(155 days)
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.
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.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (BD SurePath Specimens) |
|---|---|---|
| Clinical Performance | ||
| Sensitivity | Sufficient for diagnosis, as demonstrated by comparison to PIS. | Asymptomatic: 100.0% (32/32) (95% C.I.: 89.1% - 100.0%)Symptomatic: 100.0% (19/19) (95% C.I.: 82.4% - 100.0%)Total: 100.0% (51/51) (95% C.I.: 93.0% - 100.0%) |
| Specificity | Sufficient for diagnosis, as demonstrated by comparison to PIS. | Asymptomatic: 99.8% (1123/1125) (95% C.I.: 99.4% - 100.0%)Symptomatic: 100.0% (539/539) (95% C.I.: 99.3% - 100.0%)Total: 99.9% (1662/1664) (95% C.I.: 99.6% - 100.0%) |
| PPV | (Not explicitly defined, but results indicate high PPV) | Asymptomatic: 93.5%Symptomatic: 100.0%Total: 96.9% |
| NPV | (Not explicitly defined, but results indicate high NPV) | Asymptomatic: 100.0%Symptomatic: 100.0%Total: 100.0% |
| Analytical Performance | ||
| Limit of Detection (LOD) | Detection of N. gonorrhoeae at low concentrations. | < 100 GC cells per mL (for N. gonorrhoeae strain ATCC 19424 in BD SurePath specimens).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. |
| Reproducibility | Consistent proportion of correct results and low variability. | Reproducibility Panel (Positive Samples): 100.0% correct (135/135) for both GC-only and CT/GC co-infected samples containing 100-250 GC cells/mL. Low %CV for MaxRFU (4.23% to 4.42%).Reproducibility Panel (Negative Samples): 100.0% correct (135/135). |
| Interference | No interference from common vaginal substances/biologicals. | No interference observed from: Blood (≤ 1%), Seminal Fluid, Mucus, Over-The-Counter vaginal products and contraceptives, Hemorrhoidal cream, Prescription vaginal treatments, Leukocytes (1x10^6^ cells/mL), Chlamydia trachomatis (1x10^6^ EB/mL). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- Clinical Performance: 1715 compliant female subjects had evaluable BD SurePath specimen results. The study initially enrolled 1728 compliant female subjects.
- Reproducibility (LBC Specimens):
- Standard Panel: 135 replicates per panel member (9 replicates/day x 5 days x 3 sites).
- Below LOD Panel: 135 replicates per panel member (9 replicates/day x 5 days x 3 sites).
- Data Provenance: Retrospective and prospective. The clinical study involved collection of specimens from subjects attending clinics at eleven geographically diverse clinical sites in North America.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts involved in establishing the ground truth. The ground truth for clinical performance was established using a "patient infected status (PIS) algorithm" based on results from three reference endocervical swabs tested with:
- The BD ProbeTec ET CT/GC/AC assay
- The BD ProbeTec GC Qc assay
- Another commercially available NAAT (Nucleic Acid Amplification Test)
4. Adjudication method for the test set
The adjudication method for establishing the Patient Infected Status (PIS) ground truth for the clinical test set was:
- PIS-positive: At least two positive reference results from the three reference methods.
- PIS-negative: At least two negative reference results from the three reference methods.
5. 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an automated DNA amplification assay (NAAT), not an imaging device requiring human interpretation, nor does it incorporate AI for interpretation. Its output is qualitative (positive/negative) based on a predetermined threshold value of fluorescence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The BD ProbeTec GC Q* Amplified DNA Assay, when used with the BD Viper™ System, operates in an automated, algorithm-driven manner to provide qualitative results (positive, negative, or EC failure) without human interpretation of the primary reaction signals. The system uses an automated algorithm applied to fluorescent signals to determine the result.
7. The type of ground truth used
The ground truth used for the clinical performance evaluation was a Patient Infected Status (PIS) algorithm based on expert consensus/multiple reference test results. This is a composite reference standard using three established Nucleic Acid Amplification Tests (NAATs) performed on endocervical swabs.
8. The sample size for the training set
The document does not specify a separate training set or its sample size. The clinical study described appears to be a validation/test set for the device's performance against a reference standard. For NAATs, the "training" (i.e., algorithm development and optimization) is typically done during the assay design and analytical validation phase, not through a separate clinical "training set" as might be seen for machine learning algorithms.
9. How the ground truth for the training set was established
As no explicit "training set" is described in the provided text in the context of clinical data for algorithm development, the method for establishing its ground truth is not detailed. The assay's underlying principles (Strand Displacement Amplification and fluorescence detection) are established molecular biology techniques, and the algorithm for interpreting fluorescence signals would have been developed and validated during the assay's R&D phase using known positive and negative controls and potentially characterized clinical samples.
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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
| 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™ 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™ Neisseria gonorrhoeae (GC) Q* AmplifiedDNA 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
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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 < 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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Image /page/2/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. Below the letters, there is a tagline that reads "Helping all people live healthy lives."
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 Fluid | |
| Mucus | |
| Over The Counter vaginal products and contraceptives | |
| Hemorrhoidal cream | |
| Prescription vaginal treatments | |
| Leukocytes (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 Qc 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 |
GC Q* Assay Performance for BD SurePath Specimens Compared to Patient Table 4 Infected Status (By Symptomatic Status)
| Performance Compared to Patient Infected Status | ||||||||
|---|---|---|---|---|---|---|---|---|
| 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 | 17151 | 100.0%(51/51) | (93.0% -100.0%) | 99.9%(1662/1664) | (99.6% -100.0%) | 96.90 | 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 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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Image /page/5/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of a stylized sun-like graphic with a human figure at the bottom 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
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.
| CTEB's/mL | GCCells/mL | % Correct | 95% CI | MeanMaxRFU | SD | %CV | SD | %CV | SD | %CV |
|---|---|---|---|---|---|---|---|---|---|---|
| Between RunsWithin 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
| 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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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
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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
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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
Page 1 of 1
BD Diagnostic Systems Becton, Dickinson and Company
Page ix
§ 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).