(88 days)
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.
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.
Here's a summary of the acceptance criteria and study details for the BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System, based on the provided text:
Acceptance Criteria and Device Performance
The general acceptance criteria for this type of diagnostic device is that the performance on the new system (BD Viper LT) should be substantially equivalent to the predicate device (BD Viper System in Extracted Mode), which implies comparable Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). While explicit numerical acceptance criteria for PPA and NPA are not stated in the document, the clinical study results are presented to demonstrate this equivalence. The analytical performance (system contamination rate and reproducibility) also contributes to the overall equivalence determination.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Clinical Performance | Positive Percent Agreement (PPA):- Female (All specimen types): 97.9% (320/327) with 95% CI (95.1%, 100.0%)- Male (QUPT): 100.0% (120/120)- Overall (All): 98.4% (440/447) with 95% CI (96.4%, 100.0%)Negative Percent Agreement (NPA):- Female (All specimen types): 98.8% (934/945) with 95% CI (97.9%, 99.6%)- Male (QUPT): 99.5% (218/219) with 95% CI (98.6%, 100.0%)- Overall (All): 99.0% (1152/1164) with 95% CI (98.1%, 99.6%) |
| Analytical Performance | System Contamination Rate:- Q* Swab Diluent: 0.32% (2/630)- LBC Specimen Matrix: 0.0% (0/630)Reproducibility (Overall for various specimen types and panels):- LBC: % Correct between 20.8% (High Negative) and 100.0% (Negative, Low Positive, Moderate Positive)- Swab: % Correct between 13.5% (High Negative) and 100.0% (Negative, Low Positive, Moderate Positive)- UPT: % Correct between 18.8% (High Negative) and 100.0% (Negative, Low Positive, Moderate Positive)- Overall %CVs range from 9.1% to 433.8% (for negative/high negative where the mean is very low and thus %CV can be high) for quantitation, but 100% agreement for positive controls. |
Study Details
-
Sample size used for the test set and the data provenance:
- Clinical Performance Test Set:
- Female subjects: 617 compliant subjects
- Male subjects: 167 compliant subjects
- Total Clinical Samples: A total of 327 positive and 945 negative results for females across various specimen types were evaluated on the BD Viper LT system. For males, 120 positive and 219 negative results were evaluated for Q*UPT.
- Data Provenance: The specimens were collected prospectively from individuals attending OB/GYN, sexually transmitted disease (STD), and family planning clinics at four geographically diverse clinical sites in North America. These were then assembled into comparison panels at BD and shipped to test sites.
- Analytical Performance Test Set:
- System Contamination: 630 Negative samples (Q* Swab Diluent or LBC Specimen Matrix) and 630 Positive samples (spike GC at 10^3 CT EB/mL) per matrix type (Q* Swab Diluent, LBC Specimen Matrix). Tested on three BD Viper LT Systems.
- Reproducibility: 3 levels of CT and GC organisms (and negative controls) seeded into LBC specimen matrix, vaginal matrix in Q* Swab Diluent, and urine specimen matrix. Two operators per site ran one panel each day for 8 days, totaling 16 runs. Each run consisted of 8 LBC, 8 swab, and 8 UPT panel members. This means for each panel type (LBC, Swab, UPT) and each level (Negative, High Negative, Low Positive, Moderate Positive), there were 96 replicates (3 sites * 2 operators * 8 days * 2 replicates per panel member or 3 sites * 16 runs * 2 replicates per panel member).
