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.

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.

AI/ML Overview

This document describes the GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae on the TIGRIS DTS System. The goal of the submission appears to be to expand the clinical performance claims of the existing assay to include gynecological specimens collected in PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System, for use on the TIGRIS DTS System.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in the document are primarily related to agreement studies and analytical performance targets rather than explicit numerical thresholds for clinical sensitivity/specificity against a gold standard for the new use case (PreservCyt specimens on the TIGRIS DTS System). The clinical studies focus on demonstrating equivalence between the TIGRIS DTS System and previously validated DTS Systems.

Acceptance Criteria (Implied)	Reported Device Performance (for PreservCyt specimens on TIGRIS DTS)
Analytical Sensitivity (Limit of Detection)
100% positivity at 50 CFU/assay (250 fg of total GC rRNA)	100% positive (95.1-100% CI) for N. gonorrhoeae rRNA spiked into post-processed PreservCyt liquid Pap specimen pool at 50 CFU/assay (250 fg). (N=60)
Analytical Specificity
No cross-reactivity with closely related organisms and common flora	All 24 tested culture isolates (including 17 phylogenetically related to N. gonorrhoeae) showed no cross-reactivity when tested at 1 x 10^6 cells/mL in PreservCyt liquid Pap media and Swab Transport Media on three different TIGRIS DTS Systems. The document does not explicitly state an "acceptance criteria" but the presented data indicates 100% specificity for the tested organisms. Some Neisseria species known to cross-react in other amplification assays were noted as potential cross-reactors, which is a disclaimer, not a failure.
Specimen-Caused Inhibition
< 5% inhibition rate for post-processed PreservCyt specimens	0% inhibition (0/240) detected in 240 negative clinical post-processed PreservCyt liquid Pap specimens.
Interference by Whole Blood
No interference up to 10% (v/v) blood in PreservCyt specimens	Background signals remained below the assay cut-off for negative PreservCyt liquid Pap specimens with up to 10% (v/v) blood. For spiked specimens, the presence of up to 10% (v/v) blood did not interfere with the recovery of a positive signal.
Clinical Equivalence (TIGRIS DTS vs. DTS Systems)
Overall agreement ≥ 90% (with acceptable CI)	100% Overall Agreement (93.0-100% CI) for all 51 PreservCyt specimens (40 positive, 11 negative) between DTS Systems and TIGRIS DTS System.
Positive agreement ≥ 90% (with acceptable CI)	100% Positive Agreement (91.2-100% CI) between DTS Systems and TIGRIS DTS System.
Negative agreement ≥ 90% (with acceptable CI)	100% Negative Agreement (71.5-100% CI) between DTS Systems and TIGRIS DTS System.
Clinical Panel Equivalence
100% agreement between TIGRIS and DTS Systems for all panel members	100% agreement for all five panel members (0 fg, 25 fg, 250 fg, 2,500 fg, 25,000 fg rRNA/Assay) between TIGRIS and DTS Systems. Overall % Agreement between TIGRIS and DTS was 100% (97.2-100% CI) for the 250 fg (Low) panel member.

2. Sample Sizes Used for the Test Set and Data Provenance

Analytical Sensitivity (LOD): N=60 for post-processed PreservCyt liquid Pap specimen. The data provenance is from laboratory spiking experiments.
Analytical Specificity: 24 culture isolates. The data provenance is from laboratory testing of known organisms.
Specimen-Caused Inhibition: N=240 negative clinical post-processed PreservCyt liquid Pap specimens. Data provenance is from clinical specimens presumably collected in the US (not explicitly stated for this part, but the clinical study below is multi-center in the US).
Interference by Whole Blood: Not specified as a precise "test set" size, but involved three negative PreservCyt liquid Pap specimen pools, tested in the absence and presence of N. gonorrhoeae and varying blood concentrations. Data provenance is from laboratory spiking experiments.
Clinical Specimen Study: N=51 PreservCyt specimens (34 symptomatic, 17 asymptomatic female subjects).
- Data Provenance: Prospective, multi-center clinical study. Patients were enrolled from family planning, OB/GYN, public health, and STD clinics. While not explicitly stated, multi-center studies for FDA submissions are typically conducted in the USA.
Clinical Panel Study: 132 replicates (30 aliquots for each of 4 positive panel members, and 12 aliquots for the negative panel member). These were created from pooled residual negative PreservCyt specimens from female subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of "experts" in the context of establishing ground truth for the test sets in this submission.

