(86 days)
The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorthoeae. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected vaginal swab and patient-collected vaginal swab specimens; female and male urine specimens.
The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female swab and urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrheae per instructions provided. Refer to the specimen collection procedure in the package insert for specimen collection instructions for specific sample types.
Self-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Abbott multi-Collect Specimen Collection Kit is not intended for home use.
The Abbott multi-Collect Specimen Collection Kit can be used to collect either a swab or a urine specimen. Each Abbott multi -Collect Specimen Collection Kit contains:
- . One capped Transport Tube containing 1.2 mL Specimen Transport Buffer
- . One Individually Packaged Sterile Specimen Collection Swab
- . One disposable transfer pipette.
The Specimen Transport Buffer is used to stabilize DNA until sample preparation. The individually packaged sterile Specimen Collection Swab is used for swab sample collection and placed directly into the Transport Tube. The transfer pipette is used to add approximately 3 mL of urine to the Transport Tube. The Abbott multi -Collect Specimen Collection Kit is for single use only.
The Abbott multi-Collect Specimen Collection Kit Swab is approximately 14 cm in length with a polyester fiber tip. The swab shaft has a polystyrene solid core that is orange in color. The swab has a molded score completely around the shaft, between 7.86 cm and 7.89 cm from the swab tip, to provide a clean break-point. The polyesterfiber swab tip is approximately 1.3 cm in length and less than 3.28 mm in diameter.
This document describes the regulatory submission for a modification to the Abbott multi-Collect Specimen Collection Kit, specifically a change in the swab fiber component. The submission focuses on demonstrating that the new swab is substantially equivalent to the previously cleared swab and does not impact the performance of the Abbott RealTime CT/NG assay.
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly state "acceptance criteria" in a numerical, threshold-based format. Instead, the studies demonstrate performance relative to the existing device and expected assay performance (e.g., detection rates approaching 100% for low positive samples). The goal of these studies is to confirm that the new swab material does not negatively impact the assay's performance.
| Study Category | Study Description | Reported Device Performance/Findings |
|---|---|---|
| Biocompatibility | Tested cytotoxicity, irritation to skin and mucosal surfaces, and sensitization based on ISO-10993. | Confirmed. (The document states "Biocompatibility... was confirmed through cytotoxicity, irritation..., and sensitization tests"). This implies the tests passed established criteria for these biological endpoints. |
| 90-Day Specimen Stability | Evaluated DNA stability in transport tubes with the proposed swab for simulated high and low positive samples stored at 2-8°C and 30°C for 14 days, then -10°C or colder for 90 days. | Intermediate data supports specimen storage at 2-30°C for 14 days and at -10°C or colder for 56 days. (The study was ongoing at the time of submission, indicating confidence in meeting the full 90-day claim eventually, and showing acceptable stability for relevant periods. The statement "The intermediate data supports..." implies that at least for these shorter durations, stability was maintained.) |
| Sample Freeze-Thaw Stability | Tested simulated high and low positive swab specimens for DNA stability after five freeze-thaw cycles. | CT analyte: 100% positive rate (90/90). |
| NG analyte: 100% positive rate (90/90). | ||
| LOD Confirmation (Analytical Sensitivity) | Determined the collection and transfer efficiency of CT and NG target analyte from the proposed swabs to transport buffer using simulated low positive swab specimens. | CT detection: 100% (234/234) at 320 copies/400 µL. Lower bound 95% one-sided CI: 99%. |
| NG detection: 98% (229/234) at 320 copies/400 µL. Lower bound 95% one-sided CI: 96%. | ||
| Reproducibility | Evaluated reproducibility using a four-member panel of simulated swab specimens with three different analyte concentrations (CT and NG) across 3 swab lots, 3 instruments, and 9 runs. | Positive panel members: ≥ 99% positive rate for each analyte. |
| Negative panel members: ≥ 99% negative rate for each analyte. | ||
| Accelerated Stressed Swab Stability | Determined DNA stability in transport tubes with swabs subjected to accelerated stress, using simulated low positive swab specimens (320 copies of CT and NG/400 µL). | The detection rate of the CT analyte was 100% and the lower bound of the 95% one-sided confidence interval detection rate was 96% for all conditions tested. The detection rate of the NG analyte ranged from 98 to 100% and the lower bound of the 95% one-sided confidence interval detection rate ranged from 93 to 96% for all conditions tested. |
| Real-time (Kit) Stability | Ongoing study for the entire Abbott multi-Collect Specimen Collection Kit, including the proposed swab. | Scheduled for completion in December 2015. (This indicates that while full long-term data was not available at submission, shorter claims were supported by the 90-Day Specimen Stability study, and comprehensive data was being collected.) |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility: The specific sample sizes for cytotoxicity, irritation, and sensitization tests are not provided in the summary.
- 90-Day Specimen Stability: Not explicitly stated, but involved testing "simulated high and low positive swab specimens."
- Sample Freeze-Thaw Stability: 90 CT analyte samples and 90 NG analyte samples (total 180 samples) were tested.
- LOD Confirmation: 234 samples were tested for both CT and NG.
- Reproducibility: 189 replicates were tested for each panel member. There were 4 panel members (3 concentrations + 1 negative) for each analyte (CT and NG). This suggests a total of
189 replicates/panel member * 4 panel members * 2 analytes = 1512individual tests for quantification, or more accurately,189 replicates per panel memberacross the different conditions. Seven replicates of each panel member were tested in each run, with nine runs performed across three m2000 instrument systems. - Accelerated Stressed Swab Stability: Not explicitly stated, but involved "testing simulated low positive swab specimens containing a target concentration of 320 copies of CT and 320 copies of NG in each 400 uL sample preparation input volume."
- Provenance: All data appears to be retrospective experimental data generated in a laboratory setting using simulated specimens rather than prospective clinical samples. The country of origin of the data is not explicitly stated but is implicitly associated with Abbott Molecular Inc. in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
No human experts were used to establish the "ground truth" in these studies. The studies are analytical performance studies, not clinical studies involving patient diagnoses. The "ground truth" (e.g., presence and concentration of CT/NG DNA) was established by spiking known concentrations of target analytes into simulated specimens in a laboratory setting.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth was established by precise laboratory spiking of analytes, not by expert consensus or clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not an MRMC study. The device is a specimen collection kit the performance of which is measured using an in vitro assay (Abbott RealTime CT/NG assay). There are no human readers or interpretation involved in the performance evaluation of the collection device itself. The studies focus on the analytical performance of the kit to collect and preserve DNA for subsequent automated testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is an algorithm-only (assay-only) performance evaluation. The "device" being evaluated is the Abbott multi-Collect Specimen Collection Kit, specifically its swab component. Its performance is assessed by how effectively it allows the Abbott RealTime CT/NG assay (an automated PCR assay) to detect targets. Therefore, the performance demonstrated is that of the collection kit in conjunction with the fully automated assay, without any human interpretation steps directly related to the collection kit's function.
7. The Type of Ground Truth Used
The ground truth used was based on known concentrations of spiked target analytes (DNA for Chlamydia trachomatis and Neisseria gonorrhoeae) in simulated laboratory specimens. This is a form of analytical truth or definitive measurement through controlled experimental design.
8. The Sample Size for the Training Set
These studies are analytical validation studies for a medical device modification (swab component), not a machine learning or AI model development. Therefore, there is no concept of a "training set" in the context of these studies. The experiments described are test/validation studies for the physical collection device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI model.
§ 866.3390
Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.(b)
Classification. Class II (performance standards).