GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199

K063451 · Gen-Probe, Inc. · MKZ · Jan 22, 2007 · Microbiology

Device Facts

• Record ID: K063451
• Device Name: GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199
• Applicant: Gen-Probe, Inc.
• Product Code: MKZ · Microbiology
• Decision Date: Jan 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3120
• Device Class: Class 1

Intended Use

The GEN-PROBE 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 chlamydial urogenital disease using the TIGRIS® DTS® Automated Analyzer or semiautomated 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 female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected 'vaginal swab specimens, and female and male urine. The assay is also intended for use with the testing of gynecological specimens, from both symptomatic and asymptomatic patients collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System. 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 an in vitro diagnostic test for Chlamydia trachomatis (CT) rRNA. It utilizes target capture, Transcription-Mediated Amplification (TMA), and Hybridization Protection Assay (HPA). The device processes clinical specimens (swabs, urine, PreservCyt) by isolating target rRNA using magnetic microparticles and capture oligomers. The TIGRIS DTS Automated Analyzer performs all steps: sample processing, amplification, detection, and data reduction. During amplification, specific primers replicate CT rRNA via DNA intermediates. Detection uses acridinium ester-labeled DNA probes that hybridize to the amplicon; chemiluminescent light is measured as Relative Light Units (RLU) in a luminometer. The system is used in clinical laboratories. Results aid healthcare providers in diagnosing chlamydial urogenital disease. The TIGRIS platform provides full automation compared to semi-automated DTS systems, reducing manual intervention and potential for error.

Clinical Evidence

Performance established in three multi-center clinical investigations (N=2,787 subjects). Sensitivity and specificity were calculated relative to a patient infected status algorithm (using two reference NAATs). Overall sensitivity for CT was 96.7% and specificity was 96.8%. Precision studies were conducted per NCCLS guidelines. Analytical sensitivity is 1 IFU/assay. No clinical data for home use.

Technological Characteristics

Target capture, TMA, and HPA technology. Uses magnetic microparticles for target isolation. Detection via acridinium ester-labeled DNA probes (chemiluminescence). Fully automated TIGRIS DTS platform. Software-controlled processing. Reagents are identical to the predicate (K053446).

Indications for Use

Indicated for the qualitative detection of Chlamydia trachomatis rRNA in symptomatic and asymptomatic individuals using clinician-collected endocervical, vaginal, and male urethral swabs, patient-collected vaginal swabs, female and male urine, and PreservCyt Solution liquid Pap specimens to aid in the diagnosis of chlamydial urogenital disease.

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).

Predicate Devices

• Gen-Probe APTIMA Assay for Chlamydia trachomatis (K053446)

Submission Summary (Full Text)

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

K06345/

Image /page/0/Picture/1 description: The image shows a stylized, abstract symbol in black against a white background. The symbol is composed of geometric shapes, primarily straight lines and sharp angles, forming an interlocking or folded design. It has a modern and minimalist aesthetic, resembling a stylized letter or logo.

APTIMA Assay* for Chlamydia trachomatis Liquid Pap Specimen/TIGRIS DTS

#### 510(k) SUMMARY 5.0

GEN-PROBE® APTIMA® Assay for Chlamydia trachomatis

# General Information

JAN 2 2 2007

| Submitted By: | Company Contact: |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gen-Probe Incorporated | E. Joseph McMullen |
| 10210 Genetic Center Drive | Associate Director, Regulatory Affairs |
| San Diego, California 92121 | |
| phone: [phone] | phone: [phone] |
| fax: [phone] | fax: [phone] |
| | e-mail: [e-mail] |
| Trade Name: | GEN-PROBE® APTIMA® Assay for Chlamydia trachomatis |
| Common or Usual Name: | Ribosomal RNA (rRNA) target-amplified nucleic acid probe test<br>for the in vitro diagnostic detection of Chlamydia trachomatis |
| Classification Name: | DNA Reagents, Chlamydia |
| Classification Code: | Medical Specialty: Microbiology |
| | Product Code: MKZ |
| | Registration Number: CFR 866.3120 |
| | Device Class: 1 |
| | Description: Reagents used to identify chlamydia<br>directly from clinical specimens or cultured<br>isolates derived from clinical specimens. The identification aids<br>in the diagnosis of disease caused by bacteria belonging to the<br>genus Chlamydia and provides epidemiological information on<br>these diseases. Chlamydia are the causative agents of psittacosis<br>(a form of pneumonia), lymphogranuloma venereum (a venereal<br>disease) and trachoma (a chronic disease of the eye and eyelid). |

# Substantially Equivalent Devices:

GEN-PROBE® APTIMA® Assay for Chlamydia trachomatis

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

Image /page/1/Picture/0 description: The image shows a stylized, abstract symbol in black against a white background. The symbol is composed of geometric shapes, primarily resembling a stylized letter 'S' or a series of connected angular forms. The design is simple and bold, with a modern or minimalist aesthetic.

