | 1.8 | Conclusions Drawn from the Studies | | 29 |

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#### 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.<br>1300 E. Touhy Ave<br>Des Plaines, IL 60018 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paul Matushek<br>Associate 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: | March 1, 2023 |

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| Trade Name | Regulation Name | Classification<br>Product Code | Regulation<br>Number | Class |
|---------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------|-------|
| Alinity m STI Assay | Nucleic Acid Detection<br>System For Non-Viral<br>Microorganism(s)<br>Causing Sexually<br>Transmitted Infections | QEP | 866.3393 | II |

#### 1.2 Device Information

#### 1.3 Predicate Device

| Device Name | Predicate Device | 510(k) | Cleared |
|---------------------|---------------------|---------|------------|
| Alinity m STI Assay | Alinity m STI Assay | K202977 | 04/29/2022 |

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#### 1.4 Device Description

#### Alinitv m STI Assav 1.4.1

The Alinity m STI Assay utilizes real time 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 endocervical swab specimens, vaginal swab specimens, oropharyngeal swab specimens, rectal swab specimens, male and female urine specimens, and gynecological specimens preserved in PreservCyt Solution. Endocervical swab, vaginal swab, oropharyngeal swab, rectal swab, and urine specimens are collected with the Alinity m multi-Collect Specimen Transport Kit. PreservCyt specimens are transferred to a transport tube for processing on the Alinity m System.

This device is similar to the predicate device originally cleared (K202977). It does not introduce any changes to the Alinity m STI Assay reagents, sample processing, assay procedure, and data reduction. This device is updating the previous FDA-cleared Intended Use (K202977) to include claims for the following specimens for the following analytes:

- CT: Gynecological specimens in ThinPrep PreservCyt Solution, female urine .
- NG: Female urine

Two studies were initiated to support these claims (refer to Section 1.7.2.) This supplemental data was used with data previously obtained from the Alinity m STI Assay clinical testing studies submitted in K202977.

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.

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

- Alinity m STI AMP Kit (List No. 09N17-095) 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 (MgCl2, TMAC, and KCl). The intended storage condition for the Alinity m STI AMP Kit is 2°C to 8°C.
- Alinity m STI CTRL Kit (List No. 09N17-085) 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 -25°C to -15°C.

Nucleic acids from specimens are extracted automatically onboard 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 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 CTRL kit configuration includes 12 vials at 0.47mL of both the Alinity m STI Negative and 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

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inhibitors are present in the sample. The ß-globin control and internal control are both used to demonstrate assay validity.

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. 09N19-015 •
- Alinity m Tubes and Caps, List No. 09N49: .
- Alinity m Transport Tube 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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#### 1.5 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, gynecological specimens in ThinPrep PreservCyt Solution, female urine, 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, female urine, 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 the 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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#### 1.6 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 uses as the predicate device. There are no technological differences between the Alinity m STI Assay (expanded claim discussed in this submission) and the predicate device (K202977); therefore, no new types of safety or effectiveness questions are raised.

These devices are similar in that there are no changes to the Alinity m STI Assay reagents, sample processing, assay procedure, and data reduction. This device is updating the previous FDA-cleared Intended Use (K202977) to include claims for the following specimens for the following analytes:

- CT: Gynecological specimens in ThinPrep PreservCyt Solution, female urine .
- NG: Female urine

The primary similarities and differences between the Alinity m STI Assay and the predicate device are shown in Table 1.

