cobas® CT/NG v2.0 Test

K163184 · Roche Molecular Systems, Inc. · LSL · Feb 9, 2017 · Microbiology

Device Facts

• Record ID: K163184
• Device Name: cobas® CT/NG v2.0 Test
• Applicant: Roche Molecular Systems, Inc.
• Product Code: LSL · Microbiology
• Decision Date: Feb 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3390
• Device Class: Class 2

Intended Use

The cobas® CT/NG v2.0 Test is an automated, in vitro nucleic acid 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 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.

Device Story

Modified ancillary specimen collection kit for cobas® CT/NG v2.0 Test; replaces spun bud swab with flocked bud swab for endocervical collection. Kit includes collection medium tube (guanidine hydrochloride/Tris-HCl buffer) and two swabs (one flocked, one woven). Flocked swab collects endocervical specimens; woven swab cleans mucus. Vaginal specimens use woven swab. Specimens transported in cobas® PCR Media to stabilize DNA. System uses real-time PCR on cobas® 4800 System to detect CT/NG DNA. Healthcare providers use results to diagnose chlamydial and gonococcal infections. Benefits include improved specimen collection and continued diagnostic accuracy for STI testing.

Clinical Evidence

Prospective clinical study of 1,949 women. Comparison of flocked vs. woven swabs for endocervical specimen collection. CT PPA: 94.3% (95% CI: 88.63%-97.19%); NPA: 99.7% (95% CI: 99.36%-99.88%). NG PPA: 86.96% (95% CI: 67.87%-95.46%); NPA: 99.95% (95% CI: 99.71%-99.92%). Student's t-test showed no significant difference (p=0.92 for CT, p=0.84 for NG). Analytical dilution sensitivity study confirmed flocked swab performance is equivalent or superior to woven swab.

Technological Characteristics

Collection kit includes polyester flocked/woven swabs, polystyrene shafts, and 4.3 mL cobas® PCR Media (≤40% w/w guanidine hydrochloride/Tris-HCl buffer). Sterilization via ethylene oxide. Operates with cobas® 4800 System for real-time PCR amplification. Designed for endocervical/vaginal specimen transport and stabilization.

Indications for Use

Indicated for use as an aid in the diagnosis of chlamydial and gonococcal disease in symptomatic and asymptomatic individuals. Prescription use only.

Regulatory Classification

Identification

Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, 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.

Predicate Devices

• cobas® CT/NG v2.0 assay (K132270)
• cobas® PCR Female Swab Sample Kit (K132270)
• cobas® PCR Urine Sample Kit (K132270)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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*)

| <span style="font-family: sans-serif;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: sans-serif;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|

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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 Drive<br>Pleasanton, CA 94588-2722 |
| Contact | David Gates<br>Phone Number: [phone]<br>Fax Number: [phone]<br>[e-mail] |
| Date Prepared | November 11, 2016 |
| Proprietary Name | cobas® CT/NG v2.0 Test |
| Proprietary Name: Collection<br>Kits | cobas® PCR Media Dual Swab Sample Kit<br>cobas® PCR Urine Sample Kit |
| Common Name | Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) Test |
| Common Name: Collection<br>Kits | Specimen Collection Kit |
| Classification Name | §866.3390 Neisseria spp. Direct serological test reagents<br>§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: Collection<br>Kits | cobas® PCR Female Swab Sample Kit<br>cobas® 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 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 ●

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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 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.

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### TECHNOLOGICAL CHARACTERISTICS 3.

| Characteristic | Legally Marketed Predicate Device<br>cobas® CT/NG v2.0 Test (K132270) | Submitted Device<br>cobas® CT/NG v2.0 Test (K163184) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cobas® CT/NG v2.0 Test is an automated,<br>in vitro nucleic acid amplification test for the<br>qualitative detection of Chlamydia trachomatis<br>(CT) and/or Neisseria gonorrhoeae (NG) DNA<br>in urogenital specimens. The Test utilizes the<br>Polymerase Chain Reaction (PCR) for the<br>detection of Chlamydia trachomatis and<br>Neisseria gonorrhoeae DNA in male and female<br>urine, self-collected vaginal swab specimens<br>(collected in a clinical setting), clinician-<br>collected vaginal swab specimens, and<br>endocervical swab specimens, all collected in<br>cobas® PCR Media (Roche Molecular Systems,<br>Inc.), and cervical specimens collected in<br>PreservCyt® solution. This test is intended as an<br>aid in the diagnosis of chlamydial and<br>gonococcal disease in both symptomatic and<br>asymptomatic individuals. | The cobas® CT/NG v2.0 Test is an automated,<br>in vitro nucleic acid amplification test for the<br>qualitative detection of Chlamydia trachomatis<br>(CT) and/or Neisseria gonorrhoeae (NG) DNA<br>in urogenital specimens. The Test utilizes the<br>Polymerase Chain Reaction (PCR) for the<br>detection of Chlamydia trachomatis and<br>Neisseria gonorrhoeae DNA in male and female<br>urine, self-collected vaginal swab specimens<br>(collected in a clinical setting), clinician-<br>collected vaginal swab specimens, and<br>endocervical swab specimens, all collected in<br>cobas® PCR Media (Roche Molecular Systems,<br>Inc.), and cervical specimens collected in<br>PreservCyt® solution. This test is intended as an<br>aid in the diagnosis of chlamydial and<br>gonococcal disease in both symptomatic and<br>asymptomatic individuals. |
| | Ancillary Collection Kits:<br>The cobas® PCR Female Swab Sample Kit is<br>used to collect and transport endocervical and<br>vaginal swab specimens. The cobas® PCR<br>Media serves as a nucleic acid stabilizing<br>transport and storage medium for gynecological<br>specimens. Use this collection kit only with the<br>cobas® CT/NG v2.0 Test. | Ancillary Collection Kits:<br>The cobas® PCR Media Dual Swab Sample Kit<br>is used to collect and transport endocervical and<br>vaginal swab specimens. The cobas® PCR<br>Media serves as a nucleic acid stabilizing<br>transport and storage medium for gynecological<br>specimens. Use this collection kit only with the<br>cobas® CT/NG v2.0 Test. |
| | The cobas® PCR Urine Sample Kit is used to<br>collect and transport urine specimens. The<br>cobas® PCR Media serves as a nucleic acid<br>stabilizing transport and storage medium for<br>urine specimens. Use this collection kit only<br>with the cobas® CT/NG v2.0 Test. | The cobas® PCR Urine Sample Kit is used to<br>collect and transport urine specimens. The<br>cobas® PCR Media serves as a nucleic acid<br>stabilizing transport and storage medium for<br>urine specimens. Use this collection kit only<br>with the cobas® CT/NG v2.0 Test. |
| Sample Type | Endocervical and vaginal Specimens | Same |
| PCR Media | ≤40% (w/w) Guanidine hydrochloride<br>Tris-HCl buffer | Same |
| PCR Media<br>Volume | 4.3 mL | Same |
| Swab Number | 2 | 2 |
| Characteristic | Legally Marketed Predicate Device<br>cobas® CT/NG v2.0 Test (K132270) | Submitted Device<br>cobas® CT/NG v2.0 Test (K163184) |
| Swab Type | 2 Spun Bud | 1 Spun Bud and<br>1 Flocked Bud |
| Sterilization<br>Method | Ethylene Oxide | Same |
| Bud Size | 5.6 mm Diameter | 5.6 mm Diameter (Spun)<br>2.9 mm Diameter (Flocked) |
| Fiber<br>Composition | Polyester | Same |
| Shaft<br>Composition | 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.