(155 days)
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 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.
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 10 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. gonorrhoede -specific signals to report results as positive, negative, or EC failure.
Here's an analysis of the BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay based on the provided document, focusing on acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in a numerical format that the device must meet. Instead, it presents the results of its clinical performance study and concludes that these results "support the determination of substantial equivalence." Therefore, the reported performance itself, particularly sensitivity and specificity, serves as the de-facto measure of whether the device is considered acceptable for its intended use.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance (BD SurePath Specimens) |
|---|---|---|
| Sensitivity | Sufficiently high to detect N. gonorrhoeae in positive cases (exact threshold not stated, but 90%+ would be typical for diagnostics) | Total: 100.0% (51/51) Symptomatic: 100.0% (19/19) Asymptomatic: 100.0% (32/32) |
| Specificity | Sufficiently high to correctly identify negative cases (exact threshold not stated, but 95%+ would be typical for diagnostics) | Total: 99.9% (1662/1664) Symptomatic: 100.0% (539/539) Asymptomatic: 99.8% (1123/1125) |
| Limit of Detection (LOD) | Max. 100 GC cells per mL (based on predicate/similar devices) | ≤ 100 GC cells per mL (with > 95% proportion positive at 50 cells/mL) |
| Interference | No significant interference from common substances | No interference observed from various substances (Blood, Seminal Fluid, Mucus, OTC vaginal products, etc.) |
| Reproducibility | Consistent results across runs, sites, and systems | High percentage of correct results (100%) and low %CV for MaxRFU values for positive and negative controls. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Performance):
- Female Subjects: 1728 compliant female subjects enrolled, 1715 included in final data analysis.
- Specimens:
- 3 randomized endocervical swab specimens per subject (for reference methods).
- 1 BD SurePath specimen per subject (for the device under evaluation).
- Data Provenance:
- Country of Origin: North America (specifically, "eleven geographically diverse clinical sites in North America").
- Retrospective or Prospective: The study describes specimen collection from "subjects attending family planning, OB/GYN, and sexually transmitted disease clinics," implying a prospective collection for the purpose of this study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of "experts" to establish ground truth in the traditional sense of a human review panel. Instead, the ground truth was established using a Patient Infected Status (PIS) algorithm rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
The adjudication method for establishing the Patient Infected Status (PIS) was algorithmic, not human adjudication:
- Method: A PIS algorithm based on the results of three reference endocervical swab methods:
- BD ProbeTec ET CT/GC/AC assay
- BD ProbeTec GC Q* assay (the predicate device)
- Another commercially available NAAT (Nucleic Acid Amplification Test)
- Criteria:
- PIS-positive: At least two positive reference results were required.
- PIS-negative: At least two negative reference results were required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is an in vitro diagnostic (IVD) assay that directly detects DNA using a machine (BD Viper System), not an image-based AI system that assists human interpretation.
6. Standalone Performance
Yes, the study primarily evaluates the standalone performance of the BD ProbeTec GC Q* Amplified DNA Assay integrated with the BD Viper System. The clinical performance table (Table 4) presents the sensitivity and specificity of the device against the "Patient Infected Status" (ground truth). This is the algorithm's performance without a human in the loop interpreting the results, as the output is a "positive, negative, or EC failure."
7. Type of Ground Truth Used
The ground truth used was a Patient Infected Status (PIS) algorithm derived from the results of multiple established reference Nucleic Acid Amplification Tests (NAATs) on endocervical swab specimens. While not direct pathology (like tissue biopsy), it represents a "composite reference standard" or "latent class analysis" approach, which is common and often considered highly accurate for infectious disease diagnostics when a single gold standard is imperfect or invasive.
8. Sample Size for the Training Set
The document does not explicitly state the sample size for a "training set." This is typical for in vitro diagnostic assays like this one. Unlike machine learning algorithms that require distinct training and test sets, the development of IVD assays often involves an iterative process of reagent optimization and analytical validation (LOD, interference, etc.) using spiked samples and smaller initial specimen panels, followed by a larger, independent clinical validation set (which is what is described here). The "training" in this context refers to the development and optimization of the assay itself and its algorithm, which is not typically quantified by a specific "training set" sample size in the same way an AI model would be.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" with a formally established ground truth, as understood in machine learning, is not described for this IVD assay. The development and optimization of the assay's internal algorithms (e.g., for calculating MaxRFU and applying the automated algorithm for positive/negative/EC failure) would have been based on analytical studies and perhaps smaller, internal clinical sample sets where results were correlated with known positive and negative samples, often confirmed by reference methods or culture. The document focuses on the validation of the final assay on a robust clinical test set.