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| Table 1. Similarities and Differences Between Alinity m STI Assay and Nucleic Acid Amplification Tests-Predicate Device | | |
|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | Subject Device | Predicate Device |
| | Alinity m STI Assay | Alinity m STI Assay (K202977) |
| General Device Characteristics--Similarities | | |
| Assay Type | Same | Qualitative<br>Nucleic acid amplification |
| Assay Targets | Same | CT ribosomal RNA<br>NG genomic DNA<br>TV ribosomal RNA<br>MG ribosomal RNA |
| Sample<br>Preparation<br>Procedure | Same | Automated |
| Amplification<br>Technology | Same | Real-Time PCR |
| Assay Controls | Same | Negative Control<br>Positive Control<br>Internal Control (IC)<br>Cellular Control (CC) |
| Table 1. Similarities and Differences Between Alinity m STI Assay and Nucleic Acid Amplification Tests-Predicate Device | | |
| Description | Subject Device | Predicate Device |
| | Alinity m STI Assay | Alinity m STI Assay (K202977) |
| | General Device Characteristics--Differences | |
| Intended Use | The Alinity m STI Assay is an in vitro polymerase chain reaction (PCR)<br>assay for use with the automated Alinity m System for the direct,<br>qualitative detection and differentiation of RNA from Chlamydia<br>trachomatis (CT), DNA from Neisseria gonorrhoeae (NG), ribosomal<br>RNA from Trichomonas vaginalis (TV), and ribosomal RNA from<br>Mycoplasma genitalium (MG), to aid in the diagnosis of disease(s)<br>caused by infection from these organisms. The assay may be used to test<br>the following specimens from symptomatic and asymptomatic<br>individuals for the following analytes:<br>CT: vaginal swabs (clinician-collected and self-collected in a clinical<br>setting), endocervical swabs, gynecological specimens in ThinPrep<br>PreservCyt Solution, female urine, male urine, oropharyngeal swabs,<br>and rectal swabs | The Alinity m STI Assay is an in vitro polymerase chain reaction<br>(PCR) assay for use with the automated Alinity m System for the<br>direct, qualitative detection and differentiation of RNA from<br>Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae<br>(NG), ribosomal RNA from Trichomonas vaginalis (TV), and<br>ribosomal RNA from Mycoplasma genitalium (MG), to aid in the<br>diagnosis of disease(s) caused by infection from these organisms.<br>The assay may be used to test the following specimens from<br>symptomatic and asymptomatic individuals for the following<br>analytes:<br>CT: vaginal swabs (clinician-collected and self-collected in a clinical<br>setting), endocervical swabs, male urine, oropharyngeal swabs, and<br>rectal swabs |
| | NG: vaginal swabs (clinician-collected and self-collected in a clinical<br>setting), endocervical swabs, gynecological specimens in ThinPrep<br>PreservCyt Solution, female urine, male urine, oropharyngeal swabs,<br>and rectal swabs | NG: vaginal swabs (clinician-collected and self-collected in a<br>clinical setting), endocervical swabs, gynecological specimens in<br>ThinPrep PreservCyt Solution, male urine, oropharyngeal swabs, and<br>rectal swabs |
| | TV: vaginal swabs (clinician-collected and self-collected in a clinical<br>setting), endocervical swabs, gynecological specimens in ThinPrep<br>PreservCyt Solution, female urine, and male urine | TV: vaginal swabs (clinician-collected and self-collected in a clinical<br>setting), endocervical swabs, gynecological specimens in ThinPrep<br>PreservCyt Solution, female urine, and male urine |
| | MG: vaginal swabs (clinician-collected and self-collected in a clinical<br>setting), endocervical swabs, and male urine | MG: vaginal swabs (clinician-collected and self-collected in a<br>clinical setting), endocervical swabs, and male urine |
| | A vaginal swab (self-collected or clinician-collected) is the preferred<br>specimen type for MG testing in females due to the higher clinical<br>sensitivity compared to endocervical swabs. If endocervical swab | A vaginal swab (self-collected or clinician-collected) is the preferred<br>specimen type for MG testing in females due to the higher clinical<br>sensitivity compared to endocervical swabs. If endocervical swab |
| Description | Subject Device | Predicate Device |
| | Alinity m STI Assay | Alinity m STI Assay (K202977) |
| | specimens test negative, testing with a vaginal swab may be indicated if<br><i>M. genitalium</i> infection is suspected. | specimens test negative, testing with a vaginal swab may be<br>indicated if <i>M. genitalium</i> infection is suspected. |
| Specimen Types | All listed under predicate and additionally:<br>Female urine (CT, NG)<br>Gynecological specimens in PreservCyt Solution (CT) | Endocervical swabs (CT, NG, TV, MG)<br>Self-collected vaginal swabs (CT, NG, TV, MG)<br>Clinician- collected vaginal swabs (CT, NG, TV, MG)<br>Male urine (CT, NG, TV, MG)<br>Female urine (TV)<br>Gynecological specimens in PreservCyt Solution (NG, TV)<br>Oropharyngeal swabs (CT, NG)<br>Rectal swabs (CT, NG) |

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#### 1.7 Performance Data

The following performance data were provided in support of the substantial equivalence determination.

