The cobas® CT/NG v2.0 Test is an automated, in vitro amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The Test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyte solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.

Device Description

The cobas® CT/NG v2.0 Test is an automated, in vitro amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The Test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems,, Inc.), and cervical specimens collected in PreservCvt® solution. The Test comprises of the assay and ancillary collection kits: (a) for female endocervical and vaginal swabs, and (b) for urine.

The changes to the previously cleared cobas® CT/NG v2.0 Test are limited to the modification of the original cobas® PCR Female Swab Sample Kit (now the cobas® PCR Media Dual Swab Sample Kit) to include one flocked endocervical swab and one spun bud swab, instead of two spun bud swabs. All the supporting clinical and analytical performance data, including stability data for specimens stabilized in the cobas® PCR Media, may be found under K132270. Additional data was generated, as described in Section 4 below, to demonstrate the substantial equivalence of the modified device to its predicate.

The modified cobas PCR Media Dual Swab Sample Kit is comprised of a collection medium tube and a packet containing two sterile swabs.

Kit Composition:

cobas® PCR Media Dual Swab Sample Kit (1 spun bud swab and 1 flocked bud . swab)
cobas® PCR Media 1 x 4.3 mL ●
<40% (w/w) Guanidine hydrochloride Tris-HCl buffer ●

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the cobas® CT/NG v2.0 Test, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on demonstrating substantial equivalence to a predicate device (cobas® CT/NG v2.0 Test, K132270) rather than setting distinct, quantitative acceptance criteria for this specific submission (K163184). The changes in this submission are limited to the swab component of the collection kit. Therefore, the "acceptance criteria" here are implied to be non-inferiority or equivalent performance compared to the predicate device with its original swab.

Acceptance Criteria (Implied)	Reported Device Performance (K163184 with new swab)
Equivalent Specimen Load / Analytical Sensitivity	Limiting Dilution LoD Determination: Limiting dilutions of specimens co-collected with the current/cleared swab and the new flocked swab exhibited consistent drop-out rates at similar levels when tested using the cobas® CT/NG v2.0 Test on the cobas® 4800 platform. "There was no indication that newly proposed flocked swab negatively impacted the analytical sensitivity of the test."
Clinical Performance (Positive/Negative Agreement)	Correlation Study with Clinical Specimens:- CT (Chlamydia trachomatis): PPA (Positive Percent Agreement) point estimate: 94.3%; NPA (Negative Percent Agreement): 99.7%; OPA (Overall Percent Agreement): 99.4%.- NG (Neisseria gonorrhoeae): The 95% confidence interval for NG PPA encompasses 95%. (Specific point estimate not provided for NG PPA, but the statement implies acceptable performance relative to the predicate).- Further statistical analyses of Ct values for positive concordant results demonstrated that specimens collected with the flocked swab are not significantly different from specimens collected with the woven swab.
Similar Technological Characteristics (for the assay itself)	The Intended Use, Sample Type, PCR Media, PCR Media Volume, Swab Number, Fiber Composition, and Shaft Composition of the submitted device are identical to the predicate device. The only differences are in Swab Type (1 Spun Bud and 1 Flocked Bud vs. 2 Spun Bud) and Bud Size (5.6 mm Diameter (Spun), 2.9 mm Diameter (Flocked) vs. 5.6 mm Diameter) due to the change in the collection kit.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a single number.
- For the limiting dilution LoD study, it involved "limiting dilutions of specimens."
- For the correlation study with clinical specimens, the percentages (PPA, NPA, OPA) imply a number of clinical samples were tested, but the exact count is not provided in this summary. It states "clinical specimens" without further detail on quantity or characteristics beyond being co-collected.
Data Provenance: Not explicitly stated. The document indicates "clinical specimens," suggesting real-world samples, but doesn't specify country of origin, whether it was retrospective or prospective, or patient demographics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. For an in vitro diagnostic device detecting microbial DNA, the "ground truth" is typically established by comparative methods (e.g., another FDA-cleared or well-validated NAAT, laboratory culture, or a composite reference standard) rather than human expert consensus on visual/imaging data.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a DNA amplification test, adjudication methods common in imaging (e.g., 2+1, 3+1) are usually not applicable. Ground truth for diagnostic tests often relies on predefined reference methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for devices where human interpretation plays a significant role (e.g., medical imaging AI tools). The cobas® CT/NG v2.0 Test is an automated in vitro diagnostic device, where the result is determined by the instrument's detection of DNA, not human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the performance described is inherently standalone. The cobas® CT/NG v2.0 Test is an automated system for qualitative detection of DNA. The reported performance refers to the device's ability to detect CT/NG DNA in specimens using its PCR-based algorithm. There is no "human-in-the-loop" aspect to the DNA detection process itself.

