← Product Code [LSL](/productcode/LSL) · K043224 # GEN-PROBE APTIMA COMBO 2 ASSAY (K043224) _Gen-Probe, Inc. · LSL · Aug 9, 2005 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K043224 ## Device Facts - **Applicant:** Gen-Probe, Inc. - **Product Code:** [LSL](/productcode/LSL.md) - **Decision Date:** Aug 9, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3390 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for Use The APTIMA Combo 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in clinician-collected endocervical, vaginal, and male urethral swab specimens, patientcollected vaginal swab specimens*, and female and male urine specimens. The assay is also intended for use with testing of gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease. *Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use. The GEN-PROBE® APTIMA® Specimen Transfer Kit is only for use with GEN-PROBE APTIMA assays for the detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae. The GEN-PROBE APTIMA Specimen Transfer Kit allows for APTIMA Assay testing of gynecological specimens collected and processed by the Cytyc ThinPrep 2000 Processor according to the instructions provided. ## Device Story The APTIMA Combo 2 Assay is a nucleic acid amplification test (NAAT) for detecting Chlamydia trachomatis and Neisseria gonorrhoeae. It utilizes target capture technology to isolate rRNA from clinical specimens. The assay is performed in a laboratory setting by trained technicians. The APTIMA Specimen Transfer Kit enables the use of gynecological specimens previously processed by the Cytyc ThinPrep 2000 System for Pap testing. The assay provides qualitative results, aiding clinicians in diagnosing urogenital infections. By enabling the use of existing liquid-based cytology samples, the device streamlines diagnostic workflows, allowing for concurrent screening for STIs and cervical abnormalities from a single specimen collection. ## Clinical Evidence Prospective multi-center study of 1,647 female subjects (symptomatic and asymptomatic). Sensitivity and specificity were calculated against a patient-infected status algorithm (requiring positive results from two reference NAATs). For C. trachomatis, overall sensitivity was 96.7% and specificity was 99.2%. For N. gonorrhoeae, overall sensitivity was 92.3% and specificity was 99.8%. Analytical studies confirmed no interference from common cervical substances and demonstrated stability of spiked samples under various storage conditions. ## Technological Characteristics Nucleic acid amplification test (NAAT) utilizing target capture and rRNA detection. Components include transport media with penetrable cap. Compatible with Cytyc ThinPrep 2000 Processor. Analytical sensitivity: 1 IFU/assay for C. trachomatis; 50 cells/assay for N. gonorrhoeae. Standalone laboratory assay. ## Regulatory Identification Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms. ## Predicate Devices - APTMA Combo 2 Assay ([K003395](/device/K003395.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 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [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} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K043224 B. Purpose for Submission: The APTIMA Combo 2 (AC2) assay is a nucleic acid amplification test (NAAT) intended for the qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in endocervical, male urethral and vaginal swab specimens and in female and male urine specimens. The assay originally received FDA clearance on May 21, 2001 (K032554). The current application is for the additional indication of testing specimens collected and processed with the Cytyc ThinPrep 2000 System. An ancillary kit called the “GEN-PROBE APTIMA Specimen Transfer Kit” is included in the current submission to facilitate specimen transport and processing. C. Measurand: Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) ribosomal RNA D. Type of Test: NAAT E. Applicant: Gen-Probe Incorporated F. Proprietary and Established Names: GEN-PROBE® APTIMA® Combo 2 Assay G. Regulatory Information: 1. Regulation section: CT: 21 CFR 866.3120 GC: 21 CFR 866.3390 {1} 2. Classification: CT: Class I GC: Class II 3. Product code: CT: MKZ GC: LSL 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): AC2 Assay package insert: The APTIMA Combo 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in clinician-collected endocervical, vaginal, and male urethral swab specimens, patient-collected vaginal swab specimens*, and female and male urine specimens. The assay is also intended for use with testing of gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease. *Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use. Ancillary Kit package insert: The GEN-PROBE® APTIMA® Specimen Transfer Kit is only for use with GEN-PROBE APTIMA assays for the detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae. The GEN-PROBE APTIMA Specimen Transfer Kit allows for APTIMA Assay testing of gynecological specimens collected and processed by the Cytyc ThinPrep 200 Processor according to the instructions provided. 