(88 days)
Not Found
No
The summary describes a nucleic acid amplification test (NAAT) based on Strand Displacement Amplification (SDA) technology. The device description focuses on the reagents, the amplification process, and the automated system for extraction, amplification, and detection. There is no mention of AI, ML, image processing, or any algorithms that would typically be associated with AI/ML in the context of diagnostic testing. The performance studies describe standard clinical validation metrics for a diagnostic assay.
No.
The device is an in vitro diagnostic (IVD) test for the qualitative detection of Neisseria gonorrhoeae DNA to aid in the diagnosis of gonococcal urogenital disease. It is used for diagnostic purposes and does not provide therapy or treatment.
Yes
The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease, directly linking it to the diagnostic process.
No
The device is an in vitro diagnostic assay that utilizes hardware (BD Viper™ System or BD Viper™ LT System) for nucleic acid extraction, amplification, and detection. It is 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 Neisseria gonorrhoeae DNA... to aid in the diagnosis of gonococcal 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 a system that performs automated extraction, amplification, and detection of nucleic acids from specimen types, which are all processes involved in in vitro diagnostic testing.
- Performance Studies: The document includes detailed performance studies (Clinical Performance Characteristics and Reproducibility) with metrics like Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA), which are standard measures used to evaluate the performance of IVD devices.
- Predicate Device: The mention of a predicate device (K081825; BD ProbeTec Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper System in extracted mode) which is also an IVD, further supports the classification of this device as an IVD.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The BD ProbeTec Neisseria gonorrhoeae (GC) 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 Neisseria gonorrhoeae 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 gonococcal urogenital disease.
Product codes
LSL
Device Description
The BD ProbeTec GCO 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 GCQ 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-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). 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. Clinical laboratory setting.
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
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 GC Qx Assay.
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 Qx 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:
Sample Size: 617 compliant female subjects and 167 compliant male subjects.
Study Design: 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 subjects attending OB/GYN, sexually transmitted disease (STD) and family planning clinics at four geographically diverse clinical sites in North America. Blinded comparison panels were sent to 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 GC Qx Assay.
Key Results (Total Across All Specimen Types and Sites):
Female: PPA 97.9% (320/327), NPA 98.8% (934/945)
Male: PPA 100.0% (120/120), NPA 99.5% (218/219)
Overall Total: PPA 98.4% (440/447), NPA 99.0% (1152/1164)
Reproducibility:
Study Design: 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, vaginal matrix in Q* Swab Diluent, and urine specimen matrix. Uninoculated matrices were used as negative samples. Two operators per site performed the study, each running one panel per day for eight days. A total of sixteen runs, each composed of 8 LBC, 8 swab and 8 UPT panel members, were performed at each site.
Key Results:
Accuracy: All low and moderate positive panels showed 100% correct results across all specimen types and sites. Negative samples showed high correct percentages, with LBC at 100.0% (96/96), Swab at 99.0% (95/96), and UPT at 100.0% (96/96). High Negative varied from 13.5% to 20.8% correct.
Variability (Total %CV):
LBC: Negative 287.6%, High Negative 76.4%, Low Positive 20.5%, Moderate Positive 12.6%
Swab: Negative 433.8%, High Negative 65.3%, Low Positive 17.8%, Moderate Positive 10.5%
UPT: Negative 221.8%, High Negative 66.3%, Low Positive 15.3%, Moderate Positive 9.1%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (PPA), Negative Percent Agreement (NPA)
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
§ 866.3390
Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.(b)
Classification. Class II (performance standards).
0
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System
MAY 2 0 2014
| 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 15, 2014 |
| Proprietary Name | BD ProbeTec™ Neisseria gonorrhoeae (GC) Q x Amplified
DNA Assay |
| Generic Name | DNA probe, nucleic acid amplification, Neisseria |
| Classification | Class II |
| Classification Name | Neisseria spp. direct serological test reagents |
| Regulation Number | 866.3390 |
| Product Code | LSL |
Predicate Device
The BD ProbeTec Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay (BD ProbeTec GCQ Assay) was cleared for use with the predicate BD Viper System in extracted mode via K081825.
