(262 days)
Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimen containing viruses, chlamydiae, mycoplasma or ureaplasma from the to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture.
UTM-RT is intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing respiratory viruses' nucleic acids. UTM-RT is intended for use with compatible molecular assays.
Copan Universal Transport Medium (UTM-RT®) System is composed of a tube with 3mL of UTM-RT® transport medium, which may be supplied in bulk or as a kit with a sterile specimen collection flocked swab. UTM-RT® medium is designed to maintain viability of viruses, chlamydiae, mycoplasma or ureaplasma during transport from the collection site to the testing laboratory for subsequent culture and to maintain the integrity of respiratory viruses' nucleic acids for testing with a compatible molecular assay.
The provided text is for a 510(k) premarket notification for a medical device called "Copan Universal Transport Medium (UTM-RT) System". This type of document describes the device, its intended use, and comparative performance data against a predicate device to demonstrate substantial equivalence, rather than a clinical trial or study in the traditional sense involving human readers or sophisticated AI algorithms.
Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/machine learning device is not fully applicable here. This document focuses on the stability and preservation of viral nucleic acids in a transport medium.
However, I can extract the relevant "acceptance criteria" and "study" details as they pertain to the chemical and biological stability performance of the transport medium, which is the device in question.
Here's the breakdown of the information as it relates to the device's performance in preserving viral nucleic acids:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Preservation of viability of microorganisms: Unchanged from original premarket notification (K042970). | Data from original premarket notification (K042970) accepted. |
| Shelf-life (reagent) stability of UTM-RT medium: Accepted for 18 months. | Data from original premarket notification (K042970) accepted. No variable has changed. |
| Performance and Stability (preservation of nucleic acids of respiratory viruses): ΔCt 2–8°C: 0–0.9 (PASS)22–28°C: 0.3–1.4 (PASS)Flu A2 (With beads): ΔCt at 96 hrs (T96 – T0): 2–8°C: 0–0.8 (PASS)22–28°C: 0.3–1.1 (PASS)Flu B: ΔCt at 96 hrs (T96 – T0): 2–8°C: -1–0.4 (PASS)22–28°C: -0.8–1 (PASS)RSV: ΔCt at 96 hrs (T96 – T0): 2–8°C: -0.4–1 (PASS)22–28°C: -0.1–1.1 (PASS)_All reported ΔCt values are |
§ 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).