Clinical Specimen Study: The "ground truth" or reference method for comparison was the AGC Assay performed on the previously validated DTS Systems, following an initial screening with FDA-cleared APTIMA COMBO 2 (AC2) Assay. The AC2 Assay results determined whether specimens were selected for the clinical specimen or panel study. This is a comparison between two automated systems rather than expert interpretation of a gold standard.
Clinical Panel Study: The "ground truth" for the panel members was their known N. gonorrhoeae ribosomal RNA (rRNA) concentration (spiked or not spiked).
Analytical Studies: Ground truth was based on known concentrations of spiked organisms or rRNA, or confirmed negative samples.

4. Adjudication Method for the Test Set

Not applicable in the typical sense of expert adjudication of imaging or clinical findings.

For the Clinical Specimen Study, the comparison was made between the results of the AGC Assay on the DTS Systems (predicate) and the TIGRIS DTS System (new system). No explicit adjudication process between discordant results from these two systems is described; rather, the agreement between them was calculated.
For the Analytical Studies and Clinical Panel Study, the "ground truth" was established by experimental design (e.g., spiking known quantities of analyte, using confirmed negative samples), not through adjudication of expert opinions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This submission is for an in vitro diagnostic (IVD) assay, specifically a nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae. It is a standalone diagnostic device with no "human reader" component in the interpretation of results in the way an imaging AI device would have. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the studies presented are essentially standalone performance evaluations of the GEN-PROBE APTIMA Assay on the TIGRIS DTS System. The assay generates a qualitative (positive/negative) result without human interpretation of raw data beyond confirming valid assay run parameters. The purpose of this submission was to demonstrate equivalence of this assay on a new automated platform (TIGRIS DTS) for a new specimen type (PreservCyt).

7. The Type of Ground Truth Used

Analytical Sensitivity: Known spiked concentrations of N. gonorrhoeae rRNA.
Analytical Specificity: Known culture isolates.
Specimen-Caused Inhibition and Interference: Known negative samples and known spiked concentrations (for inhibition/recovery).
Clinical Specimen Study: The results of the AGC Assay on the predicate DTS Systems, following initial screening with the FDA-cleared APTIMA COMBO 2 (AC2) Assay. This acts as a reference method for the comparison between the old and new platforms.
Clinical Panel Study: Known spiked concentrations of N. gonorrhoeae ribosomal RNA (rRNA) into confirmed negative PreservCyt specimens.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development or algorithm training. This is a molecular diagnostic assay, not a machine learning or AI algorithm in the conventional sense that would require a dedicated training set. The assay's parameters (e.g., cut-offs) would have been established during its initial development and validation, which is not detailed in this specific 510(k) summary, as this submission is an extension of claims for an already cleared assay.

9. How the Ground Truth for the Training Set Was Established

As no specific "training set" for an AI/ML algorithm is mentioned or applicable here, this question is not relevant to the provided documentation. The assay relies on target amplification and detection of rRNA, with predetermined analytical characteristics, rather than learning from a training dataset.

Summary

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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: (858) 410-8000
fax: (858) 410-8622	phone: (858) 410-8649fax: (858) 410-8622
	e-mail: josephm@gen-probe.com

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

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 PreservCytliquid 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	OrganismPreparation	Concentrationcells/MI
Neisseria subflava*	Clinical isolate #4854	Lysate	1 x 106
Chlamydia pneumoniae	VR1360	Lysate	10,000TCID50/mL
Chlamydia psittaci	VR601	Lysate	64,000TCID50/mL
Chlamydia psittaci	VR1369	Lysate	1 x 106TCID50/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-InhibitorySpecimens
SpecimenType	Number	RLU Range	Number	RLU Range(x1000)	InhibitionFrequency

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

PreservCyt

liquid Pap

240

3,402 - 5,148

(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+TIGRIS+	DTS-TIGRIS-	Positive %Agreement(95% CI)	Negative %Agreement(95% CI)	Overall %Agreement(95% CI)
Sympt.	34	28	6	100 (87.7-100)	100 (54.1-100)	100 (89.7-100)
Asympt.	17	12	5	100 (73.5-100)	100 (47.8-100)	100 (80.5-100)
All	51	40	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

PanelMember	Concentration(fg rRNA/Assay)	Replicates	TIGRIS %Agreement	DTS %Agreement	Overall % Agreementbetween TIGRIS and DTS(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 (240)276-0450. 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 (800) 638-2041 or (301) 443-6597 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:

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)

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)

	K063664
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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Confidential	510(k)	PDF Page 15 of 202
	Page 15 of 202

Regulation Number and Section

§ 866.3390

Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, 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.(b)
Classification. Class II (performance standards).