APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM

K061413 · Gen-Probe, Inc. · MKZ · Oct 13, 2006 · Microbiology

Device Facts

• Record ID: K061413
• Device Name: APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
• Applicant: Gen-Probe, Inc.
• Product Code: MKZ · Microbiology
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3120
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The APTIMA® Assay for Chlamydia trachomatis is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) 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. 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.

Device Story

The APTIMA CT Assay is a nucleic acid amplification test (NAAT) for Chlamydia trachomatis detection. It utilizes target capture, Transcription-Mediated Amplification (TMA), and Hybridization Protection Assay (HPA). The device processes clinical specimens (swabs/urine) to isolate rRNA using magnetic microparticles and capture oligomers. The TIGRIS DTS Automated Analyzer performs all steps: sample processing, amplification, detection, and data reduction. The system measures chemiluminescent signals (Relative Light Units) from RNA:DNA hybrids. Used in clinical laboratories, the device aids physicians in diagnosing urogenital chlamydial infections. The automated workflow reduces manual handling, improving throughput and consistency compared to semi-automated methods. Results assist in clinical decision-making for patient treatment and management.

Clinical Evidence

No clinical data provided in the document. Substantial equivalence is based on technological characteristics and performance equivalence to existing semi-automated instrumentation for the APTIMA Assay.

Technological Characteristics

The device uses Transcription-Mediated Amplification (TMA) and Hybridization Protection Assay (HPA). It employs magnetic microparticles for target capture. The system is a fully automated, networked analyzer (TIGRIS DTS). It detects chemiluminescent signals via a luminometer. The assay is a qualitative nucleic acid probe test targeting 16S rRNA.

Indications for Use

Indicated for the qualitative detection of Chlamydia trachomatis rRNA in symptomatic and asymptomatic individuals, including males and females, using clinician-collected endocervical, vaginal, and male urethral swabs, and patient-collected vaginal swabs and urine specimens.

Regulatory Classification

Identification

Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Chlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

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 features a stylized eagle with three stripes representing the department's mission. 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

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

OCT 13 2006

Re: k061413

Trade/Device Name: TIGRIS® DTS® Automated Analyzer APTIMA® Assay for Chlamydia trachomatis Regulation Number: 21 CFR 866.3120 Regulation Name: Chlamydia Serological Reagents Regulatory Class: Class I Product Code: MKZ Dated: October 12, 2006 Received: October 13, 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 indice includio is for use stated in the enclosure) to legally marketed prodicate 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 areemig southerner your device 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); and good manufacturing practice requirements as set forth in the quality systems (QS) 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 Iv(L) marketed predicate device results in a classification for your device and thus, verse to volu 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 frem mor [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sally, autry

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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## GEN-PROBE INCORPORATED

APTIMA Assay® for Chlamydia trachomatis – Special 510(k) TIGRIS DTS

## INDICATIONS FOR USE STATEMENT

| 510(k) Number:<br>(if known) | K061413 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | TIGRIS® DTS® GEN-PROBE APTIMA Assay® for Chlamydia trachomatis |
| Indications for Use: | The APTIMA Assay for Chlamydia trachomatis is a target amplification nucleix acid probe test that utilizes target capture for the <i>in vitro</i> qualitative detection of ribosomal RNA (rRNA) from <i>Chlamydia trachomatis</i> (CT) in clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected vaginal swab specimens1, and female and male urine specimens. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.<br><br>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. |

## PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <u>X</u> | OR | Over-the-Counter Use |
|----------------------|----------|----|----------------------|
| (Per 21 CFR 801.109) | | | |

Division Sign Off

Office of In Vitro Diagnostic Device

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Ko�1413