Who is the manufacturer of BD MAX CT/GC/TV, BD MAX INSTRUMENT?

Becton, Dickinson and Company filed the 510(k) submission for BD MAX CT/GC/TV, BD MAX INSTRUMENT (K151589).

What is the FDA product code for BD MAX CT/GC/TV, BD MAX INSTRUMENT?

OUY. It is classified under 21 CFR 866.3860 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for BD MAX CT/GC/TV, BD MAX INSTRUMENT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BD MAX CT/GC/TV, BD MAX INSTRUMENT?

Becton Dickinson ProbeTec™ ET Chlamydia trachomatis (CT) Qx Amplified DNA Assay (K081824); Becton Dickinson ProbeTec™ ET Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay (K081825); Becton Dickinson ProbeTec™ Trichomonas Vaginalis (TV) Qx Amplified DNA Assay (K130268).

Who can help prepare an FDA 510(k) submission like BD MAX CT/GC/TV, BD MAX INSTRUMENT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BD MAX CT/GC/TV, BD MAX INSTRUMENT

K151589 · Becton, Dickinson and Company · OUY · Sep 6, 2016 · Immunology

Device Facts

Record ID	K151589
Device Name	BD MAX CT/GC/TV, BD MAX INSTRUMENT
Applicant	Becton, Dickinson and Company
Product Code	OUY · Immunology
Decision Date	Sep 6, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3860
Device Class	Class 2

Intended Use

The BD MAX CT/GC/TV assay, as performed using the BD MAX System incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, clinician-collected female endocervical swab specimens and patient-collected vaginal swab specimens (in a clinical setting). The assay is indicated for use to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis in asymptomatic and symptomatic individuals.

Device Story

The BD MAX CT/GC/TV is a molecular diagnostic assay performed on the BD MAX System; it utilizes automated DNA extraction and real-time PCR to detect CT, GC, and TV DNA. Input samples include male/female urine, clinician-collected endocervical swabs, and patient-collected vaginal swabs. The system automates sample preparation (lysis, extraction, concentration), reagent rehydration, and PCR amplification/detection. It uses a Sample Processing Control (SPC) to monitor extraction, thermal cycling, and inhibition. The system interprets results automatically as POS, NEG, or UNR. Used in clinical laboratories, the device provides qualitative results to aid physicians in diagnosing urogenital infections. Benefits include automated workflow, reduced manual handling, and standardized interpretation, facilitating timely clinical decision-making for symptomatic and asymptomatic patients.

Clinical Evidence

Multicenter clinical study evaluated 2,166 female and 908 male subjects. Performance compared to Patient Infected Status (PIS). For CT, sensitivity ranged 91.1-100% and specificity 98.6-99.7% across specimen types. For GC, sensitivity 80.0-100% and specificity 99.3-100%. For TV, sensitivity 92.7-96.7% and specificity 97.5-99.8%. Unresolved/Indeterminate/Incomplete rates were low (<2% initial, <1% final).

Technological Characteristics

Automated real-time PCR assay using hydrolysis (TaqMan) probes. Components include microfluidic cartridges, master mixes, unitized reagent strips, and magnetic affinity beads for DNA extraction. System is networked/standalone instrument-based. Sterilization not specified. Software performs automated result interpretation based on amplification status of targets and Sample Processing Control (SPC).

Indications for Use

Indicated for use in asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease, and/or trichomoniasis. Specimens include male urine, female urine, clinician-collected female endocervical swabs, and patient-collected vaginal swabs.

Regulatory Classification

Identification

A Trichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomoniasis in asymptomatic women. The detection of trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of trichomoniasis caused by Trichomonas vaginalis.

Special Controls

*Classification.* Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of*Trichomonas vaginalis;* Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document.