- Clinical Performance Test Set:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The ground truth for the clinical performance study was established by the BD Viper System in extracted mode reference results (the predicate device). It's not explicitly stated that human experts were involved in establishing the ground truth for each individual case in the test set. Instead, the predicate device itself served as the reference standard for comparison. The document does not specify the number or qualifications of experts directly used to establish this "ground truth" beyond relying on the previously cleared predicate device. -
Adjudication method for the test set:
The document states: "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 implies that the results from the BD Viper LT System were compared against the established reference results from the predicate BD Viper System. There is no mention of a human expert adjudication method (e.g., 2+1, 3+1) for discordant results between the new device and the predicate device. The comparison appears to be direct. -
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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a molecular diagnostic assay (NAAT) for the detection of Neisseria gonorrhoeae DNA, not an imaging device requiring human reader interpretation. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable in this context. The assay provides a qualitative "positive" or "negative" result. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the device's performance is standalone. The BD ProbeTec GCQ Assay on the BD Viper LT System is an automated instrument that performs nucleic acid extraction, amplification, and detection. It provides a qualitative result ("positive" or "negative") directly. Human involvement is in specimen collection, loading the samples, and interpreting the final automated result from the instrument, but not in the analytical process of generating the result itself. The clinical performance study directly compares the results of this automated system to the predicate automated system. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for the clinical performance comparison was the results from the predicate device: the BD ProbeTec GCQ Assay on the BD Viper System in Extracted Mode. This type of ground truth is often referred to as a "reference method" or "comparator method" in device migration studies. While the predicate device itself would have initially been cleared against a gold standard (e.g., culture or a combination of clinical outcomes and other diagnostic tests), for this 510(k) submission, the predicate device serves as the established "truth" for demonstrating substantial equivalence of the new system for the same assay. -
The sample size for the training set:
The document does not explicitly state the sample size used for a "training set." This submission focuses on the migration of an existing assay formulation to a new instrument system. The assay formulation itself has "not changed." Therefore, it is implied that the assay was developed and "trained" (in a molecular biology sense, not necessarily machine learning) prior to this study on the new platform. The data provided are for analytical verification and a clinical comparison study. -
How the ground truth for the training set was established:
As there is no distinct "training set" described in the context of machine learning, the concept of establishing ground truth for it is not applicable here. The assay formulation itself was developed based on established molecular biology principles for detecting Neisseria gonorrhoeae DNA. The ground truth for the predicate device (K081825) would have been established through its own clinical trials, likely using culture as a primary reference standard, possibly augmented by discrepant analysis with other methods. For this K140448 submission, the primary ground truth for comparison is the performance of the predicate device itself.
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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System
MAY 2 0 2014
| Applicant | BD Diagnostic Systems7 Loveton CircleSparks, MD 21152 |
|---|---|
| Establishment Registration No. | 1119779 |
| Contact Person | Sherma Winston, M.S., RACtel. 410-316-4145fax. 410-316-4188sherma_winston@bd.com |
| Summary Date | May 15, 2014 |
| Proprietary Name | BD ProbeTec™ Neisseria gonorrhoeae (GC) Q x AmplifiedDNA 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
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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.
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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 theBD Viper System(K081825) | BD ProbeTec GCQ Assay on theBD 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) QxAmplified DNA Assay, when testedwith the BD Viper™ System inExtracted Mode, uses StrandDisplacement Amplificationtechnology for the direct, qualitativedetection of Neisseria gonorrhoeaeDNA in clinician-collected femaleendocervical and male urethral swabspecimens, patient-collected vaginalswab specimens (in a clinical setting),and male and female urine specimens.The assay is indicated for use withasymptomatic and symptomaticindividuals to aid in the diagnosis ofgonococcal urogenital disease. | The BD ProbeTec Neisseriagonorrhoeae (GC) Qx AmplifiedDNA Assay, when tested with eitherthe BD Viper™ System in ExtractedMode or the BD Viper™ LT System,uses Strand DisplacementAmplification technology for thedirect, qualitative detection ofNeisseria gonorrhoeae DNA inclinician-collected femaleendocervical and male urethral swabspecimens, patient-collected vaginalswab specimens (in a clinical setting),and male and female urine specimens(both UPT and neat). The assay is alsointended for use with gynecologicalspecimens collected in BDSurePath™ Preservative Fluid orPreservCyt™ Solution using analiquot that is removed prior toprocessing for either the BD SurePathor ThinPrep™ Pap test. The assay isindicated for use with asymptomaticand symptomatic individuals to aid inthe diagnosis of gonococcal urogenitaldisease. |
| 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 |
| Item | BD ProbeTec GCQ Assay on theBD Viper System(K081825) | BD ProbeTec GCQ Assay on theBD Viper LT System(K140448) |
| Male specimens:urethral swabneat urineUPT urine | LBC specimens collected inPreservCyt SolutionMale specimens:urethral swabneat urineUPT urine | |
| Priming Microwell | ||
| Primers | Target a sequence within the GC pilingene 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 andcofactors | 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 andcofactors | Buffering components, magnesium ions,salt and stabilizing reagents | Same |
| Assay Buffer | Bicine-potassium hydroxide-based | Same |
Table 1 Comparison to Predicate Device
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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
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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 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 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% |
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.
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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%) |
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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.
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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 Runwithin Day | Between Daywithin Site | Between Site | Total | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SpecimenType | 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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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)
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Concurrence of Center for Devices and Radiological Health (CDRH)
Tamara V. Feidblyum -S 2014.05.16 15:38:53 -04'00'
§ 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).