(88 days)
Not Found
No
The summary describes a DNA amplification and detection assay based on Strand Displacement Amplification (SDA) technology. The device description focuses on the reagents, enzymes, and the automated system for nucleic acid extraction, amplification, and detection. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the context of medical devices. The performance studies and key metrics are standard for diagnostic assays and do not indicate the use of AI/ML algorithms for interpretation or analysis.
No
The device is an in vitro diagnostic (IVD) assay designed to detect Chlamydia trachomatis DNA to aid in the diagnosis of chlamydial urogenital disease. It is used for diagnostic purposes, not for treating or preventing disease.
Yes
The device is intended "to aid in the diagnosis of chlamydial urogenital disease," which explicitly states its role in the diagnostic process.
No
The device description explicitly states it is a "table-top instrument" (BD Viper LT System) that performs automated extraction, amplification, and detection, indicating it is a hardware device with associated software, not a software-only device.
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 from the human body to provide information for diagnostic purposes.
- Device Description: The description details the use of the device with "specimens from multiple specimen types" and its function in "automated extraction of nucleic acids... in addition to amplification and detection of target nucleic acid sequences." This aligns with the definition of an IVD, which analyzes biological samples.
- Clinical Performance Studies: The document describes clinical performance studies using "specimens from 617 compliant female subjects and 167 compliant male subjects" and comparing the results to a predicate device. This type of clinical validation is a hallmark of IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K081824) indicates that this device is being compared to a previously cleared IVD device, further confirming its classification as an IVD.
The information provided strongly supports the conclusion that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BD ProbeTec Chlamydia trachomatis (CT) Q* Amplified DNA Assay, when tested with either the BD Viper™ System in Extracted Mode or the BD Viper™ LT System, uses Strand Displacement Amplification technology for the direct, qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid or PreservCyt™ Solution using an aliquot that is removed prior to processing for either the BD SurePath or ThinPrep™ Pap test. 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 CTQ Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe The reagents for strand displacement amplification (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. In alignment with the FDA Guidance Document, "Assay Migration Studies for In Vitro Diagnostic Devices, Guidance for Industry and FDA Staff", April 25, 2013 the BD ProbeTec CTQ Assay is being migrated from the existing BD Viper System operating in extracted mode (Viper XTR) to the new BD Viper LT System. The BD Viper LT System is a table-top instrument that is designed to be fully contained on a standard laboratory bench-top. The system performs automated extraction of nucleic acids from multiple specimen types in addition to amplification and detection of target nucleic acid sequences when utilized with legally marketed in vitro diagnostic assays.
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, laboratory
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance Characteristics:
System Contamination: A study was conducted to evaluate the risk of producing a false positive result in either the same run on the BD Viper LT System or in a subsequent run. Negative and positive samples were tested on each of three BD Viper LT Systems. Negative samples consisted of Q Swab Diluent or LBC Specimen Dilution Tube with LBC Specimen Matrix (PreservCyt LBC media). Positive samples consisted of a representative analyte (at 10° CT EB/mL) spiked into Q Swab Diluent or LBC Specimen Dilution Tube with LBC Specimen Matrix. The overall rate of contamination (i.e., with alternating columns of positive and negative samples and a prevalence of 50%) was 0.32% (2/630) for Q* Swab Diluent and 0.0% (0/630) for LBC Specimen Matrix.
Clinical Performance Characteristics:
Clinician-collected BD SurePath and PreservCyt specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female Q* UPT urine specimens were collected from 653 female subjects and 170 male subjects attending OB/GYN, sexually transmitted disease (STD) and family planning clinics at four geographically diverse clinical sites in North America. Subjects were classified as symptomatic if symptoms were reported by the subject. The final data analysis included 617 compliant female subjects and 167 compliant male subjects. All specimens were shipped to BD on cold packs for specimen screening, aliquoting, and comparison panel assembly. Each comparison panel consisted of randomly chosen positive and negative specimens (based on BD Viper System in extracted mode reference results). The positive and negative specimens were randomized within the panel, and labeled such that the instrument user was blinded to the specimen results. Panels were identical across all of the BD Viper LT test sites. The blinded comparison panels were sent to the 3 external sites for testing on the BD Viper LT System and one internal site for testing using the BD Viper System in extracted mode with the BD ProbeTec CTQ Assay.
