(62 days)
Not Found
No
The device description details a standard nucleic acid amplification test (NAAT) with fluorescence detection and a simple threshold-based algorithm for result determination. There is no mention of AI or ML techniques.
No
This device is an in vitro diagnostic (IVD) device used for the qualitative detection of Neisseria gonorrhoeae DNA, which aids in the diagnosis of gonococcal urogenital disease. It does not provide therapy or treatment.
Yes
The device is intended for the "qualitative detection of Neisseria gonorrhoeae DNA" and is "indicated for use with asymptomatic females and symptomatic males to aid in the diagnosis of gonococcal urogenital disease," classifying it as a diagnostic device.
No
The device description clearly outlines physical components like microwells, reagents, enzymes, and a fluorescently-labeled detector probe, indicating it is a hardware-based assay with associated software for analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "direct, qualitative detection of Neisseria gonorrhoeae DNA" in various human specimens. It also mentions its use "to aid in the diagnosis of gonococcal urogenital disease." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes.
- Device Description: The description details the process of analyzing purified DNA from specimens using amplification and detection technologies. This is a typical process for in vitro diagnostic tests that analyze biological samples.
- Performance Studies: The document includes detailed information about analytical and clinical performance characteristics, including sensitivity, specificity, and reproducibility studies conducted on human specimens. This type of testing and reporting is standard for IVD devices to demonstrate their accuracy and reliability for diagnostic use.
- Predicate Device(s): The mention of predicate devices (K081825 and K062440) which are also IVD assays for Neisseria gonorrhoeae further supports the classification of this device as an IVD.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. 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 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 (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in PreservCyt® Solution using an aliquot that is removed prior to processing for additional gynecological testing. The assay is indicated for use with asymptomatic females and symptomatic males to aid in the diagnosis of gonococcal urogenital disease.
The BD Viper System, when used with the BD ProbeTec amplified nucleic assay(s), is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent package insert(s).
Product codes
LSL
Device Description
The BD ProbeTec GC Q* Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe. The reagents for SDA are dried in two separate disposable microwells: the Priming Microwell contains the amplification primers, fluorescently-labeled detector probe, nucleotides and other reagents necessary for amplification, while the Amplification Microwell contains the two enzymes (a DNA polymerase and a restriction endonuclease) that are required for SDA. The BD Viper TM System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermally-controlled fluorescent readers. The presence or absence of N. gonorrhoeae DNA is determined by calculating the peak fluorescence (Maximum Relative Fluorescent Units (MaxRFU)) over the course of the amplification process and by comparing this measurement to a predetermined threshold value.
In addition to the fluorescent probe used to detect amplified N. gonorrhoeae target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the N. gonorrhoeae -specific target and is used to confirm the validity of the extraction process. The EC is dried in the Extraction Tubes and is rehydrated upon addition of the specimen and extraction reagents. At the end of the extraction process, the EC fluorescence is monitored by the BD Viper System and an automated algorithm is applied to both the EC and N. gonorrhoeae -specific signals to report results as positive, negative, or EC failure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Female endocervical, male urethral, vaginal (patient-collected), urogenital
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician-collected, patient-collected (in a clinical 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
Clinical Performance Characteristics:
Endocervical swab specimens and PreservCyt specimens were collected from 2079 compliant female subjects attending family planning. OB/GYN, and sexually transmitted disease clinics at eleven geographically diverse clinical sites in North America. Subjects were classified as symptomatic if they reported symptoms such as dysuria, coital pain/difficulty/bleeding, abnormal vaginal discharge, or pelvic/uterine/adnexal pain. Subjects were classified as asymptomatic if they did not report symptoms. Two subjects were excluded due to an undetermined patient infected status. Three subjects did not have a PreservCyt specimen result. Therefore there were 2074 subjects evaluated.
Three randomized endocervical swab specimens and a PreservCyt specimen were collected from each female subject. The three reference endocervical swabs were tested with the BD ProbeTec ET CT/GC/AC assay, the BD ProbeTec GC Q assay, and another commercially available NAAT (Nucleic Acid Amplification Test). Sensitivity and specificity for PreservCyt specimens were calculated by comparing results to a patient infected status (PIS) algorithm. The designation of positive or negative PIS was based on the endocervical swab specimen results from the three reference methods. At least two positive reference results were required to establish a subject as PIS-positive. At least two negative reference results were required to establish a subject as PIS-negative.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance Characteristics - Limit of Detection (Analytical Sensitivity):
The Limits of Detection (LODs) for the GC Q* Assay with Neisseria gonorrhoeae strain ATCC 19424 in PreservCyt specimens when extracted on the BD Viper System were determined to be 95% proportion positive at a concentration of 50 cells per mL in clean diluted PreservCyt Solution.
