Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard PCR assay and automated system for detecting specific pathogens. There is no mention of AI or ML in the device description, intended use, or performance studies. The data analysis involves comparing results to a Composite Comparator Algorithm, which is a rule-based method, not AI/ML.

Therapeutic

No.
The device is an in vitro diagnostic (IVD) PCR assay used for the qualitative detection and differentiation of specific
bacterial and parasitic ribosomal RNA/DNA to aid in the diagnosis of infections. It does not provide any form of
therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the Alinity m STI Assay is used "to aid in the diagnosis of disease(s) caused by infection from these organisms." This indicates its purpose is to help clinicians make a medical diagnosis.

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic (IVD) assay that utilizes real-time PCR and is performed on the automated Alinity m System, which is a hardware analyzer. While software is involved in data reduction and reporting, the core functionality relies on reagents, sample processing, and the physical Alinity m System.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Alinity m STI Assay is an in vitro polymerase chain reaction (PCR) assay. It is designed for the direct, qualitative detection and differentiation of specific organisms (CT, NG, TV, MG) to aid in the diagnosis of diseases caused by these infections. This clearly indicates that the device is used to test specimens outside of the body to provide diagnostic information.
Device Description: The "Device Description" further reinforces this by describing the assay as utilizing real-time PCR to amplify and detect genetic material from various human specimens. It also mentions that the assay is performed on the automated Alinity m System, which is a laboratory instrument.
Specimen Types: The assay is designed to test various human specimens (vaginal swabs, endocervical swabs, urine, oropharyngeal swabs, rectal swabs, gynecological specimens in ThinPrep PreservCyt Solution), which are collected from the patient and analyzed in vitro.
Purpose: The purpose is to "aid in the diagnosis of disease(s) caused by infection from these organisms," which is a core function of an in vitro diagnostic device.

Therefore, based on the provided information, the Alinity m STI Assay fits the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 (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.

Product codes (comma separated list FDA assigned to the subject device)

QEP

Device Description

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.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vaginal, endocervical, female urine, male urine, oropharyngeal, rectal

Indicated Patient Age Range

female subjects 14 years of age or older

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

Comparator Testing of ThinPrep (PreservCyt) for CT:
Each female subject in the study provided a gynecological specimen collected in PreservCyt Solution. A total of 1939 specimens from the multicenter clinical study were included in the analysis.
The CT result of the Alinity m STI Assay was compared against a specimen-specific CT CCA status. The PreservCyt CCA specimen-specific status was determined using the results of up to 3 NAATs. 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. A PreservCyt specimen was considered positive for CT if at least 2 comparator NAATs were positive for the PreservCyt specimen. A PreservCyt specimen was considered negative if at least 2 comparator NAATs were negative.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Alinity m STI Clinical Testing Study of Female Urine for CT and NG:
CT specimen-specific positive and negative agreement for female urine by symptom status:
Symptomatic (N=714): PPA 95.9% (86.3,98.9) (47/49), NPA 99.8% (99.2,100.0) (664/665)
Asymptomatic (N=2071): PPA 97.0% (92.6,98.8) (130/134), NPA 99.8% (99.5,99.9) (1934/1937)
All (N=2785): PPA 96.7% (93.0,98.5) (177/183), NPA 99.8% (99.6,99.9) (2598/2602)
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.

NG specimen-specific positive and negative agreement for female urine by symptom status:
Symptomatic (N=714): PPA 100.0% (79.6,100.0) (15/15), NPA 100.0% (99.5,100.0) (699/699)
Asymptomatic (N=2070): PPA 97.1% (85.1,99.5) (33/34), NPA 99.9% (99.6,100.0) (2034/2036)
All (N=2784): PPA 98.0% (89.3,99.6) (48/49), NPA 99.9% (99.7,100.0) (2733/2735)
The NG clinical sensitivity based on the PIS was up to 9.8% lower in female urine than in vaginal swab specimens.

