(167 days)
Not Found
No
The device description mentions an "automated algorithm" for reporting results, but this is a standard term for a set of predefined rules or calculations, not necessarily indicative of AI/ML which typically involves learning from data. There is no mention of training data, models, or any other AI/ML specific terminology.
No.
This device is an in vitro diagnostic (IVD) device used to detect Chlamydia trachomatis DNA to aid in the diagnosis of chlamydial urogenital disease, not to treat it.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is "indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease."
No
The device description clearly outlines the use of physical reagents (dried in microwells), enzymes, and a hardware system (BD Viper™ System) for amplification and detection. While there is an automated algorithm for result reporting, the core of the device is a laboratory-based assay with physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the direct, qualitative detection of Chlamydia trachomatis DNA... to aid in the diagnosis of chlamydial urogenital disease." This clearly indicates the device is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details the process of analyzing biological specimens (swabs and urine) using chemical and biological reagents (primers, probes, enzymes) to detect a specific analyte (Chlamydia trachomatis DNA). This is a hallmark of an in vitro diagnostic test.
- Specimen Types: The device is designed to be used with human specimens (endocervical swabs, urethral swabs, vaginal swabs, and urine).
- Performance Studies: The document includes performance studies evaluating the device's ability to accurately detect the target analyte in human specimens, providing metrics like sensitivity and specificity, which are standard for IVD validation.
- Predicate Devices: The mention of predicate devices (BD ProbeTec ET CT/GC Amplified DNA Assay and APTIMA Combo 2 Assay) which are known IVDs further supports the classification of this device as an IVD.
Therefore, based on the provided information, the BD ProbeTec Chlamydia trachomatis (CT) Q* Amplified DNA Assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD ProbeTec Chlamydia trachomatis (CT) Q* Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis DNA in cliniciancollected female endocervical and male urethral swabs, patient-collected vaginal swab specimens (in a clinical setting), and female and male urine specimens. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.
Product codes (comma separated list FDA assigned to the subject device)
MKZ
Device Description
The BD ProbeTec CT Q Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe. The reagents for SDA are dried in two separate disposable microwells: the Priming Microwell contains the amplification primers, fluorescently-labeled detector probe, nucleotides and other reagents necessary for amplification, while the Amplification Microwell contains the two enzymes (a DNA polymerase and a restriction endonuclease) that are required for SDA. The BD Viper™ System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermallycontrolled fluorescent readers. The presence or absence of C. trachomatis DNA is determined by calculating the peak fluorescence (Maximum Relative Fluorescent Units (MaxRFU)) over the course of the amplification process and by comparing this measurement to a predetermined threshold value.
In addition to the fluorescent probe used to detect amplified C. trachomatis target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the C. trachomatis-specific target and is used to confirm the validity of the extraction process. The EC is dried in the Extraction Tubes and is rehydrated upon addition of the specimen and extraction reagents. At the end of the extraction process, the EC fluorescence is monitored by the BD Viper System and an automated algorithm is applied to both the EC and C. trachomatis-specific signals to report results as positive, negative, or EC failure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Female endocervical, male urethral, vaginal, urogenital
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician, Clinical setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Clinician-collected endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female Q UPT and neat urine specimens were collected from 1059 female subjects and 479 male subjects attending OB/GYN, sexually transmitted disease (STD) and family planning clinics at seven geographically diverse clinical sites in North America. Subjects were classified as symptomatic if they reported symptoms such as dysuria, urethral discharge, coital pain/difficulty/bleeding, testicular or scrotum pain/swelling, abnormal vaginal discharge, or pelvic/uterine/adnexal pain. Subjects were classified as asymptomatic if they did not report symptoms. Sixty five female subjects and 7 male subjects were excluded from the data analysis due to age requirement violations, antibiotic treatment in the last 21 days, opting to withdraw from the study after initially consenting, failure to obtain paired swab and urine specimens, urine quantity less than 20 mL, or transport and storage errors related to specimen collection. Therefore, the final data analysis included 994 compliant female subjects and 472 compliant male subjects. Total of 5388 CT Q* Assay results was used.
