(88 days)
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.
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. 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.
The BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay on the BD Viper LT System underwent a study to demonstrate its performance and establish substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). However, the clinical performance study aimed to compare the performance of the BD ProbeTec CTQ Assay on the BD Viper LT System against the existing BD Viper System in extracted mode. The presented data represents the "reported device performance."
| Metric | Specimen Type (Gender) | Reported Performance (Total) | 95% Confidence Interval |
|---|---|---|---|
| Positive Percent Agreement (PPA) | Vaginal Swab (Female) | 100.0% (138/138) | Not provided (NA) |
| Negative Percent Agreement (NPA) | Vaginal Swab (Female) | 95.0% (171/180) | (90.6%, 98.3%) |
| PPA | Q*UPT (Female) | 97.2% (137/141) | (92.2%, 100.0%) |
| NPA | Q*UPT (Female) | 98.9% (175/177) | (96.6%, 100.0%) |
| PPA | BD SurePath (Female) | 100.0% (117/117) | Not provided (NA) |
| NPA | BD SurePath (Female) | 97.0% (195/201) | (93.0%, 100.0%) |
| PPA | PreservCyt (Female) | 95.8% (115/120) | (89.2%, 100.0%) |
| NPA | PreservCyt (Female) | 98.0% (194/198) | (96.0%, 99.5%) |
| PPA | Q*UPT (Male) | 96.5% (139/144) | (92.4%, 100.0%) |
| NPA | Q*UPT (Male) | 99.5% (194/195) | (98.5%, 100.0%) |
| PPA (Overall) | All Specimen Types (Total) | 97.9% (646/660) | (96.0%, 99.4%) |
| NPA (Overall) | All Specimen Types (Total) | 97.7% (929/951) | (96.3%, 98.8%) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Performance (Test Set):
- 617 compliant female subjects
- 167 compliant male subjects
- Total number of individual specimens tested on the BD Viper LT System and compared against the reference method is not explicitly stated as a single number but can be derived from the "Total" rows in Table 3:
- Positive tests: 660 total (sum of individual specimen types)
- Negative tests: 951 total (sum of individual specimen types)
- This suggests a total of 1611 comparison panel tests.
- Data Provenance: The specimens were collected from clinical sites in North America. The study involved prospective collection of samples from symptomatic and asymptomatic individuals. All specimens were shipped to BD for screening, aliquoting, and comparison panel assembly.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the use of human experts to establish ground truth for the test set. Instead, the "BD Viper System in extracted mode reference results" were used as the basis for classifying specimens as positive or negative to create the comparison panels (ground truth). The nature and qualifications of personnel performing the predicate device testing are not specified beyond being part of "one internal site."
4. Adjudication Method for the Test Set
The document describes how comparison panels were assembled: "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." This indicates that the reference results from the predicate BD Viper System served as the adjudicated ground truth, and there was no further human expert adjudication process described for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers or AI assistance in interpretation. This study evaluates the performance of an in vitro diagnostic (IVD) device (the BD ProbeTec CTQ Assay on the BD Viper LT System) compared to a predicate device. The results are quantitative (Positive Percent Agreement, Negative Percent Agreement) based on instrument output, not human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The BD ProbeTec CTQ Assay on the BD Viper LT System is an automated, qualitative molecular diagnostic test. The clinical performance data presented (Table 3) represents the performance of the device itself (algorithm and system) in detecting Chlamydia trachomatis DNA, with no direct human interpretation component in the primary outcome. The "instrument user was blinded to the specimen results," implying a standalone evaluation of the device.
7. The Type of Ground Truth Used
The ground truth used for the clinical performance study (test set) was established by the results from the predicate device, the BD Viper System in extracted mode. "Each comparison panel consisted of randomly chosen positive and negative specimens (based on BD Viper System in extracted mode reference results)."