Comparator Testing of ThinPrep (PreservCyt) for CT:
CT specimen-specific positive and negative agreement for PreservCyt by symptom status:
Symptomatic (N=953): PPA 98.5% (92.0,99.7) (66/67), NPA 99.9% (99.4,100.0) (885/886)
Asymptomatic (N=986): PPA 98.1% (90.1,99.7) (52/53), NPA 99.4% (98.6,99.7) (927/933)
All (N=1939): PPA 98.3% (94.1,99.5) (118/120), NPA 99.6% (99.2,99.8) (1812/1819)
The CT clinical sensitivity based on the PIS was up to 10.7% lower in PreservCyt than in vaginal swab specimens.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

See summary of performance studies above for PPA and NPA.
PPV and NPV are calculated using hypothetical prevalence rates and the Alinity m STI Assay sensitivity and specificity determined from the clinical study previously reported in K202977. Estimates for urogenital specimens:
CT Predictive Values:
For Female Urine (FU): PPV 52.2% (at 0.5% prevalence) to 98.9% (at 30.0% prevalence), NPV 99.9% (at 0.5% prevalence) to 94.4% (at 30.0% prevalence).
For PreservCyt: PPV 42.8% (at 0.5% prevalence) to 98.5% (at 30.0% prevalence), NPV 99.9% (at 0.5% prevalence) to 95.0% (at 30.0% prevalence).

NG Predictive Values:
For Female Urine (FU): PPV 67.5% (at 0.5% prevalence) to 99.4% (at 30.0% prevalence), NPV 100.0% (at 0.5% prevalence) to 96.0% (at 30.0% prevalence).

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K202977

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.3393 Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).

(a)
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.(b)
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.

Summary

0

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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)

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

510(k) Summary		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.
1300 E. Touhy Ave
Des Plaines, IL 60018 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paul Matushek
Associate Director Regulatory Affairs
Abbott Molecular, Inc.
1300 E. Touhy Avenue
Des Plaines, IL 60018
Phone: 224-361-7331
Fax: 224-361-7269 |
| Date Prepared: | March 1, 2023 |

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| Trade Name | Regulation Name | Classification
Product Code | Regulation
Number | Class |
|---------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------|-------|
| Alinity m STI Assay | Nucleic Acid Detection
System For Non-Viral
Microorganism(s)
Causing Sexually
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.

7

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

8

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 •

9

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.

10

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.

11

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
Nucleic acid amplification
Assay Targets	Same	CT ribosomal RNA
NG genomic DNA
TV ribosomal RNA
MG ribosomal RNA
Sample
Preparation
Procedure	Same	Automated
Amplification
Technology	Same	Real-Time PCR
Assay Controls	Same	Negative Control
Positive Control
Internal Control (IC)
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)
assay for use with the automated Alinity m System for the direct,
qualitative detection and differentiation of 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	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 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, 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, 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	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	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	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
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
M. genitalium infection is suspected.	specimens test negative, testing with a vaginal swab may be
indicated if M. genitalium infection is suspected.
Specimen Types	All listed under predicate and additionally:
Female urine (CT, NG)
Gynecological specimens in PreservCyt Solution (CT)	Endocervical swabs (CT, NG, TV, MG)
Self-collected vaginal swabs (CT, NG, TV, MG)
Clinician- collected vaginal swabs (CT, NG, TV, MG)
Male urine (CT, NG, TV, MG)
Female urine (TV)
Gynecological specimens in PreservCyt Solution (NG, TV)
Oropharyngeal swabs (CT, NG)
Rectal swabs (CT, NG)

12

13

14

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.

15

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.

16

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.

17

| Analyte | Specimen
Type | Symptom
Status | N | Alinity+
CCA+ | Alinity+
CCA- | Alinity-
CCA- | Alinity-
CCA+ | PPA | | NPA | |
|---------|------------------|-------------------|------|------------------|------------------|------------------|------------------|----------------------|---------|----------------------|-----------|
| | | | | | | | | Estimate
(95% CI) | n / N | Estimate
(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

18

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.