#### Device Description

Clearance of this premarket notification extends the clinical performance claims of the commercially available GEN-PROBE®APTIMA® Assay for Chlamydia trachomatis with the testing of gynecological specimens collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System, for use on the TIGRIS® DTS® System. The ancillary kit for this application is commercially available as the GEN-PROBE APTIMA Specimen Transfer Kit. The components of the APTIMA Specimen Transfer Kit include: (1) a transport tube containing transport media with a penetrable cap and (2) specific instructions for ruse regarding decontamination and specimen processing procedures. The APTIMA Transfer Kit may only be used in conjunction with the APTIMA Assays. Labeling for the transfer kit is provided in Section 13.0.

#### Intended Use

#### APTIMA® Assay Package Insert:

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 chlamydial 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 female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens. The assay is also intended for use with the testing of gynecological specimens, from both symptomatic and asymptomatic patients collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System.

⁴ 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}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a black abstract symbol on a white background. The symbol is composed of angular lines and shapes, resembling a stylized letter or logo. It has a geometric design with sharp corners and a sense of movement or directionality. The symbol is centrally positioned and appears to be a standalone graphic element.

APTIMA Assay" for Chlamvdia trachomatis Liquid Pap Specimen/TIGRIS DTS

#### Ancillary Kit package insert:

The GEN-PROBE APTIMA Specimen Transfer Kit is only for use with GEN-PROBE APTIMA Assays for the detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae. The GEN-PROBE APTIMA Specimen Transfer Kit allows for APTIMA Assay testing of gynecological specimens collected and processed by the Cytyc ThinPrep 2000 Processor according to the instructions provided. No changes have been made to the Specimen Transfer Kit package insert as provided in K053446, GEN-PROBE APTIMA Assay for Chlamvdia tachomatis with use of Cytyc ThinPrep (liquid pap transport) cleared on July 25, 2006. The Specimen Transfer Kit package insert is being provided with this application for reference. There have been no changes.

## Summary of Non-Clinical (Analytical Laboratory) Performance Data

#### Limit of Detection (Analytical Sensitivity)

To assess analytical scnsitivity of C. trachomatis on the TIGRIS DTS System, C. trachomatis rRNA was spiked into post-processed PreservCyt liquid Pap specimen pool at the analytical sensitivity claim, or the equivalent of one Inclusion Forming Unit (IFU) per assay (5 fg of total CT rRNA). A summary of the percent positivity of C. trachomatis in post-processed PreservCyt liquid Pap specimens is shown in Table 5.0-01 1, and a detailed listing of individual test results are shown in Table 5.0-02.

| | | Table 5.0-01: Summary of CT Analytical Sensitivity at 1 IFU (5fg) / assay | | | | |
|--|--|----------------------------------------------------------------------------|--|--|--|--|
|--|--|----------------------------------------------------------------------------|--|--|--|--|

| Specimen Type | N | Positive Results | Percent Positive (95% C.I.) |
|-----------------------------------------|----|------------------|-----------------------------|
| Post-processed PreservCyt<br>liquid Pap | 60 | 60 | 100% (95.1 - 100) |

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains a black and white abstract symbol. The symbol is composed of angular lines and shapes, creating a stylized and geometric design. It appears to be a unique and potentially stylized representation of a letter or logo.