Reproducibility:
Reproducibility of the BD Viper LT System using the BD ProbeTec CTO Amplified DNA Assay was evaluated at three test sites (two external clinical sites and one internal site) on one BD Viper LT System per site. Panels comprised of three levels of CT and GC organisms seeded into LBC specimen matrix (0.5 mL spiked into LBC Dilution Tubes for the BD ProbeTec O' Amplified DNA Assays), vaginal matrix in Q Swab Diluent (containing a clean male urethral swab), and urine specimen matrix (in Q* UPT). CT and GC organisms were spiked into each specimen matrix. Uninoculated LBC specimen matrix in O diluent, and urine matrix were used as negative samples. Two operators per site performed the BD Viper LT reproducibility study. Both operators ran one panel each day, over a total of eight days. A total of sixteen runs, each composed of 8 LBC. 8 swab and 8 UPT panel members described above were performed at each of two external BD Viper LT test sites and one internal BD Viper LT test site.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
System Contamination Rates:
BD Viper LT System 1: Qx Sample Diluent 0.00% (0/210), LBC Specimen Matrix 0.00% (0/210)
BD Viper LT System 2: Qx Sample Diluent 0.48% (1/210), LBC Specimen Matrix 0.00% (0/210)
BD Viper LT System 3: Qx Sample Diluent 0.48% (1/210), LBC Specimen Matrix 0.00% (0/210)
Overall: Qx Sample Diluent 0.32% (2/630), LBC Specimen Matrix 0.00% (0/630)
PPA and NPA for the BD ProbeTec CTQ Assay on BD Viper LT System:
Female Vaginal Swab:
Site A: PPA 100.0% (46/46) (92.3%, 100.0%), NPA 95.0% (57/60) (86.3%, 98.3%)
Site B: PPA 100.0% (46/46) (92.3%, 100.0%), NPA 98.3% (59/60) (91.1%, 99.7%)
Site C: PPA 100.0% (46/46) (92.3%, 100.0%), NPA 91.7% (55/60) (81.9%, 96.4%)
Total: PPA 100.0% (138/138) NA, NPA 95.0% (171/180) (90.6%, 98.3%)
Female Q'UPT:
Site A: PPA 97.9% (46/47) (88.9%, 99.6%), NPA 98.3% (58/59) (91.0%, 99.7%)
Site B: PPA 97.9% (46/47) (88.9%, 99.6%), NPA 100.0% (59/59) (93.9%, 100.0%)
Site C: PPA 95.7% (45/47) (85.8%, 98.8%), NPA 98.3% (58/59) (91.0%, 99.7%)
Total: PPA 97.2% (137/141) (92.2%, 100.0%), NPA 98.9% (175/177) (96.6%, 100.0%)
Female BD SurePath:
Site A: PPA 100.0% (39/39) (91.0%, 100.0%), NPA 97.0% (65/67) (89.8%, 99.2%)
Site B: PPA 100.0% (39/39) (91.0%, 100.0%), NPA 97.0% (65/67) (89.8%, 99.2%)
Site C: PPA 100.0% (39/39) (91.0%, 100.0%), NPA 97.0% (65/67) (89.8%, 99.2%)
Total: PPA 100.0% (117/117) NA, NPA 97.0% (195/201) (93.0%, 100.0%)
Female PreservCyt:
Site A: PPA 97.5% (39/40) (87.1%, 99.6%), NPA 97.0% (64/66) (89.6%, 99.2%)
Site B: PPA 95.0% (38/40) (83.5%, 98.6%), NPA 98.5% (65/66) (91.9%, 99.7%)
Site C: PPA 95.0% (38/40) (83.5%, 98.6%), NPA 98.5% (65/66) (91.9%, 99.7%)
Total: PPA 95.8% (115/120) (89.2%, 100.0%), NPA 98.0% (194/198) (96.0%, 99.5%)
Male Q'UPT:
Site A: PPA 97.9% (47/48) (89.1%, 99.6%), NPA 100.0% (65/65) (94.4%, 100.0%)
Site B: PPA 95.8% (46/48) (86.0%, 98.8%), NPA 100.0% (65/65) (94.4%, 100.0%)
Site C: PPA 95.8% (46/48) (86.0%, 98.8%), NPA 98.5% (64/65) (91.8%, 99.7%)
Total: PPA 96.5% (139/144) (92.4%, 100.0%), NPA 99.5% (194/195) (98.5%, 100.0%)
Overall Total: PPA 97.9% (646/660) (96.0%, 99.4%), NPA 97.7% (929/951) (96.3%, 98.8%)
Reproducibility Data on the BD Viper LT System:
LBC:
Negative: % Correct 99.0% (95/96), 95% CI (94.3 - 99.8%)
High Negative: % Correct 41.7% (40/96), 95% CI (32.3 - 51.7%)
Low Positive: % Correct 100.0% (96/96), 95% CI (96.2 - 100.0%)
Moderate Positive: % Correct 98.9% (93/94), 95% CI (94.2 - 99.8%)
Swab:
Negative: % Correct 100.0% (96/96), 95% CI (96.2 - 100.0%)
High Negative: % Correct 24.0% (23/96), 95% CI (16.5 - 33.4%)
Low Positive: % Correct 95.8% (91/95), 95% CI (89.7 - 98.4%)
Moderate Positive: % Correct 100.0% (96/96), 95% CI (96.2 - 100.0%)
UPT:
Negative: % Correct 99.0% (95/96), 95% CI (94.3 - 99.8%)