8. The Sample Size for the Training Set
The document implies that the BD ProbeTec CTQ Assay formulation for the BD Viper LT System has not changed from that used with the existing BD Viper System. Therefore, there isn't a "training set" in the context of an algorithm learning from data. The device itself (reagents, amplification, detection) is pre-established. The studies conducted are for "migrating" the assay to a new instrument platform (BD Viper LT). Thus, the concept of a training set for algorithm development is not directly applicable here.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, a training set for an algorithm is not described or applicable in this context. The "ground truth" for the original development and validation of the BD ProbeTec CTQ Assay on the predicate BD Viper System would have been established through a combination of well-characterized positive and negative clinical specimens, spiked samples, and potentially confirmatory testing methods, but details are not provided in this submission for the predicate device's original development.
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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 Systems7 Loveton CircleSparks, MD 21152 |
|---|---|
| Establishment Registration No. | 1119779 |
| Contact Person | Sherma Winston, M.S., RACtel. 410-316-4145fax. 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.
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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.
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BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay on the BD Viper LT System
| Item | BD ProbeTec CTQ Assay onBD Viper System(K081824) | BD ProbeTec CTQ Assay onBD 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* AmplifiedDNA Assay when tested with the BDViper™ System in Extracted Mode,uses Strand DisplacementAmplification technology for thedirect, qualitative detection ofChlamydia trachomatis DNA inclinician- collected femaleendocervical and male urethral swabspecimens, patient-collected vaginalswab specimens (in a clinicalsetting), and male and female urinespecimens. The assay is indicated foruse with asymptomatic andsymptomatic individuals to aid in thediagnosis of chlamydial urogenitaldisease. | The BD ProbeTec Chlamydiatrachomatis (CT) Q* Amplified DNAAssay when tested with either theBD Viper™ System in ExtractedMode or the BD Viper™ LT System,uses Strand DisplacementAmplification technology for thedirect, qualitative detection ofChlamydia trachomatis DNA inclinician- collected femaleendocervical and male urethral swabspecimens, patient-collected vaginalswab specimens (in a clinicalsetting), and male and female urinespecimens (both UPT and Neat). Theassay is also intended for use withgynecological specimens collected inBD SurePath™ Preservative Fluid orPreservCyt™ Solution using analiquot that is removed prior toprocessing for either the BDSurePath or ThinPrep™ Pap test.The assay is indicated for use withasymptomatic and symptomaticindividuals to aid in the diagnosis ofchlamydial urogenital disease. |
| Technology | Strand Displacement Amplification(SDA) | same |
| Specimen Types | Female specimens:endocervical swabpatient-collected vaginal swabneat urineUPT urine | Female specimens:endocervical swabpatient-collected vaginal swabneat urineUPT urineLBC specimens collected in SurePathPreservative Fluid |
Table 1 Comparison to Predicate Device
Page 3 of 10
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BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay on the BD Viper LT System
| Item | BD ProbeTec CTQ Assay onBD Viper System(K081824) | BD ProbeTec CTQ Assay onBD Viper LT System(K140446) |
|---|---|---|
| urethral swabneat urineUPT urine | LBC specimens collected in PreservCytSolution | |
| Male specimens:urethral swabneat urineUPT urine | ||
| Priming Microwell | ||
| Primers | Region of cryptic CT plasmid | Same |
| Detector | Linear, analyte-specific Detector ProbeFluorescein (fluorophore)Dabcyl (quencher)● | Same |
| Nucleotides | 4 nucleotides required for SDA | Same |
| Non-specific reagents andcofactors | 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 andcofactors | Buffering components, magnesium ions,salt and stabilizing reagents | Same |
| Assay Buffer | Bicine-potassium hydroxide-based | Same |
Page 4 of 10
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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 ViperLTSystem | Qx Sample Diluent | LBC Specimen Matrix | ||||
|---|---|---|---|---|---|---|
| n | PositiveResults | PercentPositive | n | PositiveResults | PercentPositive | |
| 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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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%) |
Page 7 of 10
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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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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 Runwithin Day | Between Daywithin Site | Between Site | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SpecimenType | 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% |
Page 9 of 10
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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)
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Concurrence of Center for Devices and Radiological Health (CDRH)
Tamara V. Feldblyum -S 2014.05.16 15:40:29 -04'00'
§ 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).