Predicate Devices

Becton Dickinson ProbeTec™ ET Chlamydia trachomatis (CT) Qx Amplified DNA Assay (K081824)
Becton Dickinson ProbeTec™ ET Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay (K081825)
Becton Dickinson ProbeTec™ Trichomonas Vaginalis (TV) Qx Amplified DNA Assay (K130268)

Related Devices

K182692 — BD MAX CTGCTV2, BD MAX System · Becton, Dickinson and Company · Jan 8, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a sense of movement. September 6, 2016 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Public Health Service BD Diagnostic Systems Becton, Dickinson, and Company Katie Edwards, Regulatory Affairs Project Manager 7 Loveton Circle Sparks, MD 21152 Re: K151589 Trade/Device Name: BD MAX™ CT/GC/TV Regulation Number: 21 CFR 866.3860 Regulation Name: Trichomonas vaginalis nucleic acid assay Regulatory Class: II Product Code: OUY, MKZ, LSL Dated: August 19, 2016 Received: August 22, 2016 Dear Ms. Edwards: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Steven R. Gitterman -S for Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K151589 Device Name BD MAX™ CT/GC/TV #### Indications for Use (Describe) The BD MAX CT/GC/TV assay, as performed using the BD MAX System incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from Chlamydia (CT), Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, cliniciancollected female endocervical swab speciment-collected vaginal swab specimens (in a clinical setting). The assay is indicated for use to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis in asymptomatic and symptomatic individuals. Type of Use (Select one or both, as applicable) | | Prescription Use (Part 21 CFR 801 Subpart D) | |---------------|----------------------------------------------| | | Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary ## BD MAX CT/GC/TV ### Summary Preparation Date: September 1, 2016 ## Submitted by: BD Life Sciences Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 ## Contact: Katie Edwards Regulatory Affairs Project Manager Tel: 410-316-4975 Fax: 410-316-4188 Email: Katie_Edwards@bd.com ## Proprietary Names: For the instrument: BD MAX™ For the assay: ## BD MAX CT/GC/TV ## Common Names: For the instrument: Bench-top molecular diagnostics workstation For the assay: CT Assay GC Assay TV Assay {4}------------------------------------------------ # Regulatory Information ### Regulation section: 866.3120 - Chlamydia serological reagents 866.3390 - Neisseria spp. direct serological test reagents 866.3860 – Trichomonas vaginalis Nucleic Acid Amplification Test System Classification: Class II Panel: Microbiology (83) Product Code(s): Chlamydia trachomatis MKZ Neisseria gonorrhoeae LSL OUY Trichomonas vaginalis ## Predicate Device Becton Dickinson ProbeTec™ ET Chlamydia trachomatis (CT) Q* Amplified DNA Assay [510(k) K0818241 Becton Dickinson ProbeTec™ ET Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay [510(k) K081825] Becton Dickinson ProbeTec™ Trichomonas Vaginalis (TV) Q* Amplified DNA Assay [510(k) K130268] ## Device Establishment GeneOhm Sciences Canada, Inc. (BD Diagnostics) 2555 Boul. du Parc-Technologique Quebec, QC G1P 4S5 Canada Registration Number: 3007420875 ## Performance Standards No performance standards have been developed under Section 514 of the Food, Drug and Cosmetic Act. {5}------------------------------------------------ #### Intended Use The BD MAX CT/GC/TV assay, as performed using the BD MAX System incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, clinician-collected female endocervical swab specimens and patient-collected vaginal swab specimens (in a clinical setting). The assay is indicated for use to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis in asymptomatic and symptomatic individuals. #### Special Conditions for Use Statement: For prescription use #### Special Instrument Requirements: BD MAX System ### Device Description The BD MAX System and the BD MAX CT/GC/TV are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. A test result may be called as POS, NEG or UNR