← Product Code [OUY](/submissions/IM/subpart-d%E2%80%94serological-reagents/OUY) · DEN110012 # APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) _Gen-Probe Incorporated · OUY · Apr 19, 2011 · Immunology · DENG_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OUY/DEN110012 ## Device Facts - **Applicant:** Gen-Probe Incorporated - **Product Code:** [OUY](/submissions/IM/subpart-d%E2%80%94serological-reagents/OUY.md) - **Decision Date:** Apr 19, 2011 - **Decision:** DENG - **Submission Type:** Post-NSE - **Regulation:** 21 CFR 866.3860 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Intended Use The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, female urine specimens, and specimens collected in PreservCyt solution. ## Device Story The Aptima Trichomonas vaginalis (ATV) assay is a nucleic acid amplification test (NAAT) performed on the automated TIGRIS DTS System. The device processes patient-collected first-catch urine or clinician-collected vaginal/endocervical swabs and PreservCyt liquid Pap specimens. The assay utilizes target capture with magnetic particles to isolate rRNA, followed by Transcription Mediated Amplification (TMA) and Hybridization Protection Assay (HPA) for detection. The TIGRIS DTS System measures chemiluminescent signals as Relative Light Units (RLU). The system software automatically interprets RLU values to provide qualitative results (negative, positive, or invalid). The device is used in clinical settings to aid in the diagnosis of trichomoniasis. Healthcare providers use the results to guide clinical management of patients. The automated process reduces manual handling, improving laboratory efficiency and diagnostic accuracy. ## Clinical Evidence Prospective multicenter clinical trial (n=1025) across 9 US sites. Performance compared to patient-infected status (culture/wet mount). Sensitivity ranged from 95.2% (urine) to 100% (swabs/PreservCyt). Specificity ranged from 98.9% (urine) to 99.6% (PreservCyt). PPV and NPV were high across all matrices. Performance was consistent in both symptomatic and asymptomatic populations. ## Technological Characteristics Nucleic acid amplification test (NAAT) using target capture, Transcription Mediated Amplification (TMA), and Hybridization Protection Assay (HPA). Employs magnetic particles for target isolation. Detection via chemiluminescent labels measured as Relative Light Units (RLU). Automated on TIGRIS DTS System. Software-based interpretation of RLU thresholds. Complies with CLSI guidelines EP5-A2 and EP15-A2 for precision. ## Regulatory 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 - In Pouch Trichomonas vaginalis ([K896296](/device/K896296.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a De Novo](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE ## A. 510(k) Number: K102911 #### B. Purpose for Submission: Evaluation of automatic Class III designation for the Aptima Trichomonas vaginalis (ATV) assay ### C. Measurand: Ribosomal RNA from T. vaginalis # D. Type of Test: Nucleic acid amplification test ### E. Applicant: Gen Probe Inc. ## F. Proprietary and Established Names: Aptima Trichomonas vaginalis assay # G. Regulatory Information: - 1. Regulation section: - 21 CFR 866.3860 - 2. Classification: Class II - 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system - 4. Panel: - 83 Microbiology {1}------------------------------------------------ ## H. Intended Use: - 1. Intended use: The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, female urine specimens, and specimens collected in PreservCyt solution. - 2. Indications for use: The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, female urine specimens, and specimens collected in PreservCyt solution. - 3. Special conditions for use statement: For prescription use - 4. Special instrument requirements: The automated TIGRIS DTS System # I. Device Description: The ATV assay is a nucleic acid amplification test intended for the in vitro qualitative detection of ribosomal RNA from T. vaginalis in patient-collected first catch urine and clinician collected vaginal swabs, endocervical swab and ThinPrep Pap Test specimens collected in Cytyc Preservcyt solution. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System automated analyzer. There are 4 kits (1 master and 3 ancillary) that are required to perform the ATV assay on the TIGRIS DTS System. The Master Kit contains 9 reagents and 2 controls and is made up of 3 boxes. Box 1 - the Refrigerated box contains ATV amplification reagent, ATV enzyme reagent, ATV probe reagent and ATV Target Capture reagent-B. Box 2 - the Room Temperature box contains ATV amplification reconstitution solution, ATV enzyme reconstitution reagent, ATV probe reconstitution reagent, ATV selection reagent and ATV target capture reagent. Box 3-the Controls kit box contains ATV positive and negative controls. The three ancillary kits consist of the APTIMA Assay Fluids kit, the APTIMA Auto Detect Reagents kit and APTIMA System Fluids Preservative kit. In addition to the reagents provided in the kit, the assay utilizes four specimen collection kits - the APTIMA unisex swab specimen collection kit for endocervical and male urethral swab specimens, APTIMA {2}------------------------------------------------ vaginal swab specimen collection kit, APTIMA urine specimen collection kit for male and female urine specimens and the APTIMA specimen transfer kit. ### J. Substantial Equivalence Information: - 1. Predicate device name: In Pouch Trichomonas vaginalis - 2. Predicate 510(k) number: K896296 - 3. Comparison with predicate: | Similarities | | | |--------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | Device | Predicate | | Intended Use | NAAT test for detection of
T. vaginalis ribosomal RNA
(rRNA) | Accurate system for early
microscopic identification
and culture confirmation of
T. vaginalis from female
and male urogenital sites | | Differences | | | |----------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | Item | Device | Predicate | | Specimen types | Urine, vaginal swab,
endocervical swab, Thin
Prep in PreservCyt solution | Vaginal swab ,seminal
fluid, urine | | Assay type | Target capture, transcription
mediated amplification
assay | Culture media | | Detection | Direct microscopic
observation, then
inoculation for culture | Hybridization protection
assay, providing relative
light units (RLUs) | # K. Standard/Guidance Document Referenced (if applicable): EP5-A2, 2004: Evaluation of Precision Performance of Quantitative Measurement Methods, CLSI Approved Guideline EP 15-A2, 2006: User Verification of Performance For Precision and Trueness, CLSI approved Guideline Format for Traditional and Abbreviated 510(k)s; Guidance for Industry and Staff, Aug.2005 General Principles of Software Validation; final guidance for Industry and FDA Staff, Jan. 2002 {3}------------------------------------------------ Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, May 2005 # L. Test Principle: The Aptima TV assay involves 3 main steps which take place in a single tube: target capture (TC), target amplification by Transcription Mediated Amplification (TMA) and detection of the amplification products (amplicon) by Hybridization