High Negative: % Correct 32.3% (31/96), 95% CI (23.8 - 42.2%)
Low Positive: % Correct 99.0% (95/96), 95% CI (94.3 - 99.8%)
Moderate Positive: % Correct 100.0% (96/96), 95% CI (96.2 - 100.0%)
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.
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
KIY04Y6
Image /page/0/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a stylized graphic on the left and the letters "BD" on the right. The graphic appears to be a stylized representation of a person with arms raised towards a sun-like object. Below the letters "BD" is the company's slogan: "Helping all people live healthy lives."
MAY 2 0 2014
BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay on the BD Viper LT System
| Applicant | BD Diagnostic Systems
7 Loveton Circle
Sparks, MD 21152 |
|--------------------------------|---------------------------------------------------------------------|
| Establishment Registration No. | 1119779 |
| Contact Person | Sherma Winston, M.S., RAC
tel. 410-316-4145
fax. 410-316-4188 |
sherma winston@bd.com Summary Date May 16, 2014
Proprietary Name
BD ProbeTec"™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
DNA probe, nucleic acid amplification, Chlamydia
Generic Name
| Classification | Class I |
|---|---|
| Classification Name | Chlamydia serological reagents |
| Regulation Number | 866.3120 |
| Product Code | MKZ |
Predicate Device
The BD ProbeTec Chlamydia trachomatis (CT) Q* Amplified DNA Assay (BD ProbeTec CTQ Assay) was cleared for use with the predicate BD Viper System in extracted mode via K081824.
Device Description
The BD ProbeTec CTO Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe The reagents for strand displacement amplification (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. In alignment with the FDA Guidance Document, "Assay Migration Studies for In Vitro Diagnostic Devices, Guidance for Industry and FDA Staff", April 25, 2013 the BD ProbeTec CTQ Assay is being migrated from the existing BD Viper System operating in extracted mode (Viper XTR) to the new BD Viper LT System.
1
Image /page/1/Picture/1 description: The image shows the logo for BD, a global medical technology company. The logo consists of a stylized sun-like graphic to the left of the letters "BD" in a bold, sans-serif font. Below the letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller, sans-serif font.
BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay on the BD Viper LT System
The BD Viper LT System is a table-top instrument that is designed to be fully contained on a standard laboratory bench-top. The system performs automated extraction of nucleic acids from multiple specimen types in addition to amplification and detection of target nucleic acid sequences when utilized with legally marketed in vitro diagnostic assays.
Intended Use
The BD ProbeTec Chlamydia trachomatis (CT) Q* Amplified DNA Assay when tested with either the BD Viper™ System in Extracted Mode or the BD Viper™ LT System, uses Strand Displacement Amplification technology for the direct, qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid or PreservCyt™ Solution using an aliquot that is removed prior to processing for either the BD SurePath or ThinPrep™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.
Comparison to Predicate Device
A comparison of the BD ProbeTec CTO Assay on the BD Viper LT System with the predicate BD Viper System is summarized below.
2
Image /page/2/Picture/0 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a stylized graphic on the left and the letters "BD" on the right. The graphic resembles a stylized sun or flower with radiating lines. Below the letters "BD" is the company's slogan: "Helping all people live healthy lives."
BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay on the BD Viper LT System
| Item | BD ProbeTec CTQ Assay on
BD Viper System
(K081824) | BD ProbeTec CTQ Assay on
BD Viper LT System
(K140446) |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | I | I |
| Regulation Specialty | Microbiology | Microbiology |
| Assay Results | Qualitative | Qualitative |
| Type of Assay | Molecular NAAT | Molecular NAAT |
| 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 swab
specimens, patient-collected vaginal
swab specimens (in a clinical
setting), and male and female urine
specimens. The assay is indicated for
use with asymptomatic and
symptomatic individuals to aid in the
diagnosis of chlamydial urogenital
disease. | The BD ProbeTec Chlamydia
trachomatis (CT) Q* Amplified DNA
Assay when tested with either the
BD Viper™ System in Extracted
Mode or the BD Viper™ LT System,
uses Strand Displacement
Amplification technology for the
direct, qualitative detection of
Chlamydia trachomatis DNA in
clinician- collected female
endocervical and male urethral swab
specimens, patient-collected vaginal
swab specimens (in a clinical
setting), and male and female urine
specimens (both UPT and Neat). The
assay is also intended for use with
gynecological specimens collected in
BD SurePath™ Preservative Fluid or
PreservCyt™ Solution using an
aliquot that is removed prior to
processing for either the BD
SurePath or ThinPrep™ Pap test.
The assay is indicated for use with
asymptomatic and symptomatic
individuals to aid in the diagnosis of
chlamydial urogenital disease. |
| Technology | Strand Displacement Amplification
(SDA) | same |
| Specimen Types | Female specimens:
endocervical swab
patient-collected vaginal swab
neat urine
UPT urine | Female specimens:
endocervical swab
patient-collected vaginal swab
neat urine
UPT urine
LBC specimens collected in SurePath
Preservative Fluid |
Table 1 Comparison to Predicate Device
Page 3 of 10
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Image /page/3/Picture/0 description: The image shows the logo for BD, a medical technology company. The logo consists of a stylized sun-like graphic on the left, followed by the letters "BD" in bold, sans-serif font. 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 on the BD Viper LT System
| Item | BD ProbeTec CTQ Assay on
BD Viper System
(K081824) | BD ProbeTec CTQ Assay on
BD Viper LT System
(K140446) |
|----------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| | urethral swab
neat urine
UPT urine | LBC specimens collected in PreservCyt
Solution |
| | | Male specimens:
urethral swab
neat urine
UPT urine |
| Priming Microwell | | |
| Primers | Region of cryptic CT plasmid | Same |
| Detector | Linear, analyte-specific Detector Probe
Fluorescein (fluorophore)
Dabcyl (quencher)
● | Same |
| Nucleotides | 4 nucleotides required for SDA | Same |
| Non-specific reagents and
cofactors | Buffering components, magnesium ions.
salt and stabilizing reagents | Same |
| Amplification Microwell | | |
| Restriction Enzyme | BsoBl restriction enzyme | Same |
| Polymerase | Bst DNA polymerase | Same |
| Non-specific reagents and
cofactors | Buffering components, magnesium ions,
salt and stabilizing reagents | Same |
| Assay Buffer | Bicine-potassium hydroxide-based | Same |
Page 4 of 10
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. .
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Image /page/4/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a stylized graphic on the left and the letters "BD" on the right. The graphic appears to be a stylized representation of a person with arms outstretched under a sun-like shape. Below the letters "BD" is the tagline "Helping all people live healthy lives" in a smaller font.
BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay on the BD Viper LT System
Analytical Performance Characteristics
The BD ProbeTec CTQ Assay formulation for the BD Viper LT System has not changed from that used with the BD Viper System in extracted mode. Studies were conducted to support analytical performance of the BD Viper LT System.
