(155 days)
No
The description focuses on traditional molecular diagnostic techniques (SDA, fluorescence detection) and a simple automated algorithm for result interpretation based on a predetermined threshold. There is no mention of AI, ML, or related concepts.
No.
The device is described as an "Amplified DNA Assay" for direct, qualitative detection of Neisseria gonorrhoeae DNA, intended "to aid in the diagnosis of gonococcal urogenital disease." This indicates its function as a diagnostic tool, not one that provides therapy or treatment.
Yes
The device is intended "to aid in the diagnosis of gonococcal urogenital disease," which clearly indicates a diagnostic purpose.
No
The device description clearly outlines physical components like microwells, reagents, enzymes, and the BD Viper™ System, which is a hardware instrument. While software is involved in data analysis and reporting, the device is not solely software.
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 used for the "direct, qualitative detection of Neisseria gonorrhoeae DNA" in various human specimens (swabs and urine). This is a classic definition of an in vitro diagnostic test, as it is performed outside of the body on biological samples to aid in the diagnosis of a disease (gonococcal urogenital disease).
- Device Description: The description details the components and process of the assay, which involves the analysis of DNA from the collected specimens using chemical and biological reagents and a detection system (fluorescence). This is consistent with the methodology of an IVD.
- Performance Studies: The document includes details about clinical performance studies conducted on human specimens to evaluate the assay's sensitivity and specificity in detecting Neisseria gonorrhoeae. This type of testing is required for IVD devices to demonstrate their accuracy and reliability for diagnostic purposes.
- Key Metrics: The reporting of metrics like Sensitivity, Specificity, PPV, and NPV are standard performance indicators for IVD devices.
- Predicate Device(s): The mention of predicate devices, which are other legally marketed IVDs, further confirms that this device falls under the IVD category.
In summary, the BD ProbeTecT™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay meets the criteria of an In Vitro Diagnostic device based on its intended use, methodology, and the type of performance data presented.
N/A
Intended Use / Indications for Use
The BD ProbeTecT™ 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 BD SurePath™ Preservative Fluid using an aliquot that is removed prior to processing for the BD SurePath™ 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 GC O* 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™ 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, urogenital
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician, 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
A reproducibility study of the BD Viper System using the BD ProbeTec GC Qd 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 ProbeTec GC Q* 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.
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 Q* 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Limit of Detection (Analytical Sensitivity):
The Limits of Detection (LODs) for the GC Q* Assay with Neisseria gonorrhoeae strain ATCC 19424 in BD SurePath specimens when extracted on the BD Viper System were determined to be
§ 866.3120 Chlamydia serological reagents.
(a)
Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/2 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 under a sunburst. Below the letters "BD" is the tagline "Helping all people live healthy lives" in a smaller font.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
| Applicant | BD Diagnostic Systems
7 Loveton Circle
Sparks, MD 21152 |
| ----------- | --------------------------------------------------------------- |
|---|
NOV 13 2009
| Establishment Registration No. | 1119779 |
|---|---|
| Contact Person | Saba Modjarrad |
| tel. 410-316-4685 | |
| fax. 410-316-4499 | |
| saba_modjarrad@bd.com | |
| Summary Date | June 10, 2009 |
| Proprietary Name | BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* 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™ Neisseria gonorrhoeae (GC) Q* Amplified |
| DNA Assay (K081825), | |
| Gen-Probe APTIMA Assay for Neisseria gonorrhoeae (AGC) | |
| (K062440) |
Device Description
The BD ProbeTec GC O* 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™ 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
1
Image /page/1/Picture/1 description: The image shows the BD logo. The logo consists of a stylized sun-like figure on the left and the letters "BD" on the right. Below the letters, there is the text "Helping all people live healthy lives".
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
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.
Intended Use
The BD ProbeTecT™ 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 BD SurePath™ Preservative Fluid using an aliquot that is removed prior to processing for the BD SurePath™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals 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 Q* Amplified DNA Assay 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 BD SurePath specimens when extracted on the BD Viper System were determined to be 1 Of the 1728 compliant female subjects did not have a GC Q assay result for the BD SurePath specimen, therefore the final data analysis included 1715 compliant female subjects.
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Image /page/4/Picture/1 description: The image shows the BD logo. The logo consists of a stylized sun-like symbol with a human figure at the bottom left and the letters "BD" in bold font to 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
A total of 1715 GC Q* Assay results from BD SurePath 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 (BD SurePath Figure A Specimens)
Image /page/4/Figure/5 description: The image is a bar graph showing the frequency of MaxRFU values. The x-axis represents the MaxRFU ranges, and the y-axis represents the frequency. The highest frequency is in the 0-49 range, with a value of 1659. The frequency is very low for the other ranges, with the >=800 range having a frequency of 53.
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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
Reproducibility
A reproducibility study of the BD Viper System using the BD ProbeTec GC Qd Assay was also 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 ProbeTec GC Q* 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 Q* 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 | SD | %CV | SD | %CV | SD | %CV |
|---------------|----------------|---------------------|---------------------|----------------|-------|--------|-----------------------------|------|--------------|-------|
| | | | | | | | 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 |
Table 5 Summary of Reproducibility Data for LBC Specimens on the BD Viper System for the GC Q* Assay
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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) | (18.8 - 34.2) | 21.2 |
| 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 BD SurePath specimens support the determination of substantial equivalence in accordance with the intended use as stated in the product labeling.
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Image /page/7/Picture/0 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Becton, Dickinson and Company Saba Mojarrad, Regulatory Affairs Specialist / Regulatory Affairs 7 Loveton Circle Sparks, MD 21152
NOV 1 3 2009
Re: K091724
Trade/Device Name: BD ProbeTecCT Q4 Amplified DNA Assay Regulation Number: 21 CFR 866.3120 Regulation Name: Chlamydia Serological Reagents Regulatory Class: Class I Product Code: MKZ Dated: June 10, 3009 Received: June 11, 2009
Dear Ms. Mojarrad:
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). 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
8
Page 2 - Ms. Saba Mojarrad
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,
Vau, atatn
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
510(k) Number (if known):
Device Name: BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay
Indications For Use:
The BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Chlamydia trachomatis DNA in cliniciancollected 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 using an aliquot that is removed prior to processing for the BD SurePath™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.
Prescription Use V (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)
M.A.A.W. for Uwe Scherf
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K091724
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BD Diagnostic Systems Becton, Dickinson and Company
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