(225 days)
Not Found
Not Found
No
The summary describes a nucleic acid probe test for detecting Chlamydia trachomatis. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description or performance studies. The focus is on the biological assay and specimen processing.
No.
This device is an in vitro diagnostic test used for the qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis to aid in diagnosis, not for treating or preventing disease.
Yes
The "Intended Use" section explicitly states that the assay is "intended for use... to aid in the diagnosis of chlamydial urogenital disease."
No
The device description explicitly mentions physical components like a transport tube, transport media, and a penetrable cap, indicating it is a hardware-based assay kit, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro qualitative detection" test. This phrase is a key indicator of an In Vitro Diagnostic device, as it describes a test performed outside of the body on biological samples to diagnose a condition.
N/A
Intended Use / Indications for Use
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) in 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 collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.
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.
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 to include PreservCyt liquid Pap specimens (collected and processed by the Cytyc ThinPrep 2000 Processor) as acceptable testing specimens. The ancillary kit formulated for this specific application is the commercially available 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 Specimen Transfer Kit may only be used in conjunction with GEN-PROBE APTIMA Assays for the detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endocervical, vaginal, male urethral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician-collected, patient-collected
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
A prospective multi-center clinical study was conducted to evaluate the use of the PreservCyt Solution (a component of the ThinPrep 2000 System) as an alternative medium for gynecological specimens for the detection of CT by the APTIMA CT Assay. One thousand six hundred forty-seven (1,647) symptomatic and asymptomatic female subjects attending OB/GYN, family planning, public health, women's, and STD clinics were evaluated in the clinical study. Of the 1,647 evaluable subjects, 1,288 were asymptomatic subjects and 359 were symptomatic subjects. Subjects were enrolled from sites with CT prevalence that ranged from 2.8% to 14.0%.
Two specimens were collected from each eligible subject: one PreservCyt Solution liquid Pap specimen and one endocervical swab specimen. PreservCyt Solution liquid Pap specimens were collected with the spatula/cyto-brush or a broom-like brush cervical sampling device. The distribution of cervical sampling devices is summarized in Table 3 by specimen collection site and overall.
PreservCyt Solution liquid Pap specimens were processed in accordance with the ThinPrep 2000 Processor Operator's Manual and APTIMA Specimen Transfer Kit Package Insert. After processing the PreservCyt Solution liquid Pap specimen with the ThinPrep 2000 Processor, the specimen was transferred into the APTIMA Specimen Transfer Kit for testing with the APTIMA CT Assay.
Sensitivity and specificity of the APTIMA CT Assay in PreservCvt Solution liguid Pap specimens were calculated by comparing results to a patient infected status algorithm. The algorithm included APTIMA Combo 2 Assay and APTIMA CT Assay results in endocervical swab specimens. Both reference NAATs were required to be positive to establish an infected patient status. At least one reference NAAT was required to be negative to establish a noninfected patient status.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Study
Sample Size: 1,647 female subjects
Key Results:
Overall sensitivity was 95.6% (86/90). In symptomatic and asymptomatic subjects, sensitivities were 96.7% (29/30) and 95.0% (57/60), respectively. Overall specificity was 98.8% (1539/1557). In symptomatic and asymptomatic subjects, specificities were 98.8% (325/329) and 98.9% (1214/1228), respectively.
Sensitivities ranged from 92.9% to 100%. Specificities ranged from 96.5% to 100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall sensitivity: 95.6% (86/90)
Sensitivity in symptomatic subjects: 96.7% (29/30)
Sensitivity in asymptomatic subjects: 95.0% (57/60)
Overall specificity: 98.8% (1539/1557)
Specificity in symptomatic subjects: 98.8% (325/329)
Specificity in asymptomatic subjects: 98.9% (1214/1228)
Site 1: Sensitivity 100% (14/14), Specificity 96.5% (83/86), PPV 82.4%, NPV 100%
Site 2: Sensitivity 100% (4/4), Specificity 100% (120/120), PPV 100%, NPV 100%
Site 3: Sensitivity 93.5% (29/31), Specificity 98.6% (438/444), PPV 82.9%, NPV 99.5%
Site 4: Sensitivity 100% (8/8), Specificity 98.6% (275/279), PPV 66.7%, NPV 100%
Site 5: Sensitivity 92.9% (13/14), Specificity 98.9% (280/283), PPV 81.3%, NPV 99.6%
Site 6: Sensitivity 94.7% (18/19), Specificity 99.4% (343/345), PPV 90.0%, NPV 99.7%
Overall: Sensitivity 95.6% (86/90), Specificity 98.8% (1539/1557), PPV 82.7%, NPV 99.7%
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo and text for GEN-PROBE INCORPORATED. The logo is a stylized black shape on the left. Below the company name is the text "APTIMA Assay for Chlamydia trac."
APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimens
GEN-PROBE® APTIMA® Assay for Chlamydia trachomatis
IJUL 2 5 2006
General Information
| Submitted By: | Company Contact: |
|---|---|
| Gen-Probe Incorporated | Brian J. Shea, RAC |
| 10210 Genetic Center Drive | Regulatory Affairs Associate |
| San Diego, California 92121 | |
| phone: (858) 410-8000 | phone: (858) 410-8535 |
| fax: (858) 410-8622 | fax: (858) 410-8622 |
| e-mail: brians@gen-probe.com | |
| Trade Name: | GEN-PROBE® APTIMA® Assay for Chlamydia trachomatis |
| Common or Usual Name: | rRNA target-amplified nucleic acid probe test for the in vitro |
| diagnostic detection of Chlamydia trachomatis | |
| Classification Name: | DNA Probe, Nucleic Acid Amplification, 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 Device:
GEN-PROBE® APTIMA® Assay for Chlamydia trachomatis
1
Image /page/1/Picture/0 description: The image shows a black and white graphic of a stylized fist. The fist is clenched and angled slightly to the right. The design is simple and bold, with clean lines and a focus on the shape of the fist. The background is plain white, which makes the black fist stand out.
PTIMA Assay for Chlamydia trachomtias - Expanded Indication: ThinPrep Specimens
Device Description
Clearance of this premarket notification extends the clinical performance claims of the commercially available GEN-PROBE APTIMA Assay for Chlamydia trachomatis to include PreservCyt liquid Pap specimens (collected and processed by the Cytyc ThinPrep 2000 Processor) as acceptable testing specimens. The ancillary kit formulated for this specific application is the commercially available 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 Specimen Transfer Kit may only be used in conjunction with GEN-PROBE APTIMA Assays for the detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae.
Intended Use
APTIMA Assay for Chlamydia trachomatis 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) in 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 collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.
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.
2
APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimens
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.
APTIMA Assay for Chlamydia trachomatis
A complete description of the APTIMA Assay for Chlamydia trachomatis is provided in the commercialized package insert.
3
Image /page/3/Picture/0 description: The image contains a black and white graphic. The graphic appears to be a stylized symbol or logo. It is composed of geometric shapes, primarily angled lines and curves, forming an abstract design. The symbol is solid black against a white background, creating a high contrast image.
GEN-PROBE INCORPORATED PTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimens
Summary of Non-Clinical (Analytical Laboratory) Performance Data
Limit of Detection (Analytical Sensitivity)
C. trachomatis analytical sensitivity (limit of detection) was determined by directly comparing dilutions of CT organisms in cell culture and in the APTIMA CT assay. The analytical sensitivity claim for the assay is one Inclusion-Forming Unit (IFU) per assay (7.25 IFU/swab, 5 IFU/mL urine, and 9.75 IFU/mL PreservCyt Solution liquid Pap) for all 15 CT serovars. However, dilutions of less than one IFU/assay of all serovars tested positive.
Analytical Specificity
A total of 154 culture isolates were evaluated using the APTIMA CT Assay. These isolates included 86 organisms that may be isolated from the urogenital tract and 68 additional organisms that represent a phylogenetic cross-section of organisms. The tested organisms included bacteria, fungi, yeast, parasites and viruses. All organisms except C. psittaci, C. pneumoniae, U. urealyticum and the viruses were tested at 1.0x100 cells/assay in Kova-trol/Urine Transport Media and 60 organisms were tested in Swab Transport Media. The Chlamydia and Neisseria organisms were tested in the PreservCyt Solution media. C. psittaci VR601 was tested at 8x104 cells/assay and C. psittaci VR125 was tested at 1x105 cells/assay. C. pneumoniaewas tested at 4x103 cells/assay and U. urealyticum was tested at 6.7x106 cells/assay. The viruses were tested as follows: (a) herpes simplex virus I: 2.5x104 TCID50/assay, (b) herpes simplex virus II: 6.0x104 TCID50/assay, (c) human papillomavirus 16: 2.9x106 DNA copies/assay and (d) cytomegalovirus: 4.8x10 cells/assay. The list of organisms tested is shown in Table 1.