Analytical Performance Characteristics - Interfering Substances:
Potential interfering substances which may be encountered in PreservCyt specimens were extracted from diluted PreservCyt matrix in the absence and presence of GC target (300 GC cells/mL) and tested with the BD ProbeTec GC Q* Amplified DNA Assay on the BD Viper System.
No Interference Observed for Blood (≤ 1%), Seminal Fluid, Mucus, Over The Counter vaginal products and contraceptives, Hemorrhoidal cream, Prescription vaginal treatments, Leukocytes (1x106 cells/mL), 1x106 EB/mL Chlamydia trachomatis.
May cause extraction control (EC) failures or False Negative results for Glacial Acetic Acid + Blood (≤5%/1% V/V).
Clinical Performance Characteristics:
Sample Size: 2074 subjects evaluated for PreservCyt specimens.
The BD ProbeTec GC Q* Assay performance for PreservCyt specimens compared to Patient Infected Status (by symptomatic status):
- Total (n=2074): Sensitivity 95.3% (41/43); Specificity 99.95% (2030/2031); PPV 100.0%; NPV 99.9%.
- Asymptomatic (n=1349): Sensitivity 92.3% (24/26); Specificity 100.0% (1323/1323); PPV 100.0%; NPV 99.9%.
- Symptomatic (n=725): Sensitivity 100.0% (17/17); Specificity 99.9% (707/708); PPV 95.9%; NPV 100.0%.
Reproducibility:
A reproducibility study of the BD Viper System using the BD ProbeTec GC Q* Assay was evaluated for Liquid Based Cytology (LBC) specimens at three clinical sites on one BD Viper System per site. A panel of simulated specimens comprising CT and GC organisms seeded into LBC Specimen Dilution Tubes containing LBC medium was tested with the BD ProbeTee GC O Assay. Uninoculated LBC Specimen Dilution Tubes containing LBC medium were used for the GC negative samples. Nine replicates of each panel member were tested every day for five days on each BD Viper System.
Results for GC cells/mL:
- 0 GC cells/mL: % Correct 100.0% (135/135), Mean MaxRFU 1.21.
- 100 GC cells/mL: % Correct 100.0% (135/135), Mean MaxRFU 1982.77.
- 250 GC cells/mL (with 30 CT EB's/mL): % Correct 100.0% (135/135), Mean MaxRFU 1983.66.
Two additional levels (1:10 and 1:100 of the analytical LODs) were included to characterize reproducibility at levels below LOD.
- 1:10 dilution of Analytical LOD: % Positive 74.1 (100/135), MaxRFU Mean (Positive) 1159.2.
- 1:100 dilution of Analytical LOD: % Positive 8.9 (12/135), MaxRFU Mean (Positive) 1136.5.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Performance Characteristics (Total):
- Sensitivity: 95.3% (41/43)
- Specificity: 99.95% (2030/2031)
- PPV: 100.0%
- NPV: 99.9%
Clinical Performance Characteristics (Asymptomatic):
- Sensitivity: 92.3% (24/26)
- Specificity: 100.0% (1323/1323)
- PPV: 100.0%
- NPV: 99.9%
Clinical Performance Characteristics (Symptomatic):
- Sensitivity: 100.0% (17/17)
- Specificity: 99.9% (707/708)
- PPV: 95.9%
- NPV: 100.0%
Reproducibility (Percentage Correct):
- 0 CT EB's/mL, 0 GC Cells/mL: 100.0% (135/135)
- 30 CT EB's/mL, 0 GC Cells/mL: 100.0% (135/135)
- 0 CT EB's/mL, 100 GC Cells/mL: 100.0% (135/135)
- 30 CT EB's/mL, 250 GC Cells/mL: 100.0% (135/135)
- 75 CT EB's/mL, 100 GC Cells/mL: 100.0% (135/135)
Reproducibility at Target Levels below Analytical LOD (Percentage Positive/Negative):
- 1:10 Dilution of Analytical LOD: % Positive 74.1 (100/135), % Negative 25.9 (35/135)
- 1:100 Dilution of Analytical LOD: % Positive 8.9 (12/135), % Negative 91.1 (123/135)
Predicate Device(s)
BD ProbeTec TM Neisseria gonorrhoeae (GC) Q x Amplified DNA Assay (K081825), Gen-Probe APTIMA Assay for Neisseria gonorrhoeae (AGC) (K062440)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/2 description: The image shows the BD logo, which consists of a stylized sun-like graphic to the left and the letters "BD" in bold, sans-serif font to the right. 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 clean, with a focus on the company's name and mission.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
| Applicant | BD Diagnostic Systems 7 Loveton Circle Sparks, MD 21152 | MAY 27 2009 |
|---|---|---|
| Establishment Registration No. | 1119779 | |
| Contact Person | Saba Modjarrad tel. 410-316-4685 fax. 410-316-4499 saba_modjarrad@bd.com | |