Five specimens were collected from each of the 994 eligible female subjects. A urine specimen was collected and split into Q UPT, neat urine and the two reference urine specimen collection devices followed by a vaginal swab specimen and three randomized endocervical swab specimens. Up to four specimens were collected from each of the 472 eligible male subjects. Up to three randomized urethral swab specimens were collected followed by a urine specimen that was split into Q UPT, neat urine and the two reference urine specimen collection devices. BD ProbeTec CT Q assay results were generated from the Q UPT and neat urine specimens, the vaginal swab specimen, one endocervical swab specimen and one male urethral swab specimen. The remaining two endocervical swab specimens, up to two male urethral swab specimens, and the two reference urine specimens for each male and female subject were tested using two reference methods: the BD ProbeTec ET CT/AC assay and another commercially available NAAT (Nucleic Acid Amplification Test). Specimen testing was conducted either at the site of specimen collection or at a designated BD Viper testing site.
Annotation Protocol: All performance calculations were based on the total number of BD ProbeTec CT Q assays results for endocervical, vaginal and male urethral swab specimens, and male and female Q UPT and neat urine specimens compared to a patient infected status (PIS) algorithm for each gender. In the algorithm, the designation of a subject as being infected with CT or not was based on endocervical swab and urine specimen results from the commercially available BD ProbeTec ET CT/AC assay and the other commercially available NAAT. Subjects were considered infected with CT if two of the four endocervical swab and urine specimens (or two of the three or four urethral swab and urine specimens) tested positive in the BD ProbeTec ET CT/AC assay and the other reference NAAT (one specimen testing positive in each NAAT). Subjects were considered non-infected if less than two reference NAAT results were positive.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance Characteristics:
- Limit of Detection (Analytical Sensitivity): The LODs for the CT Q* Assay with C. trachomatis serovar H in urine and swab specimens when extracted on the BD Viper System were determined to be ≤15 CT elementary bodies (EB) per mL for neat and UPT treated urine and ≤30 CT EB per mL for expressed vaginal and endocervical swab specimens. A correlation of EB to IFU suggests that the CT Q* assay LODs with serovar H in urine and swab specimens correspond to ≤ 1 IFU per mL (15). The CT Q* Assay on the BD Viper System in extracted mode was able to detect 16 CT serovars with ≥ 95% proportion positive at a concentration of 15 EB per mL in Q* Swab Diluent.
- Analytical Specificity: 141 organisms were tested. All potential cross-reactive species were tested at ≥ 1x10^6 cells/mL except where noted. The CT Q Assay did not cross-react with any of the organisms tested.
- Interfering Substances: Potential interfering substances in swab and/or urine specimens were tested. Results indicated no interference for various substances in blood, seminal fluid, mucus, vaginal products, prescription treatments, leukocytes, antibiotics, analgesics, deodorant sprays, powders, hormones, albumin, glucose, acidic/alkaline urine, bilirubin, and UTC infection organisms. Blood (> 60%) in swab specimens may cause extraction control (EC) failures.
Clinical Performance Characteristics:
- Study Type: Clinical study comparing BD ProbeTec CT Q* Assay results to a patient infected status (PIS) algorithm.
- Sample Size: 994 compliant female subjects and 472 compliant male subjects. Total of 5388 BD ProbeTec CT Q* Assay results.
- Key Results: Sensitivity and Specificity by specimen type and symptomatic status are presented in Table 3.
- For Female Endocervical Swabs (FS) (N=993): Sensitivity 91.3% (105/115), Specificity 98.3% (863/878).
- For Female Vaginal Swabs (FV) (N=993): Sensitivity 96.5% (111/115), Specificity 99.2% (871/878).
- For Female Neat Urine (FN) (N=993): Sensitivity 93.0% (107/115), Specificity 99.4% (873/878).
- For Female Urine in Q* UPT (FUPT) (N=993): Sensitivity 93.0% (107/115), Specificity 99.2% (871/878).
- For Male Urethral Swabs (MS) (N=472): Sensitivity 92.1% (93/101), Specificity 98.4% (365/371).
- For Male Neat Urine (MN) (N=472): Sensitivity 98.0% (99/101), Specificity 99.2% (368/371).