#### Specific Performance Characteristics 1.7.1

Verification studies were conducted previously to support the clearance of K202977. There is no change to Alinity m STI reagents manufacturing process or specifications, reagents, sample processing, assay procedure, and data reduction. Therefore, there is no need for additional verification studies for the Alinity m STI Assay. Urine specimens and PreservCyt specimens were previously assessed to support the clearance of K202977.

#### 1.7.1.1 Analytical Sensitivity

Analytical Sensitivity was conducted previously to support the clearance of K202977. Please refer to decision summary of K202977.

#### 1.7.1.2 Inclusivity

Inclusivity was conducted previously to support the clearance of K202977. Please refer to decision summary of K202977.

#### 1.7.1.3 Evaluation of Potential Cross Reacting Microorganisms

Evaluation of Potential Cross Reacting Microorganisms was conducted previously to support the clearance of K202977. Please refer to decision summary of K202977.

#### Evaluation of Potential Interfering Substances 1.7.1.4

Evaluation of Potential Interfering Substances was conducted previously to support the clearance of K202977. Please refer to decision summary of K202977.

#### 1.7.1.5 Competitive Interference Study

Competitive Interference study was conducted previously to support the clearance of K202977. Please refer to decision summary of K202977.

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#### 1.7.1.6 Within-Laboratory Precision

Within-Laboratory Precision was conducted previously to support the clearance of K202977. Please refer to decision summary of K202977.

#### 1.7.1.7 Sample Carryover

Sample Carryover was conducted previously to support the clearance of K202977. Please refer to decision summary of K202977.

#### 1.7.2 Clinical Performance

#### Reproducibility 1.7.2.1

Reproducibility was conducted previously to support the clearance of K202977. Please refer to decision summary of K202977.

#### 1.7.2.2 Clinical Study Results - Urogenital Specimens

Performance characteristics of the Alinity m STI Assay with urogenital specimens were established in a multicenter clinical study conducted in the United States to support the clearance of K202977 (refer to Decision Summary for K202977). Claims for CT, NG, TV, and MG in vaginal swabs, endocervical swabs and male urine, for TV in female urine, and for NG and TV in gynecological specimens in ThinPrep PreservCyt solution were cleared. Additional data to obtain claims for CT and NG in female urine, and for CT in gynecological specimens in ThinPrep PreservCyt solution have been submitted in this 510(k). Please see supporting studies for these specimen types discussed in Section 1.7.2.4. and Section 1.7.2.5.

#### Clinical Study Results - Extragenital Specimens 1.7.2.3

Performance characteristics of the Alinity m STI Assay with extragenital specimens were established in a multicenter clinical study conducted in the United States to support the clearance of K202977. Please refer to decision summary of K202977.

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#### 1.7.2.4 Alinity m STI Clinical Testing Study of Female Urine for CT and NG

Urine specimens were collected from female subjects 14 years of age or older at 14 geographically diverse sites. A total of 2,798 asymptomatic and symptomatic subjects were enrolled. Study subjects were classified as symptomatic if the subject reported STI related symptoms. Each subject provided 1 urine specimen.

Specimen testing methods included the Alinity m STI Assay and comparator assays for CT and NG. Alinity m STI Assay testing was performed at clinical testing sites. Comparator assays for CT and NG included 3 commercially available nucleic acid amplification tests (NAAT) tested on the urine specimens were initially tested with 2 NAATs. If the NAATs did not agree or if 1 result was missing or indeterminate, a third tiebreaker NAAT was used.

For each subject, a Composite Comparator Algorithm (CCA) was determined for each analyte (CT and NG) based on the combined urine results from the comparator assays. A female subject was categorized as "Positive" for CT or NG if at least 2 comparator assay results were positive and "Negative" for CT or NG if at least 2 comparator assay results were negative.