Device Description
The BD ProbeTec GCO 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 GCQ 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
1
Image /page/1/Picture/1 description: The image shows the BD logo, which consists of a stylized sun-like symbol with a bird-like shape in the center, followed by the letters "BD" in bold. Below the logo, there is the text "Helping all people live healthy lives". The image also contains some illegible text on the left side.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System
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 Neisseria gonorrhoeae (GC) 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 Neisseria gonorrhoeae 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 gonococcal urogenital disease.
Comparison to Predicate Device
A comparison of the BD ProbeTec GCQ 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 BD logo. The logo consists of a stylized sun and human figure 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, sans-serif font.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System
| Item | BD ProbeTec GCQ Assay on the
BD Viper System
(K081825) | BD ProbeTec GCQ Assay on the
BD Viper LT System
(K140448) |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | II | II |
| Regulation Specialty | Microbiology | Microbiology |
| Assay Results | Qualitative | Qualitative |
| Type of Assay | Molecular NAAT | Molecular NAAT |
| Intended Use | The BD ProbeTec (GC) Qx
Amplified DNA Assay, when tested
with the BD Viper™ System in
Extracted Mode, uses Strand
Displacement Amplification
technology for the direct, qualitative
detection of Neisseria gonorrhoeae
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
gonococcal urogenital disease. | The BD ProbeTec Neisseria
gonorrhoeae (GC) Qx 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
Neisseria gonorrhoeae 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 gonococcal 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 |
| Item | BD ProbeTec GCQ Assay on the
BD Viper System
(K081825) | BD ProbeTec GCQ Assay on the
BD Viper LT System
(K140448) |
| | Male specimens:
urethral swab
neat urine
UPT urine | LBC specimens collected in
PreservCyt Solution
Male specimens:
urethral swab
neat urine
UPT urine |
| Priming Microwell | | |
| Primers | Target a sequence within the GC pilin
gene inverting protein homologue | 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 | Bso BI 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 |
Table 1 Comparison to Predicate Device
Page 3 of 10
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Image /page/3/Picture/0 description: The image contains the BD logo, which consists of a stylized sun-like graphic with a human figure at the bottom, next to 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, sans-serif font. The logo is simple and conveys a sense of health and well-being.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System
4
Image /page/4/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a circular symbol on the left and the letters "BD" on the right. The circular symbol features a stylized human figure with arms raised, surrounded by radiating lines, resembling a sun. Below the "BD" letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller font size.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System
Analytical Performance Characteristics
The BD ProbeTec GCO 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 Qx 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. 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% |
Table 2 System Contamination
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Image /page/5/Picture/1 description: The image shows the BD logo, which consists of a stylized sun-like graphic to the left of 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, sans-serif font. The logo is black and white.
BD ProbeTec™ Neisseria gonorrhoeae (GC) O* Amplified DNA Assav on the BD Viper LT System
Clinical Performance Characteristics
The BD ProbeTec GCQ 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 GC Qx Assay.