- For Male Urine in Q* UPT (MUPT) (N=472): Sensitivity 98.0% (99/101), Specificity 98.1% (364/371).
- Overall Total (N=5388): Sensitivity 94.5% (721/763), Specificity 98.9% (4575/4625).
- Reproducibility: Evaluated at three clinical sites on one BD Viper System per site using a panel of simulated specimens. Nine replicates of each panel member were tested every day for five days.
- Endocervical/Urethral (0 EB/mL): % Correct 98.5% (133/135), MaxRFUMean 29.9.
- Endocervical/Urethral (30 EB/mL): % Correct 100.0% (135/135), MaxRFUMean 2011.2.
- Urine/Vaginal (0 EB/mL): % Correct 100.0% (135/135), MaxRFUMean 0.9.
- Urine/Vaginal (30 EB/mL): % Correct 100.0% (135/135), MaxRFUMean 1999.8.
- System Reproducibility at Target Levels below the Analytical Limit of Detection:
- Endocervical/Urethral (1:10 CT): % Positive 70.2% (158/225), % Negative 29.8% (67/225).
- Endocervical/Urethral (1:100 CT): % Positive 10.2% (23/225), % Negative 89.8% (202/225).
- Urine/Vaginal (1:10 CT): % Positive 64.4% (145/225), % Negative 35.6% (80/225).
- Urine/Vaginal (1:100 CT): % Positive 10.7% (24/225), % Negative 89.3% (201/225).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity, PPV%, NPV%, % Correct (for reproducibility).
See values in "Summary of Performance Studies".
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.
BD ProbeTec ET CT/GC Amplified DNA Assay (K984631), APTIMA Combo 2 Assay (K003395)
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
K0Y1324
Image /page/0/Picture/1 description: The image shows the BD logo, which consists of a stylized sun-like symbol with a human figure at the center, followed by the letters "BD" in bold. Below the letters, there is a tagline that reads "Helping all people live healthy lives". The logo is in black and white.
BD ProbeTec™ Chlamydia trachomatis (CT) O* Amplified DNA Assay
510(k) Summary
DEC 11 2008
| Applicant | BD Diagnostic Systems
7 Loveton Circle
Sparks, MD 21152 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No. | 1119779 |
| Contact Person | Kathryn Babka Carr, RAC
tel. 410-316-4260
fax. 410-316-4041
Kathy_Carr@bd.com |
| Summary Date | December 1, 2008 |
| Proprietary Name | BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay |
| Generic Name | DNA probe, nucleic acid amplification, Chlamydia |
| Classification | Class I |
| Classification Name | Chlamydia serological reagents |
| Regulation Number | 866.3120 |
| Product Code | MKZ |
| Predicate Devices | BD ProbeTec ET CT/GC Amplified DNA Assay (K984631),
APTIMA Combo 2 Assay (K003395) |
Device Description
The BD ProbeTec CT Q Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe. The reagents for SDA are dried in two separate disposable microwells: the Priming Microwell contains the amplification primers, fluorescently-labeled detector probe, nucleotides and other reagents necessary for amplification, while the Amplification Microwell contains the two enzymes (a DNA polymerase and a restriction endonuclease) that are required for SDA. The BD Viper™ System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermallycontrolled fluorescent readers. The presence or absence of C. trachomatis DNA is determined by calculating the peak fluorescence (Maximum Relative Fluorescent Units (MaxRFU)) over the course of the amplification process and by comparing this measurement to a predetermined threshold value.
In addition to the fluorescent probe used to detect amplified C. trachomatis target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the C. trachomatis-specific target and is used to confirm the validity of the extraction process. The EC is dried in the Extraction Tubes and is rehydrated
1
Image /page/1/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a stylized sun-like symbol on the left and the letters "BD" in bold, sans-serif font on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller font size.
BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
upon addition of the specimen and extraction reagents. At the end of the extraction process, the EC fluorescence is monitored by the BD Viper System and an automated algorithm is applied to both the EC and C. trachomatis-specific signals to report results as positive, negative, or EC failure.