Protection Assay (HPA). Specimens to be tested are collected and transferred into their respective specimen transport tubes. The transport solutions in the specimen transport tubes release the rRNA targets and protect them from degradation. When the TV assay is performed, the target rRNA is isolated from the specimen by use of capture oligomers via target capture that utilizes magnetic particles. When target capture is complete, the TV rRNA is amplified via TMA. Detection of the amplicon is achieved by HPA using single stranded nucleic acid probes with chemiluminescent labels that are complimentary to the amplicon. During the detection step, light emitted from the labeled RNA: DNA hybrids is measured as photon signals in a luminometer and are reported as Relative Light Units (RLU). ### M. Performance Characteristics (if/when applicable): - 1. Analytical performance: - a. Precision/Reproducibility: Reproducibility was evaluated at 3 external US labs using the TIGRIS DTS System. Six operators, 2 at each site, performed reproducibility testing using 3 reagent kit lots. At each site, testing was performed over 6 days. Each site performed 2 runs per day. Each run contained 3 replicates of an 8 member reproducibility panel. The panels consisted of Trichomonas vaginalis negative and positive specimens prepared in either a urine or PreservCyt solution. For each sample matrix, there was a high negative, moderate positive, high positive and negative sample. Results are shown in the chart below. | | | | | | | Between Sites | | | Between Operators | | | Between Lots | | | Between Worklists | | | Within Worklists | | | Total | | |---|----|--------|-------|--------|--------|---------------|------|------|-------------------|-------|------|--------------|------|-------|-------------------|-------|------|------------------|--|--|-------|--| | | | | Conc | Target | | Mean | | CV | | CV | | CV | | CV | | CV | | CV | | | | | | | PM | Matrix | Level | Conc¹ | N | RLU | SD | (%) | SD | (%) | SD | (%) | SD | (%) | SD | (%) | SD | (%) | | | | | | A | P | Neg | N/A | 106 | 2.0 | 1.1 | 56.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.4 | 21.3 | 0.8 | 42.5 | 1.5 | 74.1 | | | | | | | B | P | HNeg | 0.01 | 106 | 58.3 | 17.2 | 29.4 | 0.0 | 0.0 | 11.1 | 19.1 | 0.0 | 0.0 | 22.2 | 38.0 | 30.2 | 51.7 | | | | | | | C | P | MPos | 0.1 | 108 | 367.0 | 32.8 | 8.9 | 0.0 | 0.0 | 57.5 | 15.7 | 51.0 | 13.9 | 140.6 | 38.3 | 163.6 | 44.6 | | | | | | | D | P | HPos | 1 | 107 | 1110.4 | 53.9 | 4.9 | 0.0 | 0.0 | 109.6 | 9.9 | 60.9 | 5.5 | 77.1 | 6.9 | 156.8 | 14.1 | | | | | | | E | U | Neg | N/A | 108 | 2.1 | 1.0 | 45.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.3 | 62.4 | 1.7 | 77.3 | | | | | | | F | U | HNeg | 0.006 | 107 | 60.2 | 11.2 | 18.7 | 0.0 | 0.0 | 9.6 | 15.9 | 9.8 | 16.2 | 12.0 | 19.9 | 21.4 | 35.6 | | | | | | | G | U | MPos | 0.1 | 107 | 781.6 | 53.2 | 6.8 | 0.0 | 0.0 | 66.6 | 8.5 | 56.0 | 7.2 | 83.7 | 10.7 | 131.9 | 16.9 | | | | | | | H | U | HPos | 1 | 108 | 1122.8 | 49.5 | 4.4 | 15.0 | 1.3 | 119.3 | 10.6 | 109.2 | 9.7 | 106.9 | 9.5 | 200.7 | 17.9 | | | | | | Reproducibility Study: Signal Variability of the ATV Assay by Panel Member, Including Samples With Discordant Test Results Conc=concentration, HNeg=high positive, MPos=moderate positive, Neg=negative, P=PreservCyt, PM=panel member, U=Urine 1 Concentration units = trichomonads/mL Note: The RLU value reported by the software is the total measured RLU divided by 1000 with the decimal point truncated. Variability from some factors may be numerically negative. This can occur if the variability due to those factors is very