6
3 BD
BD BD
BD ProbeTec™ Neisseria gonorrhoeae (GC) QF
Amplified DNA Assay on the BD Viper LT Syster
PPA and NPA for the BD ProbeTec GCQ Assay on the BD Viper LT Systen Table 3:
| Gender | Specimen Type | Site | Positive Percent Agreement | Negative Percent Agreement | ||
|---|---|---|---|---|---|---|
| Percent | 95% CI | Percent | 95% CI | |||
| Female | Vaginal Swab | A | 100.0% (27/27) | (87.5%, 100.0%) | 94.9% (75/79) | (87.7%, 98.0%) |
| Vaginal Swab | B | 96.3% (26/27) | (81.7%, 99.3%) | 96.2% (76/79) | (89.4%, 98.7%) | |
| Vaginal Swab | C | 96.3% (26/27) | (81.7%, 99.3%) | 96.2% (76/79) | (89.4%, 98.7%) | |
| Vaginal Swab | Total | 97.5% (79/81) | (92.6%, 100.0%) | 95.8% (227/237) | (92.0%, 98.7%) | |
| Female | Q'UPT | A | 96.3% (26/27) | (81.7%, 99.3%) | 100.0% (79/79) | (95.4%, 100.0%) |
| Q'UPT | B | 100.0% (27/27) | (87.5%, 100.0%) | 100.0% (79/79) | (95.4%, 100.0%) | |
| Q'UPT | C | 96.3% (26/27) | (81.7%, 99.3%) | 100.0% (79/79) | (95.4%, 100.0%) | |
| Q'UPT | Total | 97.5% (79/81) | (92.6%, 100.0%) | 100.0% (237/237) | NA | |
| Female | SurePath | A | 96.4% (27/28) | (82.3%, 99.4%) | 100.0% (78/78) | (95.3%, 100.0%) |
| SurePath | B | 96.4% (27/28) | (82.3%, 99.4%) | 100.0% (78/78) | (95.3%, 100.0%) | |
| SurePath | C | 96.4% (27/28) | (82.3%, 99.4%) | 98.7% (77/78) | (93.1%, 99.8%) | |
| SurePath | Total | 96.4% (81/84) | (89.3%, 100.0%) | 99.6% (233/234) | (98.7%, 100.0%) | |
| Female | PreservCyt. | A | 100.0% (27/27) | (87.5%, 100.0%) | 100.0% (79/79) | (95.4%, 100.0%) |
| PreservCyt. | B | 100.0% (27/27) | (87.5%, 100.0%) | 100.0% (79/79) | (95.4%, 100.0%) | |
| PreservCyt. | C | 100.0% (27/27) | (87.5%, 100.0%) | 100.0% (79/79) | (95.4%, 100.0%) | |
| PreservCyt. | Total | 100.0% (81/81) | NA | 100.0% (237/237) | NA | |
| All | Total | 97.9% (320/327) | (95.1%, 100.0%) | 98.8% (934/945) | (97.9%, 99.6%) | |
| Male | Q'UPT | A | 100.0% (40/40) | (91.2%, 100.0%) | 100.0% (73/73) | (95.0%, 100.0%) |
| Q'UPT | B | 100.0% (40/40) | (91.2%, 100.0%) | 100.0% (73/73) | (95.0%, 100.0%) | |
| Q'UPT | C | 100.0% (40/40) | (91.2%, 100.0%) | 98.6% (72/73) | (92.6%, 99.8%) | |
| Q'UPT | Total | 100.0% (120/120) | NA | 99.5% (218/219) | (98.6%, 100.0%) | |
| Total | All | Total | 98.4% (440/447) | (96.4%, 100.0%) | 99.0% (1152/1164) | (98.1%, 99.6%) |
Page 7 of 10
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Image /page/7/Picture/1 description: The image contains the logo for BD, a medical technology company. The logo consists of a stylized human figure with arms raised towards a sun-like burst of light, followed by the letters "BD" in bold font. Below the letters is the tagline "Helping all people live healthy lives" in a smaller font.
BD ProbeTec™ Neisseria gonorrhoeae (GC) O* Amplified DNA Assay on the BD Viper LT System
Reproducibility
Reproducibility of the BD Viper LT System using the BD ProbeTec GCQ 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 Q* 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, vaginal matrix in Q 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.