Intended Use
The BD ProbeTec" CT Q Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swabs, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay is indicated for use with asymptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.
Summary and Principles of Operation
When used with the BD Viper System, the BD ProbeTec CT Q* Amplified DNA Assay (CT Q* Assay) involves automated extraction of DNA from clinical specimens through the chemical lysis of cells, followed by binding of DNA to para-magnetic particles, washing of the bound nucleic acid and elution in an amplification-compatible buffer. When present, C. trachomatis DNA is then detected by Strand Displacement Amplification (SDA) of a specific target sequence in the presence of a fluorescently labeled detector probe.
Analytical Performance Characteristics
Limit of Detection (Analytical Sensitivity)
The Limits of Detection (LODs) for the CT Q* Assay with C. trachomatis serovar H in urine and swab specimens when extracted on the BD Viper System were determined to be ≤15 CT elementary bodies (EB) per mL for neat and UPT treated urine and ≤30 CT EB per mL for expressed vaginal and endocervical swab specimens. A correlation of EB to IFU suggests that the CT Q* assay LODs with serovar H in urine and swab specimens correspond to ≤ 1 IFU per mL (15). The CT Q* Assay on the BD Viper System in extracted mode was able to detect 16 CT serovars with ≥ 95% proportion positive at a concentration of 15 EB per mL in Q* Swab Diluent.
2
Image /page/2/Picture/1 description: The image shows the BD logo, which consists of a stylized sun-like symbol to the left and the letters "BD" in bold to the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives." The logo is in black and white.
BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
Analytical Specificity
The 141 organisms listed in Table 1 were tested with the BD ProbeTec CT Q Amplified DNA Assay on the BD Viper System. All potential cross-reactive species were tested at ≥ 1x10° cells/mL except where noted. The CT Q Assay did not cross-react with any of the organisms tested.
| Acinetobacter calcoaceticus | Epstein Barr Virus *** | Peptostreptococcus productus | Neisseria elongata subsp.
nitroreduscens (2) |
|-----------------------------|-------------------------------------|--------------------------------------|-------------------------------------------------|
| Acinetobacter Iwoffi | Escherichia coli | Plesiomonas shigelloides | Neisseria elongata |
| Actinomyces israelii | Flavobacterium meningosepticum | Propionibacterium acnes | Neisseria flava (4) |
| Adenovirus*** | Gardnerella vaginalis | Providencia stuartii | Neisseria flavescens (4) |
| Aeromonas hydrophilia | Gemella haemolysans | Pseudomonas aeruginosa | Neisseria gonorrhoeae |
| Alcaligenes faecalis* | Haemophilus influenzae | Salmonella minnesota | Neisseria lactamica (7) |
| Bacillus subtilis* | Herpes Simplex Virus ** | Salmonella typhimurium | Neisseria meningitidis (12) |
| Bacteroides fragilis | Human papillomavirus (16 and 18)*** | Staphylococcus aureus | Neisseria mucosa (5) |
| Candida albicans* | Kingella kingae | Staphylococcus epidermidis | Neisseria perflava (8) |
| Candida glabrata* | Klebsiella pneumoniae | Streptococcus agalactiae | Neisseria polysaccharea (2) |
| Candida tropicalis* | Lactobacillus acidophilus* | Streptococcus mitis | Neisseria sicca (5) |
| Chlamydia pneumoniae**** | Lactobacillus brevis | Streptococcus mutans | Neisseria subflava (15) |
| Chlamydia psittaci* | Lactobacillus jensenii* | Streptococcus pneumoniae* | Neisseria weaverii (3) |
| Citrobacter freundii | Listeria monocytogenes | Streptococcus pyogenes | |
| Clostridium perfringens | Mobiluncus mulieris | Streptomyces griseus** | |
| Corynebacterium renale | Moraxella lacunata* | Trichomonas vaginalis** | |
| Cryptococcus neoformans* | Moraxella osloensis | Veillonella parvula | |
| Cytomegalovirus** | Morganella morganii | Vibrio parahaemolyticus | |
| Edwardsiella tarda | Mycobacterium gordonae | Yersinia enterocolitica | |
| Enterobacter cloacae | Mycobacterium smegmatis | Branhamella catarrhalis (5) | |
| Enterococcus faecalis | Peptostreptococcus anaerobius | Neisseria cinerea (2) | |
| Enterococcus faecium | Peptostreptococcus asaccharolyticus | Neisseria elongata ss
glycolytica | |
(n) number of strains tested in the BD ProbeTec CT Q* Assay
- Tested at > 1x10 cells/nL; ** Tested at > 1x10 cells or viral particles per mL; *** Tested at ≥ 1x10 genomic equivalents per mL;
*** tested at ≥ 1x108 TCID30/mL
3
Image /page/3/Picture/1 description: The image shows the BD logo. The logo consists of a stylized sun-like graphic on the left and the letters "BD" in bold font on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller font.
BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
Interfering Substances
Potential interfering substances which may be encountered in swab and/or urine specimens were extracted from urine and vaginal swab matrix in the absence and presence of CT target (30 CT EBs/mL for urine and 90 CT EBs/mL for swabs) and tested with the BD ProbeTec CT Q* Amplified DNA Assay on the BD Viper System. Results are summarized in Table 2.
| Interpretation | Swab | Urine |
|---|---|---|
| No Interference Observed | Blood (≤ 60%) | |
| Seminal Fluid | ||
| Mucus | ||
| Over The Counter vaginal | ||
| products and contraceptives | ||
| Hemorrhoidal cream | ||
| Prescription vaginal treatments | ||
| Leukocytes (1x106 cells/mL) | ||
| 1x106 cells/mL Neisseria | ||
| gonorrhoeae | Blood (1%) | |
| Seminal fluid | ||
| Mucus | ||
| Antibiotics | ||
| Analgesics | ||
| Over The Counter deodorant sprays and | ||
| powders | ||
| Hormones | ||
| Leukocytes | ||
| Albumin 60%) | Not observed |
Table 2: Interfering Substances
Clinical Performance Characteristics
Clinician-collected endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female Q UPT and neat urine specimens were collected from 1059 female subjects and 479 male subjects attending OB/GYN, sexually transmitted disease (STD) and family planning clinics at seven geographically diverse clinical sites in North America. Subjects were classified as symptomatic if they reported symptoms such as dysuria, urethral discharge, coital pain/difficulty/bleeding, testicular or scrotum pain/swelling, abnormal vaginal discharge, or pelvic/uterine/adnexal pain. Subjects were classified as asymptomatic if they did not report symptoms. Sixty five female subjects and 7 male subjects were excluded from the data analysis due to age requirement violations, antibiotic treatment in the last 21 days, opting to withdraw from the study after initially consenting, failure to obtain paired swab and urine specimens, urine quantity less than 20 mL, or transport and storage errors related to specimen collection. Therefore, the final data analysis included 994 compliant female subjects and 472 compliant male subjects.
4
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BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
Five specimens were collected from each of the 994 eligible female subjects. A urine specimen was collected and split into Q UPT, neat urine and the two reference urine specimen collection devices followed by a vaginal swab specimen and three randomized endocervical swab specimens. Up to four specimens were collected from each of the 472 eligible male subjects. Up to three randomized urethral swab specimens were collected followed by a urine specimen that was split into Q UPT, neat urine and the two reference urine specimen collection devices. BD ProbeTec CT Q assay results were generated from the Q UPT and neat urine specimens, the vaginal swab specimen, one endocervical swab specimen and one male urethral swab specimen. The remaining two endocervical swab specimens, up to two male urethral swab specimens, and the two reference urine specimens for each male and female subject were tested using two reference methods: the BD ProbeTec ET CT/AC assay and another commercially available NAAT (Nucleic Acid Amplification Test). Specimen testing was conducted either at the site of specimen collection or at a designated BD Viper testing site.