small. In these cases, SD and CV are shown as 0. {4}------------------------------------------------ ### b. Linearity/assay reportable range: The ATV Assay is designed for and validated on the TIGRIS DTS System. The assay test results are automatically interpreted by the TIGRIS DTS System APTIMA Trichomonas vaginalis Software. A test result may be negative, positive or invalid as determined by the total RLU in the detection step. A test result may be invalid due to RLU values outside the normal expected ranges. Initial invalid results should be retested. | Test Interpretation | Total RLU (x 1000) | |---------------------|--------------------| | Negative | 0* to <100 | | Positive | 100 to <2400 | | Invalid | 0* or >/= 2400 | *If the RLU measured on the TIGRIS DTS System in between 0 and 999, a result of "O" is reported in the "Total RLU (000s)" column in the run report. Measured RLU values less than 690 are reported as invalid. RLU values between 690 and 999 are reported as valid. - Traceability, Stability, Expected values (controls, calibrators, or methods): C. Data to support the recommended shipping and storage conditions for the vaginal swab, PreservCyt liquid Pap and urine specimens were generated with negative clinical specimens spiked with T. vaginalis to a final concentration of 250 TV/mL. Greater than 95% positivity was observed in all matrices (vaginal swab, PreservCyt liquid Pap, and urine) at all times and temperatures tested confirming the validity of the claimed maximum storage times and temperatures. Quality Control Results and Acceptability The APTIMA Negative Control for Trichomonas and APTIMA Positive Control for Trichomonas act as controls for the target capture, amplification and detection steps of the assay. The Positive Control contains non-infectious Trichomonas vaginalis trichomonads rRNA. | Control | Total RLU (x1000) | Trichomonas
vaginalis Result | |------------------|-------------------|---------------------------------| | Negative Control | 0* and <20 | Negative | | Positive Control | >/=500 and < 2400 | Positive | The APTIMA Trichomonas vaginalis Controls must produce the following test results: *If the RLU measured on the TIGRIS DTS System in between 0 and 999, a result of "O" is reported in the "Total RLU (000s)" column in the run report. Measured RLU values less than 690 are reported as invalid. RLU values between 690 and 999 are reported as valid. {5}------------------------------------------------ #### d. Detection limit: Panel samples containing 0.1 TV/mL in urine specimen matrix, PreservCyt liquid Pap specimen matrix, and vaginal swab matrix (90 replicates per matrix) were prepared with two strains of T. vaginalis (one Metronidazole-susceptible strain and one Metronidazoleresistant strain). Testing showed 100% positivity in all specimen matrices and in both T. vaginalis strains. #### Analytical specificity: e. Analytical specificity of the APTIMA Trichomonas vaginalis Assay was evaluated by testing various microorganisms, including common flora of the female genitourinary tract, opportunistic organisms, and closely related organisms. Testing was conducted in vaginal swab, PreservCyt liquid Pap, and urine matrices with 25 replicates of each isolate per matrix. The list of organisms and the concentrations tested are provided in Table 7. No cross-reactivity or significant effect on APTIMA Trichomonas vaginalis Assay specificity was observed with any of the organisms tested. The APTIMA Trichomonas vaginalis Assay was also evaluated by testing the same organisms (Table 7) in vaginal swab, PreservCyt liquid Pap, and urine