(87 days)
No
The description focuses on a PCR-based in vitro diagnostic test and changes to sample collection swabs. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an automated, in vitro amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA. It is intended "as an aid in the diagnosis of chlamydial and gonococcal disease," and does not treat or prevent disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals." This directly indicates its diagnostic purpose.
No
The device description explicitly states it is an "automated, in vitro amplification test" and includes physical components like collection media tubes and swabs, indicating it is a hardware-based diagnostic test, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states it is an "in vitro amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens." This clearly indicates the test is performed outside of the body on biological samples.
- Device Description: The description reiterates that it is an "automated, in vitro amplification test."
- Specimen Types: The test is designed to analyze biological specimens such as urine and various types of swabs (vaginal, endocervical, cervical).
- Purpose: The test is intended as an "aid in the diagnosis of chlamydial and gonococcal disease," which is a diagnostic purpose.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LSL, MKZ, OOI
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 ●
§ 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).
0
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
1
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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3
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 |
| Pleasanton, CA 94588-2722 | |
| Contact | David Gates |
| Phone Number: (925) 730-8237 | |
| Fax Number: (925) 730-8128 | |
| david.gates@roche.com | |
| Date Prepared | November 11, 2016 |
| Proprietary Name | cobas® CT/NG v2.0 Test |
| Proprietary Name: Collection | |
| Kits | cobas® PCR Media Dual Swab Sample Kit |
| cobas® PCR Urine Sample Kit | |
| Common Name | Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) Test |
| Common Name: Collection | |
| Kits | 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: Collection | |
| Kits | cobas® PCR Female Swab Sample Kit |
| cobas® PCR Urine Sample Kit |
4
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 ●