GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091

K063664 · Gen-Probe, Inc. · LSL · Jan 25, 2007 · Microbiology

Device Facts

• Record ID: K063664
• Device Name: GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091
• Applicant: Gen-Probe, Inc.
• Product Code: LSL · Microbiology
• Decision Date: Jan 25, 2007
• 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 Neisseriagonorrhoeae (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 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; patient-collected vaginal swab specimens1; 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.

Device Story

The APTIMA Assay is a nucleic acid amplification test (NAAT) for detecting Neisseria gonorrhoeae rRNA. It utilizes target capture technology to isolate target sequences from clinical specimens. The TIGRIS DTS System automates the assay process, including sample preparation, amplification, and detection. Used in clinical laboratories by trained technicians. The system provides qualitative results (positive/negative) to clinicians to aid in the diagnosis of gonococcal urogenital disease. By enabling automated, high-throughput testing of various specimen types, including liquid Pap samples, the device facilitates efficient screening and diagnostic workflows, supporting timely clinical management of patients.

Clinical Evidence

Prospective multi-center study compared TIGRIS DTS System performance against previously validated DTS systems using 51 PreservCyt liquid Pap specimens (34 symptomatic, 17 asymptomatic). Results showed 100% overall agreement (95% CI: 93.0-100%). A clinical panel study using 132 replicates of spiked PreservCyt specimens confirmed 100% agreement across varying GC concentrations. No inhibition was detected in 240 negative clinical specimens.

Technological Characteristics

The assay utilizes target capture with magnetic microparticles, Transcription-Mediated Amplification (TMA), and Hybridization Protection Assay (HPA). Detection is chemiluminescent using acridinium ester-labeled DNA probes. The system is fully automated (TIGRIS DTS). It is designed for use with swab, urine, and PreservCyt liquid Pap specimens. The software performs automated data reduction and RLU measurement. The assay is a nucleic acid probe test for qualitative detection of rRNA.

Indications for Use

Indicated for symptomatic and asymptomatic individuals, including males and females, for the detection of Neisseria gonorrhoeae (GC) in endocervical, vaginal, and male urethral swabs, as well as female and male urine and PreservCyt Solution liquid Pap 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 Assay for Chlamydia trachomatis (K053446)

Submission Summary (Full Text)

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K063664

GEN-PROBE INCORPORATED

APTIMA Assay for Neisseria gonorrhoeae – Liquid Pap Specimen/TIGRIS DTS

#### 510(k) SUMMARY 5.0

# GEN-PROBE® APTIMA® Assay for Neisseria gonorrhoeae

JAN 2 5 2007

# General Information

| Submitted By: | Company Contact: | | |
|-----------------------------|-----------------------------------------------------------------|--|--|
| Gen-Probe Incorporated | E. Joseph McMullen | | |
| 10210 Genetic Center Drive | Associate Director, Regulatory Affairs | | |
| San Diego, California 92121 | | | |
| phone: [phone] | | | |
| fax: [phone] | phone: [phone]<br>fax: [phone] | | |
| | e-mail: [e-mail] | | |
| | | | |
| Trade Name: | GEN-PROBE® APTIMA® Assay for Neisseria gonorrhoeae | | |
| Common or Usual Name: | Ribosomal RNA (rRNA) target-amplified nucleic acid probe | | |
| | test for the in vitro diagnostic detection of Neisseria | | |
| | gonorrhoeae | | |
| | | | |
| Classification Name: | DNA Reagents, Neisseria | | |
| Classification Code: | Medical Specialty: Microbiology | | |
| | Product Code: LSL | | |
| | Registration Number: CFR 866.3390 | | |
| | Device Class: 2 | | |
| | Description: Reagents used to identify Neisseria spp. 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 Neisseria, | | |
| | such as epidemic cerebrospinal meningitis, meningococcal | | |
| | disease, and gonorrhea, and also provides epidemiological | | |
| | information on diseases caused by these microorganisms. | | |

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APTIMA Assay for Neisseria gonorrhoeae – Liquid Pap Specimen/TIGRIS DTS

#### Substantially Equivalent Devices

GEN-PROBE® APTIMA® Assay for Neisseria gonorrhoeae

#### Device Description

Clearance of this premarket notification extends the clinical performance claims of the commercially available GEN-PROBE®APTIMA® Assay for Neisseria gonorrhoeae 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 use 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 for Neisseria gonorrhoeae Package Insert:

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 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; 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.