| Summary Date | March 25, 2009 | |
| Proprietary Name | BD ProbeTec TM Neisseria gonorrhoeae (GC) Q x Amplified DNA Assay | |
| Generic Name | DNA Reagents, Neisseria | |
| Classification | Class II | |
| Classification Name | Neisseria spp. direct serological test reagents | |
| Regulation Number | 866.3390 | |
| Product Code | LSL | |
| Predicate Devices | BD ProbeTec TM Neisseria gonorrhoeae (GC) Q x Amplified DNA Assay (K081825), Gen-Probe APTIMA Assay for Neisseria gonorrhoeae (AGC) (K062440) |
Device Description
The BD ProbeTec GC Q* Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe. The reagents for SDA are dried in two separate disposable microwells: the Priming Microwell contains the amplification primers, fluorescently-labeled detector probe, nucleotides and other reagents necessary for amplification, while the Amplification Microwell contains the two enzymes (a DNA polymerase and a restriction endonuclease) that are required for SDA. The BD Viper TM System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermally-controlled fluorescent readers. The presence or absence of N. gonorrhoeae DNA is determined by calculating the peak fluorescence
1
Image /page/1/Picture/1 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized graphic on the left and the letters "BD" on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives."
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
(Maximum Relative Fluorescent Units (MaxRFU)) over the course of the amplification process and by comparing this measurement to a predetermined threshold value.
In addition to the fluorescent probe used to detect amplified N. gonorrhoeae target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the N. gonorrhoeae -specific target and is used to confirm the validity of the extraction process. The EC is dried in the Extraction Tubes and is rehydrated upon addition of the specimen and extraction reagents. At the end of the extraction process, the EC fluorescence is monitored by the BD Viper System and an automated algorithm is applied to both the EC and N. gonorrhoeae -specific signals to report results as positive, negative, or EC failure.
Intended Use
The BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of 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 PreservCyt® Solution using an aliquot that is removed prior to processing for additional gynecological testing. The assay is indicated for use with asymptomatic and symptomatic females and symptomatic males to aid in the diagnosis of gonococcal urogenital disease.
Summary and Principles of Operation
When used with the BD Viper System, the BD ProbeTec GC O* Amplified DNA Assav involves automated extraction of DNA from clinical specimens through the chemical lysis of cells, followed by binding of DNA to para-magnetic particles, washing of the bound nucleic acid and elution in an amplification-compatible buffer. When present, N. gonorrhoeae DNA is then detected by Strand Displacement Amplification (SDA) of a specific target sequence in the presence of a fluorescently labeled detector probe.
Analytical Performance Characteristics
Limit of Detection (Analytical Sensitivity)
The Limits of Detection (LODs) for the GC Q* Assay with Neisseria gonorrhoeae strain ATCC 19424 in PreservCyt specimens when extracted on the BD Viper System were determined to be 95% proportion positive at a concentration of 50 cells per mL in clean diluted PreservCyt Solution.
2
Image /page/2/Picture/1 description: The image shows the logo for BD, a global 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, possibly symbolizing health and well-being. Below the letters "BD" is the tagline "Helping all people live healthy lives" in a smaller font.
BD ProbeTecTM Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
Interfering Substances
Potential interfering substances which may be encountered in PreservCyt specimens were extracted from diluted PreservCyt matrix in the absence and presence of GC target (300 GC cells/mL) and tested with the BD ProbeTec GC Q* Amplified DNA Assay on the BD Viper System. Results are summarized in Table 2.