All performance calculations were based on the total number of BD ProbeTec CT Q assays results for endocervical, vaginal and male urethral swab specimens, and male and female Q UPT and neat urine specimens compared to a patient infected status (PIS) algorithm for each gender. In the algorithm, the designation of a subject as being infected with CT or not was based on endocervical swab and urine specimen results from the commercially available BD ProbeTec ET CT/AC assay and the other commercially available NAAT. Subjects were considered infected with CT if two of the four endocervical swab and urine specimens (or two of the three or four urethral swab and urine specimens) tested positive in the BD ProbeTec ET CT/AC assay and the other reference NAAT (one specimen testing positive in each NAAT). Subjects were considered non-infected if less than two reference NAAT results were positive. A total of 5388 BD ProbeTec CT Q* Assay results was used to calculate sensitivity and specificity. Sensitivity and specificity by specimen type and symptomatic status are presented in Table 3.
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Image /page/5/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of a stylized sunburst with a human figure in the center, followed by the letters "BD" in bold font. Below the letters, the tagline "Helping all people live healthy lives" is printed in a smaller font.
BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
Table 3: CT Q+ Assay Performance Compared to Patient Infected Status (by specimen type and symptomatic status)
| Specimen
Type | Symptomatic | N | Sensitivity | 95% C.I. | Specificity | 95% C.I. | PPV% | NPV% | Error
Initial/Final |
|------------------|-------------|------|-----------------|-----------------|-------------------|----------------|-------|-------|------------------------|
| FS | N | 450 | 93.0% (53/57) | (83.0%-98.1%) | 98.0% (385/393) | (96.0%-99.1%) | 86.9 | 99.0 | 2/0 |
| | Y | 543 | 89.7% (52/58) | (78.8% -96.1%) | 98.6% (478/485) | (97.0%-99.4%) | 88.1 | 98.8 | 1/1 |
| | Total | 993 | 91.3% (105/115) | (84.6%-95.8%) | 98.3% (863/878) | (97.2%-99.0%) | 87.5 | 98.9 | 3/1 |
| FV | N | 449 | 98.2% (56/57) | (90.6%-100.0%) | 99.5% (390/392) | (98.2%-99.9%) | 96.6 | 99.7 | 0/0 |
| | Y | 544 | 94.8% (55/58) | (85.6%-98.9%) | 99.0% (481/486) | (97.6%-99.7%) | 91.7 | 99.4 | 0/0 |
| | Total | 993 | 96.5% (111/115) | (91.3%-99.0%) | 99.2% (871/878) | (98.4%-99.7%) | 94.1 | 99.5 | 0/0 |
| FN | N | 450 | 93.0% (53/57) | (83.0% -98.1%) | 100.0% (393/393) | (99.1%-100.0%) | 100.0 | 99.0 | 0/0 |
| | Y | 543 | 93.1% (54/58) | (83.3%-98.1%) | 99.0% (480/485) | (97.6%-99.7%) | 91.5 | 99.2 | 0/0 |
| | Total | 993 | 93.0% (107/115) | (86.8%-96.9%) | 99.4% (873/878) | (98.7%-99.8%) | 95.5 | 99.1 | 0/0 |
| FUPT | N | 450 | 94.7% (54/57) | (85.4%-98.9%) | 99.5% (391/393) | (98.2%-99.9%) | 96.4 | 99.2 | 0/0 |
| | Y | 543 | 91.4% (53/58) | (81.0% - 97.1%) | 99.0% (480/485) | (97.6%-99.7%) | 91.4 | 99.0 | 0/0 |
| | Total | 993 | 93.0% (107/115) | (86.8%-96.9%) | 99.2% (871/878) | (98.4%-99.7%) | 93.9 | 99.1 | 0/0 |
| MS | N | 215 | 88.6% (31/35) | (73.3% -96.8%) | 98.9% (178/180) | (96.0%-99.9%) | 93.9 | 97.8 | 1/0 |
| | Y | 257 | 93.9% (62/66) | (85.2%- 98.3%) | 97.9% (187/191) | (94.7%-99.4%) | 93.9 | 97.9 | 1/0 |
| | Total | 472 | 92.1% (93/101) | (85.0%-96.5%) | 98.4% (365/371) | (96.5%-99.4%) | 93.9 | 97.9 | 2/0 |
| MN | N | 215 | 100.0% (35/35) | (90.0% 100.0%) | 98.9% (178/180) | (96.0%-99.9%) | 94.6 | 100.0 | 0/0 |
| | Y | 257 | 97.0% (64/66) | (89.5%-99.6%) | 99.5% (190/191) | (97.1% 100.0%) | 98.5 | 99.0 | 0/0 |