2 {2} 2. Indication(s) for use: See intended use above 3. Special conditions for use statement(s): This device is for prescription use only. 4. Special instrument requirements: Gen-Probe Leader HC+ liminometer and Gen-Probe Target Capture System I. Device Description: The APTIMA Combo 2 (AC2) assay is a nucleic acid amplification test (NAAT). See Test Principle below for more details. J. Substantial Equivalence Information: 1. Predicate device name(s): APTMA Combo 2 Assay 2. Predicate 510(k) number(s): K003395 3. Comparison with predicate: Same device as current submission, but with added PreservCyt (PC) specimen indication. Collection device and media are different, as are specimen handling and storage instructions. K. Standard/Guidance Document Referenced (if applicable): Not Applicable L. Test Principle: The GEN-PROBE APTIMA Combo 2 Assay combines the technologies of target capture, Transcription-Mediated Amplification (TMA), and Dual Kinetic Assay (DKA). During target capture, rRNA molecules are isolated from specimens by capture oligomers on magnetic microparticles. After target capture, the specimens are ready for TMA. The GEN-PROBE APTIMA Combo 2 Assay reaction replicates a specific region of the 23S rRNA from C. trachomatis and a specific region of the 16S rRNA from N. gonorrhoeae via DNA intermediates. Detection of the rRNA 3 {3} amplicons is achieved using single-stranded chemiluminescent DNA probes, which are labeled with different acridinium ester molecules. The labeled DNA probes combine with amplicon to form stable RNA:DNA hybrids and light emitted from the labeled RNA:DNA hybrids is reported as Relative Light Units (RLU). In DKA, differences in the kinetic profiles of the CT and GC probes allow for the differentiation of signal. The chemiluminescent detection reaction for CT signal has the "flasher" kinetic type. The chemiluminescent detection reaction for the GC signal has the "glower" kinetic type. Assay results are determined by a cut-off based on the total RLU and the kinetic curve type. ## M. Performance Characteristics (if/when applicable): ### 1. Analytical performance: #### a. Precision/Reproducibility: Precision testing was performed at three sites to obtain measures of repeatability and reproducibility. Reproducibility was established with a 12-member panel generated by spiking PreservCyt Solution with 0 to 2000 fg/assay of C. trachomatis and 0 to 5,000 fg/assay of N. gonorrhoeae rRNA and aliquotting 1mL into the APTIMA Specimen Transfer Kit collection tube. Two (2) operators at each of the three sites performed one run per day on each of three days, totaling three valid runs per operator. Testing was performed using one assay kit lot. The results of this precision study are summarized below. Reproducibility when testing PreservCyt liquid Pap clinical specimens containing target organism has not been determined. | Concentration (fg/assay) | | | | | Intra-Run | | Inter-Run | | Inter-Site | | Inter-Operator | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | CT | GC | N | Agreement | Mean RLU (x 1,000) | SD (x 1,000) | CV (%) | SD (x 1,000) | CV (%) | SD (x 1,000) | CV (%) | SD (x 1,000) | CV (%) | | 0 | 0 | 162 | 97.5% | 9.7 | 31.6 | N/A | 3.4 | N/A | 6.4 | N/A | 4.7 | N/A | | 0 | 5,000 | 54 | 96.3% | 1296 | 146 | 11.3 | 54.8 | 4.2 | 0.0 | 0.0 | 0.0 | 0.0 | | 2,000 | 0 | 54 | 100% | 1140 | 54.1 | 4.7 | 79.8 | 7.0 | 101 | 8.9 | 2.4 | 0.2 | | 2,000 | 5,000 | 54 | 100% | 2345 | 79.6 | 3.4 | 78.0 | 3.3 | 94.7 | 4.0 | 37.9 | 1.6 | | 0 | 250 | 54 | 100% | 953 | 114 | 12.0 | 0.0 | 0.0 | 161 | 16.9 | 90.7 | 9.5 | | 5 | 0 | 54 | 100% | 971 | 58.3 | 6.0 | 71.7 | 7.4 | 22.8 | 2.4 | 85.0 | 8.8 | | 1,000 | 2,500 | 54 | 100% | 2294 | 114 | 5.0 | 88.9 | 3.9 | 153 | 6.7 | 0.0 | 0.0 | | 100 | 250 | 54 | 98.1% | 1911 | 139 | 7.3 | 130 | 6.8 | 348 | 18.2 | 39.7 | 2.1 | | 5 | 5,000 | 54 | 100% | 2136 | 113 | 5.3 | 130 | 6.1 | 98.8 | 4.6 | 166 | 7.8 | | 2,000 | 250 | 54 | 96.3% | 2044 | 138 | 6.7 | 169 | 8.3 | 360 | 17.6 | 26.9 | 1.3 | RLU - Relative Light Units SD = Standard Deviation CV = Coefficient of Variation N/A = Not applicable for negative panel members {4} b. Linearity/assay reportable range: Not Applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Not Applicable d. Detection limit: A study was performed that showed the AC2 Assay detected CT cells at least 4 fold below the analytical sensitivity claim (claim = 1 IFU/assay) for 3 replicates of each of 15 CT serovars tested in PC media. Likewise, 3 replicates of each of 20 GC clinical isolates were detected in PC media at 10 fold below the analytical sensitivity claim (claim = 50 cells/assay). Table 5.5-10: Analytical Sensitivity for Detection of CT | Serovar | IFU/ Assay | Replicate 1 | | Replicate 2 | | Replicate 3 | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | RLU | Result | RLU | Result | RLU | Result | | A | 10 | 1,006,000 | CT+ | 1,019,000 | CT+ | 964,000 | CT+ | | | 1.0 | 402,000 | CT+ | 