for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System failure. ## Test Principle The specimen is collected from the patient using the BD MAX UVE Specimen Collection Kit and transported to the laboratory under conditions of time and temperature that have been determined to maintain the integrity of the target nucleic acids. The sample is vortexed briefly and then heated on the BD Pre-warm Heater to dissolve mucous, homogenize the specimen matrix and lyse the target organisms. After cooling automatically, the BD MAX UVE Sample Buffer Tubes are recapped with a septum cap. A worklist is created and the BD MAX UVE Sample Buffer Tube, the BD MAX CT/GC/TV Unitized Reagent Strip and the BD MAX PCR Cartridge are loaded on the BD MAX System. The BD MAX System automates sample preparation, including target organism lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The BD MAX System performs results interpretation automatically. The assay also includes a Sample Processing Control that is present in the Extraction Tube. The Sample Processing Control monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. Following cell lysis, the released nucleic acids are captured on magnetic affinity beads. The beads, with the bound nucleic acids, are washed using Wash Buffer and the nucleic acids are eluted by heat in Elution Buffer. Eluted DNA is neutralization Buffer and transferred to the Master Mix to rehydrate the PCR reagents. After reconstitution, the BD MAX System dispenses a fixed volume of PCRready solution containing extracted nucleic acids into the BD MAX PCR Cartridge. Microvalves in the BD MAX PCR Cartridge are sealed by the system prior to initiating PCR to contain the amplification mixture, thus preventing evaporation and contamination. The amplified DNA targets are detected using hydrolysis {6}------------------------------------------------ (TagMan") probes, labeled at one end with a fluorescent reporter dye (fluorophore), and at the other end, with a quencher moiety. Probes labeled with different fluorophores are used to detect amplicons for target analytes and the Sample Processing Control in four different optical channels of the BD MAX System. When the probes are in their native state, the fluorescence of the fluorophore is quenched due to its proximity to the quencher. However, in the presence of target DNA, the probes hybridize to their complementary sequences and are hydrolyzed by the 5'-3' exonuclease activity of the DNA polymerase as it synthesizes the nascent strand along the DNA template. As a result, the fluorophores are separated from the quencher molecules and fluorescence is emitted. The BD MAX System monitors these signals at each cycle and interprets the data at the end of the reaction to provide qualitative test results for each analyte (i.e., positive or negative). ## Substantial Equivalence ' Table 1 shows the similarities and differences between the BD MAX CT/GC/TV and the predicate device. The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts. {7}------------------------------------------------ | Items | BD MAX CT/GC/TV | BD ProbeTec™ ET CT Q Amplified DNA Assay | BD ProbeTec™ ET GC Q Amplified DNA Assay | BD ProbeTec™ TV Q Amplified DNA Assay | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k)# | K151589 | K081824 | K081825 | K130268 | | Regulation | 866.3120, 866.3390, 866.3680 | 866.3120 | 866.3390 | 866.3860 | | Product Code | MKZ, LSL, OUY | MKZ | LSL | OUY | | Device Class | II | I | Same | Same | | Intended Use | The BD MAX CT/GC/TV assay, as performed using the BD MAX System incorporates automated DNA extraction and real- time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, clinician-collected female endocervical swab specimens and patient- collected vaginal swab specimens (in a clinical setting). The assay is indicated for use to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis in asymptomatic and symptomatic individuals. | The BD ProbeTec™ Chlamydia trachomatis Qx Amplified DNA Assay, when tested with either the BD Viper™ System in Extracted Mode or the BD Viper LT System, uses