| | Total | 472 | 98.0% (99/101) | (93.0%-99.8%) | 99.2% (368/371) | (97.7%-99.8%) | 97.1 | 99.5 | 0/0 |
| MUPT | N | 215 | 100.0% (35/35) | (90.0% 100.0%) | 98.9% (178/180) | (96.0%-99.9%) | 94.6 | 100.0 | 0/0 |
| | Y | 257 | 97.0% (64/66) | (89.5%-99.6%) | 97.4% (186/191) | (94.0%-99.1%) | 92.8 | 98.9 | 0/0 |
| | Total | 472 | 98.0% (99/101) | (93.0%-99.8%) | 98.1% (364/371) | (96.2%-99.2%) | 93.4 | 99.5 | 0/0 |
| Total | | 5388 | 94.5% (721/763) | (92.6% -96.0%) | 98.9% (4575/4625) | (98.6%-99.2%) | 93.5 | 99.1 | 5/1 |
A
Filu FS
Asymptomatic Confidence Interval Female Neal Urine
Female endocervical swab Female urine in Q* UPT Female vaginal swab
Male Neat Unne Male urethral swab
FUPT
MNU
ભટ
UPT
ab
Male urine in Q* UPT
number
Symptomatic
MUPT
n
S
6
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BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
A total of 5388 CT Q* Assay results was evaluated at seven geographically diverse clinical sites. A frequency distribution of the initial MaxRFU values for the CT Q Assay with an assay cutoff of 125 MaxRFU is shown in Figure A.
Image /page/6/Figure/4 description: This bar graph shows frequency on the y-axis and different ranges of numbers on the x-axis. The first bar is the tallest, with a value of 4590 in the 0-49 range. The last bar is the second tallest, with a value of 755 in the >=800 range. The other ranges have values between 0 and 26.
Image /page/6/Figure/5 description: The image is titled "Figure A: Frequency Distribution of MaxRFU for the CT Q* Assay". The title is written in a bold, sans-serif font. The text is centered horizontally.
MaxRFU
7
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BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
Reproducibility
Reproductibility of the BD Viper System using the BD ProbeTec CT Q* Assay was evaluated at three clinical sites on one BD Viper System per site. A panel of simulated specimens was tested that comprised CT and GC organisms seeded into swab diluent for the BD ProbeTec CT Q Assay. Simulated endocervical and urethral specimens contained a clean endocervical swab whereas the simulated urine end vaginal swab specimens did not. Uninoculated swab diluent for the BD ProbeTec CT Q* Assay was used for the CT negative samples. Nine replicates of each panel member were tested every day for five days on each BD Viper System. The data are summarized in Table 4.
| 'Table 4: Summary of Reproducibility Data on the BD Viper Svstem for the CT Of Assa . | |||
|---|---|---|---|
| Specimen Type | CT
EB/mL | GC
Cells/mL | % Correct | 95% CI | MaxRFUMean | Within Run | | Between Runs
Within Site | | Between Site | |
|-----------------------|-------------|----------------|---------------------|---------------|------------|------------|-------|-----------------------------|------|--------------|-------|
| | | | | | | SD | %CV | SD | %CV | SD | %CV |
| Endocervical/Urethral | 0 | 0 | 98.5%
(133/135) | (94.8-99.8%) | 29.9 | 233.0 | 778.5 | 0.0 | 0.0 | 33.9 | 113.4 |
| | 30 | 0 | 100.0%
(135/135) | (97.3-100.0%) | 2011.2 | 114.1 | 5.7 | 0.0 | 0.0 | 14.8 | 0.7 |
| | 0 | 100 | 100.0%
(135/135) | (97.3-100.0%) | 1.4 | 6.0 | 442.7 | 1.0 | 76.9 | 0.0 | 0.0 |
| | 30 | 250 | 100.0%
(135/135) | (97.3-100.0%) | 1991.9 | 118.0 | 5.9 | 17.6 | 0.9 | 10.4 | 0.5 |
| | 75 | 100 | 100.0%
(135/135) | (97.3-100.0%) | 1954.8 | 169.4 | 8.7 | 0.0 | 0.0 | 0.0 | 0.0 |
| Urine/Vaginal | 0 | 0 | 100.0%
(135/135) | (97.3-100.0%) | 0.9 | 5.0 | 542.4 | 0.0 | 0.0 | 0.0 | 0.0 |
| | 30 | 0 | 100.0%
(135/135) | (97.3-100.0%) | 1999.8 | 131.8 | 6.6 | 34.2 | 1.7 | 0.0 | 0.0 |