4
APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimens
| Table 1 - APTIMA CT Assay Analytical Specificity
| ORGANISM | ORGANISM | ORGANISM |
|---|---|---|
| Achromobacter xerosis | Escherichia coli | Neisseria mucosa (3) |
| Acinetobacter calcoaceticus | Flavobacterium meningosepticum | Neisseria sicca (3) |
| Acinetobacter Iwoffi | Fusobacterium nucleatum | Neisseria subflava (14) |
| Actinomyces israelii | Gardnerella vaginalis | Neisseria perflava |
| Actinomyces pyogenes | Gemella haemolysans | Neisseria polysaccharea |
| Aerococcus viridans | Haemophilus ducreyi | Paracoccus denitrificans |
| Aeromonas hydrophila | Haemophilus influenzae | Peptostreptococcus |
| anaerobius | ||
| Agrobacterium radiobacter | Herpes simplex virus I | Peptostreptococcus |
| productus | ||
| Alcaligenes faecalis | Herpes simplex virus II | Plesiomonas shigelloides |
| Bacillus subtilis | Human papilloma virus 16 | Propionibacterium acnes |
| Bacteriodes fragilis | Kingella dentrificans | Proteus mirabilis |
| Bacteriodes ureolyticus | Kingella kingae | Proteus vulgaris |
| Bifidobacterium adolescentis | Klebsiella oxytoca | Providencia stuartii |
| Bifidobacterium brevi | Klebsiella pneumoniae | Pseudomonas aeruginosa |
| Branhamella catarrhalis | Lactobacillus acidophilus | Pseudomonas fluorescens |
| Brevibacterium linens | Lactobacillus brevis | Pseudomonas putida |
| Campylobacter jejuni | Lactobacillus jensonii | Rahnella aquatilis |
| Candida albicans | Lactobacillus lactis | Rhodospirillum rubrum |
| Candida glabrata | Legionella pneumophila (2) | Saccharomyces cerevisiae |
| Candida parapsilosis | Leuconostoc paramensenteroides | Salmonella minnesota |
| Candida tropicalis | Listeria monocytogenes | Salmonella typhimurium |
| Chlamydia pneumoniae | Micrococcus luteus | Serratia marcescens |
| Chlamydia psittaci (2) | Moraxella lacunata | Staphylococcus |
| saprophyticus | ||
| Chromobacterium violaceum | Moraxella osloensis | Staphylococcus aureus |
| Citrobacter freundii | Morganella morganii | Staphylococcus |
| epidermidis | ||
| Clostridium perfringens | Mycobacterium smegmatis | Streptococcus agalactiae |
| Corynebacterium genitalium | Mycoplasma genitalium | Streptococcus bovis |
| Corynebacterium xerosis | Mycoplasma hominis | Streptococcus mitis |
| Cryptococcus neoformans | N. meningitidis Serogroup A | Streptococcus mutans |
| Cytomegalovirus | N. meningitidis Serogroup B | Streptococcus pneumoniae |
| Deinococcus radiodurans | N. meningitidis Serogroup C (4) | Streptococcus pyogenes |
| Derxia gummosa | N. meningitidis Serogroup D | Streptococcus salivarius |
| Eikenella corrodens | N. meningitidis Serogroup Y | Streptococcus sanguis |
| Enterobacter aerogenes | N. meningitidis Serogroup W135 | Streptomyces griseinus |
| Enterobacter cloacae | Neisseria cinerea (4) | Trichomonas vaginalis |
| Entercoccus avium | Neisseria dentrificans | Ureaplasma urealyticum |
| Entercoccus faecalis | Neisseria elongata (3) | Vibrio parahaemolyticus |
| Entercoccus faecium | Neisseria flava | Yersinia enterocolitica |
| Erwinia herbicola | Neisseria flavescens (2) | |
| Erysipelothrix rhusiopathiae | Neisseria lactamica (9) |
A PTIMA CT Assay Analytical Specificity Table
(n) = number of strains tested
All organisms tested produced a negative result in the APTIMA CT Assay.