System Contamination
A study was conducted to evaluate the risk of producing a false positive result in either the same run on the BD Viper LT System or in a subsequent run. Negative and positive samples were tested on each of three BD Viper LT Systems. Negative samples consisted of Q Swab Diluent or LBC Specimen Dilution Tube with LBC Specimen Matrix (PreservCyt LBC media). Positive samples consisted of a representative analyte (at 10° CT EB/mL) spiked into Q Swab Diluent or LBC Specimen Dilution Tube with LBC Specimen Matrix. The overall rate of contamination (i.e., with alternating columns of positive and negative samples and a prevalence of 50%) was 0.32% (2/630) for O* Swab Diluent and 0.0% (0/630) for LBC Specimen Matrix. Contamination rates across the three BD Viper LT Systems are summarized in Table 2.
| BD Viper
LT
| System | Qx Sample Diluent | LBC Specimen Matrix | ||||
|---|---|---|---|---|---|---|
| n | Positive | |||||
| Results | Percent | |||||
| Positive | n | Positive | ||||
| Results | Percent | |||||
| Positive | ||||||
| 1 | 210 | 0 | 0.00% | 210 | 0 | 0.00% |
| 2 | 210 | 1 | 0.48% | 210 | 0 | 0.00% |
| 3 | 210 | 1 | 0.48% | 210 | 0 | 0.00% |
| Overall | 630 | 2 | 0.32% | 630 | 0 | 0.00% |
System Contamination Table 2
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Image /page/5/Picture/0 description: The image shows the BD logo. The logo consists of a stylized sun-like graphic on the left, followed by the letters "BD" in bold, sans-serif font. Below the letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller font size. The logo is black and white.
BD ProbeTec™ Chlamydia trachomatis (CT) O* Amplified DNA Assay on the BD Viper LT System
Clinical Performance Characteristics
The BD ProbeTec CTQ Assay formulation for the BD Viper LT System has not changed from that used with the BD Viper System in Extracted Mode. The following studies were conducted to support clinical performance of the BD Viper LT System.
Clinician-collected BD SurePath and PreservCyt specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female Q* UPT urine specimens were collected from 653 female subjects and 170 male subjects attending OB/GYN, sexually transmitted disease (STD) and family planning clinics at four geographically diverse clinical sites in North America. Subjects were classified as symptomatic if symptoms were reported by the subject. The final data analysis included 617 compliant female subjects and 167 compliant male subjects. All specimens were shipped to BD on cold packs for specimen screening, aliquoting, and comparison panel assembly.
Each comparison panel consisted of randomly chosen positive and negative specimens (based on BD Viper System in extracted mode reference results). The positive and negative specimens were randomized within the panel, and labeled such that the instrument user was blinded to the specimen results. Panels were identical across all of the BD Viper LT test sites. The blinded comparison panels were sent to the 3 external sites for testing on the BD Viper LT System and one internal site for testing using the BD Viper System in extracted mode with the BD ProbeTec CTQ Assay.
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Image /page/6/Picture/1 description: The image shows a logo with the letters "BD" stacked vertically on the left side. To the right of the logo are two lines of text that appear to be vertically oriented. The text is difficult to read, but it seems to say "Help ng zil people" on the top line and "liva haa thy thes" on the bottom line. There are also the letters "C BL" at the bottom.
BD ProbeTecTM Chlamydia trachomatis (CT) Q Taranatis (CT) Q Tarananis (CT) Q T
The Amplified DNA Assay on the BD Viper LT System
