(68 days)
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 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.
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.
Acceptance Criteria and Device Performance for APTIMA® Assay for Chlamydia trachomatis
The APTIMA® Assay for Chlamydia trachomatis (CT) on the TIGRIS® DTS® System extends the clinical performance claims for testing gynecological specimens collected in PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System. The study aimed to demonstrate equivalent performance between the previously validated DTS Systems and the TIGRIS DTS System.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity | Detection of Chlamydia trachomatis rRNA at 1 Inclusion Forming Unit (IFU) / assay (5 fg of total CT rRNA) in post-processed PreservCyt liquid Pap specimens should show high percent positivity. | 100% positive results (60/60 replicates) with a 95% Confidence Interval of (95.1 - 100) at 1 IFU (5 fg)/assay. This demonstrates robust analytical sensitivity. |
| Analytical Specificity | Diverse culture isolates, especially those phylogenetically related to C. trachomatis, and those known to cross-react in other amplification assays, should produce negative results when tested in PreservCyt liquid Pap media and Swab Transport Media (STM) on the TIGRIS DTS System. | All 24 culture isolates (including Neisseria species and Chlamydia pneumoniae/psittaci, some known to cross-react in other assays) produced negative results on the TIGRIS DTS System when tested in PreservCyt liquid Pap media. This indicates good analytical specificity and minimal cross-reactivity. |
| Specimen-Caused Inhibition | The frequency of inhibition in negative clinical post-processed PreservCyt liquid Pap specimens, when spiked with CT rRNA at the limit of detection, should be minimal or absent. | 0% inhibition (0/239 specimens) was detected in post-processed PreservCyt liquid Pap specimens. All 239 spiked negative specimens yielded CT positive results, indicating no inhibition. |
| Interference by Whole Blood | The presence of whole blood (up to 10% v/v) in PreservCyt liquid Pap specimens should not interfere with background signals in negative samples or with the recovery of a positive signal in CT-spiked samples. | PreservCyt liquid Pap specimens with up to 10% (v/v) blood yielded background signals below the assay cut-off for unspiked samples. For spiked samples, the presence of up to 10% (v/v) blood did not interfere with the recovery of a positive signal. |
| Clinical Performance Equivalence (Clinical Specimen Study) | Performance of the ACT Assay on the TIGRIS System should be equivalent to performance on the DTS Systems in PreservCyt specimens, demonstrated by high percent agreement (overall, positive, and negative) for both symptomatic and asymptomatic individuals. | Agreement between TIGRIS and DTS Systems was 100% (116/116) across all symptomatic (81 subjects) and asymptomatic (35 subjects) female subjects. Specifically: - Positive % Agreement: 100% (94.4-100% CI) - Negative % Agreement: 100% (93.2-100% CI) - Overall % Agreement: 100% (96.9-100% CI) |
| Clinical Performance Equivalence (Clinical Panel Study) | The ACT Assay on the TIGRIS System should show 100% agreement with expected CT results for panel members with varying CT rRNA concentrations (including 0 fg/assay and various positive concentrations) in PreservCyt liquid Pap specimens, and demonstrate equivalence to the DTS Systems. | The percent agreement for each level of rRNA in PreservCyt liquid Pap specimens with the expected CT results for both the TIGRIS System and the DTS Systems was 100% for all panel members. The overall % agreement between TIGRIS and DTS was 100% (97.2-100% CI). |
2. Sample Sizes and Data Provenance
- Analytical Sensitivity: 60 replicates of C. trachomatis rRNA spiked into post-processed PreservCyt liquid Pap specimen pool.
- Analytical Specificity: 24 culture isolates tested.
- Specimen-Caused Inhibition: 239 negative clinical post-processed PreservCyt liquid Pap specimens.
- Interference by Whole Blood: Clinical post-processed PreservCyt liquid Pap specimen pools, tested with 0% and 10% whole blood, both unspiked and spiked with CT rRNA.
- Clinical Specimen Study: 116 PreservCyt specimens from female subjects (81 symptomatic, 35 asymptomatic).
- Clinical Panel Study: 5 panel members, including a negative control and 4 positive concentrations of CT rRNA, prepared by spiking. Total of 132 replicates (12 for negative, 30 for each positive concentration).
Data Provenance: The report indicates a "prospective, multi-center clinical study" was conducted for the clinical performance data. Patient enrollment occurred at "family planning, OB/GYN, public health, and STD clinics." This suggests the clinical data is prospective and collected from various clinical sites. The country of origin is not explicitly stated but implied to be the USA given the FDA 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the "number of experts" or their specific "qualifications" used to establish ground truth in the traditional sense of expert review for image interpretation or diagnosis.
- For the Clinical Specimen Study, specimens were first screened using "FDA-cleared applications of the APTIMA COMBO 2 (AC2) Assay." The results from this FDA-cleared assay served as the reference standard (ground truth proxy) for comparing the DTS Systems and TIGRIS System results.