295,000 | CT+ | 455,000 | CT+ | | | 0.1 | 55,000 | CTa | 82,000 | CTa | 41,000 | CTa | | | 0.01 | 10,000 | CT- | 19,000 | CT- | 12,000 | CT- | | B | 10 | 1,044,000 | CT+ | 1,127,000 | CT+ | 1,005,000 | CT+ | | | 1.0 | 607,000 | CT+ | 725,000 | CT+ | 724,000 | CT+ | | | 0.1 | 165,000 | CT+ | 44,000 | CTa | 155,000 | CT+ | | | 0.01 | 68,000 | CTa | 27,000 | CT- | 18,000 | CT- | | Ba | 10 | 1,159,000 | CT+ | 1,201,000 | CT+ | 1,275,000 | CT+ | | | 1.0 | 973,000 | CT+ | 1,045,000 | CT+ | 1,083,000 | CT+ | | | 0.1 | 699,000 | CT+ | 826,000 | CT+ | 783,000 | CT+ | | | 0.01 | 422,000 | CT+ | 271,000 | CT+ | 262,000 | CT+ | | C | 10 | 1,179,000 | CT+ | 1,205,000 | CT+ | 1,078,000 | CT+ | | | 1.0 | 740,000 | CT+ | 716,000 | CT+ | 576,000 | CT+ | | | 0.1 | 175,000 | CT+ | 172,000 | CT+ | 240,000 | CT+ | | | 0.01 | 7,000 | CT- | 17,000 | CT- | 40,000 | CTa | | D | 10 | 989,000 | CT+ | 1,005,000 | CT+ | 993,000 | CT+ | | | 1.0 | 577,000 | CT+ | 498,000 | CT+ | 473,000 | CT+ | | | 0.1 | 48,000 | CTa | 56,000 | CTa | 91,000 | CTa | | | 0.01 | 15,000 | CT- | 11,000 | CT- | 7,000 | CT- | | E | 10 | 1,182,000 | CT+ | 1,168,000 | CT+ | 1,262,000 | CT+ | | | 1.0 | 1,134,000 | CT+ | 1,150,000 | CT+ | 1,204,000 | CT+ | | | 0.1 | 845,000 | CT+ | 791,000 | CT+ | 773,000 | CT+ | | | 0.01 | 442,000 | CT+ | 403,000 | CT+ | 268,000 | CT+ | | F | 10 | 1,167,000 | CT+ | 1,179,000 | CT+ | 1,169,000 | CT+ | | | 1.0 | 851,000 | CT+ | 838,000 | CT+ | 804,000 | CT+ | | | 0.1 | 241,000 | CT+ | 6,000 | CT- | 19,000 | CT- | | | 0.01 | 6,000 | CT- | 5,000 | CT- | 5,000 | CT- | | G | 10 | 1,190,000 | CT+ | 1,236,000 | CT+ | 1,175,000 | CT+ | | | 1.0 | 1,018,000 | CT+ | 1,030,000 | CT+ | 979,000 | CT+ | | | 0.1 | 816,000 | CT+ | 916,000 | CT+ | 675,000 | CT+ | | | 0.01 | 71,000 | CTa | 412,000 | CT+ | 454,000 | CT+ | a = Equivocal Result {5} | Serovar | IFU/Assay | Replicate 1 | | Replicate 2 | | Replicate 3 | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | RLU | Result | RLU | Result | RLU | Result | | H | 10 | 1,156,000 | CT+ | 1,120,000 | CT+ | 1,111,000 | CT+ | | | 1.0 | 872,000 | CT+ | 937,000 | CT+ | 998,000 | CT+ | | | 0.1 | 795,000 | CT+ | 733,000 | CT+ | 657,000 | CT+ | | | 0.01 | 369,000 | CT+ | 251,000 | CT+ | 114,000 | CT+ | | I | 10 | 1,039,000 | CT+ | 1,015,000 | CT+ | 1,039,000 | CT+ | | | 1.0 | 1,025,000 | CT+ | 992,000 | CT+ | 896,000 | CT+ | | | 0.1 | 907,000 | CT+ | 884,000 | CT+ | 938,000 | CT+ | | | 0.01 | 899,000 | CT+ | 924,000 | CT+ | 928,000 | CT+ | | J | 10 | 1,159,000 | CT+ | 1,221,000 | CT+ | 1,297,000 | CT+ | | | 1.0 | 1,160,000 | CT+ | 1,086,000 | CT+ | 1,049,000 | CT+ | | | 0.1 | 802,000 | CT+ | 805,000 | CT+ | 788,000 | CT+ | | | 0.01 | 524,000 | CT+ | 487,000 | CT+ | 486,000 | CT+ | | K | 10 | 1,175,000 | CT+ | 1,189,000 | CT+ | 1,117,000 | CT+ | | | 1.0 | 886,000 | CT+ | 844,000 | CT+ | 909,000 | CT+ | | | 0.1 | 469,000 | CT+ | 672,000 | CT+ | 478,000 | CT+ | | | 0.01 | 5,000 | CT- | 5,000 | CT- | 7,000 | CT- | | L1 | 10 | 1,192,000 | CT+ | 1,147,000 | CT+ | 1,127,000 | CT+ | | | 1.0 | 947,000 | CT+ | 935,000 | CT+ | 942,000 | CT+ | | | 0.1 | 276,000 | CT+ | 806,000 | CT+ | 787,000 | CT+ | | | 0.01 | 504,000 | CT+ | 334,000 | CT+ | 294,000 | CT+ | | L2 | 10 | 1,072,000 | CT+ | 1,096,000 | CT+ | 1,203,000 | CT+ | | | 1.0 | 979,000 | CT+ | 859,000 | CT+ | 901,000 | CT+ | | | 0.1 | 509,000 | CT+ | 213,000 | CT+ | 471,000 | CT+ | | | 0.01 | 11,000 | CT- | 5,000 | CT- | 230,000 | CT+ | | L3 | 10 | 1,205,000 | CT+ | 1,250,000 | CT+ | 1,133,000 | CT+ | | | 1.0 | 999,000 | CT+ | 967,000 | CT+ | 951,000 | CT+ | | | 0.1 | 566,000 | CT+ | 582,000 | CT+ | 637,000 | CT+ | | | 0.01 | 196,000 | CT+ | 9,000 | CT- | 111,000 | CT+ | a = Equivocal Result {6} Table 5.5-11: Additional Dilution Testing of CT Serovars A, B, D and F. | Serovar A | | | | | | | --- | --- | --- | --- | --- | --- | | IFU/Assay | Rep # | PreservCyt/STM | | STM only | | | | | RLU | Results | RLU | Results | | 1.0 | 1 | 713,000 | CT+ | 769,000 | CT+ | | | 2 | 632,000 | CT+ | 675,000 | CT+ | | | 3 | 594,000 | CT+ | 741,000 | CT+ | | 0.75 | 1 | 412,000 | CT+ | 692,000 | CT+ | | | 2 | 287,000 | CT+ | 674,000 | CT+ | | | 3 | 618,000 | CT+ | 606,000 | CT+ | | 0.50 | 1 | 565,000 | CT+ | 365,000 | CT+ | | | 2 | 344,000 | CT+ | 109,000 | CT+ | | | 3 | 316,000 | CT+ | 120,000 | CT+ | | 0.25 | 1 | 322,000 | CT+ | 170,000 | CT+ | | | 2 | 272,000 | CT+ | 279,000 | CT+ | | | 3 | 189,000 | CT+ | 509,000 | CT+ | | 0.10 | 1 | 14,000 | CT- | 38,000 | CTa | | | 2 | 43,000 | CTa | 44,000 | CTa | | | 3 | 45,000 | CTa | 83,000 | CTa | | Serovar B | | | | | | | IFU/Assay | Rep # | PreservCyt/STM | | STM only | | | | | RLU | Results | RLU | Results | | 1.0 | 1 | 771,000 | CT+ | 533,000 | CT+ | | | 2 | 754,000 | CT+ | 572,000 | CT+ | | | 3 | 663,000 | CT+ | 546,000 | CT+ | | 0.75 | 1 | 616,000 | CT+ | 562,000 | CT+ | | | 2 | 576,000 | CT+ | 539,000 | CT+ | | | 3 | 581,000 | CT+ | 640,000 | CT+ | | 0.50 | 1 | 473,000 | CT+ | 556,000 | CT+ | | | 2 | 454,000 | CT+ | 620,000 | CT+ | | | 3 | 483,000 | CT+ | 557,000 | CT+ | | 0.25 | 1 | 439,000 | CT+ | 426,000 | CT+ | | | 2 | 514,000 | CT+ | 360,000 | CT+ | | | 3 | 376,000 | CT+ | 527,000 | CT+ | | 0.10 | 1 | 154,000 | CT+ | 295,000 | CT+ | | | 2 | 216,000 | CT+ | 175,000 | CT+ | | | 3 | 283,000 | CT+ | 280,000 | CT+ | a = Equivocal Result {7} Table 5.5-11 (cont.). Additional Dilution Testing of CT Serovars A, B, D and F. | Serovar D | | | | | | | --- | --- | --- | --- | --- | --- | | IFU/Assay | Rep # | PreservCyt/STM | | STM only | | | | | RLU | Results | RLU | Results | | 1.0 | 1 | 873,000 | CT+ | 897,000 | CT+ | | | 2 | 904,000 | CT+ | 928,000 | CT+ | | | 3 | 701,000 | CT+ | 764,000 | CT+ | | 0.75 | 1 | 609,000 | CT+ | 731,000 | CT+ | | | 2 | 422,000 | CT+ | 649,000 | CT+ | | | 3 | 859,000 | CT+ | 542,000 | CT+ | | 0.50 | 1 | 803,000 | CT+ | 588,000 | CT+ | | | 2 | 628,000 | CT+ | 465,000 | CT+ | | | 3 | 714,000 | CT+ | 531,000 | CT+ | | 0.25 | 1 | 429,000 | CT+ | 147,000 | CT+ | | | 2 | 366,000 | CT+ | 250,000 | CT+ | | | 3 | 348,000 | CT+ | 122,000 | CT+ | | 0.10 | 1 | 28,000 | CT- | 153,000 | CT+ | | | 2 | 92,000 | CTa | 170,000 | CT+ | | | 3 | 122,000 | CT+ | 69,000 | CTa | | Serovar F | | | | | | | IFU/Assay | Rep # | PreservCyt/STM | | STM only | | | | | RLU | Results | RLU | Results | | 1.0 | 1 | 741,000 | CT+ | 552,000 | CT+ | | | 2 | 863,000 | CT+ | 133,000 | CT+ | | | 3 | 855,000 | CT+ | 168,000 | CT+ | | 0.75 | 1 | 734,000 | CT+ | 341,000 | CT+ | | | 2 | 716,000 | CT+ | 168,000 | CT+ | | | 3 | 485,000 | CT+ | 26,000 | CT- | | 0.50 | 1 | 676,000 | CT- | 1,049,000 | CT+ | | | 2 | 310,000 | CT+ | 911,000 | CT+ | | | 3 | 408,000 | CT+ | 919,000 | CT+ | | 0.25 | 1 | 631,000 | CT+ | 439,000 | CT+ | | | 2 | 561,000 | CT+ | 725,000 | CT+ | | | 3 | 656,000 | CT+ | 526,000 | CT+ | | 0.10 | 1 | 6,000 | CT- | 5,000 | CT- | | | 2 | 7,000 | CT- | 6,000 | CT- | | | 3 | 6,000 | CT- | 5,000 | CT- | a = Equivocal Result {8} Table 5.5-12: Analytical Sensitivity for Detection of GC | GP Cl# | GC Cells Per Assay | Replicate 1 | | Replicate 2 | | Replicate 3 | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | RLU | Result | RLU | Result | RLU | Result | | 760 | 500 | 1,195,000 | GC+ | 1,181,000 | GC+ | 1,051,000 | GC+ | | | 50 | 707,000 | GC+ | 859,000 | GC+ | 659,000 | GC+ | | | 5 | 326,000 | GC+ | 420,000 | GC+ | 466,000 | GC+ | | | 0.5 | 50,000 | GC- | 65,000 | GC- | 70,000 | GC- | | 764 | 500 | 1,203,000 | GC+ | 1,169,000 | GC+ | 1,198,000 | GC+ | | | 50 | 1,073,000 | GC+ | 1,049,000 | GC+ | 1,120,000 | GC+ | | | 5 | 665,000 | GC+ | 679,000 | GC+ | 633,000 | GC+ | | | 0.5 | 79,000 | GC- | 107,000 | GC- | 45,000 | GC- | | 772 | 500 | 1,277,000 | GC+ | 1,255,000 | GC+ | 1,234,000 | GC+ | | | 50 | 912,000 | GC+ | 631,000 | GC+ | 1,085,000 | GC+ | | | 5 | 532,000 | GC+ | 394,000 | GC+ | 652,000 | GC+ | | | 0.5 | 100,000 | GC- | 135,000 | GC- | 66,000 | GC- | | 783 | 500 | 1,075,000 | GC+ | 1,064,000 | GC+ | 1,101,000 | GC+ | | | 50 | 983,000 | GC+ | 938,000 | GC+ | 963,000 | GC+ | | | 5 | 693,000 | GC+ | 719,000 | GC+ | 786,000 | GC+ | | | 0.5 | 226,000 | GC+ | 237,000 | GC+ | 283,000 | GC+ | | 787 | 500 | 1,146,000 | GC+ | 1,046,000 | GC+ | 1,093,000 | GC+ | | | 50 | 959,000 | GC+ | 871,000 | GC+ | 875,000 | GC+ | | | 5 | 295,000 | GC+ | 397,000 | GC+ | 396,000 | GC+ | | | 0.5 | 95,000 | GC- | 47,000 | GC- | 58,000 | GC- | | 789 | 500 | 1,186,000 | GC+ | 1,181,000 | GC+ | 1,118,000 | GC+ | | | 50 | 954,000 | GC+ | 1,014,000 | GC+ | 941,000 | GC+ | | | 5 | 209,000 | GC+ | 551,000 | GC+ | 628,000 | GC+ | | | 0.5 | 264,000 | GC+ | 129,000 | GC- | 93,000 | GC- | | 790 | 500 | 1,041,000 | GC+ | 1,011,000 | GC+ | 1,034,000 | GC+ | | | 50 | 791,000 | GC+ | 793,000 | GC+ | 814,000 | GC+ | | | 5 | 365,000 | GC+ | 313,000 | GC+ | 275,000 | GC+ | | | 0.5 | 25,000 | GC- | 18,000 | GC- | 16,000 | GC- | | 793 | 500 | 1,259,000 | GC+ | 1,246,000 | GC+ | 1,239,000 | GC+ | | | 50 | 1,182,000 | GC+ | 1,150,000 | GC+ | 1,139,000 | GC+ | | | 5 | 830,000 | GC+ | 792,000 | GC+ | 915,000 | GC+ | | | 0.5 | 343,000 | GC+ | 386,000 | GC+ | 349,000 | GC+ | | 794 | 500 | 1,192,000 | GC+ | 1,117,000 | GC+ | 1,237,000 | GC+ | | | 50 | 1,166,000 | GC+ | 1,132,000 | GC+ | 1,157,000 | GC+ | | | 5 | 797,000 | GC+ | 159,000 | GC+ | 706,000 | GC+ | | | 0.5 | 220,000 | GC+ | 205,000 | GC+ | 200,000 | GC+ | | 795 | 500 | 1,148,000 | GC+ | 1,116,000 | GC+ | 1,113,000 | GC+ | | | 50 | 923,000 | GC+ | 1,038,000 | GC+ | 1,053,000 | GC+ | | | 5 | 702,000 | GC+ | 547,000 | GC+ | 714,000 | GC+ | | | 0.5 | 177,000 | GC+ | 93,000 | GC+ | 158,000 | GC+ | {9} | GP Cl# | GC Cells Per Assay | Replicate 1 | | Replicate 2 | | Replicate 3 | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | RLU | Result | RLU | Result | RLU | Result | | 799 | 500 | 1,170,000 | GC+ | 1,134,000 | GC+ | 1,109,000 | GC+ | | | 50 | 976,000 | GC+ | 950,000 | GC+ | 992,000 | GC+ | | | 5 | 544,000 | GC+ | 580,000 | GC+ | 524,000 | GC+ | | | 0.5 | 62,000 | GC* | 54,000 | GC- | 103,000 | GC* | | 800 | 500 | 1,231,000 | GC+ | 1,221,000 | GC+ | 1,213,000 | GC+ | | | 50 | 1,164,000 | GC+ | 1,111,000 | GC+ | 1,118,000 | GC+ | | | 5 | 903,000 | GC+ | 931,000 | GC+ | 900,000 | GC+ | | | 0.5 | 147,000 | GC* | 214,000 | GC+ | 191,000 | GC+ | | 801 | 500 | 1,059,000 | GC+ | 1,091,000 | GC+ | 1,175,000 | GC+ | | | 50 | 1,002,000 | GC+ | 1,025,000 | GC+ | 974,000 | GC+ | | | 5 | 442,000 | GC+ | 469,000 | GC+ | 491,000 | GC+ | | | 0.5 | 62,000 | GC* | 69,000 | GC* | 40,000 | GC- | | 802 | 500 | 1,156,000 | GC+ | 1,187,000 | GC+ | 1,168,000 | GC+ | | | 50 | 1,026,000 | GC+ | 1,122,000 | GC+ | 1,100,000 | GC+ | | | 5 | 709,000 | GC+ | 622,000 | GC+ | 323,000 | GC+ | | | 0.5 | 72,000 | GC* | 134,000 | GC* | 153,000 | GC+ | | 806 | 500 | 1,145,000 | GC+ | 1,088,000 | GC+ | 1,010,000 | GC+ | | | 50 | 781,000 | GC+ | 851,000 | GC+ | 822,000 | GC+ | | | 5 | 255,000 | GC+ | 247,000 | GC+ | 178,000 | GC+ | | | 0.5 | 61,000 | GC* | 31,000 | GC- | 39,000 | GC- | | 813 | 500 | 1,112,000 | GC+ | 1,134,000 | GC- | 1,163,000 | GC+ | | | 50 | 1,006,000 | GC+ | 1,030,000 | GC+ | 1,108,000 | GC+ | | | 5 | 669,000 | GC+ | 688,000 | GC+ | 608,000 | GC+ | | | 0.5 | 141,000 | GC* | 135,000 | GC* | 176,000 | GC+ | | 827 | 500 | 1,192,000 | GC+ | 1,089,000 | GC+ | 1,250,000 | GC+ | | | 50 | 1,168,000 | GC+ | 1,192,000 | GC+ | 1,133,000 | GC+ | | | 5 | 744,000 | GC+ | 841,000 | GC+ | 712,000 | GC+ | | | 0.5 | 178,000 | GC+ | 245,000 | GC+ | 202,000 | GC+ | | 3043 | 500 | 1,235,000 | GC+ | 1,238,000 | GC+ | 1,232,000 | GC+ | | | 50 | 1,090,000 | GC+ | 1,036,000 | GC+ | 1,125,000 | GC+ | | | 5 | 292,000 | GC+ | 591,000 | GC+ | 493,000 | GC+ | | | 0.5 | 78,000 | GC* | 99,000 | GC* | 73,000 | GC* | | 3045 | 500 | 1,184,000 | GC+ | 1,110,000 | GC+ | 1,211,000 | GC+ | | | 50 | 1,116,000 | GC+ | 1,077,000 | GC+ | 978,000 | GC+ | | | 5 | 641,000 | GC+ | 808,000 | GC+ | 513,000 | GC+ | | | 0.5 | 110,000 | GC* | 111,000 | GC* | 151,000 | GC+ | | 3047 | 500 | 1,189,000 | GC+ | 1,174,000 | GC+ | 1,163,000 | GC+ | | | 50 | 1,071,000 | GC+ | 1,148,000 | GC+ | 1,182,000 | GC+ | | | 5 | 880,000 | GC+ | 896,000 | GC+ | 794,000 | GC+ | | | 0.5 | 70,000 | GC* | 207,000 | GC+ | 177,000 | GC+ | * = Equivocal Result e. Analytical specificity: The Chlamydia and Neisseria species were used to evaluate the analytical specificity of the AC2 Assay. A total of 50 culture isolates were tested in the liquid Pap media. None of the 50 culture isolates produced a positive result in the AC2 Assay. See results below: {10} Table 5.5-13: Specificity of the AC2 Assay | PHYLOGENETIC CROSS-SECTION | GP No. | ATCC No. | Concentration Tested/Assay | Rep # | Results (RLU) | | --- | --- | --- | --- | --- | --- | | Chlamydia psittaci | 1557 | VR601 | 7.9 x 10^{4} cells | 1 | 5,000 | | | | | | 2 | 4,000 | | Chlamydia psittaci | 768 | VR629 | 1 x 10^{4}CELD_{50}0.2 ml | 1 | 4,000 | | | | | | 2 | 5,000 | | Chlamydia pneumoniae | 1404 | VR1360 | 4.0 x 10^{7} cells | 1 | 5,000 | | | | | | 2 | 6,000 | | Neisseria elongata | CI1502 | 49377 | 1.2 x 10^{9} cells | 1 | 6,000 | | | | | | 2 | 6,000 | | Neisseria elongata | CI1503 | 49378 | 1.2 x 10^{9} cells | 1 | 5,000 | | | | | | 2 | 5,000 | | Neisseria elongata | CI1504 | 49379 | 1.8 x 10^{9} cells | 1 | 9,000 | | | | | | 2 | 10,000 | | Neisseria flava | 1558 | 14221 | 2.5 x 10^{9} cells | 1 | 4,000 | | | | | | 2 | 4,000 | | Neisseria mucosa | 190 | 19696 | 2.4 x 10^{9} cells | 1 | 5,000 | | | | | | 2 | 5,000 | | Neisseria mucosa | 791 | 25999 | 1.3 x 10^{9} cells | 1 | 5,000 | | | | | | 2 | 4,000 | | Neisseria perflava | 1559 | 10555 | 1.0 x 10^{9} cells | 1 | 6,000 | | | | | | 2 | 4,000 | | Neisseria sicca | 272 | 9913 | 5.9 x 10^{9} cells | 1 | 5,000 | | | | | | 2 | 4,000 | | Neisseria sicca | 762 | 29193 | 7.2 x 10^{7} cells | 1 | 4,000 | | | | | | 2 | 4,000 | | Neisseria subflava | CI3113 | NA | 4.5 x 10^{7} cells | 1 | 4,000 | | | | | | 2 | 4,000 | | Neisseria subflava | NH1 | NA | 2.2 x 10^{7} cells | 1 | 4,000 | | | | | | 2 | 3,000 | | Neisseria subflava | NH5 | NA | 2.4x 10^{7} cells | 1 | 3,000 | | | | | | 2 | 4,000 | | Neisseria subflava | NH6 | NA | 2.7 x 10^{9} cells | 1 | 4,000 | | | | | | 2 | 4,000 | | Neisseria subflava | NH7 | NA | 1.2 x 10^{9} cells | 1 | 4,000 | | | | | | 2 | 5,000 | | Neisseria subflava | NH8 | NA | 4.7 x 10^{9} cells | 1 | 6,000 | | | | | | 2 | 4,000 | | Neisseria subflava | NH11 | NA | 1.0 x 10^{9} cells | 1 | 5,000 | | | | | | 2 | 5,000 | | Neisseria subflava | NH13 | NA | 3.0 x 10^{7} cells | 1 | 6,000 | | | | | | 2 | 6,000 | {11} | PHYLOGENETIC CROSS-SECTION | GP No. | ATCC No. | Concentration Tested/Assay | Rep # | Result: (RLU) | | --- | --- | --- | --- | --- | --- | | Neisseria subflava | NH14 | NA | 4.5 x 10^{7} cells | 1 2 | 6,000 5,000 | | Neisseria subflava | NH15 | NA | 8.7 x 10^{7} cells | 1 2 | 4,000 4,000 | | Neisseria subflava | NH17 | NA | 1.1 x 10^{9} cells | 1 2 | 3,000 4,000 | | Neisseria subflava | NH18 | NA | 5.7 x 10^{7} cells | 1 2 | 5,000 5,000 | | Neisseria subflava | NH20 | NA | 2.1 x 10^{6} cells | 1 2 | 6,000 5,000 | | Neisseria cinerea | 761 | 14685 | 1.6 x 10^{9} cells | 1 2 | 8,000 8,000 | | Neisseria cinerea | CI3051 | NA | 2.9 x 10^{8} cells | 1 2 | 8,000 8,000 | | Neisseria cinerea | CI4543 | NA | 1.3 x 10^{8} cells | 1 2 | 9,000 10,000 | | Neisseria cinerea | CI4546 | NA | 4.9 x 10^{8} cells | 1 2 | 7,000 7,000 | | Neisseria dentrificans | 763 | 14686 | 3.0 x 10^{9} cells | 1 2 | 5,000 4,000 | | Neisseria lactamica | 760 | 23970 | 1.1 x 10^{9} cells | 1 2 | 6,000 6,000 | | Neisseria lactamica | CI3013 | NA | 9.5 x 10^{9} cells | 1 2 | 5,000 5,000 | | Neisseria lactamica | CI3018 | NA | 1.5 x 10^{8} cells | 1 2 | 5,000 4,000 | | Neisseria lactamica | CI3021 | NA | 5.0 x 10^{9} cells | 1 2 | 4,000 14,000 | | Neisseria lactamica | CI3022 | NA | 9.4 x 10^{9} cells | 1 2 | 5,000 4,000 | | Neisseria lactamica | CI3049 | NA | 2.3 x 10^{10} cells | 1 2 | 5,000 4,000 | | Neisseria lactamica | CI3065 | NA | 1.5 x 10^{10} cells | 1 2 | 4,000 5,000 | | Neisseria lactamica | CI3067 | NA | 2.9 x 10^{10} cells | 1 2 | 4,000 4,000 | | Neisseria lactamica | CI834 | NA | 6.0 x 10^{9} cells | 1 2 | 6,000 5,000 | | N. meningitidis Serogroup A | 755 | 13077 | 4.0 x 10^{10} cells | 1 2 | 9,000 8,000 | | N. meningitidis Serogroup B | 756 | 13090 | 3.1 x 10^{6} cells | 1 2 | 6,000 6,000 | {12} | PHYLOGENETIC CROSS-SECTION | GP No. | ATCC No. | Concentration Tested/Assay | Rep # | Result: (RLU) | | --- | --- | --- | --- | --- | --- | | N. meningitidis Serogroup C | 757 | 13102 | 5.0 x 10^{8} cells | 1 | 8,000 | | | | | | 2 | 8,000 | | N. meningitidis Serogroup C | 1388 | 13109 | 2.9 x 10^{11} cells | 1 | 5,000 | | | | | | 2 | 4,000 | | N. meningitidis Serogroup C | 1389 | 13100 | 8.0 x 10^{10} cells | 1 | 5,000 | | | | | | 2 | 4,000 | | N. meningitidis Serogroup C | 1390 | 13112 | 2.7 x 10^{9} cells | 1 | 10,000 | | | | | | 2 | 7,000 | | N. meningitidis Serogroup D | 401 | 13113 | 1.7 x 10^{11} cells | 1 | 8,000 | | | | | | 2 | 7,000 | | N. meningitidis Serogroup Y | 787 | 35561 | 3.0 x 10^{10} cells | 1 | 8,000 | | | | | | 2 | 9,000 | | N. meningitidis Serogroup W135 | 1387 | 43744 | 1.6 x 10^{9} cells | 1 | 10,000 | | | | | | 2 | 10,000 | | Neisseria polysaccharea | 1489 | 43768 | 3.0 x 10^{9} cells | 1 | 12,000 | | | | | | 2 | 12,000 | f. Assay cut-off: Not Applicable 2. Comparison studies: a. Method comparison with predicate device: Not Applicable 3. Clinical studies: A prospective multi-center clinical study was conducted to evaluate the use of the PreservCyt Solution (a component of the ThinPrep 2000 System) as an alternative medium for gynecological specimens for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. One thousand six hundred forty-seven (1,647) symptomatic and asymptomatic female subjects attending OB/GYN, family planning, public health, women's and STD clinics were evaluated in the clinical study. Of the 1,647 evaluable subjects, 1,288 were asymptomatic subjects and 359 were symptomatic subjects. Subjects were enrolled from sites with CT prevalence that ranged from 3.2 to 14.0% and GC prevalence that ranged from 0 to 5.0%. Two specimens were collected from each eligible subject: one PreservCyt Solution specimen and one endocervical swab. PreservCyt Solution specimens were processed in accordance with the ThinPrep 2000 Processor Operator's Manual and APTIMA Specimen Transfer Kit Package Insert. After processing the PreservCyt Solution specimen with the ThinPrep 2000 Processor, the specimen was transferred into the APTIMA {13} Specimen Transfer Kit for testing with the APTIMA Combo 2 Assay. The PreservCyt liquid Pap specimens and endocervical swab specimens were tested with the APTIMA Combo 2 Assay. Sensitivity and specificity for PreservCyt liquid Pap specimens were calculated by comparing results to a patient infected status algorithm. In the algorithm, the designation of a subject as being infected or non-infected with C. trachomatis or N. gonorrhoeae was based on endocervical swab specimen results from two commercially-available NAATs. For C. trachomatis, the reference NAATs included the APTIMA Combo 2 Assay and the APTIMA CT Assay. For N. gonorrhoeae, the reference NAATs included the APTIMA Combo 2 Assay and the APTIMA GC Assay. Positive results from both reference NAATs were required to establish an infected patient. A non-infected patient was established if the results from the two reference NAATs disagreed or were negative. Sensitivity and specificity for C. trachomatis in PreservCyt liquid Pap specimens tested in the APTIMA Combo 2 Assay, by symptom status and overall, is presented in Table 5c. For C. trachomatis, overall sensitivity was 96.7% (87/90). In symptomatic and asymptomatic subjects, sensitivity was 96.7% (29/30) and 96.7% (58/60), respectively. Overall specificity for C. trachomatis PreservCyt liquid Pap specimens was 99.2% (1545/1557). In symptomatic and asymptomatic subjects, specificity was 98.5% (324/329) and 99.4% (1221/1228), respectively. Table 6c shows the APTIMA Combo 2 Assay sensitivity and specificity values for C. trachomatis in PreservCyt liquid Pap specimens by clinical site and overall. For C. trachomatis, the