PPA and NPA for the BD ProbeTec CTQ Assay on
Table 3:
| Gender | Specimen Type | Site | Positive Percent Agreement | Negative Percent Agreement | ||
|---|---|---|---|---|---|---|
| Percent | 95% CI | Percent | 95% CI | |||
| Vaginal Swab | A | 100.0% (46/46) | (92.3%, 100.0%) | 95.0% (57/60) | (86.3%, 98.3%) | |
| B | 100.0% (46/46) | (92.3%, 100.0%) | 98.3% (59/60) | (91.1%, 99.7%) | ||
| C | 100.0% (46/46) | (92.3%, 100.0%) | 91.7% (55/60) | (81.9%, 96.4%) | ||
| Total | 100.0% (138/138) | NA | 95.0% (171/180) | (90.6%, 98.3%) | ||
| Female | Q'UPT | A | 97.9% (46/47) | (88.9%, 99.6%) | 98.3% (58/59) | (91.0%, 99.7%) |
| B | 97.9% (46/47) | (88.9%, 99.6%) | 100.0% (59/59) | (93.9%, 100.0%) | ||
| C | 95.7% (45/47) | (85.8%, 98.8%) | 98.3% (58/59) | (91.0%, 99.7%) | ||
| Total | 97.2% (137/141) | (92.2%, 100.0%) | 98.9% (175/177) | (96.6%, 100.0%) | ||
| Female | BD SurePath | A | 100.0% (39/39) | (91.0%, 100.0%) | 97.0% (65/67) | (89.8%, 99.2%) |
| B | 100.0% (39/39) | (91.0%, 100.0%) | 97.0% (65/67) | (89.8%, 99.2%) | ||
| C | 100.0% (39/39) | (91.0%, 100.0%) | 97.0% (65/67) | (89.8%, 99.2%) | ||
| Total | 100.0% (117/117) | NA | 97.0% (195/201) | (93.0%, 100.0%) | ||
| PreservCyt | A | 97.5% (39/40) | (87.1%, 99.6%) | 97.0% (64/66) | (89.6%, 99.2%) | |
| B | 95.0% (38/40) | (83.5%, 98.6%) | 98.5% (65/66) | (91.9%, 99.7%) | ||
| C | 95.0% (38/40) | (83.5%, 98.6%) | 98.5% (65/66) | (91.9%, 99.7%) | ||
| Total | 95.8% (115/120) | (89.2%, 100.0%) | 98.0% (194/198) | (96.0%, 99.5%) | ||
| Male | Q'UPT | A | 97.9% (47/48) | (89.1%, 99.6%) | 100.0% (65/65) | (94.4%, 100.0%) |
| B | 95.8% (46/48) | (86.0%, 98.8%) | 100.0% (65/65) | (94.4%, 100.0%) | ||
| C | 95.8% (46/48) | (86.0%, 98.8%) | 98.5% (64/65) | (91.8%, 99.7%) | ||
| Total | 96.5% (139/144) | (92.4%, 100.0%) | 99.5% (194/195) | (98.5%, 100.0%) | ||
| Total | All | Total | 97.9% (646/660) | (96.0%, 99.4%) | 97.7% (929/951) | (96.3%, 98.8%) |
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Image /page/7/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a symbol on the left and the letters "BD" on the right. The symbol appears to be a stylized representation of a person with arms raised under a sun-like shape. Below the logo is the text "Helping all people live healthy lives."
BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay on the BD Viper LT System
Reproducibility
Reproducibility of the BD Viper LT System using the BD ProbeTec CTO Amplified DNA Assay was evaluated at three test sites (two external clinical sites and one internal site) on one BD Viper LT System per site. Panels comprised of three levels of CT and GC organisms seeded into LBC specimen matrix (0.5 mL spiked into LBC Dilution Tubes for the BD ProbeTec O' Amplified DNA Assays), vaginal matrix in Q Swab Diluent (containing a clean male urethral swab), and urine specimen matrix (in Q* UPT). CT and GC organisms were spiked into each specimen matrix. Uninoculated LBC specimen matrix in O diluent, and urine matrix were used as negative samples. Two operators per site performed the BD Viper LT reproducibility study. Both operators ran one panel each day, over a total of eight days. A total of sixteen runs, each composed of 8 LBC. 8 swab and 8 UPT panel members described above were performed at each of two external BD Viper LT test sites and one internal BD Viper LT test site. The data are summarized in Table 4.
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Image /page/8/Picture/1 description: The image shows a logo with the letters 'BD' stacked vertically. To the right of the logo, there is text that reads 'Help ng al people live hea thy lives'. The text is stacked vertically and appears to be a slogan or mission statement associated with the logo.
