(90 days)
The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens. The specimens are shipped to a clinical laboratory for testing using the Alinity m STI Assay with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from CT, DNA from NG, ribosomal RNA from TV, and ribosomal RNA from MG, to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following self-collected specimens from symptomatic and asymptomatic individuals for the following analytes:
- · CT: vaginal swabs, female urine and male urine .
- NG: vaginal swabs, female urine, and male urine .
- . · TV: vaginal swabs, female urine and male urine
- . • MG: vaginal swabs and male urine
The simpli-COLLECT STI Test contains all the necessary components for the selfcollection and transport of urine from male and female patients (simpli-COLLECT Urine Collection Kit) or vaginal swabs from female patients (simpli-COLLECT Swab Collection Kit) in their home, or in similar environments. The simpli-COLLECT Collection Kits may also be used to self-collect specimens in a clinic.
The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens (simpli-COLLECT Urine Collection Kit [09N93001] and the simpli-COLLECT Swab Collection Kit [09R02-001]).
This test system uses the Alinity m STI Assay (cleared under K202977 and K222379) for real time RT-PCR to amplify and detect Chlamydia trachomatis (CT) ribosomal RNA sequences, Neisseria gonorrhoeae (NG) genomic DNA sequences, Trichomonas vaginalis (TV) ribosomal RNA sequences, Mycoplasma genitalium (MG) ribosomal RNA sequences, and human genomic DNA sequences that have been extracted from vaginal swab specimens or male and female urine specimens.
The Alinity m STI assay requires two separate assay-specific kits as follows:
- . Alinity m STI AMP Kit (09N17-095), which consists of multi-well amplification plates containing lyophilized, unit-dose RT-PCR amplification/detection reagents, and multi-well activator plates containing liquid, unit-dose activation reagents (MgC12. TMAC, and KC1). The intended storage condition for the Alinity m STI AMP Kit is 2°C to 8°C.
- . Alinity m STI CTRL Kit (09N17-085), which consists of negative controls and positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m STI Control Kit is -15°C to -25°C.
The steps of the Alinity m STI assay consist of sample preparation. RT-PCR assembly, amplification/detection, and result calculation and reporting. All stages of the Alinity m STI assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m STI assay in parallel with other Alinity m assays on the same instrument.
Nucleic acids from specimens are extracted automatically on-board the Alinity m System using the Alinity m Sample Prep Kit 1, Alinity m Lysis Solution, Alinity m Ethanol Solution or Alinity m Bottle for Ethanol Use filled with Ethanol supplied by customers, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash, and elution. The resulting purified nucleic acids are then combined with the liquid unit dose activator reagent, lyophilized unit-dose Alinity m STI amplification reagents, and Alinity m Vapor Barrier Solution, and transferred by the instrument to an amplification/detection module for reverse transcription, PCR amplification, and real-time fluorescence detection.
Assay controls are tested at or above an established minimum frequency to help ensure that instrument and reagent performance remain satisfactory. During each control event, a negative control and a positive control are processed through sample preparation and RT-PCR procedures that are identical to those used for specimens. Assay controls are used to demonstrate proper sample processing and assay validity. The CTRL kit configuration includes 12 vials at 0.47 mL of both the Alinity m STI Negative CTRL and Alinity m STI Positive CTRL.
The Alinity m STI amplification reagents include primers and probes that amplify and detect the single copy human gene, ß-globin. Amplification and detection of the ß-globin gene demonstrates proper sample processing and adequate sample input. In addition, an exogenous internal control (containing an armored RNA sequence) is included in the lyophilized Alinity m STI amplification reagents and is used to confirm that no PCR inhibitors are present in the sample. The ß-globin control and internal control are both used to demonstrate assay validity. The AMP kit configuration includes 4 trays (96 tests per tray) of both an AMP TRAY 1 and ACT TRAY 2. The AMP Kit provides sufficient reagents for 384 tests.
The simpli-COLLECT Urine Collection Kit is used to collect, stabilize, and transport male urine specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae. Trichomonas vaginalis, and Mycoplasma genitalium, and female urine specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Each kit can be used to collect 1 urine specimen. The collected specimens are intended for testing with the Alinity m STI assay. The simpli-COLLECT Urine Collection Kit contains the following components: 1 Abbott Sample Collection pack, which contains 1 Alinity m Sample Tube with Liguid Buffer and 1 Transfer Pipette, 1 Tube and Bag Label Sheet, 1 Urine Cup/Urine Collection Cup, 1 simpli-COLLECT Urine Collection Kit Patient Instructions For Use, 1 Biohazard Bag with Absorbent Pad, 1 Tube and Cap Holder, and 1 simpli-COLLECT Urine Collection Kit Box.
The simpli-COLLECT Swab Collection Kit is used to collect, stabilize, and transport vaginal swab specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Each kit can be used to collect 1 vaginal swab specimen. The collected specimens are intended for testing with the Alinity m STI assay. The simpli-COLLECT Swab Collection Kit contains the following components: 1 Abbott Swab Collection pack, which contains 1 Alinity m Sample Tube with Liguid Buffer and 1 Specimen Collection Swab, 1 Tube and Bag Label Sheet, 1 Biohazard Bag with Absorbent Pad, 1 Tube and Cap Holder, 1 simpli-COLLECT Swab Collection Kit Patient Instructions For Use, and 1 simpli-COLLECT Swab Collection Kit Box.