# Analytical Specificity

Twenty-four (24) culture isolates were selected from the panel of one hundred fifty four (154) organisms originally tested for the APTIMA CT assay (K043072). These included the 3 organisms that are most closely related phylogenetically to C. trachomatis. Testing was performed on three different TIGRIS DTS Systems. The culture isolates were tested in PreservCyt liquid Pap media and Swab Transport Media (STM) prepared in a 1-part PreservCyt liquid Pap media and 3-part STM ratio. This mimics the PreservCyt liquid Pap specimens. The majority of organisms were tested at a concentration of 1 x 10° cells/mL. A list of all organisms tested and their concentrations can be found in Table 5.0-02. All culture isolates produced negative results on the TIGRIS DTS System.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a stylized, abstract symbol in black against a white background. The symbol is composed of angular lines and shapes that interlock or overlap, creating a sense of connection or unity. The design is simple yet distinctive, resembling a stylized letter or a geometric emblem.

APTIMA Assay" for Chlamydia trachomatis Liquid Pap Specimen/TIGRIS DTS

| ORGANISM | ATCC<br>Number | Organism<br>Preparation | Concentration<br>cells/mL |
|---------------------------------|------------------------|-------------------------|---------------------------|
| Derxia gummosa | 15994 | Lysate | 1 x 106 |
| Enterococcus faecalis | 19433 | Lysate | 1 x 106 |
| Kingella kingae | 23332 | Lysate | 1 x 106 |
| Moraxella osloensis | 19976 | Lysate | 1 x 106 |
| Neisseria cinerea* | 14685 | Lysate | 1 x 106 |
| Neisseria elongata | 49379 | Lysate | 1 x 106 |
| Neisseria flava | 14221 | Lysate | 1 x 106 |
| Neisseria flavescens | 13120 | Lysate | 1 x 106 |
| Neisseria lactamica | 23970 | Lysate | 1 x 106 |
| N. meningitidis, Serogroup A | 13077 | Lysate | 1 x 106 |
| N. meningitidis, Serogroup B | Clinical isolate #399 | Lysate | 1 x 106 |
| N. meningitidis, Serogroup C | 13109 | Lysate | 1 x 106 |
| N. meningitidis, Serogroup C | 13110 | Lysate | 1 x 106 |
| N. meningitidis, Serogroup C | 13112 | Lysate | 1 x 106 |
| N. meningitidis, Serogroup D | 13113 | Lysate | 1 x 106 |
| N. meningitidis, Serogroup W135 | 43744 | Lysate | 1 x 106 |
| N. meningitidis, Serogroup Y | 35561 | Lysate | 1 x 106 |
| Neisseria mucosa | 19696 | Lysate | 1 x 106 |
| Neisseria polysaccharea | 43768 | Lysate | 1 x 106 |
| Neisseria sicca | 29193 | Lysate | 1 x 106 |
| Neisseria subflava* | Clinical isolate #4854 | Lysate | 1 x 106 |
| Chlamydia pneumoniae | VR1360 | Lysate | 10,000 TCID50/mL |
| Chlamydia psittaci | VR601 | Lysate | 64,000 TCID50/mL |

#### Table 5.0-02: Analytical Specificity - List of Culture Isolates

* Species shown to crossract in some amplification assays (Amplicor package insert, 1999; ProbeTec Package Insert , 2001; Farrell, D. J. 1999. J. Clin. Microbiol., 37(2):386-390).

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a stylized, abstract symbol in black against a white background. The symbol is composed of geometric shapes, primarily straight lines and sharp angles, forming an interlocking design. It resembles a stylized letter or a logo, with a modern and minimalist aesthetic. The symbol is centrally positioned and appears to be a standalone graphic element.

APTIMA Assay" for Chlamvdia trachomatis Liquid Pap Specimen/TIGRIS DTS

# Specimen-Caused Inhibition

The frequency of specimen inhibition observed in the APTIMA CT Assay on the TIGRIS DTS System was determined by evaluating the inhibitory status of 239 negative clinical postprocessed PreservCyt liquid Pap specimens. Negative specimens were tested for inhibition by the addition of CT rRNA at the limits of detection (5 fg CT rRNA/assay). Spiked negative specimens yielding CT positive results were considered non-inhibitory, whereas specimens yielding repeatable CT equivocal or negative results were considered inhibitory. The frequencies of inhibition for the specimens tested were calculated by dividing the number of inhibitory specimens by the total number tested for inhibition.

