(344 days)
iClean Viral Transport System (VTM-RT) is intended for the collection and transport of clinical specimens containing respiratory viruses, Chlamydiae, or Mycoplasma hominis from the collection site to the testing laboratory. The collection system is a culture based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles or bacteria.
iClean Viral Transport System (VTM-RT) is intended for the collection and transport of clinical specimens containing respiratory viruses, Chlamydiae, or Mycoplasma hominis from the collection site to the testing laboratory. iClean Viral Transport System (VTM-RT) includes a plastic screw-cap tube with conical bottom containing 3mL transport medium. iClean Viral Transport System (VTM-RT) tubes can be supplied alone, or in a kit format with a flocked swab in a sterile peel pouch (or 100 kits packed together in a color box). iClean Viral Transport System (VTM-RT) medium is stable at room temperature and consists of: Hanks balanced salt solution (HBSS), Bovine Serum Albumin (BSA), Gentamicin sulfate, Amphotericin B, Colistin, L-glutamic acid, HEPES buffer and Phenol red.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study demonstrating that the iClean Viral Transport System (VTM-RT kit) meets those criteria.
Please note that the document describes a transport medium, not an AI-powered device. Therefore, several sections of your request (e.g., sample size for the test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, sample size for the training set, how ground truth for training set was established) are not applicable as they relate specifically to AI/ML device studies.
Acceptance Criteria and Device Performance for iClean Viral Transport System (VTM-RT kit)
The iClean VTM-RT kit is a transport medium, and its performance is assessed by its ability to safely preserve and transport various microorganisms while maintaining their viability. The acceptance criteria and reported performance are based on recovery studies for viral and bacterial test strains, and stability studies examining physical and chemical properties of the medium over time.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for iClean Viral Transport System (VTM-RT kit)
| Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Shelf-Life Stability | Appearance: Clear (no turbidity, cloudiness, precipitation), pink color. | All results were acceptable; visually inspected media at T=0, 1, 3, 6, 9, 12 months maintained clear, pink appearance. |
| Volume: 3.0 mL per tube. | All results acceptable; media volume assessed at T=0, 1, 3, 6, 9, 12 months ensured each tube was filled to 3.0mL. | |
| pH: 7.4 ± 0.4. | All results acceptable; pH measured at T=0, 1, 3, 6, 9, 12 months across three lots remained within 7.4 ± 0.4. | |
| Antibiotic Stability: Inhibit bacterial/yeast growth (no growth at 24/48 hrs after inoculation). | Inoculated media with S. aureus, E. coli, C. albicans showed growth at T=0, but no growth at 24 and 48 hours for all plates, demonstrating effective antibiotic stability over time. | |
| Sterility: Absence of bacteria and fungi after filtration and aseptic filling. | Quality control process confirmed absence of growth of bacteria and fungi on nutrient agar and Sabouraud media plates after incubation, validating aseptic status. | |
| Microorganism Recovery | Viral Recovery: Acceptable preservation of Fluorescent Foci Count for Influenza A, Parainfluenza 3, Respiratory Syncytial Virus, Chlamydia pneumoniae, and C. trachomatis over 48 hours at 4°C and 25°C. | At 4°C: Declines in foci count range from -6% to 92% over 48 hours, with most below 60%. The document does not specify a numerical acceptance threshold for percent decline, but implies that these levels demonstrate "recovery." |
| At 25°C: Declines in foci count range from -194% (likely an error or high variability) to 96% over 48 hours. Most declines are significantly higher than at 4°C, indicating sensitivity to higher temperatures, but still demonstrating recovery. The wide range and some negative declines suggest variability or specific strain behavior. | ||
| Bacterial Recovery (Roll-Plate): ≥ 10 CFU recovery after specified maintenance time. | All reported average CFU/roll-plate values for Mycoplasma hominis at 24 and 48 hours (both 2-8°C and 22-25°C) are well above 10 CFU, ranging from 72 to 289 CFU at 48 hours, thus meeting the criteria. | |
| Bacterial Recovery (Swab Elution): No more than a 3 log10 change in CFU count between 0-time and 48 hours. | For Mycoplasma hominis, the change in log10 CFU from 0 to 48 hours ranges from -0.5 to -1.0 at 2-8°C, and from -0.7 to -1.3 (or showing gains/inconsistent values for some logs that are likely typos, e.g., 2.1x10^6 and 1.1x10^6 in old lot) at 22-25°C. These values are all well within the acceptable limit of "no more than a 3 log10 change", with reported changes typically around 1 log10 or less. |
Study Proving Device Meets Acceptance Criteria
The study conducted is a series of in vitro performance and stability tests designed to assess the iClean VTM-RT kit's ability to maintain the viability of specified microorganisms and the integrity of the transport medium over its claimed shelf-life.