matrices spiked with T. vaginalis lysate to a final concentration of 2.5 TV/mL (25 replicates of each isolate per matrix). The APTIMA Trichomonas vaginalis Assay was not significantly affected by the presence of the microorganisms tested, except in the presence of Trichomonas tenax and Pentatrichomonas hominis (where lower signal outputs were observed). T. tenax is a commensal of the oral cavity and Pentatrichomonas hominis is a commensal of the large intestine. {6}------------------------------------------------ | Microorganism | Concentration Tested | | | |-------------------------------|-----------------------|--------------------|-----------------------| | | STM | PreservCyt | Urine | | Acinetobacter lwoffi | 4.6x107 CFU/mL | 4.6x107 CFU/mL | 2.3x107 CFU/mL | | Actinomyces israelii | 2.1x108 CFU/mL | 2.1x108 CFU/mL | 1.1x108 CFU/mL | | Atopobium vaginae | 6.2x106 CFU/mL | 6.2x106 CFU/mL | 6.2x106 CFU/mL | | Bacteroides fragilis | 6.4x108 CFU/mL | 6.4x108 CFU/mL | 3.2x108 CFU/mL | | Bifidobacterium adolescentis | 7.2x107 CFU/mL | 7.2x107 CFU/mL | 3.6x107 CFU/mL | | Campylobacter jejuni | 7.2x107 CFU/mL | 7.2x107 CFU/mL | 3.6x107 CFU/mL | | Candida albicans | 1.2x108 CFU/mL | 1.2x108 CFU/mL | 5.9x107 CFU/mL | | Candida glabrata | 1.3x108 CFU/mL | 1.4x108 CFU/mL | 6.4x107 CFU/mL | | Candida parapsilosis | 9.2x107 CFU/mL | 9.2x107 CFU/mL | 4.6x107 CFU/mL | | Candida tropicalis | 1.8x107 CFU/mL | 1.8x107 CFU/mL | 9.1x106 CFU/mL | | Chlamydia trachomatis | 2.0x104 TCID
50/mL | 2.0x104 TCID 50/mL | 2.0x104 TCID
50/mL | | Clostridium difficile | 2.6x107 CFU/mL | 2.6x107 CFU/mL | 1.3x107 CFU/mL | | Clostridium perfringens | 1.9x108 CFU/mL | 1.9x108 CFU/mL | 9.4x107 CFU/mL | | Corynebacterium genitalium | 2.8x107 CFU/mL | 2.8x107 CFU/mL | 1.4x107 CFU/mL | | Cryptococcus neoformans | 5.8x107 CFU/mL | 5.8x107 CFU/mL | 2.9x107 CFU/mL | | Enterobacter aerogenes | 1.5x109 CFU/mL | 1.5x109 CFU/mL | 1.0x108 CFU/mL | | Enterococcus faecalis | 9.2x107 CFU/mL | 9.2x107 CFU/mL | 9.2x107 CFU/mL | | Escherichia coli | 2.2x108 CFU/mL | 2.2x108 CFU/mL | 2.2x108 CFU/mL | | Fusobacterium nucleatum | 1.3x108 CFU/mL | 1.3x108 CFU/mL | 6.4x107 CFU/mL | | Gardnerella vaginalis | 8.2x106 CFU/mL | 8.2x106 CFU/mL | 4.1x106 CFU/mL | | Haemophilus ducreyi | 2.1x109 CFU/mL | 2.1x109 CFU/mL | 3.1x109 CFU/mL | | Herpes simplex virus I | 2.0x105 TCID
50/mL | 2.0x105 TCID 50/mL | 2.0x105 TCID
50/mL | | Herpes simplex virus II | 2.0x105 TCID
50/mL | 2.0x105 TCID 50/mL | 2.0x105 TCID
50/mL | | HIV-1 | 3.0x107 copies/mL | 3.0x107 copies/mL | 3.0x107 copies/mL | | HPV 16 (SiHa) | 1.0x105 cell/mL | 1.0x105 cells/mL | 1.0x105 cells/mL | | Klebsiella oxytoca | 9.6x108 CFU/mL | 9.6x108 CFU/mL | 4.8x108 CFU/mL | | Lactobacillus acidophilus | 1.0x108 CFU/mL | 1.0x108 CFU/mL | 5.2x107 CFU/mL | | Lactobacillus jensenii | 1.6x109 CFU/mL | 1.6x109 CFU/mL | 8.2x108 CFU/mL | | Lactobacillus vaginalis | 4.6x108 CFU/mL | 4.6x108 CFU/mL | 2.3x108 CFU/mL | | Listeria monocytogenes | 2.1x109 CFU/mL | 2.1x109 CFU/mL | 1.0x109 CFU/mL | | Mobiluncus curtisii | 4.1x107 CFU/mL | 4.1x107 CFU/mL | 4.1x107 CFU/mL | | Mycoplasma hominis | 1.0x108 CFU/mL | 1.0x108 CFU/mL | 1.0x108 CFU/mL | | Neisseria gonorrhoeae | 2.7x108 CFU/mL | 2.7x108 CFU/mL | 1.4x108 CFU/mL | | Pentatrichomonas hominis | 2.2x106 CFU/mL | 2.2x106 CFU/mL | 1.3x106 CFU/mL | | Peptostreptococcus anaerobius | 2.2x108 CFU/mL | 2.2x108 CFU/mL | 1.1x108 CFU/mL | | Prevotella bivia | 5.2x108 CFU/mL | 5.2x108 CFU/mL | 2.6x108 CFU/mL | | Propionibacterium acnes | 1.6x108 CFU/mL | 1.6x108 CFU/mL | 1.6x108 CFU/mL | | Proteus mirabilis | 1.2x109 CFU/mL | 1.2x109 CFU/mL | 6.0x108 CFU/mL | | Pseudomonas aeruginosa | 1.5x108 CFU/mL | 1.5x108 CFU/mL | 1.5x108 CFU/mL | | Staphylococcus aureus | 2.8x108 CFU/mL | 2.8x108 CFU/mL | 2.8x108 CFU/mL | | Staphylococcus epidermidis | 3.0x108 CFU/mL | 3.0x108 CFU/mL | 1.5x108 CFU/mL | | Streptococcus pyogenes | 1.0x108 CFU/mL | 1.0x108 CFU/mL | 8.9x107 CFU/mL | | Streptococcus agalactiae | 1.0x108 CFU/mL | 1.0x108 CFU/mL | 1.0x108 CFU/mL | | Trichomonas tenax | 2.7x105 CFU/mL | 2.7x105 CFU/mL | 1.3x105 CFU/mL | | Ureaplasma urealyticum | 1.6x108 CFU/mL | 1.4x108 CFU/mL | 1.3x108 CFU/mL | # Table 7: Microorganisms Tested in the APTIMA Trichomonas vaginalis Assay {7}------------------------------------------------ {8}------------------------------------------------ #### Interference Studies The following substances (at a concentration of 1% vol/vol or wt/vol) were individually spiked into vaginal swab, PreservCyt liquid Pap, and urine matrices and tested in the APTIMA Trichomonas vaginalis Assay: over-the-counter personal lubricants, spermicides, deodorant sprays/powders, anti-fungal/anti-itch medications, intravaginal hormones, porcine gastric mucus, glacial acetic acid, vinegar, and seminal fluid. Whole blood was tested at 10% vol/vol and KOVA-Trol I High Abnormal w/ Urobilinogen Urinalysis Control was substituted for urine to test for high levels of protein, glucose, ketones, bilirubin, nitrite, and urobilinogen. No interference was observed with any of the tested substances in the APTIMA Trichomonas vaginalis Assay with the exception of porcine gastric mucus, which exhibited lower signal output when present at a final concentration of 1% (V/V or W/V). #### f. Assay cut-off: The ATV Assay is designed for and validated on the TIGRIS DTS System. The assay test results are automatically interpreted by the TIGRIS DTS System APTIMA Trichomonas vaginalis Software. A test result may be negative, positive or invalid as determined by the total RLU in the detection step. A test result may be invalid due to RLU values outside the normal expected ranges. Initial invalid results should be retested. | Test Interpretation | Total RLU (x 1000) | |---------------------|--------------------| | Negative | 0* to <100 | | Positive | 100 to <2400 | | Invalid | 0* or >/= 2400 | *If the RLU measured on the TIGRIS DTS System in between 0 and 999, a result of "0" is reported in the "Total RLU (000s)" column in the run report. Measured RLU values less than 690 are reported as invalid. RLU values between 690 and 999 are reported as valid. - 2. Comparison studies: - a. Method comparison with predicate device: See 3 (a) below {9}------------------------------------------------ #### b. Matrix comparison: N/A #### 3. Clinical studies: - a. Clinical Sensitivity: A pivotal prospective multicenter clinical trial was conducted with 1025 symptomatic and asymptomatic women enrolled from 9 US clinical sites, including obstetric and gynecology, family planning and STD clinics. Up to 6 specimens were collected from each subject (1 first catch urine, 3 vaginal swabs, 1 endocervical swab and 1 PreservCyt solution liquid Pap specimen). All specimens were clinician-collected except urine specimens. 