For post-processed PreservCyt liquid Pap specimen, no inhibition was detected. The data is shown in Table 5.0-03.

| Specimen<br>Type | Inhibitory Specimens | | Non-Inhibitory<br>Specimens | | Inhibition<br>Frequency |
|--------------------------|----------------------|-----------|-----------------------------|----------------------|-------------------------|
| | Number | RLU Range | Number | RLU Range<br>(x1000) | |
| PreservCyt<br>liquid Pap | 0 | NA | 239 | 1,193 –<br>7,135 | 0%<br>(0/239) |

Table 5.0-03: Results of post-processed PreservCyt liquid Pap Specimen Inhibition Testing

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows a black abstract symbol on a white background. The symbol is composed of geometric shapes, primarily straight lines and sharp angles. It resembles a stylized letter or a combination of interconnected shapes, with a sense of movement or directionality implied by its form. The design is simple yet distinctive, suggesting a logo or icon.

# Interference by Whole Blood

Fresh blood was added to clinical post-processed PreservCyt liquid Pap specimen pools, then tested for potential assay interference in the absence and presence of C. trachomatis at the estimated rRNA equivalent of one CT IFU/assay (5 fg/assay). Specimens were tested on two TIGRIS instruments.

To evaluate blood interference, spiked and unspiked specimens were tested with 0% and 10% whole blood. Subsequently, the PreservCyt liquid Pap specimen pools containing blood was processed with Swab Transport Mcdia at a 1-part PrescrvCyt liquid Pap specimen and 3-part STM ratio. One aliquot of each post-processed PreservCyt liquid Pap specimen pool to which no blood was added served as a control.

The post-processed PreservCyt liquid Pap specimen aliquots were tested for the absence and presence of CT rRNA. The data demonstrate that PreservCyt liquid Pap specimens with up to 10% (v/v) blood yielded background signals bclow the assay cut-off. For spiked PreservCyt liquid Pap specimens, the data demonstrate that the presence of up to 10% (v/v) blood in the specimen did not interfere with the recovery of a positive signal.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows a black and white abstract symbol. The symbol is composed of thick lines that form a stylized shape. It resembles a stylized fist or a geometric design, with sharp angles and a bold appearance.

APTIMA Assay for Chlamydia trachomatis Liquid Pap Specimen/TIGRIS DTS

#### Summary of Clinical Performance Data

A prospective, multi-center clinical study was conducted to ascertain equivalent performance between the previously validated DTS Systems and the TIGRIS DTS System (TIGRIS System) when performing the APTIMA CT (ACT) Assay (Gen-Probe Incorporated, San Diego, CA) in PreservCyt liquid Pap specimens. Symptomatic and asymptomatic female subjects attending family planning, OB/GYN, public health, and STD clinics were enrolled in the clinical study and PreservCyt liquid Pap specimens were collected. The PreservCyt liquid Pap specimens were processed for cytology and then transferred for testing in accordance with the ThinPrep 2000 Processor Operator's Manual and the APTIMA Specimen Transfer Kit package insert, respectively. These specimens were first screened using FDA-cleared applications of the APTIMA COMBO 2 (AC2) Assay, Based on the screening results, these specimens were then assigned for use in the Clinical Specimen and/or Clinical Panel study. Specimens with final invalid or equivocal screening results were not selected for testing in the APTIMA CT Clinical Specimen study.

In a Clinical Specimen study, 116 PreservCyt specimens were tested with the ACT Assay on the DTS Systems and on the TIGRIS System. Results from the DTS Systems and TIGRIS System were compared by calculating percent agreement. Table 5.0-04 shows a summary of the DTS Systems and TIGRIS System results, the overall, positive, and negative agreements (with 95% Cl) by symptom status. For 81 symptomatic and 35 asymptomatic female subjects with PreservCyt specimens, agreements were 100% (116/116). Therefore, performance of the ACT Assay on the TIGRIS System was equivalent to performance on the DTS Systems in PreservCyt specimens.

A Clinical Panel study was also performed to equivalent performance between the DTS Systems and the TIGRIS System when using the ACT Assay in Gen-Probe-prepared clinical panels. Residual volume from PreservCyt specimens from female subjects with negative CT results (as determined by screening with the AC2 Assay) were pooled and confirmed to be negative by testing with the ACT Assay on the DTS Systems.

#### Confidential

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows a stylized, abstract symbol in black against a white background. The symbol is composed of angular, geometric shapes that interlock or overlap in a way that suggests a stylized letter or monogram. The design is simple yet distinctive, with a modern and minimalist aesthetic.

