(68 days)
No
The summary describes a nucleic acid probe test and automated analyzer, which are standard laboratory technologies and do not mention or imply the use of AI/ML for analysis or interpretation.
No
This device is a diagnostic test for the detection of Chlamydia trachomatis, used to aid in diagnosis, not to treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is used "to aid in the diagnosis of chlamydial urogenital disease."
No
The device description explicitly mentions an "ancillary kit" with physical components (transport tube, transport media, penetrable cap) and instructions for use, indicating it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) to aid in the diagnosis of chlamydial urogenital disease". The term "in vitro" is a key indicator of an IVD, meaning it's used to test samples outside of the body.
- Device Description: The description refers to it as a "target amplification nucleic acid probe test that utilizes target capture". This describes a laboratory-based test method.
- Specimen Types: The assay is designed to test various biological specimens (swabs, urine, gynecological specimens) collected from patients.
- Purpose: The stated purpose is to "aid in the diagnosis" of a disease, which is a primary function of IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MKZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urogenital, endocervical, vaginal, male urethral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician, family planning, OB/GYN, public health, and STD clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Summary of Non-Clinical (Analytical Laboratory) Performance Data:
Limit of Detection (Analytical Sensitivity): To assess analytical sensitivity 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). N=60 post-processed PreservCyt liquid Pap specimens.
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. The majority of organisms were tested at a concentration of 1 x 10^6 cells/mL. All culture isolates produced negative results on the TIGRIS DTS System.
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). For post-processed PreservCyt liquid Pap specimen, no inhibition was detected.
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. Spiked and unspiked specimens were tested with 0% and 10% whole blood. The data demonstrate that PreservCyt liquid Pap specimens with up to 10% (v/v) blood yielded background signals below the assay cut-off, and for spiked specimens, the presence of up to 10% (v/v) blood did not interfere with the recovery of a positive signal.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Data:
A prospective, multi-center clinical study was conducted comparing the TIGRIS DTS System (TIGRIS System) with previously validated DTS Systems for the APTIMA CT (ACT) Assay in PreservCyt liquid Pap specimens. Symptomatic and asymptomatic female subjects attending family planning, OB/GYN, public health, and STD clinics were enrolled. Specimens were processed for cytology and then transferred for testing. These specimens were first screened using FDA-cleared applications of the APTIMA COMBO 2 (AC2) Assay.
Clinical Specimen Study: 116 PreservCyt specimens (81 symptomatic, 35 asymptomatic) were tested with the ACT Assay on both DTS Systems and the TIGRIS System. Results from both systems were compared by calculating percent agreement.
Clinical Panel Study: Residual volume from PreservCyt specimens from female subjects with negative CT results (as determined by screening with the AC2 Assay) were pooled and confirmed negative. The negative PreservCyt 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 panel 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.
Key Results:
Clinical Specimen Study: Agreements between DTS Systems and TIGRIS System were 100% (116/116).
Symptomatic: Positive % Agreement = 100 (91.0-100), Negative % Agreement = 100 (91.6-100), Overall % Agreement = 100 (95.5-100); N=81.
Asymptomatic: Positive % Agreement = 100 (86.3-100), Negative % Agreement = 100 (69.2-100), Overall % Agreement = 100 (90.0-100); N=35.
All: Positive % Agreement = 100 (94.4-100), Negative % Agreement = 100 (93.2-100), Overall % Agreement = 100 (96.9-100); N=116.
Clinical Panel Study: 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. Overall % Agreement between TIGRIS and DTS was 100 (97.2-100) for the Low concentration (5 fg rRNA/Assay) panel member.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: 100% (95% C.I.: 95.1 - 100) for C. trachomatis at 1 IFU (5fg) / assay (N=60).
Analytical Specificity: All 24 culture isolates produced negative results on the TIGRIS DTS System.
Inhibition Frequency: 0% (0/239) for post-processed PreservCyt liquid Pap specimen.
Clinical Percent Agreement:
Symptomatic: Positive % Agreement = 100, Negative % Agreement = 100, Overall % Agreement = 100.
Asymptomatic: Positive % Agreement = 100, Negative % Agreement = 100, Overall % Agreement = 100.
All: Positive % Agreement = 100, Negative % Agreement = 100, Overall % Agreement = 100.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 test |
| 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 | |
| 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). |
Substantially Equivalent Devices:
GEN-PROBE® APTIMA® Assay for Chlamydia trachomatis
1
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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.
2
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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 PreservCyt | |||
| liquid 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 | ATCC
Number | Organism
Preparation | Concentration
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).
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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.
| Specimen
Type | Inhibitory Specimens | | Non-Inhibitory
Specimens | | Inhibition
Frequency |
|--------------------------|----------------------|-----------|-----------------------------|----------------------|-------------------------|
| | Number | RLU Range | Number | RLU Range
(x1000) | |
| PreservCyt
liquid 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 | |||
| Panel
Member | Concentration
(fg rRNA/Assay) | Replicates | TIGRIS %
Agreement | DTS %
Agreement | Overall %
Agreement
between TIGRIS and
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 | |
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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).
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 (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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510(k) k06345,
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