TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196

K061509 · Gen-Probe, Inc. · LSL · Oct 4, 2006 · Microbiology

Device Facts

• Record ID: K061509
• Device Name: TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196
• Applicant: Gen-Probe, Inc.
• Product Code: LSL · Microbiology
• Decision Date: Oct 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3390
• Device Class: Class 2

Intended Use

The APTIMA® Assay for Neisseria gonorrhoeae is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease using the TIGRIS® DTS® Automated Analyzer or semi-automated instrumentation as specified. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; and patient-collected female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical and vaginal swab specimens; and patient-collected vaginal swab specimens¹ and female and male urine specimens. ¹Patient-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.

Device Story

TIGRIS DTS is an automated analyzer for in vitro diagnostic testing. It processes clinical specimens (swabs, urine) to detect Neisseria gonorrhoeae rRNA. The system utilizes target capture and target amplification nucleic acid probe technology. The device automates the assay workflow, reducing manual intervention compared to semi-automated methods. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output is a qualitative result indicating the presence or absence of N. gonorrhoeae, which assists clinicians in diagnosing gonococcal urogenital disease. The automation improves throughput and consistency in diagnostic testing.

Clinical Evidence

No new clinical data provided; substantial equivalence is based on the performance of the assay on the TIGRIS DTS platform compared to previously cleared semi-automated instrumentation.

Technological Characteristics

Target amplification nucleic acid probe test; utilizes target capture technology. Automated analyzer (TIGRIS DTS) for processing clinical specimens. Detects ribosomal RNA (rRNA).

Indications for Use

Indicated for qualitative detection of Neisseria gonorrhoeae rRNA to aid diagnosis of gonococcal urogenital disease. Applicable to symptomatic and asymptomatic individuals. Specimen types: clinician-collected endocervical, vaginal, and male urethral swabs; patient-collected female/male urine; patient-collected vaginal swabs (screening).

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.

Submission Summary (Full Text)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a stylized, abstract symbol in black against a white background. It consists of three parallel, curved lines that appear to be connected at the left side. The lines have varying thicknesses and end in a flourish at the bottom, resembling a calligraphic design or a stylized representation of a bird in flight.

Public Heaith Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. E. Joseph McMullen Associate Director, Regulatory Affairs Gen-Probe Incorporated 10210 Genetic Center Drive San Diego. CA 92121-4362

OCT - 4 2006

k061509 Re: K001509
Trade/Device Name: TIGRIS® DTS® GEN-PROBE® APTIMA Assay for Neisseria gonorrhoeae Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL Dated: September 25, 2006 Received: September 26. 2006

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 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 Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r head be actived and itermination 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 (QS) regulation (21 CFR Part 820).

{1}------------------------------------------------

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 prarketed 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, n you stions 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,

Sally, attorn

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

{2}------------------------------------------------

GEN-PROBE INCORPORATED

APTIMA Assay® for Neisseria gonorrhoeae – Special 510(k) TIGRIS DTS

## INDICATIONS FOR USE STATEMENT

| 510(k) Number:<br>(if known) | K061509 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | TIGRIS® DTS® GEN-PROBE APTIMA Assay® for Neisseria<br>gonorrhoeae |
| Indications for<br>Use: | The APTIMA® Assay for Neisseria gonorrhoeae is a target<br>amplification nucleic acid probe test that utilizes target capture for<br>the in vitro qualitative detection of ribosomal RNA (rRNA) from<br>Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal<br>urogenital disease using the TIGRIS® DTS® Automated Analyzer<br>or semi-automated instrumentation as specified. The assay may be<br>used to test the following specimens from symptomatic<br>individuals: clinician-collected endocervical, vaginal and male<br>urethral swab specimens; and patient-collected female and male<br>urine specimens. The assay may be used to test the following<br>specimens from asymptomatic individuals: clinician-collected<br>endocervical and vaginal swab specimens; and patient-collected<br>vaginal swab specimens¹ and female and male urine specimens.<br><br>¹Patient-collected vaginal swab specimens are an option for screening women<br>when a pelvic exam is not otherwise indicated. The vaginal swab specimen<br>collection kit is not for home use. |

## PAGE IF NEEDED

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR

sion Sign Off

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k 061509