BD ProbeTec™ CT/GC
Chlamydia trachomatis (CT)
Neisseria gonorrhoeae (GC)
DNAssay.uploadedbyuser_id
BB Probe Tec BD Probe Tech Chlumydia trachomatis (CT) Q"
Amplified DNA Assay on the BD Viper LT System
Assay of Reproducibility Data on the BD Viper LT System for the BD Prob Table 4:
| | | | | | | Within Run | | Between Run
within Day | | Between Day
within Site | | Between Site | | | |
|------------------|-------------------|----------------|-----------------|--------|-------|------------|-------|---------------------------|------|----------------------------|-------|--------------|-------|--------|-------|
| Specimen
Type | Panel | % Correct | 95% CI | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | Total |
| LBC | Negative | 99.0% (95/96) | (94.3 - 99.8%) | 14.6 | 104.7 | 718.8% | 0.0 | 0.0% | 7.2 | 49.1% | 6.9 | 47.4% | 105.2 | 722.0% | |
| | High Negative | 41.7% (40/96) | (32.3 - 51.7%) | 565.0 | 533.2 | 94.4% | 226.5 | 40.1% | 0.0 | 0.0% | 0.0 | 0.0% | 579.3 | 102.5% | |
| | Low Positive | 100.0% (96/96) | (96.2 - 100.0%) | 1435.3 | 372.3 | 25.9% | 0.0 | 0.0% | 85.2 | 5.9% | 86.4 | 6.0% | 391.6 | 27.3% | |
| | Moderate Positive | 98.9% (93/94) | (94.2 - 99.8%) | 1752.4 | 241.0 | 13.8% | 0.0 | 0.0% | 36.1 | 2.1% | 0.0 | 0.0% | 243.7 | 13.9% | |
| Swab | Negative | 100.0% (96/96) | (96.2 - 100.0%) | 22.1 | 28.6 | 129.3% | 8.7 | 39.5% | 0.0 | 0.0% | 5.0 | 22.5% | 30.3 | 137.0% | |
| | High Negative | 24.0% (23/96) | (16.5 - 33.4%) | 974.0 | 716.7 | 73.6% | 0.0 | 0.0% | 0.0 | 0.0% | 105.1 | 10.8% | 724.4 | 74.4% | |
| | Low Positive | 95.8% (91/95) | (89.7 - 98.4%) | 1603.8 | 535.8 | 33.4% | 115.0 | 7.2% | 0.0 | 0.0% | 0.0 | 0.0% | 548.0 | 34.2% | |
| | Moderate Positive | 100.0% (96/96) | (96.2 - 100.0%) | 1780.6 | 320.3 | 18.0% | 0.0 | 0.0% | 59.6 | 3.3% | 52.2 | 2.9% | 330.0 | 18.5% | |
| UPT | Negative | 99.0% (95/96) | (94.3 - 99.8%) | 21.5 | 171.4 | 797.4% | 0.0 | 0.0% | 0.0 | 0.0% | 5.8 | 27.0% | 171.5 | 797.9% | |
| | High Negative | 32.3% (31/96) | (23.8 - 42.2%) | 678.3 | 578.6 | 85.3% | 276.0 | 40.7% | 0.0 | 0.0% | 0.0 | 0.0% | 641.1 | 94.5% | |
| | Low Positive | 99.0% (95/96) | (94.3 - 99.8%) | 1549.4 | 432.5 | 27.9% | 0.0 | 0.0% | 85.9 | 5.5% | 0.0 | 0.0% | 441.0 | 28.5% | |
| | Moderate Positive | 100.0% (96/96) | (96.2 - 100.0%) | 1747.0 | 223.9 | 12.8% | 133.5 | 7.6% | 0.0 | 0.0% | 22.5 | 1.3% | 261.6 | 15.0% | |
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Image /page/9/Picture/1 description: The image shows the BD logo, which consists of a stylized sun-like symbol to the left and the letters "BD" to the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives." The logo is simple and clean, with a focus on the company's mission of promoting health and well-being.
BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay on the BD Viper LT System
Conclusions
The analytical and clinical study results for the BD ProbeTec Chlamydia trachomatis (CT) Q* Amplified DNA Assay tested on the BD Viper LT System support the determination of substantial equivalence in accordance with the intended use as stated in the product labeling.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002
May 20, 2014
Becton, Dickinson and Company Sherma Winston, M.S., RAC 7 Loveton Circle Sparks, MD 21152
Re: K140446
Trade/Device Name: BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
Regulation Number: 21 CFR 866.3120 Regulation Name: Chlamydia serological reagents Regulatory Class: I Product Code: MKZ Dated: February 20, 2014 Received: February 21, 2014
Dear Ms. Winston:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Ms. Winston
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tamara V. Feldblyum -S for
Sally Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K140446
Device Name: BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
Indications for Use:
The BD Probe Tec Chlamydia trachomatis (CT) Q* Amplified DNA Assay, when tested with either the BD Viper™ System in Extracted Mode or the BD Viper™ LT System, uses Strand Displacement Amplification technology for the direct, qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid or PreservCyt™ Solution using an aliquot that is removed prior to processing for either the BD SurePath or ThinPrep™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.
Prescription Use ___________________________________(21 CFR 801 Subpart
(21 CFR 801 Subpart C)
(Please Do not WRITE Below This Line - Continue on another PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Tamara V. Feldblyum -S 2014.05.16 15:40:29 -04'00'