19

| Analyte | Specimen
Type | Symptom
Status | N | Alinity+
CCA+ | Alinity+
CCA- | Alinity-
CCA- | Alinity-
CCA+ | PPA | | NPA | |
|---------|------------------|-------------------|------|------------------|------------------|------------------|------------------|----------------------|-------|----------------------|-----------|
| | | | | | | | | Estimate
(95% CI) | n / N | Estimate
(95% CI) | n / N |
| NG | Female
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
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.

20

Table 4. CT Analysis Per CCA POSITIVE FEMALE Urine Specimens
NAAT 1
FU	NAAT 2
FU	NAAT 3
FU	Alinity m STI
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
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

21

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

| NAAT 1
FU | NAAT 2
FU | NAAT 3
FU | Alinity m STI
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.

22

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

| Site | % Positivity (Number Positive /
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 /
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

23

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

24

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	NPV (%)	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0
E	PPV (%)	66.9	80.3	89.2	95.5	97.8	98.6	99.0	99.3	99.4
E	NPV (%)	100.0	99.9	99.8	99.6	99.2	98.7	98.2	97.6	96.9
PreservCyt	PPV (%)	92.8	96.3	98.1	99.3	99.6	99.8	99.8	99.9	99.9
PreservCyt	NPV (%)	100.0	99.9	99.9	99.7	99.4	99.0	98.6	98.2	97.7
FU	PPV (%)	67.5	80.6	89.4	95.6	97.9	98.6	99.0	99.3	99.4
FU	NPV (%)	100.0	99.9	99.8	99.5	98.9	98.3	97.6	96.8	96.0
MU	PPV (%)	77.3	87.3	93.3	97.3	98.7	99.2	99.4	99.6	99.7
MU	NPV (%)	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0

Table 11. NG Positive and Negative Predictive Value Using Hypothetical Prevalence for Urogenital Specimens

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

25

1.7.2.5 Comparator Testing of ThinPrep (PreservCyt) for CT

Performance characteristics of the Alinity m STI Assay with urogenital specimens were established in a multicenter clinical study conducted in the United States (refer to K202977). Each female subject in the study provided a gynecological specimen collected in PreservCyt Solution, which was tested with both the Alinity m STI Assay and up to 3 comparator NAATs. A total of 1939 specimens from the multicenter clinical study were included in the analysis.

The CT result of the Alinity m STI Assay was compared against a specimen-specific CT CCA status. The PreservCyt CCA specimen-specific status was determined using the results of up to 3 NAATs. 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. A PreservCyt specimen was considered positive for CT if at least 2 comparator NAATs were positive for the PreservCyt specimen. A PreservCyt specimen was considered negative if at least 2 comparator NAATs were negative. CT specimen-specific positive and negative agreement for PreservCyt by symptom status are presented in Table 12. The CT clinical sensitivity based on the PIS was up to 10.7% lower in PreservCyt than in vaginal swab specimens.

26

| Analyte | Specimen
Type | Symptom
Status | N | Alinity+
CCA+ | Alinity+
CCA- | Alinity-
CCA- | Alinity-
CCA+ | PPA | | NPA | |
|---------|------------------|-------------------|------|------------------|------------------|------------------|------------------|----------------------|---------|----------------------|-----------|
| | | | | | | | | Estimate
(95% CI) | n / N | Estimate
(95% CI) | n / N |
| CT | PreservCyt | Symptomatic | 953 | 66 | 1 | 885 | 1 | 98.5 (92.0,99.7) | 66/67 | 99.9 (99.4,100.0) | 885/886 |
| CT | PreservCyt | Asymptomatic | 986 | 52 | 6 | 927 | 1 | 98.1 (90.1,99.7) | 52/53 | 99.4 (98.6,99.7) | 927/933 |
| CT | PreservCyt | All | 1939 | 118 | 7 | 1812 | 2 | 98.3 (94.1,99.5) | 118/120 | 99.6 (99.2,99.8) | 1812/1819 |

Table 12. CT Specimen-Specific Positive and Negative Agreement for ThinPrep (PreservCyt) by Symptom Status

CCA = Composite Comparator Algorithm

27

The number of specimens in all combinations of CCA, individual comparator results and the Alinity m STI Assay result are summarized. CT results for infected and non-infected female subjects are presented in Table 13 and Table 14.