Here's a breakdown of the acceptance criteria and study information for the simpli-COLLECT STI Test, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details the performance in terms of usability and absence of interference, rather than specific quantitative diagnostic accuracy metrics (like sensitivity/specificity) for the simpli-COLLECT STI Test itself. The diagnostic accuracy is implicitly covered by the reference to the cleared Alinity m STI Assay (K202977 and K222379).
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Human Factors/Usability (Lay Users) | Lay users are able to collect and ship urine and vaginal swab specimens with minimal error using the simpli-COLLECT Urine Collection Kit and simpli-COLLECT Swab Collection Kit. User label comprehension was also demonstrated to be easy to understand by lay users. (Pass) |
| Interference by Hand Contaminants | No interference observed in the presence of 9 out of 11 tested hand contaminants at specified concentrations. Limitations for assay use were identified for Purell Advanced Hand Sanitizer, Germ X Advanced Moisturizing Hand Sanitizer with Aloe (at concentrations >0.1% v/v in urine and swab matrix), and Vaseline Intensive Care Deep Restore Lotion (at concentrations >0.5% v/v in urine matrix). These limitations are reflected in assay labeling. (Pass, with noted limitations addressed in labeling) |
2. Sample Size Used for the Test Set and Data Provenance
-
Human Factors Study:
- Sample Size: 223 participants.
- Data Provenance: Prospective, simulated home environment study conducted in the United States.
-
Interference Study:
- Sample Size: Not explicitly stated as a number of "samples" but involved testing 11 potential hand contaminants diluted into negative or positive swab and urine matrices. The number of replicates for each condition is not specified in this summary.
- Data Provenance: Laboratory study, likely conducted internally by Abbott Molecular.
-
Clinical Performance (Reference to K202977 & K222379):
- The document states that "Performance characteristics of the Alinity m STI assay with swab and urine specimens were established in a multicenter clinical study conducted in the United States to support the clearance of K202977 and K222379." The sample sizes for these previous clearances are not detailed in the provided K243410 summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not directly stated for the specific studies presented in this document (Human Factors and Interference).
- For the Human Factors study, "ground truth" was evaluated by observing participants' actions and evaluating packaged samples for errors based on laboratory accessioning criteria. This doesn't involve medical experts establishing diagnostic ground truth.
- For the Interference study, "ground truth" refers to the known positive or negative status of the spiked matrices, against which assay performance (presence/absence of interference) was assessed. This is laboratory-controlled.
- For the underlying Alinity m STI assay (K202977 and K222379), clinical studies would have involved a gold standard for establishing ground truth, likely including culture, other cleared NAATs, and/or clinical diagnosis, but the details are not available in this summary.
4. Adjudication Method for the Test Set
This information is not explicitly provided for the studies in this summary.
- For the Human Factors study, "difficulties were noted" and "packaged samples were then evaluated for errors according to the laboratory accessioning criteria." This suggests an objective assessment based on predefined criteria rather than a multi-expert adjudication of clinical diagnoses.
- For the Interference study, it's a technical and controlled laboratory experiment, not requiring adjudication in the clinical sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. without AI Assistance
This is not applicable as the simpli-COLLECT STI Test is a molecular diagnostic test system for in vitro detection, not an AI-assisted diagnostic imaging or interpretation device. Therefore, no MRMC study or AI assistance effect size is mentioned or relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable in the context of an "algorithm only" performance. The simpli-COLLECT STI Test is a collection and transport system intended to be used with the Alinity m STI Assay, which performs the actual detection. The Alinity m STI Assay operates automatically on the Alinity m System (an automated instrument), so its "standalone" performance would be its analytical and clinical performance as an automated assay, which was established in K202977 and K222379. The current submission focuses on the collection and transport component for home use.
7. The Type of Ground Truth Used
- Human Factors Study: Ground truth was based on pre-defined protocol steps for correct specimen collection and packaging, and laboratory accessioning criteria for evaluating collected samples.
- Interference Study: Ground truth was established by preparing matrices with known positive (spiked with target organisms) or negative status, and then adding interfering substances at defined concentrations.
- For the Alinity m STI Assay (from referenced K202977 and K222379): Likely clinical diagnosis, culture, and/or comparison to other legally marketed nucleic acid amplification tests (NAATs). The specific details are not in this summary.
8. The Sample Size for the Training Set
- Human Factors Study: 223 participants used as the test set. There isn't a separate "training set" mentioned for this usability evaluation. The design presumably refined the kit instructions prior to this summative study, but specific training set details are not provided.
- Interference Study: No explicit "training set" concept applies here; it's a validation experiment.
- For the Alinity m STI Assay (from referenced K202977 and K222379): Not detailed in this summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there's no explicitly defined "training set" for the type of studies presented here for the simpli-COLLECT STI Test. For the underlying Alinity m STI Assay, the ground truth for its training and validation would have been established through methods applicable to clinical diagnostic assays, as mentioned in point 7.
N/A