7. The Type of Ground Truth Used

The summary mentions "clinical specimens" and "limiting dilutions of specimens." For a diagnostic test, the ground truth for clinical performance is typically established by comparing the device's results to a composite reference standard (CRS) or a well-established, highly sensitive, and specific laboratory gold standard method (e.g., another CDC-validated NAAT or culture for NG) applied to the same or split clinical samples. The "PPA," "NPA," and "OPA" values are derived by comparing the test results against such a reference. The details of this gold standard are not explicitly described in this summary but would be present in the full submission (K132270) which underlies the "predicate device" performance.

8. The Sample Size for the Training Set

This information is not provided in the K163184 summary. As this submission is primarily about a change in a collection component to an already cleared and trained device (cobas® CT/NG v2.0 Test K132270), the focus is on demonstrating non-inferiority with the new component, not new algorithm development or training. The original training data for K132270 would have been much larger.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the K163184 summary. This would refer to how the original device (K132270) was developed and validated. Typically, for PCR-based in vitro diagnostics, the "training" involves optimizing primers, probes, and reaction conditions using well-characterized samples (often seeded with known quantities of target DNA) and comparing them against established reference methods for positive and negative controls.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing, wave-like design connecting them.

March 6, 2017

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Roche Molecular Systems, Inc. David W. Gates, Ph.D. Sr. Director, Regulatory Affairs 4300 Hacienda Drive Pleasanton, CA 94588-2722

Re: K163184

Trade/Device Name: cobas® CT/NG v2.0 Test Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. Direct serological test reagents Regulatory Class: Class II Product Code: LSL, MKZ, OOI Dated: November 11, 2016 Received: November 14, 2016

Dear Dr. Gates:

This letter corrects our substantially equivalent letter of February 9, 2017.

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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If vou desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Steven R. Gitterman -S

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163184

Device Name cobas® CT/NG v2.0 Test

Indications for Use (Describe)

The cobas® CT/NG v2.0 Test is an automated, in vitro amplification test for the qualitative detection of Chlamycha trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The Test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Nexseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyte solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.

Ancillary Collection Kits

The cobas® PCR Media Dual Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens. Use this collection kit only with the cobas® CT/NG v2.0 Test.

The cobas® PCR Urine Sample Kit is used to collect and transport urine specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for urine specimens. Use this collection kit only with the cobas® CT/NG v2.0 Test.

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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cobas® CT/NG v2.0 Test 510(k) Summary

This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter Name	Roche Molecular Systems, Inc.
Address	4300 Hacienda DrivePleasanton, CA 94588-2722
Contact	David GatesPhone Number: (925) 730-8237Fax Number: (925) 730-8128david.gates@roche.com
Date Prepared	November 11, 2016
Proprietary Name	cobas® CT/NG v2.0 Test
Proprietary Name: CollectionKits	cobas® PCR Media Dual Swab Sample Kitcobas® PCR Urine Sample Kit
Common Name	Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) Test
Common Name: CollectionKits	Specimen Collection Kit
Classification Name	§866.3390 Neisseria spp. Direct serological test reagents§866.3120 Chlamydia serological reagents
Product Codes	LSL, MKZ, OOI
Predicate Devices	cobas® CT/NG Test (K110923) and cobas® CT/NG v2.0 Test (K132270).
Predicate Devices: CollectionKits	cobas® PCR Female Swab Sample Kitcobas® PCR Urine Sample Kit

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DEVICE DESCRIPTION 1.

The cobas® CT/NG v2.0 Test is an automated, in vitro amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The Test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems,, Inc.), and cervical specimens collected in PreservCvt® solution. The Test comprises of the assay and ancillary collection kits: (a) for female endocervical and vaginal swabs, and (b) for urine.

The modified cobas PCR Media Dual Swab Sample Kit is comprised of a collection medium tube and a packet containing two sterile swabs.

Kit Composition:

cobas® PCR Media Dual Swab Sample Kit (1 spun bud swab and 1 flocked bud . swab)
cobas® PCR Media 1 x 4.3 mL ●
<40% (w/w) Guanidine hydrochloride Tris-HCl buffer ●

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2. INTENDED USE

The cobas® CT/NG v2.0 Test is an automated, in vitro amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The Test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems., Inc.), and cervical specimens collected in PreservCyt® solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.

Ancillary Collection Kits

The cobas PCR Urine Sample Kit is used to collect and transport urine specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for urine specimens. Use this collection kit only with the cobas CT/NG v2.0 Test.

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TECHNOLOGICAL CHARACTERISTICS 3.