Table 13. CT Analysis Per CCA POSITIVE FEMALE PreservCyt Specimens
NAAT 1	NAAT 2	NAAT 3	Alinity m
STI	Number of Subjects
PreservCyt	PreservCyt	PreservCyt	PreservCyt	Symptomatic	Asymptomatic	Total
+	+	N/A	+	64	52	116
+	+	N/A	-	1	1	2
+	-	+	+	2	0	2

N/A = Not Available

| NAAT 1 | NAAT 2 | NAAT 3 | Alinity m
STI | Number of Subjects | | |
|------------|------------|------------|------------------|--------------------|--------------|-------|
| PreservCyt | PreservCyt | PreservCyt | PreservCyt | Symptomatic | Asymptomatic | Total |
| - | - | N/A | - | 881 | 923 | 1804 |
| - | - | N/A | + | 1 | 6 | 7 |
| - | + | - | - | 4 | 2 | 6 |
| + | - | - | - | 0 | 1 | 1 |
| - | - | - | - | 0 | 1 | 1 |

N/A = Not Available

Expected Values

The prevalence of CT 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 each specimen type, is presented by collection site and overall in Table 15. The expected values for endocervical swab, self-collected vaginal swab, clinician-collected vaginal swab, and male urine in this table were previously reported in K202977.

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	% Positivity (# positive/# tested with valid results)
Site	E	SCV	CCV	PreservCyt	MU
01	2.4 (1/41)	2.4 (1/41)	5.1 (2/39)	2.8 (1/36)	15.3 (9/59)
02	4.0 (22/552)	4.6 (26/568)	4.2 (24/567)	3.4 (9/268)	4.7 (42/889)
03	2.7 (6/225)	4.1 (9/222)	4.3 (10/232)	2.7 (6/224)	3.5 (9/260)
04	21.1 (4/19)	15.8 (3/19)	21.1 (4/19)	15.8 (3/19)	17.2 (20/116)
05	7.2 (17/237)	7.1 (18/254)	7.2 (18/251)	6.8 (18/263)	3.9 (9/233)
06	0.0 (0/4)	0.0 (0/3)	0.0 (0/4)	0.0 (0/4)	0.0 (0/24)
07	3.5 (14/395)	3.4 (15/438)	3.2 (14/433)	2.9 (9/310)	3.6 (22/606)
08	2.9 (3/103)	2.9 (3/105)	2.9 (3/104)	1.9 (2/105)	15.2 (12/79)
09	6.6 (7/106)	7.5 (8/107)	6.6 (7/106)	9.3 (10/108)	4.3 (2/47)
10	4.8 (5/105)	3.8 (4/105)	4.8 (5/104)	5.7 (6/106)	12.7 (14/110)
11	0.0 (0/18)	0.0 (0/18)	0.0 (0/18)	0.0 (0/18)	6.3 (1/16)
12	4.2 (2/48)	4.2 (2/48)	4.2 (2/48)	4.2 (2/48)	5.6 (2/36)
13	7.7 (4/52)	9.8 (5/51)	7.7 (4/52)	6.8 (3/44)	18.8 (6/32)
14	0.0 (0/39)	2.6 (1/38)	0.0 (0/39)	0.0 (0/39)	8.0 (2/25)
15	8.1 (3/37)	10.8 (4/37)	8.1 (3/37)	8.1 (3/37)	14.7 (10/68)
16	11.8 (2/17)	12.5 (2/16)	12.5 (2/16)	11.8 (2/17)	16.7 (1/6)
17	0.0 (0/43)	0.0 (0/43)	0.0 (0/43)	0.0 (0/41)	8.3 (2/24)
18	0.0 (0/5)	0.0 (0/5)	0.0 (0/5)	0.0 (0/5)	0.0 (0/1)
19	11.1 (1/9)	11.1 (1/9)	12.5 (1/8)	11.1 (1/9)	7.7 (1/13)
20	-	-	-	-	0.0 (0/1)
21	7.5 (10/133)	9.9 (13/131)	9.8 (13/133)	6.1 (8/132)	14.3 (11/77)
22	5.9 (2/34)	5.7 (2/35)	8.6 (3/35)	2.9 (1/34)	19.2 (5/26)
23	7.6 (9/118)	9.2 (11/120)	10.7 (13/121)	9.8 (12/122)	4.4 (2/45)
24	5.3 (2/38)	5.4 (2/37)	8.1 (3/37)	2.6 (1/38)	8.2 (5/61)
25	12.0 (6/50)	12.0 (6/50)	15.7 (8/51)	10.6 (5/47)	4.1 (2/49)
26	10.3 (3/29)	6.9 (2/29)	10.3 (3/29)	7.4 (2/27)	18.2 (6/33)
27	6.0 (5/84)	4.7 (4/85)	4.7 (4/85)	6.0 (5/83)	7.3 (4/55)
28	12.9 (29/225)	13.4 (31/231)	13.4 (31/231)	11.7 (27/230)	14.7 (20/136)
29	9.2 (8/87)	9.2 (8/87)	8.1 (7/86)	7.0 (6/86)	16.8 (20/119)
30	20.0 (13/65)	25.0 (16/64)	21.9 (14/64)	20.0 (13/65)	25.4 (15/59)
31	14.1 (10/71)	12.9 (9/70)	12.5 (9/72)	12.7 (9/71)	18.6 (11/59)
Site	E	SCV	CCV	PreservCyt	MU
32	9.8 (5/51)	10.0 (5/50)	10.0 (5/50)	9.8 (5/51)	19.6 (10/51)
33	27.7 (13/47)	29.8 (14/47)	29.8 (14/47)	25.5 (12/47)	26.4 (19/72)
All	6.7 (206/3087)	7.1 (225/3163)	7.1 (226/3166)	6.6 (181/2734)	8.4 (294/3487)