Table 2 Interfering Substances
| Interpretation | PreservCyt |
|---|---|
| No Interference Observed | Blood (≤ 1%) |
| Seminal Fluid | |
| Mucus | |
| Over The Counter vaginal products and contraceptives | |
| Hemorrhoidal cream | |
| Prescription vaginal treatments | |
| Leukocytes (1x106 cells/mL) | |
| 1x106 EB/mL Chlamydia trachomatis | |
| May cause extraction control (EC) | |
| failures | Glacial Acetic Acid + Blood (≤5%/1% V/V) |
| May cause False Negative results | Glacial Acetic Acid + Blood (≤5%/1% V/V) |
Clinical Performance Characteristics
Endocervical swab specimens and PreservCyt specimens were collected from 2079 compliant female subjects attending family planning. OB/GYN, and sexually transmitted disease clinics at eleven geographically diverse clinical sites in North America. Subjects were classified as symptomatic if they reported symptoms such as dysuria, coital pain/difficulty/bleeding, abnormal vaginal discharge, or pelvic/uterine/adnexal pain. Subjects were classified as asymptomatic if they did not report symptoms. Two subjects were excluded due to an undetermined patient infected status. Three subjects did not have a PreservCyt specimen result. Therefore there were 2074 subjects evaluated.
Three randomized endocervical swab specimens and a PreservCyt specimen were collected from each female subject. The three reference endocervical swabs were tested with the BD ProbeTec ET CT/GC/AC assay, the BD ProbeTec GC Q assay, and another commercially available NAAT (Nucleic Acid Amplification Test). Sensitivity and specificity for PreservCyt specimens were calculated by comparing results to a patient infected status (PIS) algorithm. The designation of positive or negative PIS was based on the endocervical swab specimen results
3
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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
from the three reference methods. At least two positive reference results were required to establish a subject as PIS-positive. At least two negative reference results were required to establish a subject as PIS-negative. Sensitivity and specificity by symptomatic status are presented in Table 4.
The distribution of cervical sampling devices used in the clinical study according to clinical collection site is summarized in Table 3.
Summary of Cervical Sampling Devices Used in the PreservCyt Specimen Table 3 Clinical Study
| Cervical Sampling Device Used | Clinical Collection Site Number | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | Total | |
| Broom-Type Device | 89 | 0 | 0 | 45 | 16 | 464 | 272 | 83 | 0 | 99 | 0 | 1068 |
| Spatula/Cytobrush | 74 | 154 | 95 | 0 | 0 | 52 | 0 | 209 | 282 | 0 | 145 | 1011 |
GC Q* Assay Performance for PreservCyt Specimens Compared to Patient Infected Table 4 Status (by symptomatic status)
| Performance Compared to Patient Infected Status | ||||||||
|---|---|---|---|---|---|---|---|---|
| Symptomatic | ||||||||
| Status | n | Sensitivity | 95% C.I. | Specificity | 95% C.I. | PPV% | NPV% | Error |
| Initial/Final | ||||||||
| A | 1349 | 92.3% | ||||||
| (24/26) | (74.9% - | |||||||
| 99.1%) | 100.0% | |||||||
| (1323/1323) | (99.7% - | |||||||
| 100.0%) | 100.0% | 99.9% | 1/0 | |||||
| S | 725 | 100.0% | ||||||
| (17/17) | (80.5% - | |||||||
| 100.0%) | 99.9% | |||||||
| (707/708) | (99.2% - | |||||||
| 100.0%) | 95.9% | 100.0% | 0/0 | |||||
| Total | 2074 | 95.3% | ||||||
| (41/43) | (84.2% - | |||||||
| 99.4%) | 99.95% | |||||||
| (2030/2031) | (99.7% - | |||||||
| 100.0%) | 100.0% | 99.9% | 1/0 |
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Image /page/4/Picture/1 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized graphic on the left and the letters "BD" on the right. The graphic resembles a person with arms raised, with sun rays emanating from above. Below the letters "BD" is the tagline "Helping all people live healthy lives".
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
A total of 2074 GC Q* Assay results from PreservCyt specimens was evaluated from eleven geographically diverse clinical sites. A frequency distribution of the initial MaxRFU values for the GC Q* assay is shown in Figure A..
Frequency Distribution of MaxRFU for the GC Q* Assay (PreservCyt Figure A Specimens)
Image /page/4/Figure/5 description: This bar graph shows the frequency of MaxRFU values. The x-axis represents the MaxRFU ranges, while the y-axis represents the frequency. The highest frequency is observed in the 0-49 range, with a value of 2025. Other ranges have significantly lower frequencies, such as 6 in the 50-99 range, 1 in the 100-124 range, and 42 in the >=800 range.
