TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY

K060652 · Gen-Probe, Inc. · LSL · Aug 17, 2006 · Microbiology

Device Facts

• Record ID: K060652
• Device Name: TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY
• Applicant: Gen-Probe, Inc.
• Product Code: LSL · Microbiology
• Decision Date: Aug 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3390
• Device Class: Class 2

Intended Use

The APTIMA COMBO 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae in clinician-collected endocervical, vaginal and male urethral swab specimens, patientcollected vaginal swab specimens', female and male urine specimens and gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified. 1 Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use. 2 Gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System have only been reviewed and cleared for use with the APTIMA Combo 2 Assay in the United States by the Food and Drug Administration (FDA).

Device Story

Tigris DTS Automated Analyzer performs fully automated nucleic acid amplification testing for Chlamydia trachomatis and Neisseria gonorrhoeae. Input: clinician/patient-collected vaginal/endocervical/urethral swabs, urine, or PreservCyt-processed gynecological specimens. Process: instrument automates sample processing, target capture, amplification, and detection using Aptima Combo 2 assay reagents. Output: qualitative detection/differentiation of rRNA, provided as printed worklists for clinical review. Used in clinical laboratories; operated by trained technicians. System automates steps previously performed semi-manually, improving throughput and consistency. Results aid clinicians in diagnosing urogenital infections, enabling timely patient treatment.

Clinical Evidence

Bench testing only. Study compared Tigris automated results against semi-automated DTS results using 170 vaginal swabs and 170 PreservCyt specimens. Agreement ranged from 96% to 100% across all result combinations. Analytical precision verified using 13 stock pools spiked with CT/GC RNA; 132/132 samples agreed with expected results. No clinical sensitivity/specificity data provided.

Technological Characteristics

Nucleic acid amplification and hybridization protection assay. Fully automated instrument platform. Software-controlled sample processing, amplification, and detection. Connectivity: standalone instrument with printed worklist output. Sterilization: N/A (reagents). Algorithm: Kinetic profile-based interpretation (parameters A, B, C, D and specific zones).

Indications for Use

Indicated for symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease. Patient-collected vaginal swabs are for screening women when a pelvic exam is not indicated; not for home use.

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

• APTIMA COMBO 2 Assay (K010652)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Brian J. Shea, RAC Regulatory Affairs Associate Gen-Probe Incorporated 10210 Genetic Center Drive San Diego, CA 92121-1589

AUG 1 7 2006

Re: k060652 Trade/Device Name: TIGRIS® DTS® GEN-PROBE® APTIMA COMOBO 2® Assay Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL, MKZ Dated: May 26, 2005 Received: May 30, 2005

Dear Mr. Shea:

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 Foond, Or to 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 not 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Parts 20).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its tolli-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Sally, atton

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: TIGRIS® DTS® GEN-PROBE® APTIMA COMBO 2® Assay

## Indications For Use:

The APTIMA COMBO 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae in clinician-collected endocervical, vaginal and male urethral swab specimens, patientcollected vaginal swab specimens', female and male urine specimens and gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.

1 Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use. 2 Gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System have only been reviewed and cleared for use with the APTIMA Combo 2 Assay in the United States by the Food and Drug Administration (FDA).

| Prescription Use | √ |
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| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
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| Division Sign-Off |

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k010652