If a CCA could not be determined due to missing and/or indeterminate results from the comparator assays, the subject was excluded from the analysis for that analyte. Out of 2798 subjects, a total of 2785 CT and 2784 NG results were used in the analysis.

CT specimen-specific positive and negative agreement for female urine by symptom status are presented in Table 2. The CT clinical sensitivity based on the Patient Infect Status (PIS) was up to 12.3% lower in female urine than in vaginal swab specimens.

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| Analyte | Specimen<br>Type | Symptom<br>Status | N | Alinity+<br>CCA+ | Alinity+<br>CCA- | Alinity-<br>CCA- | Alinity-<br>CCA+ | PPA | | NPA | |
|---------|------------------|-------------------|------|------------------|------------------|------------------|------------------|----------------------|---------|----------------------|-----------|
| | | | | | | | | Estimate<br>(95% CI) | n / N | Estimate<br>(95% CI) | n / N |
| CT | Female Urine | Symptomatic | 714 | 47 | 1 | 664 | 2 | 95.9 (86.3,98.9) | 47/49 | 99.8 (99.2,100.0) | 664/665 |
| CT | Female Urine | Asymptomatic | 2071 | 130 | 3 | 1934 | 4 | 97.0 (92.6,98.8) | 130/134 | 99.8 (99.5,99.9) | 1934/1937 |
| CT | Female Urine | All | 2785 | 177 | 4 | 2598 | 6 | 96.7 (93.0,98.5) | 177/183 | 99.8 (99.6,99.9) | 2598/2602 |

|

CCA=Composite Comparator Algorithm

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The specimen-specific NG status could not be determined for 1 subject. NG specimenspecific positive and negative agreement for female urine by symptom status are presented in Table 3. The NG clinical sensitivity based on the PIS was up to 9.8% lower in female urine than in vaginal swab specimens.

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| Analyte | Specimen<br>Type | Symptom<br>Status | N | Alinity+<br>CCA+ | Alinity+<br>CCA- | Alinity-<br>CCA- | Alinity-<br>CCA+ | PPA | | NPA | |
|---------|------------------|-------------------|------|------------------|------------------|------------------|------------------|----------------------|-------|----------------------|-----------|
| | | | | | | | | Estimate<br>(95% CI) | n / N | Estimate<br>(95% CI) | n / N |
| NG | Female<br>Urine | Symptomatic | 714 | 15 | 0 | 699 | 0 | 100.0 (79.6,100.0) | 15/15 | 100.0 (99.5,100.0) | 699/699 |
| NG | Female<br>Urine | Asymptomatic | 2070 | 33 | 2 | 2034 | 1 | 97.1 (85.1,99.5) | 33/34 | 99.9 (99.6,100.0) | 2034/2036 |
| | | All | 2784 | 48 | 2 | 2733 | 1 | 98.0 (89.3,99.6) | 48/49 | 99.9 (99.7,100.0) | 2733/2735 |

CCA = Composite Comparator Algorithm

The numbers of specimens in all combinations of PIS, CCA, individual comparator results and the Alinity m STI Assay result are summarized. CT results for infected and non-infected female urine specimens are presented in Table 5. NG results for infected and non-infected female urine specimens are presented in Table 6 and Table 7.

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| Table 4. CT Analysis Per CCA POSITIVE FEMALE Urine Specimens | | | | | | | | | |
|--------------------------------------------------------------|--------------|--------------|---------------------|-------------|--------------|-------|--|--|--|
| NAAT 1<br>FU | NAAT 2<br>FU | NAAT 3<br>FU | Alinity m STI<br>FU | Symptomatic | Asymptomatic | Total | | | |
| + | + | N/A | + | 44 | 127 | 171 | | | |
| - | + | + | - | 1 | 2 | 3 | | | |
| + | + | N/A | - | 1 | 1 | 2 | | | |
| + | - | + | + | 0 | 2 | 2 | | | |
| - | + | + | + | 2 | 0 | 2 | | | |
| + | + | + | + | 1 | 0 | 1 | | | |
| + | N/A | + | + | 0 | 1 | 1 | | | |
| + | - | + | - | 0 | 1 | 1 | | | |