The general conclusion, as stated in the document, is: "The iClean VTM demonstrated the recovery of tested viruses, Chlamydia pneumoniae, C. trachomatis and Mycoplasma hominis in all replicates at tested incubation times and storage conditions." This statement implies that all acceptance criteria were met, based on their internal definitions of "recovery" and "stability."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set):
- Shelf-Life Studies: Three lots of iClean VTM-RT media were used for appearance, volume, pH, and antibiotic stability testing.
- Recovery Studies: Nine lots of media were used, categorized as "New" (newly manufactured), "Mid" (middle-aged, ~5 months old), and "Old" (about to expire or recently expired). The tables show 3 lots for each age category for a total of 9 lots. For each lot and condition (time point, temperature), multiple replicates were used (e.g., swabs in triplicate for bacterial studies, 15 tubes for pH).
- Data Provenance: The document does not explicitly state the country of origin for the data collection. However, the manufacturer is Huachenyang (Shenzhen) Technology Co. Ltd. (China), suggesting the studies were likely conducted in China or a related facility. The studies are retrospective in the sense that they are laboratory evaluations of manufactured product lots, not prospective patient studies.
3. Number of Experts and Qualifications (Not Applicable)
This information is relevant for AI/ML diagnostic devices requiring expert interpretation. For a transport medium, the assessment is based on quantifiable laboratory measures of microorganism viability and chemical/physical stability, not expert interpretation of results.
4. Adjudication Method (Not Applicable)
This is relevant for AI/ML diagnostic devices where multiple experts might disagree on ground truth. For a transport medium, the "ground truth" is based on objective laboratory measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Not Applicable)
This is specific to AI/ML devices that assist human readers. The iClean VTM-RT is a laboratory instrument/reagent, not an AI system.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance) (Not Applicable)
This is specific to AI/ML devices. The iClean VTM-RT is a transport medium, and its performance is inherently "standalone" in the sense that it functions based on its chemical and physical properties to preserve microorganisms.
7. Type of Ground Truth Used
The ground truth used for these studies is based on:
- Viral Recovery: Fluorescent Foci Count method. This is a quantitative measure of infectious viral particles after storage.
- Bacterial Recovery (Roll-Plate): Colony-Forming Units (CFU) counts directly from plates rolled with the swab.
- Bacterial Recovery (Swab Elution): CFU counts from serial dilutions of the eluate.
- Stability Studies: Objective measurements of pH, visual inspection for appearance, volume measurements, and microbial growth/no-growth for antibiotic efficacy.
These are all laboratory-based, quantitative measures of the viability of the target microorganisms and the integrity of the medium.
8. Sample Size for the Training Set (Not Applicable)
This is relevant for AI/ML models that require a training dataset. The iClean VTM-RT is a chemical/biological product, not an AI model.
9. How the Ground Truth for the Training Set Was Established (Not Applicable)
As there is no AI/ML training set, this question is not applicable.
§ 866.2390 Transport culture medium.
(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).