- For the Clinical Panel Study, negative PreservCyt specimens were pooled and confirmed negative by testing with the ACT Assay on the DTS Systems. Then, CT ribosomal RNA (rRNA) was spiked at known concentrations to create panel members. The "expected CT results" based on the known spiked concentrations served as the ground truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method like 2+1 or 3+1. For the clinical specimen study, the "ground truth" was established by prior testing with an "FDA-cleared" assay (APTIMA COMBO 2 Assay), implying it was considered a reliable reference. Discrepancies, if any, between the test systems (TIGRIS vs. DTS) were analyzed for percent agreement, rather than adjudicated by independent readers. "Specimens with final invalid or equivocal screening results were not selected for testing," suggesting a pre-screening step to ensure data quality.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed as this is an in vitro diagnostic (IVD) assay detection system, not an imaging device requiring human reader interpretation. The study compares the performance of two automated systems (TIGRIS DTS System vs. DTS Systems) for detecting Chlamydia trachomatis. There is no human-in-the-loop component for which an improvement effect size with AI assistance would be relevant.
6. Standalone Performance Study
Yes, a standalone performance study was done for the algorithm (the APTIMA Assay on the TIGRIS DTS System). The entire document describes the analytical and clinical performance of the device on its own, comparing it against a reference standard or a previously cleared device. The "overall % agreement" in the clinical studies directly reflects the standalone performance of the TIGRIS DTS System relative to the DTS system and the expected results.
7. Type of Ground Truth Used
- Analytical Studies (Sensitivity, Specificity, Inhibition, Interference): Ground truth was established by known concentrations of C. trachomatis rRNA or culture isolates, or by the absence of target/interfering substance in controlled laboratory settings.
- Clinical Specimen Study: Ground truth was established by results from a previously FDA-cleared assay (APTIMA COMBO 2 Assay), acting as the reference standard.
- Clinical Panel Study: Ground truth was established by known spiked concentrations of CT ribosomal RNA (rRNA) into confirmed negative PreservCyt specimens.
8. Sample Size for the Training Set
The document describes an analytical validation and clinical performance study for a diagnostic assay, not a machine learning or AI algorithm in the context of a "training set." Therefore, a "training set" as understood in AI/ML development is not applicable here. The assays are based on target amplification nucleic acid probe technology.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, there is no explicit "training set" as this is not an AI/ML device that requires machine learning for its core function. The assay's parameters and cut-offs would have been established during earlier development and validation phases (not detailed in this 510(k) summary), likely using characterized positive and negative samples, similar to the "panel" approach seen in the clinical panel study.
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K06345/
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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: (858) 410-8000 | phone: (858) 410-8649 |
| fax: (858) 410-8622 | fax: (858) 410-8622 |
| e-mail: josephm@gen-probe.com | |
| Trade Name: | GEN-PROBE® APTIMA® Assay for Chlamydia trachomatis |
| Common or Usual Name: | Ribosomal RNA (rRNA) target-amplified nucleic acid probe testfor 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 chlamydiadirectly from clinical specimens or culturedisolates derived from clinical specimens. The identification aidsin the diagnosis of disease caused by bacteria belonging to thegenus Chlamydia and provides epidemiological information onthese diseases. Chlamydia are the causative agents of psittacosis(a form of pneumonia), lymphogranuloma venereum (a venerealdisease) and trachoma (a chronic disease of the eye and eyelid). |
Substantially Equivalent Devices:
GEN-PROBE® APTIMA® Assay for Chlamydia trachomatis
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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.
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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 PreservCytliquid Pap | 60 | 60 | 100% (95.1 - 100) |
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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.
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APTIMA Assay" for Chlamydia trachomatis Liquid Pap Specimen/TIGRIS DTS
| ORGANISM | ATCCNumber | OrganismPreparation | Concentrationcells/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).
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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.
| SpecimenType | Inhibitory Specimens | Non-InhibitorySpecimens | InhibitionFrequency | ||
|---|---|---|---|---|---|
| Number | RLU Range | Number | RLU Range(x1000) | ||
| PreservCytliquid Pap | 0 | NA | 239 | 1,193 –7,135 | 0%(0/239) |
Table 5.0-03: Results of post-processed PreservCyt liquid Pap Specimen Inhibition Testing
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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 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.
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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
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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+TIGRIS+ | DTS+TIGRIS- | DTS-TIGRIS+ | DTS-TIGRIS- | Positive %Agreement(95% CI) | Negative %Agreement(95% CI) | Overall %Agreement(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 | |||
| PanelMember | Concentration(fg rRNA/Assay) | Replicates | TIGRIS %Agreement | DTS %Agreement | Overall %Agreementbetween TIGRIS andDTS (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 |
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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).
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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, 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
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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)
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§ 866.3120 Chlamydia serological reagents.
(a)
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 genusChlamydia 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).(b)
Classification. Class I (general controls).