| | 0 | 100 | 100.0%
(135/135) | (97.3-100.0%) | 0.8 | 3.4 | 442.4 | 0.0 | 0.0 | 0.0 | 0.0 |
| | 30 | 250 | 100.0%
(135/135) | (97.3-100.0%) | 1995.2 | 125.8 | 6.3 | 33.1 | 1.7 | 52.9 | 2.7 |
| | 75 | 100 | 100.0%
(135/135) | (97.3-100.0%) | 2014.4 | 109.5 | 5.4 | 0.0 | 0.0 | 0.0 | 0.0 |
A second study was conducted internally to characterize the reproducibility of test results (i.e., proportion positive or negative) at target levels below the analytical Limit of Detection (LOD) of the BD ProbeTec CT Q* Assay. A panel of simulated specimens was tested that comprised CT and GC organisms seeded into Q* swab diluent at two different levels each of which was below the respective analytical LOD for the organisms (1:10, 1:100). These levels were selected to fall within the dynamic range of the analytical LOD curve of the assay. Fifteen replicates of each panel member were tested every day for five days across three BD Viper Systems. The data are summarized in Table 5.
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BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
Table 5: Characterization of System Reproducibility at Target Levels below the Analytical Limit of Detection for the CT Q* Assay.
| Endocervical/Urethral | 1:10 | 70.2
(158/225) | (63.8, 76.1) | 1794.2 | 29.8
(67/225) | (23.9, 36.2) | 2.6 |
|-----------------------|-------|-------------------|--------------|--------|-------------------|--------------|-----|
| Endocervical/Urethral | 1:100 | 10.2
(23/225) | (6.6,14.9) | 1643.8 | 89.8
(202/225) | (85.1, 93.4) | 1.6 |
| Urine/Vaginal | 1:10 | 64.4
(145/225) | (57.8, 70.7) | 1733.9 | 35.6
(80/225) | (29.3, 42.2) | 4.6 |
| Urine/Vaginal | 1:100 | 10.7
(24/225) | (7.0, 15.5) | 1666.6 | 89.3
(201/225) | (84.5, 93.0) | 2.4 |
Conclusions
The analytical and clinical study results for the BD ProbeTec Chlamydia trachomatis (CT) Q* Amplified DNA Assay support the determination of substantial equivalence in accordance with the intended use as stated in the product labeling.
9
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Public Health Service
DEC I 1 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Becton, Dickinson and Company Kathryn Babka Carr, Sr. Regulatory Affairs Specialist / Regulatory Affairs 7 Loveton Circle Sparks, MD 21152
Re: K081824
Trade/Device Name: BD ProbeTecCT Q* Amplified DNA Assay Regulation Number: 21 CFR 866.3120 Regulation Name: Chlamydia Serological Reagents Regulatory Class: Class I Product Code: MKZ Dated: December 5, 2008 Received: December 9, 2008
Dear Ms. Carr:
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). 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
10
Page 2 -
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 advice for your device on our labeling regulation (21 CFR Part 801), 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ' (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attaym
Sally A. Hoivat, 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
11
Indications for Use
510(k) Number: K081824
Device Name: BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
Indications For Use:
The BD ProbeTec Chlamydia trachomatis (CT) Q* Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis DNA in cliniciancollected female endocervical and male urethral swabs, patient-collected vaginal swab specimens (in a clinical setting), and female and male urine specimens. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Une Schaf
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 6 8 18 24
BD Diagnostic Systems Becton, Dickinson and Company
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