Strand Displacement Amplification technology for the direct, qualitative detection of Chlamydia trachomatis DNA in clinician collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid or PreservCyt™ Solution using an aliquot that is removed prior to processing for either the BD SurePath or ThinPrep™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease. | The BD ProbeTec™ Neisseria gonorrhoeae Qx Amplified DNA Assay, when tested with either the BD Viper™ System in Extracted Mode or the BD Viper LT™ System, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid or PreservCyt™ Solution using an aliquot that is removed prior to processing for either the BD SurePath or ThinPrep™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease. | The BD ProbeTec™ Trichomonas vaginalis (TV) Qx Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Trichomonas vaginalis DNA in clinician-collected female endocervical swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and female urine specimens. The assay is indicated for use with asymptomatic and symptomatic females to aid in the diagnosis of trichomoniasis. | | Indications for Use | Asymptomatic and Symptomatic Patients | Same | Same | Same | | Specimen Type | Endocervical swab, patient-collected vaginal swab, female and male urine | Endocervical swab, patient- collected vaginal swab, male urethral swab, male and female urine (UPT and neat) | Endocervical swab, patient-collected vaginal swab, male urethral swab, male and female urine (UPT and neat) | Endocervical swab, patient-collected vaginal swab, female urine | | Technology | PCR | SDA | SDA | SDA | | Organisms Detected | CT, GC and TV | CT | GC | TV | | Sample Prep /Interpretation of Results | Automated by BD MAX System | Automated by BD Viper System | Automated by BD Viper System | Automated by BD Viper System | | Assay Controls | Sample Processing Control | Extraction Control | Extraction Control | Extraction Control | Table 1: Comparison to Predicate Device {8}------------------------------------------------ ## Analytical Performance ## Precision Within-laboratory precision was evaluated for the BD MAXCT/GC/TV at one (1) internal site. The Precision Study panel members were divided into four (4) categories, based upon organism concentration relative to the LoDs established for each of the three (3) assay targets and expected correct percent positive/negative, as follows: - True negative (TN - Negative Clinical Matrix): negative 100% of the time - Moderate positive (MP): Above the assay LoD ("C100", ~2-3x LoD); positive 100% of the time ● - Low positive (LP): At assay LoD ("C95", ~1–1.5x LoD); positive approximately 95% of the time ● - High negative (HN): Below assay LoD (~0.25-0.5x LoD); negative between 5 and 85% of the time ● Each panel member was prepared in a matrix of either pooled negative vaginal clinical swab specimen or female urine. Testing was performed in duplicate, over 12 days, with 2 runs per day, by 2 different technologists. The Precision Study results are summarized in Table 2, stated as percent observed versus expected. | Panel Member Level | Percent (%) Observed versus Expected | | | | | | |--------------------|--------------------------------------|-------------------------------|-------------------------------|-------------------------------|-------------------------------|-----------------------------| | | C. trachomatis | | N. gonorrhoeae | | T. vaginalis | | | | Swab | Urine | Swab | Urine | Swab | Urine | | True Negative | 100% (336/336) 98.9-100 | 100% (336/336) 98.9-100 | 100% (48/48) 92.6-100 | 100% (336/336) 98.9-100 | 100% (336/336) 98.9-100 | 100% (48/48) 92.6-100 | | High Negative | 79.2% (38/48) 65.7-88.3 | 79.2% (38/48) 65.7-88.3 | 54.2% (26/48) 40.3-67.4 | 10.4% (5/48) 4.5-22.2 | 56.3% (27/48) 42.3-69.3 | 14.6% (7/48) 7.2-27.2 | | Low Positive | 100% (48/48) 92.6-100 | 100% (48/48) 92.6-100 | 100% (48/48) 92.6-100 | 100% (48/48) 92.6-100 | 97.9% (47/48) 89.1-99.6 | 100% (48/48) 92.6-100 | | Moderate Positive | 100% (48/48) 92.6-100 | 100% (48/48) 92.6-100 | 100% (48/48) 92.6-100 | 