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Image /page/5/Picture/1 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a graphic symbol on the left and the letters "BD" on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives." The graphic symbol appears to be a stylized representation of a person with arms raised towards a sun-like burst of light.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
Reproducibility
A reproducibility study of the BD Viper System using the BD ProbeTec GC Q* Assay was evaluated for Liquid Based Cytology (LBC) specimens at three clinical sites on one BD Viper System per site. A panel of simulated specimens comprising CT and GC organisms seeded into LBC Specimen Dilution Tubes containing LBC medium was tested with the BD ProbeTee GC O Assay. Uninoculated LBC Specimen Dilution Tubes containing LBC medium were used for the GC negative samples. Nine replicates of each panel member were tested every day for five days on each BD Viper System. The data are summarized in Table 5.
Two additional levels were included in the panels to characterize the reproducibility of test results (i.e., proportion positive or negative) at target levels below the analytical Limit of Detection (LOD) of the BD ProbeTec GC Qc Assay. These additional specimens comprised CT and GC organisms seeded into LBC Specimen Dilution Tubes containing LBC medium at dilutions of 1:10 and 1:100 of the respective analytical LODs of each analyte. These levels were selected to fall within the dynamic range of the analytical LOD curves for the BD ProbeTec CT Q and GC Q assays. Nine replicates of each panel member were tested every day for five days across the three BD Viper Systems. The data are summarized in Table 6.
| CT
EB's/mL | GC
Cells/mL | % Correct | 95% CI | Mean
MaxRFU | Within Run | | Between Runs
Within Site | | Between Site | |
|---------------|----------------|---------------------|---------------------|----------------|------------|--------|-----------------------------|------|--------------|-------|
| 0 | 0 | 100.0%
(135/135) | (97.3% -
100.0%) | 1.21 | 4.00 | 330.38 | 0.00 | 0.00 | 0.00 | 0.00 |
| 30 | 0 | 100.0%
(135/135) | (97.3% -
100.0%) | 0.98 | 7.47 | 761.30 | 0.00 | 0.00 | 0.17 | 17.04 |
| 0 | 100 | 100.0%
(135/135) | (97.3% -
100.0%) | 1982.77 | 83.92 | 4.23 | 0.00 | 0.00 | 0.00 | 0.00 |
| 30 | 250 | 100.0%
(135/135) | (97.3% -
100.0%) | 1983.66 | 87.76 | 4.42 | 0.00 | 0.00 | 24.80 | 1.25 |
| 75 | 100 | 100.0%
(135/135) | (97.3% -
100.0%) | 1920.14 | 81.94 | 4.27 | 59.45 | 3.10 | 0.00 | 0.00 |
Summary of Reproducibility Data for LBC Specimens on the BD Viper Table 5 System for the GC Qx Assay
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Image /page/6/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 resembles a person with arms outstretched, with sun rays emanating from the top of their head. Below the letters "BD" is the company's slogan: "Helping all people live healthy lives."
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
Characterization of System Reproducibility at Target Levels below the Table 6 Analytical Limit of Detection for the GC Q* Assay for LBC Specimens
| Dilution
of
Analytical
LOD | % Positive | 95% CI
(Positive) | MaxRFU
Mean
(Positive) | % Negative | 95% CI
(Negative) | MaxRFU
Mean
(Negative) | |
|-------------------------------------|------------|----------------------|------------------------------|---------------|----------------------|------------------------------|---------------|
| | 1:10 | 74.1 (100/135) | | (65.8 - 81.2) | 1159.2 | | 25.9 (35/135) |
| | 1:100 | 8.9 (12/135) | (4.7 - 15.0) | 1136.5 | 91.1 (123/135) | (85.0 - 95.3) | 6.6 |
Conclusions
The analytical and clinical study results for the BD ProbeTec Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay with PreservCyt specimens 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
Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
MAY 27 2009
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Saba Modjarrad Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Re: K090827
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: Class II Product Code: LSL Dated: March 25, 2009 Received: March 26, 2009
Dear Ms. Modjarrad:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
8
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ' (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attyma
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
Indications for Use
k 090827 510(k) Number (if known):
Device Name: BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
Indications For Use:
The BD ProbeTec™ Neisseria gonorrhoeae (GC) O* 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 (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in PreservCyt® Solution using an aliquot that is removed prior to processing for additional gynecological testing. The assay is indicated for use with asymptomatic females and symptomatic males to aid in the diagnosis of gonococcal urogenital disease.
The BD Viper System, when used with the BD ProbeTec amplified nucleic assay(s), is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent package insert(s).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety K090827 510(k). Page 1 of 1
BD Diagnostic Systems Becton, Dickinson and Company
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