Table 15. Positivity of CT as Determined by the Alinity m STI Assay by
Specimen Type and Clinical Site for Urogenital Specimens

29

Table 15. Positivity of CT as Determined by the Alinity m STI Assay by Specimen Type and Clinical Site for Urogenital Specimens

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

30

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 16. The predictive values for endocervical swab, self-collected vaginal swab, cliniciancollected 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 16. CT Positive and Negative Predictive Value Using Hypothetical Prevalence for Urogenital Specimens

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

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1.8 Conclusions Drawn from the Studies

The fundamental scientific technology of the Alinity m STI Assay is the same as the FDA cleared Alinity m STI Assay. The additional studies included in this submission support the inclusion of claims for the following specimens for the following analytes:

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

The Alinity m STI Assay is substantially equivalent to the predicate device.

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

§ 866.3393 Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).

Re: K222379

Dear Paul Matushek:

Himani Bisht -S

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Section 5: 510(k) Summary

Table of Contents

1.0 510(k) Summary

1.1 Submitter

1.2 Device Information

1.3 Predicate Device

1.4 Device Description

Alinitv m STI Assav 1.4.1

1.5 Intended Use

1.6 Similarities and Differences to Predicate Devices

1.7 Performance Data

Specific Performance Characteristics 1.7.1

1.7.1.1 Analytical Sensitivity

1.7.1.2 Inclusivity

1.7.1.3 Evaluation of Potential Cross Reacting Microorganisms

Evaluation of Potential Interfering Substances 1.7.1.4

1.7.1.5 Competitive Interference Study

1.7.1.6 Within-Laboratory Precision

1.7.1.7 Sample Carryover

1.7.2 Clinical Performance

Reproducibility 1.7.2.1

1.7.2.2 Clinical Study Results - Urogenital Specimens

Clinical Study Results - Extragenital Specimens 1.7.2.3

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

Expected Values

Positive and Negative Predictive Values for Hypothetical Prevalence Rates

1.7.2.5 Comparator Testing of ThinPrep (PreservCyt) for CT

Expected Values

Positive and Negative Predictive Values for Hypothetical Prevalence Rates

1.8 Conclusions Drawn from the Studies