100% (48/48) 92.6-100 | 100% (48/48) 92.6-100 | 100% (48/48) 92.6-100 | Table 2: Within-laboratory Precision Testing Results For the True Negative (TN) category, the reported agreement indicates the percent of negative results. b For the High Negative (HN) category, the reported agreement indicates the percent of positive results. #### Reproducibility For the Site-to-Site reproducibility study, three (3) sites (two external and one internal) were provided with a total of sixteen (16) panels per site, each consisting of 10 tubes. The panels used were the same as described above for the Precision Study. Each site performed the study on eight (8) nonconsecutive days, wherein each day, two (2) panels were tested, each by one (1) of two (2) technologists. The overall Site-to-Site Reproducibility percent agreement ranged from 99.9 to 100.0%, 15.6% to 78.1%, 96.9% to 100% and 100% for the TN, HN, LP and MP categories, respectively (see Table 3). The qualitative and quantitative reproducibility across sites and by target is presented in Tables 4 through 9. End Point fluorescence (EP) and Second Derivative Peak Abscissa (SDPA), internal criterion used to {9}------------------------------------------------ determine final assay results, was selected as an additional means of assessing assay reproducibility. Overall mean EP and SDPA values with variance components (SD and %CV) are shown in Tables 5, 7 and 9. | Category | C. trachomatis (n), 95% CI | | N. gonorrhoeae (n), 95% CI | | T. vaginalis (n), 95% CI | | |----------|-------------------------------|--------------------------------|-------------------------------|-------------------------------|-------------------------------|-------------------------------| | | Swab | Urine | Swab | Urine | Swab | Urine | | TN | 100% (672/672) 99.4-100 | 99.9% (671/672) 99.2-100 | 100% (96/96) 96.2-100 | 100% (672/672) 99.4-100 | 100% (672/672) 99.4-100 | 100% (96/96) 96.2-100 | | HN | 78.1% (75/96) 68.9-85.2 | 75.0% (72/96) 65.5-82.6 | 55.2% (53/96) 45.3-64.8 | 15.6% (15/96) 9.7-24.2 | 52.1% (50/96) 42.2-61.8 | 35.4% (34/96) 26.6-45.4 | | LP | 100% (96/96) 96.2-100 | 100% (96/96) 96.2-100 | 100% (96/96) 96.2-100 | 100% (96/96) 96.2-100 | 96.9% (93/96) 91.2-98.9 | 100% (96/96) 96.2-100 | | MP | 100% (96/96) 96.2-100 | 100% (96/96) 96.2-100 | 100% (96/96) 96.2-100 | 100% (96/96) 96.2-100 | 100% (96/96) 96.2-100 | 100% (96/96) 96.2-100 | Table 3: MAX CT/GC/TV Site-to-Site Reproducibility Study Results 4 For the True Negative (TN) category, the reported agreement indicates the percent of negative results. b For the High Negative (HN) category, the reported agreement indicates the percent of positive results. | Table 4: | C. trachomatis Site-to-Site Qualitative Reproducibility Across Sites with Pooled Days | |----------|---------------------------------------------------------------------------------------| | | Runs and Replicates | | | Type | x LoD | Site | | | | | | | | |----------|-------|-------|---------|------|---------|------|---------|------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Category | | | 】 | | 2 | | 3 | | Total | | | | | | Agree/N | % | Agree/N | % | Agree/N | % | Agree/N | % | | TN | Swab | 0 | 224/224 | 100 | 224/224 | 100 | 224/224 | 100 | 672/672 | 100 | | | Urine | | 223/224 | 99.6 | 224/224 | 100 | 224/224 | 100 | 671/672 | 99.9 | | HN | Swab | 0.2 | 29/32 | 90.6 | 21/32 | 65.6 | 25/32 | 78.1 | 75/96 | 78.1 | | | Urine | | 28/32 | 87.5 | 20/32 | 62.5 | 24/32 | 75.0 | 72/96 | 75.0 | | LP | Swab | 1.5 | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | તે જેવા છે. જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો | 100 | | | Urine | | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | તે જેવા છે. જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો | 100 | | MP | Swab | 3 | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | તે જેવા છે. જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો | 100 | | | Urine | | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | તે જેવા છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ | 100 | {10}------------------------------------------------ | Variable | Type | Cat. | Agreed/ N | Mean | Within Run | | Between Run | | Between Day | | Between Operator | | Between Site | | Total | | |----------|-------|------|-----------|--------|------------|------|-------------|------|-------------|-----|------------------|------|--------------|------|-------|------| | | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | EP | Swab | HN | 75/96 | 1563.3 | 556.6 | 35.6 | 285.2 | 18.2 | 0.0 | 0.0 | 0.0 | 0.0 | 337.2 | 21.6 | 710.6 | 45.5 | | | Swab | LP | 96/96 | 2170.9 | 417.7 | 19.2 | 268.7 | 12.4 | 0.0 | 0.0 | 0.0 | 0.0 | 345.6 | 15.9 | 605.1 | 27.9 | | | Swab | MP | 96/96 | 2264.4 | 297.6 | 13.1 | 215.9 | 9.5 | 0.0 | 0.0 | 0.0 | 0.0 | 232.0 | 10.2 | 434.8 | 19.2 | | EP | Urine | HN | 72/96 | 1488.8 | 601.0 | 40.4 | 340.6 | 22.9 | 0.0 | 0.0 | 142.0 | 9.5 | 0.0 | 0.0 | 705.2 | 47.4 | | | Urine | LP | 96/96 | 2221.5 | 380.7 | 17.1 | 201.4 | 9.1 | 96.5 | 4.3 | 224.8 | 10.1 | 279.6 | 12.6 | 568.7 | 25.6 | | | Urine | MP | 96/96 | 2219.0 | 308.9 | 13.9 | 207.6 | 9.4 | 0.0 | 0.0 | 36.7 | 1.7 | 213.9 | 9.6 | 430.8 | 19.4 | | SDPA | Swab | HN | 75/96 | 37.3 | 1.4 | 3.9 | 0.1 | 0.3 | 0.4 | 1.0 | 0.0 | 0.0 | 0.4 | 0.9 | 1.5 | 4.1 | | | Swab | LP | 96/96 | 34.8 | 0.8 | 2.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.2 | 0.3 | 1.0 | 0.9 | 2.6 | | | Swab | MP | 96/96 | 34.4 | 0.6 | 1.8 | 0.3 | 0.8 | 0.0 | 0.0 | 0.1 | 0.2 | 0.6 | 1.6 | 0.9 | 2.6 | | SDPA | Urine | HN | 72/96 | 37.8 | 1.6 | 4.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.4 | 1.2 | 1.7 | 4.5 | | | Urine | LP | 96/96 | 33.6 | 0.7 | 2.0 | 0.3 | 1.0 | 0.3 | 0.8 | 0.1 | 0.3 | 0.6 | 1.8 | 1.0 | 2.9 | | | Urine | MP | 96/96 | 32.9 | 0.6 | 1.8 | 0.1 | 0.3 | 0.1 | 0.4 | 0.1 | 0.2 | 0.6 | 1.8 | 0.8 | 2.6 | C. trachomatis Site-to-Site Quantitative Reproducibility Across Sites, Days, Runs and Within Run Table 5: | Table 6: | N. gonorrhoeae Site-to-Site Qualitative Reproducibility Across Sites with Pooled Days | |----------|---------------------------------------------------------------------------------------| | | Runs and Replicates | | Category | Type | x LoD | Site 1 | | Site 2 | | Site 3 | | Total | | |----------|-------|-------|---------|------|---------|------|---------|------|---------|------| | TN | Swab | 0 | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | 96/96 | 100 | | TN | Urine | 0 | 224/224 | 100 | 224/224 | 100 | 224/224 | 100 | 672/672 | 100 | | HN | Swab | 0.15 | 16/32 | 50.0 | 15/32 | 46.9 | 22/32 | 68.8 | 53/96 | 55.2 | | HN | Urine | 0.25 | 8/32 | 25.0 | 3/32 | 9.4 | 4/32 | 12.5 | 15/96 | 15.6 | | LP | Swab | 1.5 | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | 96/96 | 100 | | LP | Urine | 1.5 | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | 96/96 | 100 | | MP | Swab | 3 | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | 96/96 | 100 | | MP | Urine | 3 | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | 96/96 | 100 | {11}------------------------------------------------ | Variable | Type | Cat | Agreed/ N | Mean | Within Run | | Between Run | | Between Day | | Between Operator | | Between Site | | Total | | |----------|-------|-------|--------------|--------|------------|------|-------------|------|----------------|-----|---------------------|-------|--------------|-------|-------|------| | | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | EP | Swab | HN | 53/96 | 974.2 | 369.2 | 37.9 | 0.0 | 0.0 | 0.0 | 0.0 | 55.9 | 5.7 | 119.8 | 12.3 | 392.1 | 40.3 | | | Swab | LP | 96/96 | 1518.0 | 199.1 | 13.1 | 227.5 | 15.0 | 0.0 | 0.0 | 75.8 | 5.0 | 260.2 | 17.1 | 406.0 | 26.7 | | | Swab | MP | 96/96 | 1715.0 | 265.8 | 15.5 | 186.6 | 10.9 | 84.0 | 4.9 | 0.0 | 0.0 | 299.7 | 17.5 | 449.8 | 26.2 | | | Urine | HN | 15/96 | 1615.2 | 0.9 | 0.1 | 600.8 | 37.2 | 0.0 | 0.0 | 0.0 | 0.0 | 68.3 | 4.2 | 604.6 | 37.4 | | | Urine | LP | 96/96 | 2260.4 | 364.6 | 16.1 | 225.1 | 10.0 | 0.0 | 0.0 | 107.1 | 4.7 | 437.8 | 19.4 | 621.9 | 27.5 | | Urine | MP | 96/96 | 2420.7 | 737.0 | 30.