5
APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimens
Interference Studies
The following interfering substances were individually spiked into swab, PreservCyt liquid Pap and/or urine specimens: 10% blood, contraceptive jelly, spermicide, moisturizer, hemorrhoidal anesthetic, body oil, powder, anti-fungal cream, vaginal lubricants, femininc spray and leukocytes (1x106 cells/mL). The following interfering substances were individually spiked into urine specimens: 30% blood, urine analytes, protein, glucose, ketones, bilirubin, nitrate, urobilinogen, pH 4 (acidic), pH 9 (alkaline), leukocytes (1x106 cells/mL), cellular debris, vitamins, minerals, acetaminophen, aspirin and ibuprofen. All were tested for potential assay interference in the absence and presence of CT at the estimated rRNA equivalent of 1 cell/assay (5 fg/assay). The rRNA equivalents were calculated based on the genome size and estimated DNA:RNA ratio/cell of each organism. No interference was observed with any of the tested substances. No inhibitors of amplification were observed in the APTIMA CT Assay.
Recovery
Escherichia coli, Gardnerella vaginalis, Lactobacillus acidophilus, Bacteroides ureolyticus, and Staphylococcus epidermidis (1 x 10° cells/assay) were added to samples containing the rRNA equivalent of approximately one CT IFU (5 fg). These additions did not interfere with the amplification and detection of CT rRNA using the APTIMA CT Assay.
Liquid Pap Specimen Stability Studies
Data to support the recommended shipping and storage conditions for PreservCyt Solution liquid Pap samples were generated with negative processed and unprocessed liquid Pap samples. For the unprocessed samples, four pools of PreservCyt Solution samples were tested after being stored in the Cytyc PreservCyt Solution vial. Each specimen pool was spiked with 1-10 IFU CT/assay, held at 2°C, 10°C, and 30°C, then tested at baseline and on days 5, 7, 8, 14, 18, 21, 25 and 36 depending on the storage
6
APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimens
temperature. All of the spiked samples were positive for CT at all times and temperatures.
For the processed samples, four pools of PreservCyt Solution samples were used to determine processed specimen stability at 2℃ to 30℃. Each negative sample pool was spiked with 1-10 IFU CT/assay, then tested at baseline. Prior to processing, the PreservCyt Solution samples were stored at 30℃ for seven (7) days to simulate the time lapse between sample collection, Pap processing and shipment to a microbiology testing lab. After seven days at 30°C, 1 mL aliquots of each pool were transferred to an APTIMA Specimen Transfer Tube and tested at baseline before being placed at 2°C, 10°C, and 30°C. The processed samples were then tested for 17 days stored at 30°C and 36 days stored at 2°C to 10°C. All of the spiked samples were positive for CT at all times and temperatures.
Data to support longer storage conditions were generated from four pools of negative processed PreservCyt Solution samples tested at below freezing temperatures. Each pool was spiked with 1-10 IFU CT/assay, then tested at baseline. Each pool was first placed at 30°C for 14 days and then stored at -20°C or -70°C over the course of 106 days. All of the spiked samples were positive for CT at all times and temperatures.
Precision
PreservCyt specimen within-laboratory precision with the ACT Assay was determined by spiking PreservCyt vials with 20 CT IFU per vial (0.1 IFU per reaction) and 100 CT IFU per vial (0.5 IFU per reaction). Vials containing 1,000 CT IFU per vial (5 IFU per reaction) and unspiked PreservCyt vials were tested as positive and negative controls. Ten vials spiked at each IFU level and ten unspiked vials were divided between two operators. The operators vortexed the vials and then transferred 14 aliquots (1.0 mL each) per vial into 14 APTIMA Transfer Tubes as per the APTIMA Specimen Transfer Kit package insert. The operators were blinded to the samples' titers. Each of the resulting Pap-STM samples was tested once in the ACT Assay. A total of five runs were
7
Image /page/7/Picture/0 description: The image shows the text "GEN-PROBE INCORPORATED" in a bold, sans-serif font. The text is arranged horizontally, with each word clearly legible. The word "GEN-PROBE" is hyphenated. A black arrow is pointing to the text.
APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimens
performed over a five-day period for 140 results at each IFU level. The results are summarized in Table 2.
8
PTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimen N-PROBE INCORPORAT
Table 2: APTIMA CT Assay Within-Laboratory Precision Data for PreservCyt Using a 4-Member Precision Panel Containing
to 1000 IFU/20 mL of CT Cells.
| Panel | IFU/20ml | IFU! | | | ్టర్లి మైన | Mean
RU | Within-Operator | | Between-Da | | Operator
0 | etween- | Total | |
|-------|-----------------------------------------|------|-----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-------------|----------|---------------|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Member PreservCy | rxn | tl | Agreed | Agrit. | ×1000 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
x1000
SD | (%)
CV | x1000
SD | (%
CV | (x1000
SD | (%)
CV | x1000
SD | (%
CV |
| ્ | 07 | i | 140 | 140 | 100 | 6501.7 | 734.8 | 11.3 | ੀ | 0.0 | 546.9 | 8 4 | THE ARREAL COLLECTION OF CONSULT OF CHEARTH A
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9
APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimens
PreservCyt Liquid Pap Specimen Clinical Study Results
A prospective multi-center clinical study was conducted to evaluate the use of the PreservCyt Solution (a component of the ThinPrep 2000 System) as an alternative medium for gynecological specimens for the detection of CT by the APTIMA CT Assay. One thousand six hundred forty-seven (1,647) symptomatic and asymptomatic female subjects attending OB/GYN, family planning, public health, women's, and STD clinics were evaluated in the clinical study. Of the 1,647 evaluable subjects, 1,288 were asymptomatic subjects and 359 were symptomatic subjects. Subjects were enrolled from sites with CT prevalence that ranged from 2.8% to 14.0%.
Two specimens were collected from each eligible subject: one PreservCyt Solution liquid Pap specimen and one endocervical swab specimen. PreservCyt Solution liquid Pap specimens were collected with the spatula/cyto-brush or a broom-like brush cervical sampling device. The distribution of cervical sampling devices is summarized in Table 3 by specimen collection site and overall.
PreservCyt Solution liquid Pap specimens were processed in accordance with the ThinPrep 2000 Processor Operator's Manual and APTIMA Specimen Transfer Kit Package Insert. After processing the PreservCyt Solution liquid Pap specimen with the ThinPrep 2000 Processor, the specimen was transferred into the APTIMA Specimen Transfer Kit for testing with the APTIMA CT Assay.
Sensitivity and specificity of the APTIMA CT Assay in PreservCvt Solution liguid Pap specimens were calculated by comparing results to a patient infected status algorithm. The algorithm included APTIMA Combo 2 Assay and APTIMA CT Assay results in endocervical swab specimens. Both reference NAATs were required to be positive to establish an infected patient status. At least one reference NAAT was required to be negative to establish a noninfected patient status. Table 4 summarizes the frequency of test outcomes for the two reference NAATs.
10
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APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimens
Table 5 shows the sensitivities and specificities of the APTIMA CT Assay by symptom status and overall. Overall sensitivity was 95.6% (86/90). In symptomatic and asymptomatic subjects, sensitivities were 96.7% (29/30) and 95.0% (57/60), respectively. Overall specificity was 98.8% (1539/1557). In symptomatic and asymptomatic subjects, specificities were 98.8% (325/329) and 98.9% (1214/1228), respectively.
Table 6 shows the sensitivities and specificities of the APTIMA CT Assay by specimen collection site and overall. Sensitivities ranged from 92.9% to 100%. Specificities ranged from 96.5% to 100%.