2 of the vaginal swab specimens were tested with a commercially available culture system and wet mount microscopic exam to establish infected status. The remaining 4 specimens were tested with the ATV assay at 3 external labs. Performance characteristics of the ATV assay were determined by comparing results to a patient infected status algorithm. Each subject was designated as infected or non-infected based on vaginal swab specimen results tested by culture and/or wet mount microscopic exam. At least one positive reference result established an infected patient status. Both reference tests were required to be negative to establish a non-infected patient status. Of the evaluable specimens, a total of 738 urines, 877 vaginal swabs, 922 endocervical swabs and 813 PreservCyt solution liquid Pap specimens were tested with the assay. There were 3 urines, 2 vaginal and 2 endocervical swabs with final invalid results due to hardware errors or specimen issues. Results below show the sensitivity, specificity, positive value (PPV), and negative predictive value (NPV) of the APTIMA Trichomonas vaginalis Assay and the prevalence of T. vaginalis (based on the infected status) in each specimen type. Performance was similar across specimen types. | Specimen
Type | N | TP | FP | TN | FN | Prev
% | Sensitivity%
(95% CI) | Specificity%
(95%CI) | PPV%
(95%CI) | NPV%
(95%CI) | |----------------------------------------|-----|-----|----|-----|----|-----------|--------------------------|-------------------------|---------------------|---------------------| | Urine | 735 | 80 | 7 | 644 | 4 | 11.4 | 95.2 (88.4-
98.1) | 98.9 (97.8-
99.5) | 92.0 (1-
96.4) | 99.4(98.5-
99.8) | | Clinician
collected
vaginal swab | 875 | 111 | 8 | 756 | 0 | 12.7 | 100 (96.7-
100) | 99.0(97.9-
99.5) | 93.3(87.6-
97.0) | 100(99.5-
100) | | Endocervical
swab | 920 | 114 | 5 | 801 | 0 | 12.4 | 100 (96.7-
100) | 99.4(98.6-
99.7) | 95.8(90.7-
98.6) | 100(99.6-
100) | Performance characteristics of the APTIMA Trichomonas vaginalis Assay {10}------------------------------------------------ | PreservCyt | 813 | 93 | 3 | 717 | 0 | 11.4 | 100 (96.0-
100) | 99.6 (98.8-
99.9) | 96.9(91.4-
99.3) | 100(99.5-
100) | |------------|-----|----|---|-----|---|------|--------------------|----------------------|---------------------|-------------------| |------------|-----|----|---|-----|---|------|--------------------|----------------------|---------------------|-------------------| The sensitivity, specificity, PPV, and NPV of the APTIMA Trichomonas vaginalis Assay and the prevalence of T. vaginalis (based on the infected status) in each specimen type were also evaluated by symptom status. Subjects were classified as symptomatic if symptoms were reported by the subject. Subjects were classified as asymptomatic if the subject did not report symptoms. For each specimen type, performance was similar in symptomatic and asymptomatic women. Prevalence was higher in symptomatic women. {11}------------------------------------------------ | Specimen
Type | Symptom
Status | n | TP | FP | TN | FN | Prev % | Sensitivity %
(95% CI)¹ | Specificity %
(95% CI)¹ | PPV %
(95% CI)² | NPV %
(95% CI)² | |------------------|-------------------|-----|----|----|-----|----|--------|----------------------------|----------------------------|---------------------|---------------------| | Urine | Asymptomatic | 324 | 21 | 3 | 299 | 1 | 6.8 | 95.5
(78.2-99.2) | 99.0
(97.1-99.7) | 87.5
(71.4-96.9) | 99.7
(98.4-100) | | | Symptomatic | 411 | 59 | 4 | 345 | 3 | 15.1 | 95.2
(86.7-98.3) | 98.9
(97.1-99.6) | 93.7
(85.7-98.1) | 99.1
(97.7-99.8) | | CVS | Asymptomatic | 345 | 24 | 4 | 317 | 0 | 7.0 | 100
(86.2-100) | 98.8
(96.8-99.5) | 85.7
(70.3-95.6) | 100
(98.9-100) | | | Symptomatic | 530 | 87 | 4 | 439 | 0 | 16.4 | 100
(95.8-100) | 99.1
(97.7-99.6) | 95.6
(89.5-98.8) | 100
(99.2-100) | | ES | Asymptomatic | 372 | 26 | 1 | 345 | 0 | 7.0 | 100
(87.1-100) | 99.7
(98.4-99.9) | 96.3
(82.4-99.9) | 100
(99.0-100) | | | Symptomatic | 548 | 88 | 4 | 456 | 0 | 16.1 | 100
(95.8-100) | 99.1