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.

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APTIMA Assay for Neisseria gonorrhoeae - 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 with the Cytyc ThinPrep® 2000 System according to the instructions provided. No changes have been made to the Specimen Transfer Kit package insert as provided in K062440, GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae with use of Cytyc ThinPrep (liquid pap transport) cleared on November 7, 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 sensitivity of N. gonorrhoeae on the TIGRIS DTS System, N. gonorrhoeae rRNA was spiked into a post-processed PreservCyt liquid Pap specimen pool at the analytical sensitivity claim, or the equivalent of fifty CFU per assay (250 fg of total GC rRNA). A summary of the percent positivity of N. gonorrhoeae in post-processed PreservCyt liquid Pap specimen is shown in Table 5.0-01.

| Table 5.0-01 Summary of GC Analytical Sensitivity at 50 CFU (250fg)/assay | | |
|---------------------------------------------------------------------------|--|--|
| | | |

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

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APTIMA Assay for Neisseria gonorrhoeae -- Liquid Pap Specimen/TIGRIS DTS

#### Analytical Specificity

Twenty-four (24) culture isolates were selected from the panel of one hundred fifty four (154) organisms originally tested for the APTIMA GC assay (K043144). These included the 17 organisms that are most closely related phylogenetically to N. gonorrhoeae. 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 one-part PreservCyt liquid Pap media and three-part STM ratio. This mimics the PreservCyt liquid Pap specimens. The majority of organisms were tested at a concentration of 1 x 100 cells/mL. A list of all organisms tested and their concentrations is provided below in Table 5.0-02.

| ORGANISM | ATCC Number | Organism Preparation | Concentration cells/MI |
|---------------------------------|-----------------------|----------------------|------------------------|
| 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 elongate | 49379 | Lysate | 1 x 106 |
| Neisseria flava | 14221 | Lysate | 1 x 106 |
| Neisseria flavescens | 13120 | Lysate | 1 x 106 |
| Neisseria IGCamica | 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 |

Table 5.0-02 Analytical Specificity - List of Culture Isolates

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APTIMA Assay for Neisseria gonorrhoeae - Liquid Pap Specimen/TIGRIS DTS

| ORGANISM | ATCC Number | Organism<br>Preparation | Concentration<br>cells/MI |
|-----------------------------|------------------------|-------------------------|---------------------------|
| <i>Neisseria subflava*</i> | Clinical isolate #4854 | Lysate | 1 x 106 |
| <i>Chlamydia pneumoniae</i> | VR1360 | Lysate | 10,000<br>TCID50/mL |
| <i>Chlamydia psittaci</i> | VR601 | Lysate | 64,000<br>TCID50/mL |
| <i>Chlamydia psittaci</i> | VR1369 | Lysate | 1 x 106<br>TCID50/mL |

### Table 5.0-02 Analytical Specificity - List of Culture Isolates (continued)

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

#### Specimen-Caused Inhibition

:

The frequency of specimen inhibition observed in the APTIMA GC Assay on the TIGRIS DTS System was determined by evaluating the inhibitory status of 240 negative clinical postprocessed PreservCyt liquid Pap specimens. Negative specimens were tested for inhibition by the addition of GC rRNA at the limits of detection (250 fg GC rRNA/assay). Spiked negative specimens yielding GC positive results were considered non-inhibitory, whereas specimens vielding repeatable GC 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.

| | Inhibitory Specimens | | Non-Inhibitory<br>Specimens | | |
|------------------|----------------------|-----------|-----------------------------|----------------------|-------------------------|
| Specimen<br>Type | Number | RLU Range | Number | RLU Range<br>(x1000) | Inhibition<br>Frequency |

NA

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

PreservCyt

liquid Pap

0

240

3,402 - 5,148

0%

(0/240)

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### 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 N. gonorrhoeae at the estimated rRNA equivalent of fifty GC CFU/assay (250 fg/assay). Specimens were tested on two TIGRIS instruments.

To evaluate blood interference, blood was added to three negative PreservCyt liquid Pap specimen pools to result in a final concentration of 10% (v/v). Subsequently, the PreservCyt liquid Pap specimen pools containing blood was processed with Swab Transport Media at a one-part PreservCyt liquid Pap specimen and three-part STM ratio. One aliquot of each postprocessed 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 GC rRNA. The data demonstrate that for PreservCyt liquid Pap specimens up to 10% (v/v) blood yielded background signals below 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.