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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
510(k) Summary
| Applicant | BD Diagnostic Systems7 Loveton CircleSparks, MD 21152 |
|---|---|
| NOV 13 2009 | |
| Establishment Registration No. 1119779 | |
| Contact Person | Saba Modjarradtel. 410-316-4685fax. 410-316-4499saba_modjarrad@bd.com |
| Summary Date | June 10, 2009 |
| Proprietary Name | BD ProbeTec TM Neisseria gonorrhoeae (GC) Q* AmplifiedDNA 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* AmplifiedDNA 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 10 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
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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. gonorrhoede -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 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.
Summarv 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 O* Assay with Neisseria gonorrhoeae strain ATCC 19424 in BD SurePath specimens when extracted on the BD Viper System were determined to be ≤ 100 GC cells per mL. The GC Q* Assay on the BD Viper System in extracted mode was able to detect 17 GC strains with > 95% proportion positive at a concentration of 50 cells per mL in clean diluted BD SurePath Preservative Fluid.
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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
Interfering Substances
Potential interfering substances which may be encountered in BD SurePath specimens were extracted from diluted BD SurePath 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 | BD SurePath |
|---|---|
| No Interference Observed | Blood (≤ 1%)Seminal FluidMucusOver The Counter vaginal products and contraceptivesHemorrhoidal cream |
| Prescription vaginal treatmentsLeukocytes (1x106 cells/mL)1x106 EB/mL Chlamydia trachomatis |
Clinical Performance Characteristics
Endocervical swab specimens and BD SurePath specimens were collected from 1728 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.
Three randomized endocervical swab specimens and a BD SurePath 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 BD SurePath 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. 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.
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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
Summary of Cervical Sampling Devices Used in the BD SurePath Specimen Table 3 Clinical Study
| Clinical Collection Site Number | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cervical SamplingDevice Used | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | Total |
| Broom-TypeDevice | 54 | 50 | 511 | 18 | 374 | 0 | 127 | 0 | 0 | 71 | 0 | 1205 |
| Spatula/Cytobrush | 0 | 25 | 0 | 0 | 182 | 112 | 32 | 24 | 103 | 8 | 37 | 523 |
Table 4 GC Q* Assay Performance for BD SurePath Specimens Compared to Patient Infected Status (By Symptomatic Status)
| Performance Compared to Patient InfectedStatus | ||||||||
|---|---|---|---|---|---|---|---|---|
| SymptomaticStatus | N | Sensitivity | 95% C.I. | Specificity | 95%C.I. | PPV | NPV | ErrorInitial/Final |
| A | 1157 | 100.0%(32/32) | (89.1% -100.0%) | 99.8%(1123/1125) | (99.4% -100.0%) | 93.5% | 100.0% | 2/0 |
| S | 558 | 100.0%(19/19) | (82.4% -100.0%) | 100.0%(539/539) | (99.3% -100.0%) | 100.0% | 100.0% | 0/0 |
| Total | 1715' | 100.0%(51/51) | (93.0% -100.0%) | 99.9%(1662/1664) | (99.6% -100.0%) | 96.9% | 100.0% | 2/0 |
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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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 frequency on the y-axis and MaxRFU on the x-axis. The first bar, representing 0-49 MaxRFU, has a frequency of 1659. The other bars have much lower frequencies, with 50-99 at 2, 100-124 at 1, and >=800 at 53, while the rest are at 0.
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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 Q* 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 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 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 Of 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.
| Within Run | BetweenRunsWithin Site | BetweenSite | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| CTEB's/mL | GCCells/mL | % Correct | 95% CI | MeanMaxRFU | SD | %CV | SD | %CV | SD | %CV |
| 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 O* 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
| DilutionofAnalyticalLOD | % Positive | 95% CI(Positive) | MaxRFUMean(Positive) | % Negative | 95% CI(Negative) | MaxRFUMean(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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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
NOV 1 3 2009
Ms. Saba Modjarrad Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
K091730 Re: K091750
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: November 5, 2009 Received: November 6, 2009
Dear Ms. Saba Modjarrad:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we mare revelour your boomer on (e) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, enerolded to the Medical Device Amendments, or to devices that have been reclassified in the chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require accordalice with the provisions of the reason (PMA). You may, therefore, market the device, subject to approval or a promations of the Act. The general controls provisions of the Act include the general ochiles pro revistration, 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 IT your device is classinod (300 able to) into emajor regulations affecting your device can be found in Title Subject to such architems (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 1 carar states and regarding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 Act 3 requirements, moraans, on manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jallåtyne
Hoivat, M. Sc., Ph.D.
Sally A. Hojvat, M. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): < 0 1730
Device Name: BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
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 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ ج (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.Md. W.W.L. for
Uwe Scherf
Division Sign-Off
Division Sign-Off
office of In Vitro Diag e Evaluation and
510(k) K5091730
Page 1 of 1
BD Diagnostic Systems Becton, Dickinson and Company
Page ix
§ 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).