APTIMA Assay® for Chlamydia trachomatis Liquid Pap Specimen/TIGRIS DTS

### Summary of Clinical Performance Data (cont'd)

The negative PrescrvCyt specimens were then pooled and spiked or not spiked with CT ribosomal RNA (rRNA) to create 5 panel members of varying CT concentration. thirty (30) aliquots of each CT-positive pancl member and 12 aliquots of the CT-negative panel member resulted in a panel consisting of 132 replicates. The panel was tested with the ACT Assay on the DTS Systems and on the TIGRIS System at 1 testing site. All samples had final valid results on both systems. Results from testing on the DTS Systems and the TIGRIS System were compared by calculating percent agreements. The percent agreement for each level of rRNA in PreservCyt liquid Pap specimens with the expected CT results for the TIGRIS System and for the DTS Systems was 100% for all panel members (Table 5.0-05).

| Table 5.0-4: Clinical Specimen Agreement Study: Positive, Negative, and Overall |
|---------------------------------------------------------------------------------|
| Agreements by Symptom Status in PreservCyt Liquid Pap Specimens |

| Symptom | N | DTS+<br>TIGRIS+ | DTS+<br>TIGRIS- | DTS-<br>TIGRIS+ | DTS-<br>TIGRIS- | Positive %<br>Agreement<br>(95% CI) | Negative %<br>Agreement<br>(95% CI) | Overall %<br>Agreement<br>(95% CI) |
|---------|-----|-----------------|-----------------|-----------------|-----------------|-------------------------------------|-------------------------------------|------------------------------------|
| Sympt. | 81 | 39 | 0 | 0 | 42 | 100 (91.0-100) | 100 (91.6-100) | 100 (95.5-100) |
| Asympt. | 35 | 25 | 0 | 0 | 10 | 100 (86.3-100) | 100 (69.2-100) | 100 (90.0-100) |
| All | 116 | 64 | 0 | 0 | 52 | 100 (94.4-100) | 100 (93.2-100) | 100 (96.9-100) |

"+" denotes a positive result, "-" a negative result, CI = confidence interval

| | | | Table 5.0-05: CT rRNA Spiked Clinical Panel Agreement Study in PreservCyt Liquid |
|---------------|--|--|----------------------------------------------------------------------------------|
| Pap Specimens | | | |
| | | | |

| Panel<br>Member | Concentration<br>(fg rRNA/Assay) | Replicates | TIGRIS %<br>Agreement | DTS %<br>Agreement | Overall %<br>Agreement<br>between TIGRIS and<br>DTS (95% CI) |
|-----------------|----------------------------------|------------|-----------------------|--------------------|--------------------------------------------------------------|
| No Target | 0 | 12 | 100 | 100 | |
| Very Low | 0.5 | 30 | 100 | 100 | |
| Low | 5 | 30 | 100 | 100 | 100 (97.2-100) |
| Medium | 50 | 30 | 100 | 100 | |
| High | 5,000 | 30 | 100 | 100 | |

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.

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

JAN 2 2 2007

Re: k063451

> Trade/Device Name: APTIMA Assay® for Chlamydia trachomatis Liquid Pap Specimen/TIGRIS DTS

Regulation Number: 21 CFR 866.3120 Regulation Name: Chlamydia Serological Reagents Regulatory Class: Class I Product Code: MKZ Dated: November 14, 2006 Received: November 15, 2006

Dear Mr. McMullen:

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 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).

{10}------------------------------------------------

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,

Sally, artym

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

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows a stylized symbol that resembles a combination of geometric shapes. It features a bold, angular design with a sense of interlocking or overlapping elements. The symbol is presented in black against a white background, which emphasizes its distinct form. The overall impression is abstract and modern.

APTIMA Assay® for Chlamydia trachomatis Liquid Pap Specimen/TIGRIS DTS

#### 4.0 INDICATIONS FOR USE STATEMENT

510(k) Number:

(if known)

KOG 3451

GEN-PROBE APTIMA® Assay for Chlamydia trachomatis on the Device Name: TIGRIS® DTS® System

#### Indications for Use:

The GEN-PROBE 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 chlamydial urogenital disease using the TIGRIS® DTS® Automated Analyzer or semiautomated 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 female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected 'vaginal swab specimens, and female and male urine. The assay is also intended for use with the testing of gynecological specimens, from both symptomatic and asymptomatic patients collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System.

" 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.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

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

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

Sou,ura
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Confidential

510(k) k06345,

Page 15