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 162.8 | 6.7 | 754.8 | 31.2 | | | SDPA | Swab | HN | 53/96 | 35.6 | 1.1 | 3.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.2 | 1.1 | 3.2 | | | Swab | LP | 96/96 | 33.6 | 0.7 | 2.0 | 0.3 | 0.9 | 0.0 | 0.0 | 0.1 | 0.2 | 0.1 | 0.4 | 0.7 | 2.2 | | | Swab | MP | 96/96 | 32.6 | 0.6 | 1.7 | 0.2 | 0.8 | 0.0 | 0.0 | 0.2 | 0.6 | 0.3 | 1.0 | 0.7 | 2.2 | | | Urine | HN | 15/96 | 37.8 | 0.7 | 1.9 | 2.2 | 5.8 | 0.0 | 0.0 | 0.0 | 0.0 | 1.1 | 3.0 | 2.6 | 6.7 | | | Urine | LP | 96/96 | 33.8 | 0.8 | 2.3 | 0.2 | 0.5 | 0.0 | 0.0 | 0.3 | 0.8 | 0.0 | 0.0 | 0.8 | 2.5 | | | Urine | MP | 96/96 | 32.8 | 0.6 | 2.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.2 | 0.6 | 0.7 | 2.0 | Table 7: N. gonorrhoeae Site-to-Site Quantitative Reproducibility Across Sites, Days, Runs and Within Run | Table 8: | T. vaginalis Site-to-Site Qualitative Reproducibility Across Sites with Pooled Days, Run and Replicates | |----------|-------------------------------------------------------------------------------------------------------------------| |----------|-------------------------------------------------------------------------------------------------------------------| | Category | Type | x LoD | Site 1 | | Site 2 | | Site 3 | | Total | | |----------|-------|-------|---------|------|---------|------|---------|------|---------|------| | | | | Agree/N | % | Agree/N | % | Agree/N | % | Agree/N | % | | TN | Swab | 0 | 224/224 | 100 | 224/224 | 100 | 224/224 | 100 | 672/672 | 100 | | | Urine | 0 | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | 96/96 | 100 | | HN | Swab | 0.25 | 15/32 | 46.9 | 15/32 | 46.9 | 20/32 | 62.5 | 50/96 | 52.1 | | | Urine | 0.05 | 4/32 | 12.5 | 19/32 | 59.4 | 11/32 | 34.4 | 34/96 | 35.4 | | LP | Swab | 1.5 | 30/32 | 93.8 | 31/32 | 96.9 | 32/32 | 100 | 93/96 | 96.9 | | | Urine | 1.5 | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | 96/96 | 100 | | MP | Swab | 3 | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | 96/96 | 100 | | | Urine | 3 | 32/32 | 100 | 32/32 | 100 | 32/32 | 100 | 96/96 | 100 | {12}------------------------------------------------ | Variable | Type | Cat. | Agreed/N | Mean | Within Run | | Between Run | | Between Day | | Between Operator | | Between Site | | Total | | |----------|-------|------|----------|--------|------------|------|-------------|------|-------------|------|---------------------|-----|--------------|------|--------|-------| | | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | EP | Swab | HN | 50/96 | 2172.0 | 946.7 | 43.6 | 0.0 | 0.0 | 414.0 | 19.1 | 0.0 | 0.0 | 450.2 | 20.7 | 1127.1 | 51.9 | | | | LP | 93/96 | 3068.7 | 1063.7 | 34.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 779.8 | 25.4 | 1318.9 | 43.0 | | | | MP | 96/96 | 3519.5 | 875.1 | 24.9 | 0.0 | 0.0 | 0.0 | 0.0 | 23.4 | 0.7 | 809.1 | 23.0 | 1192.1 | 33.9 | | | Urine | HN | 34/96 | 1887.5 | 747.1 | 39.6 | 200.7 | 10.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 773.6 | | | | LP | 96/96 | 3076.8 | 289.8 | 9.4 | 76.5 | 2.5 | 0.0 | 0.0 | 78.9 | 2.6 | 115.4 | 3.8 | 330.7 | 10.7 | | | | MP | 96/96 | 3092.0 | 199.4 | 6.4 | 184.0 | 5.9 | 0.0 | 0.0 | 0.0 | 0.0 | 206.0 | 6.7 | 340.6 | 11.0 | | SDPA | Swab | HN | 50/96 | 37.6 | 1.9 | 5.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.2 | 0.6 | 0.0 | 0.0 | 1.9 | 5.1 | | | | LP | 93/96 | 35.3 | 1.2 | 3.3 | 0.5 | 1.5 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.3 | 3.6 | | | | MP | 96/96 | 35.0 | 1.0 | 2.8 | 0.0 | 0.0 | 0.3 | 1.0 | 0.3 | 0.8 | 0.0 | 0.0 | 1.1 | 3.1 | | | Urine | HN | 34/96 | 38.3 | 1.6 | 4.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.6 | 4.1 | | | | LP | 96/96 | 34.6 | 0.5 | 1.6 | 0.2 | 0.6 | 0.1 | 0.2 | 0.2 | 0.5 | 0.1 | 0.2 | 0.6 | 1.8 | | | | MP | 96/96 | 33.5 | 0.3 | 1.0 | 0.2 | 0.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.4 | 1.3 | Table 9: T. vaginalis Site-to-Site Quantitative Reproducibility Across Sites, Days, Runs and Within Run For the Lot-to-Lot reproducibility study, two operators each completed a single run of 10 panel members on a single…

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