(203 days)
OmniTrans™ Transport System is intended for use in the collection of clinical specimens (i.e., sputum, throat/ oropharyngeal swab, whole blood, urine, skin lesion material or exudate) potentially containing viruses, chlamydiae, mycoplasma, or ureaplasma and in their transport from the collection site to the testing laboratory. The system can be processed using standard clinical laboratory operating procedures for culture of clinical specimens.
OmniTrans™ Transport System includes a screw-cap tube containing transport medium, which can be supplied alone, or in a kit with one of two possible collection swab options in a sterile peel pouch or with two collection swabs in sterile peel pouches.
The in-tube-only format contains labeled screw-cap tubes pre-filled with 1 mL, 1.5 mL, or 3 mL of transport medium. The in-kit screw-cap tube format is pre-filled with 1 or 3 mL of transport medium for safe transportation of biological specimens.
The format in kit is supplied in pre-packaged collection sets containing one of the two swab types or both of two swab types:
Minitip flocking swab with 8 cm breaking point.
Regular flocking swab with 3 cm breaking point.
A specimen bag, with appropriate biosafety warning labels, is also provided with the device for safe transportation of clinical specimens in the transport medium.
The provided text describes the OmniTrans Transport System, a device for collecting and transporting clinical specimens. The key acceptance criteria and performance data are primarily focused on the device's ability to maintain the viability of various microorganisms (viruses, chlamydiae, mycoplasma, and ureaplasma) over time and temperature during transport.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (OmniTrans Transport System) |
|---|---|
| Shelf-Life Stability (18 months at 2-25°C) | |
| Appearance | Intact package, no leakage; media red and transparent without color change, turbidity, or precipitation. (Passed for all lots at all time points) |
| Net Content | Not less than the labeled volume. (All tubes met pre-defined criteria) |
| pH Value | pH within 7.3 ± 0.2. (All tubes within range for all lots at all time points) |
| Sterility (Aseptic status) | No microbial growth after 14 days incubation in fluid thioglycolate medium (30-35°C) and trypticase soy broth (20-25°C). (Confirmed for media in tubes from various aged lots). Swabs are individually packaged and sterile. |
| Microbial Stasis | No increase in microbial counts (Staphylococcus aureus, Escherichia coli, Candida albicans) at 48 hours when inoculated to 10-10° CFU/mL and incubated at 37°C. (Both old and new lots passed) |
| Microbial Recovery (after 48 hours at 2-8°C or 20-25°C) | |
| Viruses & Chlamydiae (Fluorescent Foci Counts) | Recovery within 1 Log₁₀ (±90%) of initial counts at time 0. (All tested viruses and chlamydiae met this criterion for both temperature ranges and for lots of different ages) |
| Mycoplasma & Ureaplasma (CFU counts - Roll Plate & Swab Elution) | Recovery within 1 Log₁₀ (±90%) of initial counts at time 0. (All tested mycoplasma and ureaplasma met this criterion for both temperature ranges and for lots of different ages) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a single number. The shelf-life stability tests involved "all lots tested at each time point," "five replicates from each lot," and "medium lots of serial post-production ages (0-, 6-, 12-, 18-, and >18-months) and "an old (>18 months at test) and a new (
§ 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).