8
8 BD
BD
10(k) Summar
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q*
mplified DNA Assay on the BD Viper LT System
mmary of Reproducibility Data on the BD Viper LT System for the BD ProbeTcc GCQ Assa Table 4:
| | | | | | | Within Run | | Between Run
within Day | | Between Day
within Site | | Between Site | | Total |
|------------------|-------------------|----------------|-----------------|--------|-------|------------|-------|---------------------------|------|----------------------------|------|--------------|-------|--------|
| Specimen
Type | Panel | % Correct | 95% CI | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| LBC | Negative | 100.0% (96/96) | (96.2 - 100.0%) | 3.3 | 9.2 | 280.1% | 0.0 | 0.0% | 0.0 | 0.0% | 2.2 | 65.4% | 9.5 | 287.6% |
| | High Negative | 20.8% (20/96) | (13.9 - 30.0%) | 560.2 | 425.0 | 75.9% | 49.0 | 8.7% | 0.0 | 0.0% | 0.0 | 0.0% | 427.8 | 76.4% |
| | Low Positive | 100.0% (96/96) | (96.2 - 100.0%) | 1415.9 | 231.4 | 16.3% | 172.0 | 12.1% | 0.0 | 0.0% | 28.1 | 2.0% | 289.7 | 20.5% |
| | Moderate Positive | 100.0% (94/94) | (96.1 - 100.0%) | 1631.9 | 169.7 | 10.4% | 93.7 | 5.7% | 70.9 | 4.3% | 0.0 | 0.0% | 206.4 | 12.6% |
| Swab | Negative | 99.0% (95/96) | (94.3 - 99.8%) | 41.6 | 180.1 | 432.6% | 13.2 | 31.6% | 0.0 | 0.0% | 0.0 | 0.0% | 180.6 | 433.8% |
| | High Negative | 13.5% (13/96) | (8.1 - 21.8%) | 871.5 | 562.4 | 64.5% | 0.0 | 0.0% | 0.0 | 0.0% | 88.2 | 10.1% | 569.2 | 65.3% |
| | Low Positive | 100.0% (95/95) | (96.1 - 100.0%) | 1687.5 | 297.7 | 17.6% | 0.0 | 0.0% | 0.0 | 0.0% | 34.7 | 2.1% | 299.7 | 17.8% |
| | Moderate Positive | 100.0% (96/96) | (96.2 - 100.0%) | 1819.2 | 163.3 | 9.0% | 48.2 | 2.7% | 43.3 | 2.4% | 73.3 | 4.0% | 190.3 | 10.5% |
| UPT | Negative | 100.0% (96/96) | (96.2 - 100.0%) | 3.6 | 8.0 | 221.8% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 8.0 | 221.8% |
| | High Negative | 18.8% (18/96) | (12.2 - 27.7%) | 766.6 | 502.1 | 65.5% | 0.0 | 0.0% | 75.8 | 9.9% | 15.8 | 2.1% | 508.0 | 66.3% |
| | Low Positive | 100.0% (96/96) | (96.2 - 100.0%) | 1593.6 | 224.9 | 14.1% | 86.6 | 5.4% | 36.7 | 2.3% | 0.0 | 0.0% | 243.8 | 15.3% |
| | Moderate Positive | 100.0% (96/96) | (96.2 - 100.0%) | 1741.5 | 126.1 | 7.2% | 86.2 | 5.0% | 35.1 | 2.0% | 21.5 | 1.2% | 158.2 | 9.1% |
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Image /page/9/Picture/1 description: The image shows the logo for BD, a global medical technology company. The logo consists of a stylized sun-like graphic with a human figure in the center, 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.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System
Conclusions
The analytical and clinical study results for the BD ProbeTec Neisseria gonorrhoeae (GC) 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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Image /page/10/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is oriented to follow the curve of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administrati 10903 New Hampshire Avenue Document Control Center - WO66-G Silver Spring, MD 20993-0002
May 20, 2014
Becton, Dickinson and Company Sherma Winston, M.S., RAC 7 Loveton Circle Sparks, MD 21152
Re: K140448
Trade/Device Name: BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: II Product Code: LSL 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 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: K140448
Device Name: BD ProbeTec™ Neisseria gonorthoeae (GC) Q* Amplified DNA Assay
Indications for Use:
The BD ProbeTec Neisseria gonorrhoeae (GC) 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 Neisseria gonorrhoeae 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 gonococcal urogenital disease.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(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. Feidblyum -S 2014.05.16 15:38:53 -04'00'