TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS

K032194 · Gen-Probe, Inc. · LSL · Dec 24, 2003 · Microbiology

Device Facts

• Record ID: K032194
• Device Name: TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS
• Applicant: Gen-Probe, Inc.
• Product Code: LSL · Microbiology
• Decision Date: Dec 24, 2003
• 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 endocervical and male urethral swab specimens, and in female and male urine specimens. 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.

Device Story

Tigris DTS is an automated analyzer for the Aptima Combo 2 Assay; replaces semi-manual processing. System inputs: patient swab or urine specimens in transport tubes. Operation: computer workstation directs analyzer modules to perform sample processing, target capture, amplification, detection, and data reduction. Mechanical components: fluid delivery module, magnetic wash station, incubators, and luminometer. Output: qualitative detection/differentiation of C. trachomatis and N. gonorrhoeae rRNA. Used in clinical laboratories; operated by trained personnel. System software monitors status, inventories, and test results. Output used by clinicians to diagnose urogenital infections. Benefits: full automation of assay steps, reducing manual labor and potential for human error.

Clinical Evidence

No clinical trials; evidence based on parallel testing of clinical specimens (swabs/urine) and contrived panels comparing Tigris automated results to semi-manual DTS results. Overall percent agreement for urine specimens was 99.2% (95% CI: 98.1% - 99.5%). Some reduced agreement observed in asymptomatic female populations for C. trachomatis. Carry-over studies indicated potential for low-level contamination (up to 2%).

Technological Characteristics

Automated nucleic acid amplification and detection system. Utilizes target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA) technologies. System is a floor-standing automated analyzer. Software-controlled fluidics and thermal cycling. Connectivity for laboratory information systems (LIS).

Indications for Use

Indicated for symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease using endocervical swabs, male urethral swabs, and female/male urine specimens.

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

• Gen-Probe Aptima® Combo 2 Assay (k003395)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 4 2003

Mr. Wayne A. Kvetkosky Regulatory Affairs Scientist Gen-Probe Incorporated 10210 Genetic Center Drive San Diego, CA 92121-1589

Re: k032194

> Trade/Device Name: TIGRIS® DTS™ Automated Analyzer APTIMA™ Combo 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: December 2, 2003 Received: December 4, 2003

Dear Mr. Kvetkosky:

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.

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 Revister.

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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director 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): K032194

Device Name: 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 endocervical and male urethral swab specimens, and in female and male urine specimens. 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.

Prescription Use 1/ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Jalanta

Office of In Vitro Diagnostic Device Evaluation and Safety

KO32194 510(k)_