11
GEN-PROBE INCORPORATED
APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimen
able 3: Distribution of Cervical Sampling Device Used for PreservCyt Liquid Pap Specimen
| Cervical Sampling Device Used | Clinical Collection Site | 1 | 2 | 3 | 4 | 5 | 6 | Total |
|---|---|---|---|---|---|---|---|---|
| Spatula/Cytobrush | 0 | 124 | 475 | 287 | 57 | 364 | 1307 | |
| Broom-Type Device | 100 | 0 | 0 | 0 | 240 | 0 | 340 |
'able 4: PreservCyt Solution Liquid Pap Specimen Analysis for Patient Infected Statu
| | | Endocervical Swab | | Symptom Status | | | | APTIMA CT
PreservCyt
Solution result | +/+ | +/- | -/+ | -/- | Sensitivity (%)
(95% CI) | Specificity (%)
(95% CI) |
|-----|-------------------------|-------------------------|--------------------|----------------|--------------|-------------------------------|-----------------------------------|--------------------------------------------|-----|-----|-----|------|-------------------------------|-----------------------------------|
| | Patient Infected Status | APTIMA COMBO
2 Assay | APTIMA CT
Assay | Symptomatic | Asymptomatic | Total | Symptomatic | Positive | 29 | 0 | 1 | 3 | 96.7 (29/30)
(82.8 – 99.9) | 98.8 (325/329)
(96.9 – 99.7) |
| | Infected | Positive | Positive | 30 | 60 | | Symptomatic | Negative | 1 | 3 | 3 | 319 | | |
| | Non-Infected | Negative | Negative | 322 | 1214 | | Symptomatic | Total | 30 | 3 | 4 | 322 | | |
| | Non-Infected | Negative | Positive | 4 | 12 | | Asymptomatic | Positive | 57 | 0 | 1 | 13 | 95.0 (57/60)
(86.1 – 99.0) | 98.9 (1214/1228)
(98.1 – 99.4) |
| | Non-Infected | Positive | Negative | 3 | 2 | | Asymptomatic | Negative | 3 | 2 | 11 | 1201 | | |
| | Total | | | 359 | 1288 | | Asymptomatic | Total | 60 | 2 | 12 | 1214 | | |
| All | Positive | 86 | 0 | 2 | 16 | 95.6 (86/90)
(89.0 – 98.8) | 98.8 (1539/1557)
(98.2 – 99.3) | | | | | | | |
| All | Negative | 4 | 5 | 14 | 1520 | | | | | | | | | |
| All | Total | 90 | 5 | 16 | 1536 | | | | | | | | | |
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APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimen N-PROBE INCORPORATE
'able 5: Sensitivity and Specificity of the APTIMA CT Assay Relative to Patient Infected Status by Symptom Stat nd Overall for PreservCyt Solution Liquid Pap Specimen
.
বিভ্যাশ
বিভাগ
বিভাগ
বিভাগ
বিভাগ বিভাগ
বিভাগ বিভাগ = = Noservical swab speciment in the APTIMA COMEO 2 Assaylbegives wab spainer resuli in beFTMA (min PTMA PTIMA PTMA
= Negative endocervical swab specimentes (PTIMA COMBO 2 As 1
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APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimen EN-PROBE INCORPORATE
'able 6: Sensitivity, Specificity and Predictive Values of the APTIMA CT Assay Relative to Patient Infected Status Clinical Site and Overall for PreservCyt Solution Liquid Pap Specimen
| Site | APTIMA CT
PreservCyt
Solution
Result | ++ | +/- | -+ | -- | Prev
(%) | Sensitivity
(%) (95% C.I.) | Specificity (%
(95% C.I.) | PPV (%) | NPV (%) |
|------|-----------------------------------------------|----|-----|----|------|-------------|-------------------------------|---------------------------------------|---------|---------|
| 1 | Positive | 14 | 0 | 1 | 2 | 14.0 | 100 (14/14)
(76.8 – 100) | 96.5 (83/86)
(90.1 – 99.3) | 82.4 | 100 |
| | Negative | 0 | 0 | 0 | 83 | | | | | |
| | Total | 14 | 0 | 1 | 85 | | | | | |
| 2 | Positive | 4 | 0 | 0 | 0 | 3.2 | 100 (4/4)
(39.8 – 100) | 100 (120/120)
(97.0 – 100) | 100 | 100 |
| | Negative | 0 | 0 | 2 | 118 | | | | | |
| | Total | 4 | 0 | 2 | 118 | | | | | |
| 3 | Positive | 29 | 0 | 0 | 6 | 6.5 | 93.5 (29/31)
(78.6 – 99.2) | 98.6 (438/444)
(97.1 – 99.5) | 82.9 | 99.5 |
| | Negative | 2 | 0 | 2 | 436 | | | | | |
| | Total | 31 | 0 | 2 | 442 | | | | | |
| 4 | Positive | 8 | 0 | 0 | 4 | 2.8 | 100 (8/8)
(63.1 – 100) | 98.6 (275/279)