Characteristic	Legally Marketed Predicate Devicecobas® CT/NG v2.0 Test (K132270)	Submitted Devicecobas® CT/NG v2.0 Test (K163184)
Intended Use	The cobas® CT/NG v2.0 Test is an automated,in vitro nucleic acid amplification test for thequalitative detection of Chlamydia trachomatis(CT) and/or Neisseria gonorrhoeae (NG) DNAin urogenital specimens. The Test utilizes thePolymerase Chain Reaction (PCR) for thedetection of Chlamydia trachomatis andNeisseria gonorrhoeae DNA in male and femaleurine, self-collected vaginal swab specimens(collected in a clinical setting), clinician-collected vaginal swab specimens, andendocervical swab specimens, all collected incobas® PCR Media (Roche Molecular Systems,Inc.), and cervical specimens collected inPreservCyt® solution. This test is intended as anaid in the diagnosis of chlamydial andgonococcal disease in both symptomatic andasymptomatic individuals.	The cobas® CT/NG v2.0 Test is an automated,in vitro nucleic acid amplification test for thequalitative detection of Chlamydia trachomatis(CT) and/or Neisseria gonorrhoeae (NG) DNAin urogenital specimens. The Test utilizes thePolymerase Chain Reaction (PCR) for thedetection of Chlamydia trachomatis andNeisseria gonorrhoeae DNA in male and femaleurine, self-collected vaginal swab specimens(collected in a clinical setting), clinician-collected vaginal swab specimens, andendocervical swab specimens, all collected incobas® PCR Media (Roche Molecular Systems,Inc.), and cervical specimens collected inPreservCyt® solution. This test is intended as anaid in the diagnosis of chlamydial andgonococcal disease in both symptomatic andasymptomatic individuals.
	Ancillary Collection Kits:The cobas® PCR Female Swab Sample Kit isused to collect and transport endocervical andvaginal swab specimens. The cobas® PCRMedia serves as a nucleic acid stabilizingtransport and storage medium for gynecologicalspecimens. Use this collection kit only with thecobas® CT/NG v2.0 Test.	Ancillary Collection Kits:The cobas® PCR Media Dual Swab Sample Kitis used to collect and transport endocervical andvaginal swab specimens. The cobas® PCRMedia serves as a nucleic acid stabilizingtransport and storage medium for gynecologicalspecimens. Use this collection kit only with thecobas® CT/NG v2.0 Test.
	The cobas® PCR Urine Sample Kit is used tocollect and transport urine specimens. Thecobas® PCR Media serves as a nucleic acidstabilizing transport and storage medium forurine specimens. Use this collection kit onlywith the cobas® CT/NG v2.0 Test.	The cobas® PCR Urine Sample Kit is used tocollect and transport urine specimens. Thecobas® PCR Media serves as a nucleic acidstabilizing transport and storage medium forurine specimens. Use this collection kit onlywith the cobas® CT/NG v2.0 Test.
Sample Type	Endocervical and vaginal Specimens	Same
PCR Media	≤40% (w/w) Guanidine hydrochlorideTris-HCl buffer	Same
PCR MediaVolume	4.3 mL	Same
Swab Number	2	2
Characteristic	Legally Marketed Predicate Devicecobas® CT/NG v2.0 Test (K132270)	Submitted Devicecobas® CT/NG v2.0 Test (K163184)
Swab Type	2 Spun Bud	1 Spun Bud and1 Flocked Bud
SterilizationMethod	Ethylene Oxide	Same
Bud Size	5.6 mm Diameter	5.6 mm Diameter (Spun)2.9 mm Diameter (Flocked)
FiberComposition	Polyester	Same
ShaftComposition	Polystyrene	Same

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4. NON-CLINICAL PERFORMANCE EVALUATION

FMEA resulted in the identification of one significant risk for the change to the endocervical swab. To address and mitigate this risk, two studies were conducted:

Confirmation of equivalent specimen load with the new swab by limiting dilution . LoD determination. Limiting dilutions of specimens co-collected with the current, cleared swab and the new flocked swab exhibited consistent drop-out rates at similar levels when tested using the cobas® CT/NG v2.0 Test on the cobas® 4800 platform. There was no indication that newly proposed flocked swab negatively impacted the analytical sensitivity of the test.
Correlation study of swab performance between the cleared woven swab and the new flocked swab on the cobas 4800 platform with CT/NG v2.0 with clinical specimens demonstrated a PPA point estimate for CT results of 94.3%, an NPA of 99.7% and an OPA of 99.4%. The 95% confidence interval for NG PPA encompasses 95%. Further statistical analyses of the Ct values for positive concordant results demonstrated that specimens collected with the flocked swab are not significantly different from specimens collected with the woven swab

5. CONCLUSIONS

Conclusions drawn from the nonclinical studies demonstrate that the device is substantially equivalent and performs as well as the legally marketed device identified above.

Regulation Number and Section

§ 866.3390

Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.(b)
Classification. Class II (performance standards).