(97.8-99.7) | 95.7
(89.6-98.8) | 100
(99.2-100) | | PCyt | Asymptomatic | 353 | 23 | 0 | 330 | 0 | 6.5 | 100
(85.7-100) | 100
(98.8-100) | 100
(86.2-NC) | 100
(99.0-100) | | | Symptomatic | 460 | 70 | 3 | 387 | 0 | 15.2 | 100
(94.8-100) | 99.2
(97.8-99.7) | 95.9
(88.9-99.1) | 100
(99.1-100) | Table 3: Performance Characteristics of the APTIMA Trichomonas vaginalis Assay by Symptom Status CI = confidence interval, CVS = clinician-collected vaginal swab, ES = endocervical swab, FN = false negative, FP = false positive, NC = not calculable, PCyt = PreservCyt Solution liquid Pap, Prev = prevalence, TN = true negative, TP = true positive. 4Score confidence interval. 2PPV 95% confidence interval computed from the exact 95% confidence interval for the positive likelihood ratio, NPV 95% confidence interval computed from the exact 95% confidence interval from the negative likelihood ratio. Some confidence limits could not be calculated due to undefined results in the formulas. - Clinical specificity: b. See 3(a) above - Other clinical supportive data (when a. and b. are not applicable): C. N/A - 4. Clinical cut-off: N/A - 5. Expected values/Reference range: The prevalence of T. vaginalis in different populations depends on patient risk factors such as age, lifestyle, the presence or absence of symptoms, and the sensitivity of the test in detecting the infection. A summary of the prevalence of T. vaginalis, by specimen type, as determined by the APTIMA Trichomonas vaginalis Assay in the clinical trial is described below. {12}------------------------------------------------ The positivity rate for the Aptima TV assay by specimen type, collection site and overall was 11.8% (87/735) for urines, 11.8% (96/813) for PreservCyt solution Pap specimens, 12.9% (119/920) for endocervical swab specimens and 13.6% (119/875) for vaginal swab specimens. ### N. Instrument Name: The TIGRIS DTS System ### O. System Descriptions: - 1. Modes of Operation: The TIGRIS DTS System is an integrated hardware and software system that fully automates all steps of nucleic acid testing necessary to perform Gen-Probe assays. The system automates the following steps: sample processing/ target capture, amplification, detection and results processing. The 2 main components of the system are the computer work station and the analyzer. The assay software in the computer work station directs the analyzer modules to perform each sequential assay step. The analyzer holds all of the fluids, reagents and consumables needed to perform the assay. - 2. Software: FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types: Yes _X _________ or No _______________________________________________________________________________________________________________________________________________________ - 3. Specimen Identification: See Section L, Test Principle. A complete description is included in theTIGRIS DTS System Operator's Manual for system procedural information - 4. Specimen Sampling and Handling: See #3 above - 5. Calibration: N/A - 6. Quality Control: See #3 above {13}------------------------------------------------ # P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: N/A # Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. # R. Conclusion: The submitted information in this premarket notification is complete and supports reclassification into Class II --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OUY/DEN110012](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OUY/DEN110012) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a De Novo](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com