FU = Female Urine, N/A = Not Available

| | | | Table 5. CT Analysis Per CCA NEGATIVE FEMALE Urine Specimens | | | |
|--------------|--------|--------|--------------------------------------------------------------|-------------|-----------------|-------|
| NAAT 1<br>FU | NAAT 2 | NAAT 3 | Alinity m STI | | No. of Subjects | |
| | FU | FU | FU | Symptomatic | Asymptomatic | Total |
| - | - | N/A | - | 654 | 1907 | 2561 |
| - | N/A | - | - | 7 | 21 | 28 |
| - | - | - | - | 2 | 2 | 4 |
| - | - | N/A | + | 1 | 2 | 3 |
| + | - | - | - | 1 | 1 | 2 |
| N/A | - | - | - | 0 | 2 | 2 |
| + | - | - | + | 0 | 1 | 1 |
| - | + | - | - | 0 | 1 | 1 |

FU = Female Urine, N/A = Not Available

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| | | Table 6. NG Analysis Per CCA POSITIVE FEMALE Urine Specimens |
|--|--|--------------------------------------------------------------|
|--|--|--------------------------------------------------------------|

| NAAT 1<br>FU | NAAT 2<br>FU | NAAT 3<br>FU | Alinity m STI<br>FU | No. of Subjects | | |
|--------------|--------------|--------------|---------------------|-----------------|--------------|-------|
| | | | | Symptomatic | Asymptomatic | Total |
| + | + | N/A | + | 14 | 31 | 45 |
| - | + | + | + | 0 | 2 | 2 |
| + | + | + | + | 1 | 0 | 1 |
| + | + | N/A | - | 0 | 1 | 1 |

FU = Female Urine, N/A = Not Available

| Table 7. NG Analysis Per CCA NEGATIVE FEMALE Urine Specimens | | | | | | |
|--------------------------------------------------------------|--------|--------|---------------|-----------------|--------------|-------|
| NAAT 1 | NAAT 2 | NAAT 3 | Alinity m STI | No. of Subjects | | |
| FU | FU | FU | FU | Symptomatic | Asymptomatic | Total |
| - | - | N/A | - | 686 | 2003 | 2689 |
| - | N/A | - | - | 7 | 21 | 28 |
| - | - | - | - | 5 | 8 | 13 |
| N/A | - | - | - | 0 | 2 | 2 |
| - | - | N/A | + | 0 | 2 | 2 |
| + | - | - | - | 1 | 0 | 1 |

FU = Female Urine, N/A = Not Available

# Expected Values

The prevalence of CT and NG in this study was dependent on several factors including age, gender, clinic type, presence of symptoms, and the method of testing. A summary of the positivity for CT, as determined by the Alinity m STI Assay for female urine specimen type, is presented by collection site and overall in Table 8. A summary of the positivity for NG, as determined by the Alinity m STI Assay for female urine specimen type, is presented by collection site and overall in Table 9.

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Table 8. Positivity of CT Female Urine as Determined by Alinity m STI Assay by Collection Site

| Site | % Positivity (Number Positive /<br>Number Tested with Valid Results) |
|------|----------------------------------------------------------------------|
| 01 | 1.9 (2/105) |
| 02 | 8.4 (33/394) |
| 03 | 5.2 (5/96) |
| 04 | 11.8 (70/594) |
| 05 | 4.9 (23/466) |
| 06 | 9.4 (8/85) |
| 07 | 2.3 (7/305) |
| 08 | 6.0 (23/383) |
| 09 | 1.9 (2/104) |
| 10 | 1.8 (2/109) |
| 11 | 6.5 (2/31) |
| 12 | 4.0 (3/75) |
| 13 | 0.0 (0/20) |
| 14 | 5.6 (1/18) |
| All | 6.5 (181/2785) |

Table 9. Positivity of NG Female Urine as Determined by Alinity m STI Assay by Collection Site

| Site | % Positivity (Number Positive /<br>Number Tested with Valid Results) |
|------|----------------------------------------------------------------------|
| 01 | 1.0 (1/105) |
| 02 | 1.8 (7/394) |
| 03 | 1.0 (1/96) |
| 04 | 3.5 (21/594) |
| 05 | 1.3 (6/466) |
| 06 | 1.2 (1/85) |
| 07 | 1.0 (3/305) |
| 08 | 2.4 (9/382) |
| 09 | 0.0 (0/104) |
| 10 | 0.0 (0/109) |
| 11 | 0.0 (0/31) |
| 12 | 1.3 (1/75) |
| 13 | 0.0 (0/20) |
| 14 | 0.0 (0/18) |
| All | 1.8 (50/2784) |