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#### 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 GC (AGC) 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 GC Clinical Specimen study.

In a Clinical Specimen study, 51 PreservCyt specimens were tested with the AGC Assay on the DTS Systems and on the TIGRIS DTS System. Results from the DTS Systems and TIGRIS DTS 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% CI) by symptom status. For 34 symptomatic and 17 asymptomatic female subjects with PreservCyt specimens, agreements were 100% (51/51). Therefore, performance of the GC Assay on the TIGRIS System was equivalent to performance on the DTS Systems in PreservCyt specimens.

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

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APTIMA Assay for Neisseria gonorrhoeae – Liquid Pap Specimen/TIGRIS DTS

The negative PreservCyt specimens were then pooled and spiked or not spiked with GC ribosomal RNA (rRNA) to create five panel members of varying GC concentration. Thirty (30) aliquots of each GC-positive panel member and 12 aliquots of the GC-negative panel member resulted in a panel consisting of 132 replicates. The panel was tested with the AGC Assay on the DTS Systems and on the TIGRIS System at one 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 GC results for the TIGRIS System and for the DTS Systems was 100% for all panel members (Table 5.0-05).

Table 5.0-04: 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. | 34 | 28 | 0 | 0 | 6 | 100 (87.7-100) | 100 (54.1-100) | 100 (89.7-100) |
| Asympt. | 17 | 12 | 0 | 0 | 5 | 100 (73.5-100) | 100 (47.8-100) | 100 (80.5-100) |
| All | 51 | 40 | 0 | 0 | 11 | 100 (91.2-100) | 100 (71.5-100) | 100 (93.0-100) |

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

| Table 5.0-05 GC 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 % Agreement<br>between TIGRIS and DTS<br>(95% CI) |
|-----------------|----------------------------------|------------|-----------------------|--------------------|-----------------------------------------------------------|
| | | | | | |
| No Target | 0 | 12 | 100 | 100 | |
| Very Low | 25 | 30 | 100 | 100 | |
| Low | 250 | 30 | 100 | 100 | 100 (97.2-100) |
| Medium | 2,500 | 30 | 100 | 100 | |
| High | 25,000 | 30 | 100 | 100 | |

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APTIMA Assay for Neisseria gonorrhoeae - Liquid Pap Specimen/TIGRIS DTS

The findings of the Clinical Specimen Study demonstrate equivalent performance between AGC Assay on the DTS Systems and the TIGRIS System when using Cytyc® PreservCyt (ThinPrep) processed liquid Pap specimens, and support the proposed intended use of the AGC Assay on the TIGRIS System.

#### Conclusions from Non-Clinical and Clinical Data

The non-clinical and clinical study results support the use of the cleared AGC Assay using PreservCyt Solution for specimen collection and processed with the Cytyc ThinPrep® 2000 System, on the TIGRIS® DTS® Automated Analyzer.

The data demonstrate reasonable evidence that when the AGC Assay with the APTIMA Specimen Transfer Kit on the TIGRIS® DTS® System are labeled as proposed, the AGC Assay continues to be safe and effective for its stated intended use.

#### Contraindications and Cautions

There are no contraindications or cautions

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Image /page/9/Picture/1 description: The image shows a black and white logo. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is facing to the right. The logo also includes text arranged in a circular pattern around the bird. The text is difficult to read due to the image quality, but it appears to be the name of an organization or agency.

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 5 2007

Re: k063664 Trade/Device Name: GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae on the TIGRIS® DTS® System Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class I Product Code: LSL : Dated: December 7, 2006 Received: December 8, 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).

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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,

Sally, anton

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 Neisseria gonorrhoeae -- Liquid Pap Specimen/TIGRIS DTS

#### INDICATIONS FOR USE STATEMENT 4.0

KOK 3464 510(k) Number:

(if known)

| Device Name: | GEN-PROBE APTIMA® Assay for Neisseria gonorrhoeae on the |
|--------------|----------------------------------------------------------|
| | TIGRIS® DTS® System |

#### Indications for Use:

The GEN-PROBE 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 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 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.

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.

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)

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Office of In Vitro Diagnostic Device Evaluation and Safety

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