sensitivity ranged from 92.9% to 100%. The specificity ranged from 97.7% to 100%. Sensitivity and specificity for N. gonorrhoeae in PreservCyt liquid Pap specimens tested in the APTIMA Combo 2 Assay, by symptom status and overall, is presented in Table 9c. For N. gonorrhoeae, overall sensitivity was 92.3% (12/13). In symptomatic and asymptomatic subjects, sensitivity was 100% (7/7) and 83.3% (5/6), respectively. Overall specificity for N. gonorrhoeae PreservCyt liquid Pap specimens was 99.8% (1630/1633). In symptomatic and asymptomatic subjects, specificity was 100% (352/352) and 99.8% (1278/1281), respectively. Table 10c shows the APTIMA Combo 2 Assay sensitivity and specificity values for N. gonorrhoeae in PreservCyt liquid Pap specimens by clinical site and overall. For N. gonorrhoeae, the sensitivity ranged from 80.0% to 100%. Specificity ranged from 99.0% to 100% 14 {14} Table 7c. C. trachomatis PreservCyt Liquid Pap Specimen Analysis for Female Patient Infected Status | Patient Infected Status | Endocervical Swab | | Symptom Status | | | --- | --- | --- | --- | --- | | | APTIMA Combo 2 Assay | APTIMA CT Assay | Symptomatic | Asymptomatic | | Infected | + | + | 30 | 60 | | Non-infected | - | + | 4 | 12 | | Non-infected | + | - | 3 | 2 | | Non-infected | - | - | 322 | 1214 | | Total | | | 359 | 1288 | Table 5c. C. trachomatis Sensitivity and Specificity: APTIMA Combo 2 Assay PreservCyt Specimens vs. Patient Infected Status | Symptom Status | AC2/CT ThinPrep Result | +/+ | +/- | -/+ | -/- | Sensitivity (95% C.I.) | Specificity (95% C.I.) | | --- | --- | --- | --- | --- | --- | --- | --- | | Asymptomatic | Positive | 58 | 1 | 0 | 6 | 96.7% (88.5 - 99.6) | 99.4% (98.8 - 99.8) | | | Negative | 2 | 1 | 12 | 1208 | | | | | Total | 60 | 2 | 12 | 1214 | | | | Symptomatic | Positive | 29 | 0 | 0 | 5 | 96.7% (82.8 - 99.8) | 98.5% (96.5 - 99.5) | | | Negative | 1 | 3 | 4 | 317 | | | | | Total | 30 | 3 | 4 | 322 | | | | All | Positive | 87 | 1 | 0 | 11 | 96.7% (90.6 - 99.3) | 99.2% (98.7 - 99.6) | | | Negative | 3 | 4 | 16 | 1525 | | | | | Total | 90 | 5 | 16 | 1536 | | | +/+ = Positive Endocervical Swab Specimen Result in the AC2 Assay / Positive Endocervical Swab Specimen Result in the ACT Assay +/- = Positive Endocervical Swab Specimen Result in the AC2 Assay / Negative Endocervical Swab Specimen Result in the ACT Assay -/+ = Negative Endocervical Swab Specimen Result in the AC2 Assay / Positive Endocervical Swab Specimen Result in the ACT Assay -/- = Negative Endocervical Swab Specimen Result in the AC2 Assay / Negative Endocervical Swab Specimen Result in the ACT Assay {15} Table 6c. C. trachomatis Performance by Clinical Site: APTIMA Combo 2 Assay PreservCyt Specimens vs. Patient Infected Status | Site | AC2/CT ThinPrep Result | +/+ | +/- | -/+ | -/- | Prev (%) | Sensitivity (95% C.I.) | Specificity (95% C.I.) | PPV (%) | NPV (%) | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1 | Positive | 14 | 0 | 0 | 2 | 14.0 | 100% (76.8 - 100) | 97.7% (91.9 - 99.7) | 87.5 | 100 | | | Negative | 0 | 0 | 1 | 83 | | | | | | | | Total | 14 | 0 | 1 | 85 | | | | | | | 2 | Positive | 4 | 0 | 0 | 0 | 3.2 | 100% (39.8 - 100) | 100% (97.0 - 100) | 100 | 100 | | | Negative | 0 | 0 | 2 | 118 | | | | | | | | Total | 4 | 0 | 2 | 118 | | | | | | | 3 | Positive | 29 | 0 | 0 | 2 | 6.5 | 93.5% (78.6 - 99.2) | 99.5% (98.4 - 99.9) | 93.5 | 99.5 | | | Negative | 2 | 0 | 2 | 440 | | | | | | | | Total | 31 | 0 | 2 | 442 | | | | | | | 4 | Positive | 8 | 1 | 0 | 4 | 2.8 | 100% (63.1 - 100) | 98.2% (95.9 - 99.4) | 61.5 | 100 | | | Negative | 0 | 2 | 1 | 271 | | | | | | | | Total | 8 | 3 | 1 | 275 | | | | | | | 5 | Positive | 13 | 0 | 0 | 2 | 4.7 | 92.9% (66.1 - 99.8) | 99.3% (97.5 - 99.9) | 86.7 | 99.6 | | | Negative | 1 | 1 | 4 | 276 | | | | | | | | Total | 14 | 1 | 4 | 278 | | | | | | | 6 | Positive | 19 | 0 | 0 | 1 | 5.2 | 100% (82.4 - 100) | 99.7% (98.4 - 100) | 95.0 | 100 | | | Negative | 0 | 1 | 6 | 337 | | | | | | | | Total | 19 | 1 | 6 | 338 | | | | | | | All | Positive | 87 | 1 | 0 | 11 | 5.5 | 96.7% (90.6 - 99.3) | 99.2% (98.7 - 99.6) | 87.9 | 99.8 | | | Negative | 3 | 4 | 16 | 1525 | | | | | | | | Total | 90 | 5 | 16 | 1536 | | | | | | +/+ = Positive Endocervical Swab Specimen Result in the AC2 Assay / Positive Endocervical Swab Specimen Result in the ACT Assay +/- = Positive Endocervical Swab Specimen Result in the AC2 Assay / Negative Endocervical Swab Specimen Result in the ACT Assay -/+ = Negative Endocervical Swab Specimen Result in the AC2 Assay / Positive Endocervical Swab Specimen Result in the ACT Assay -/- = Negative Endocervical Swab Specimen Result in the AC2 Assay / Negative Endocervical Swab Specimen Result in the ACT Assay {16} Table 11c. N. gonorrhoea PreservCyt Liquid Pap Specimen Analysis for Female Patient Infected Status | Patient Infected Status | Endocervical Swab | | Symptom Status | | | --- | --- | --- | --- | --- | | | APTIMA Combo 2 Assay | APTIMA GC Assay | Symptomatic | Asymptomatic | | Infected | + | + | 7 | 6 | | Non-infected | = | + | 0 | 1 | | Non-infected | - | + | 0 | 5 | | Non-infected | - | - | 352 | 1276 | | Total | | | 359 | 1288 | The equal symbol ("=") represents an equivocal result. Table 9c. N. gonorrhoeae Sensitivity and Specificity: APTIMA Combo 2 Assay PreservCyt Specimens vs. Patient Infected Status | Symptom Status | AC2/GC ThinPrep Result | +/+ | +/- | -/+ | -/- | Sensitivity (95% C.I.) | Specificity (95% C.I.) | | --- | --- | --- | --- | --- | --- | --- | --- | | Asymptomatic | Positive | 5 | 0 | 0 | 3 | | | | | Negative | 1 | 0 | 5 | 1273 | 83.3% (35.9 - 99.6) | 99.8% (99.3 - 100) | | | Total | 6 | 0 | 5 | 1276 | | | | Symptomatic | Positive | 7 | 0 | 0 | 0 | | | | | Negative | 0 | 0 | 0 | 352 | 100% (59.0 - 100) | 100% (99.0 - 100) | | | Total | 7 | 0 | 0 | 352 | | | | All | Positive | 12 | 0 | 0 | 3 | | | | | Negative | 1 | 0 | 5 | 1625 | 92.3% (64.0 - 99.8) | 99.8% (99.5 - 100) | | | Total | 13 | 0 | 5 | 1628 | | | +/+ = Positive Endocervical Swab Specimen Result in the AC2 Assay / Positive Endocervical Swab Specimen Result in the AGC Assay +/- = Positive Endocervical Swab Specimen Result in the AC2 Assay / Negative Endocervical Swab Specimen Result in the AGC Assay -/+ = Negative Endocervical Swab Specimen Result in the AC2 Assay / Positive Endocervical Swab Specimen Result in the AGC Assay -/- = Negative Endocervical Swab Specimen Result in the AC2 Assay / Negative Endocervical Swab Specimen Result in the AGC Assay {17} Table 10c. N. gonorrhoeae Performance by Clinical Site: APTIMA Combo 2 Assay PreservCyt Specimens vs. Patient Infected Status | Site | AC2/GC ThinPrep Result | +/+ | +/- | -/- | -/- | Prev (%) | Sensitivity (95% C.I.) | Specificity (95% C.I.) | PPV (%) | NPV (%) | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1 | Positive | 5 | 0 | 0 | 0 | 5.0 | 100% (47.8 - 100) | 100% (96.2 - 100) | 100 | 100 | | | Negative | 0 | 0 | 0 | 95 | | | | | | | | Total | 5 | 0 | 0 | 95 | | | | | | | 2 | Positive | 1 | 0 | 0 | 0 | 0.8 | 100% (2.5 - 100) | 100% (97.0 - 100) | 100 | 100 | | | Negative | 0 | 0 | 0 | 123 | | | | | | | | Total | 1 | 0 | 0 | 123 | | | | | | | 3 | Positive | 4 | 0 | 0 | 0 | 1.1 | 80.0% (28.4 - 99.5) | 100% (99.2 - 100) | 100 | 99.8 | | | Negative | 1 | 0 | 0 | 470 | | | | | | | | Total | 5 | 0 | 0 | 470 | | | | | | | 4 | Positive | 1 | 0 | 0 | 0 | 0.3 | 100% (2.5 - 100) | 100% (98.7 - 100) | 100 | 100 | | | Negative | 0 | 0 | 3 | 283 | | | | | | | | Total | 1 | 0 | 3 | 283 | | | | | | | 5 | Positive | 0 | 0 | 0 | 3 | 0.0 | N/A | 99.0% (97.1 - 99.8) | 0.0 | 100 | | | Negative | 0 | 0 | 0 | 294 | | | | | | | | Total | 0 | 0 | 0 | 297 | | | | | | | 6 | Positive | 1 | 0 | 0 | 0 | 0.3 | 100% (2.5 - 100) | 100% (99.0 - 100) | 100 | 100 | | | Negative | 0 | 0 | 2 | 360 | | | | | | | | Total | 1 | 0 | 2 | 360 | | | | | | | All | Positive | 12 | 0 | 0 | 3 | 0.8 | 92.3% (64.0 - 99.8) | 99.8% (99.5 - 100) | 80.0 | 99.9 | | | Negative | 1 | 0 | 5 | 1625 | | | | | | | | Total | 13 | 0 | 5 | 1628 | | | | | | +/+ = Positive Endocervical Swab Specimen Result in the AC2 Assay / Positive Endocervical Swab Specimen Result in the AGC Assay +/- = Positive Endocervical Swab Specimen Result in the AC2 Assay / Negative Endocervical Swab Specimen Result in the AGC Assay -/+ = Negative Endocervical Swab Specimen Result in the AC2 Assay / Positive Endocervical Swab Specimen Result in the AGC Assay -/- = Negative Endocervical Swab Specimen Result in the AC2 Assay / Negative Endocervical Swab Specimen Result in the AGC Assay ## 4. Clinical cut-off: Not Applicable ## 5. Expected values/Reference range: The prevalence of C. trachomatis and/or N. gonorrhoeae disease in patient populations depends on risk factors such as age, gender, the presence of symptoms, the type of clinic, and the test method. A summary of the prevalence of C. trachomatis and N. gonorrhoeae as determined by the APTIMA Combo 2 Assay results on PreservCyt liquid Pap specimens is shown below by clinical site and overall. {18} 19 Table 1c. Prevalence of C. trachomatis and/or N. gonorrhoeae Disease by Clinical Site: PreservCyt liquid Pap Specimen | PreservCyt liquid Pap % Prevalence (# positive/# tested) | | | | | --- | --- | --- | --- | | Site | CT+/GC+ | CT+/GC- | CT-/GC+ | | 1 | 3.0 (3/100) | 13.0 (13/100) | 2.0 (2/100) | | 2 | 0 (0/124) | 3.2 (4/124) | 0.8 (1/124) | | 3 | 0.4 (2/475) | 6.1 (29/475) | 0.4 (2/475) | | 4 | 0.4 (1/287) | 4.2 (12/287) | 0 (0/287) | | 5 | 0 (0/297) | 5.1 (15/297) | 1.0 (3/297) | | 6 | 0 (0/364) | 5.5 (20/364) | 0.6 (2/364) | | ALL | 0.4 (6/1647) | 5.6 (93/1647) | 0.6 (10/1647) | Note: The CT and GC prevalence were calculated using the APTIMA Combo 2 Assay results of PreservCyt liquid Pap specimen. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: 1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision. --- **Source:** [https://fda.innolitics.com/device/K043224](https://fda.innolitics.com/device/K043224) **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 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [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