FU = Female Urine

FU = Female Urine

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# Positive and Negative Predictive Values for Hypothetical Prevalence Rates

The Positive and Negative Predictive Values (PPV and NPV) were calculated using hypothetical prevalence rates and the Alinity m STI Assay sensitivity and specificity determined from the clinical study previously reported in K202977. Estimates of the PPV and NPV for the Alinity m STI Assay for urogenital specimens are presented in Table 10 for CT and Table 11 for NG. The predictive values for endocervical swab, self-collected vaginal swab, clinician-collected vaginal swab, and male urine in this table were previously reported in K202977. The shaded rows refer to data relevant to the new claims that have been added to the table.

| Specimen Type | Category | 0.5% | 1.0% | 2.0% | 5.0% | 10.0% | 15.0% | 20.0% | 25.0% | 30.0% |
|---------------|----------|-------|-------|-------|------|-------|-------|-------|-------|-------|
| CCV | PPV (%) | 36.9 | 54.0 | 70.3 | 85.9 | 92.8 | 95.3 | 96.7 | 97.5 | 98.0 |
| CCV | NPV (%) | 100.0 | 100.0 | 100.0 | 99.9 | 99.8 | 99.7 | 99.5 | 99.3 | 99.2 |
| SCV | PPV (%) | 40.0 | 57.2 | 73.0 | 87.5 | 93.6 | 95.9 | 97.1 | 97.8 | 98.3 |
| SCV | NPV (%) | 100.0 | 100.0 | 100.0 | 99.9 | 99.8 | 99.7 | 99.6 | 99.5 | 99.4 |
| E | PPV (%) | 43.2 | 60.5 | 75.6 | 88.9 | 94.4 | 96.4 | 97.4 | 98.1 | 98.5 |
| E | NPV (%) | 100.0 | 99.9 | 99.9 | 99.7 | 99.4 | 99.0 | 98.6 | 98.2 | 97.7 |
| PreservCyt | PPV (%) | 42.8 | 60.1 | 75.3 | 88.7 | 94.3 | 96.3 | 97.4 | 98.0 | 98.5 |
| PreservCyt | NPV (%) | 99.9 | 99.9 | 99.8 | 99.4 | 98.7 | 97.9 | 97.0 | 96.1 | 95.0 |
| FU | PPV (%) | 52.2 | 68.7 | 81.6 | 92.0 | 96.0 | 97.5 | 98.2 | 98.6 | 98.9 |
| FU | NPV (%) | 99.9 | 99.9 | 99.7 | 99.3 | 98.5 | 97.6 | 96.6 | 95.6 | 94.4 |
| MU | PPV (%) | 49.4 | 66.3 | 79.9 | 91.1 | 95.6 | 97.2 | 98.0 | 98.5 | 98.8 |
| MU | NPV (%) | 100.0 | 100.0 | 99.9 | 99.9 | 99.7 | 99.5 | 99.3 | 99.1 | 98.8 |

Table 10. CT Positive and Negative Predictive Value Using Hypothetical Prevalence for Urogenital Specimens

CCV = Clinician-Collected Vaginal Swab, SCV = Self-Collected Vaginal Swab, E = Endocervical Swab, FU = Female Urine, MU = Male Urine

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| Specimen Type | Category | 0.5% | 1.0% | 2.0% | 5.0% | 10.0% | 15.0% | 20.0% | 25.0% | 30.0% |
|---------------|----------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
| CCV | PPV (%) | 69.2 | 81.9 | 90.1 | 95.9 | 98.0 | 98.7 | 99.1 | 99.3 | 99.5 |
| CCV | NPV (%) | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| SCV | PPV (%) | 61.1 | 75.9 | 86.4 | 94.3 | 97.2 | 98.2 | 98.7 | 99.0 | 99.3 |
| SCV…