(96.4 – 99.6) | 66.7 | 100 |
| | Negative | 0 | 3 | 1 | 271 | | | | | |
| | Total | 8 | 3 | 1 | 275 | | | | | |
| 5 | Positive | 13 | 0 | 0 | 3 | 4.7 | 92.9 (13/14)
(66.1 – 99.8) | 98.9 (280/283)
(96.9 – 99.8) | 81.3 | 99.6 |
| | Negative | 1 | 1 | 4 | 275 | | | | | |
| | Total | 14 | 1 | 4 | 278 | | | | | |
| 6 | Positive | 18 | 0 | 1 | 1 | 5.2 | 94.7 (18/19)
(74.0 – 99.9) | 99.4 (343/345)
(97.9 – 99.9) | 90.0 | 99.7 |
| | Negative | 1 | 1 | 5 | 337 | | | | | |
| | Total | 19 | 1 | 6 | 338 | | | | | |
| All | Positive | 86 | 0 | 2 | 16 | 5.5 | 95.6 (86/90)
(89.0 – 98.8) | 98.8 (1539/
1557)
(98.2 – 99.3) | 82.7 | 99.7 |
| | Negative | 4 | 5 | 14 | 1520 | | | | | |
| | Total | 90 | 5 | 16 | 1536 | | | | | |
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APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimens
Prevalence
The prevalence of CT in patient populations depends on risk factors such as age, gender, the presence of symptoms, the type of clinic, and the test method. A summary of the prevalence of CT, for PreservCyt specimens, is shown in Table 7.
Table 7: Prevalence of C. trachomatis by Clinical Site and Overall as Determined by APTIMA CT Assay Results Using PreservCyt Solution Liquid Pap Specimens
| Site | % (#positive / #tested) | |
|---|---|---|
| 1 | 17.0 | (17/100) |
| 74 | 3.2 | (4/124) |
| ﻟﻠﻘﺐ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | 7.4 | (35/475) |
| 4 | 4.2 | (12/287) |
| 5 | 5.4 | (16/297) |
| ్రీ | 5.5 | (20/364) |
| All | 6.3 | (104/1647) |
Conclusions from Non-Clinical and Clinical Data
The non-clinical and clinical study results support the use of PreservCyt liquid Pap specimens collected and processed by the Cytyc ThinPrep 2000 Processor in the currently marketed GEN-PROBE APTIMA Assay for Chlamydia trachomatis. The currently marketed GEN-PROBE APTIMA Specimen Transfer Kit provides necessary materials and instructions to allow for the testing of PreservCyt liquid Pap specimens in the APTIMA CT Assay.
The results of the clinical study demonstrate reasonable evidence that when the APTIMA CT Assay and the APTIMA Specimen Transfer Kit are labeled as proposed, the APTIMA CT Assay continues to be safe and effective for its stated intended use.
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APTIMA Assay for Chlamydia trachomtias – Expanded Indication: ThinPrep Specimens
Contraindications and Cautions
There are no contraindications or cautions.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 25 2006
Brian Shea, RAC Regulatory Affairs Associate Gen-Probe Incorporated 10210 Genetic Center Drive San Diego, CA 92121
Re: K053446
Trade/Device Name: GEN-PROBE® APTIMA® Assay for Chlamydia trachomatis Regulation Number: 21 CFR 866.3120 Regulation Name: Chlamydia serological reagents Regulatory Class: Class I Product Code: MKZ Dated: June 8, 2006 Received: June 9, 2006
Dear Mr. Shea:
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 (Spccial 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 Iogal|y marketed predicate device results in a classification for your device and thus, perroits 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 vours.
Sally, artm
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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Indications for Use
510(k) Number (if known):
Device Name: _GEN-PROBE® APTIMA® Assay for Chlamydia trachomatis
Indications For Use:
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) in 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 collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.
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 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Freddie Poole
Division Sign-Off
Division Sign-Off
Office of In Titre Diagnostic Device Evaluation and Surery
1001 K053446