(262 days)
No
The document describes a transport medium for biological specimens and its performance in preserving viral nucleic acids. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI/ML. The performance studies focus on the stability of the medium and the viability of microorganisms, not on data analysis or prediction.
No
The device is intended for the collection and transport of clinical specimens, and for the stabilization and transportation of nucleic acids, not for treating any condition.
No
This device is a transport medium for clinical specimens, designed to maintain the viability of microorganisms and the integrity of nucleic acids during transportation to a laboratory for subsequent testing. It does not perform diagnostic functions itself.
No
The device description clearly states it is composed of a tube with transport medium and may be supplied with a swab, indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for the "collection and transport of clinical specimen containing viruses, chlamydiae, mycoplasma or ureaplasma from the to the testing laboratory." It also mentions being used with "compatible molecular assays." This clearly indicates the device is used in vitro (outside the body) to prepare and transport samples for diagnostic testing.
- Device Description: The description reinforces this by stating the medium is designed to "maintain viability of viruses, chlamydiae, mycoplasma or ureaplasma during transport... for subsequent culture and to maintain the integrity of respiratory viruses' nucleic acids for testing with a compatible molecular assay." This further confirms its role in the diagnostic process.
- Performance Studies: The performance studies described involve testing the device's ability to preserve viral viability and nucleic acid integrity for subsequent testing using a molecular assay (Xpert® Xpress CoV-2/Flu/RSV plus assay). This is a direct evaluation of its performance in a diagnostic context.
- Predicate Device: The mention of a predicate device (K201674; Merit Cultura™ Collection and Transport System) which is also a collection and transport system for clinical specimens, further supports its classification as an IVD.
Therefore, based on the provided information, the Copan Universal Transport Medium (UTM-RT) System is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JSM, LIO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Culture Performance Study
Data for preservation of viability of microorganisms (i.e., viruses, chlamydiae, mycoplasma, ureaplasma) was included in the original premarket notification (K042970). This part of the Intended Use remains unchanged in the candidate device.
Shelf-life (reagent) stability
Data supporting a shelf-life of 18 months for the UTM-RT medium was accepted for the original premarket notification (K042970) and no variable has further changed in the candidate device.
LoD Verification for Performance and Stability study
LoD for ATCC strains of representative viruses (i.e., Influenza A, Influenza B, Respiratory Syncytial virus) was evaluated to determine the lowest viral amount leading to ≥ 95% of the sample replicates amplified for the viral target. 3xLoD was used for conducting the Performance and Stability study.
Performance and Stability study
Performance and stability were evaluated to provide evidence about preservation of nucleic acids of respiratory viruses when specimen is stored in UTM-RT® at 2-25°C up to 96h throughout UTM-RT® shelf life.
To support the candidate device's performance in preserving viral nucleic acids throughout the claimed shelf-life (i.e., 18 months) for the product, the tests were performed on a set of UTM-RT® lots within one-to-four months of manufacture, a set of UTM-RT® lots dated approximately a year after manufacture, and a third set of UTM-RT® lots aged beyond 18 months (applicable to UTM-RT® tubes with or without glass beads inside).
For each UTM-RT® lot and ATCC strain of representative respiratory viruses (i.e., Influenza A, Influenza B, Respiratory Syncytial virus), 5 replicates were tested at baseline / time 0 (i.e., To) and then at 72 hours (Tz2) and 96 hours (Tgs) of sample storage in the cold (2-8°C) and room temperature (22–28°C). Tests were performed using the Xpert® Xpress CoV-2/Flu/RSV plus assay in combination with GeneXpert® Dx.
The cycle threshold (Ct) values obtained from the molecular assay were used to assess performance and calculate the difference in Ct values (ΔCt) at tested time points relative to baseline (Time 0). Results were considered acceptable if the ΔCt of
§ 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).
0
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April 25, 2024
Copan Italia S.p.A. Silvia Caprini Senior Regulatory Affairs Manager via Francesco Perotti 10 Brescia, IT 25125 Italy
Re: K232357
Trade/Device Name: Copan Universal Transport Medium (UTM-RT) System Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I, reserved Product Code: JSM, LIO Dated: March 28, 2024 Received: March 28, 2024
Dear Silvia Caprini:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232357
Device Name
Copan Universal Transport Medium (UTM-RT) System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
April 2024
510(k) SUMMARY
1. General Information
| Submitter name | COPAN ITALIA S.p.A. |
|---|---|
| Address | Via F. Perotti 10 |
| 25125 Brescia, Italy | |
| Telephone number | +39 030 2687212 |
| Contact person | Ms. Silvia Caprini |
| E-mail: regulatory.affairs@copangroup.com | |
| Summary Preparation Date | 20th April, 2024 |
2. Subject device
Trade name Common/Usual name Requlation number Requlation name Requlatory Class Product code
Copan Universal Transport Medium (UTM-RT®) System UTM, UTM-RT, Specimen collection and transport system 21 CFR 866.2390 Transport Culture Medium Class I JSM, LIO
3. Predicate device
| Manufacturer | Merit Medical System, Inc. |
|---|---|
| Trade name | Merit Cultura™ Collection and Transport System |
| Common/Usual name | Specimen collection and transport system |
| Regulation number | 21 CFR 866.2390 |
| Regulation name | Transport Culture Medium |
| Regulatory Class | Class I |
| Product code | JSM, LIO |
| Premarket Notification | K201674 |
4. Device description
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.
5. Intended Use / Indications for Use
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 collection site 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.
4
| Device &
Predicate
| Devices: | Device (K232357) | Predicate (K201674) |
|---|---|---|
| Device Trade | ||
| Name | Copan Universal Transport | |
| Medium (UTM-RT) System | Merit Medical Systems | |
| Cultura Collection and | ||
| Transport System | ||
| Manufacturer | Copan Italia S.p.A. | Merit Medical Systems, Inc. |
| General Device Characteristic Similarities | ||
| Intended | ||
| Use/Indications For | ||
| Use | 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 collection site 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. | The Merit Cultura Collection | |
| and Transport System is | ||
| intended for collection and | ||
| transport of clinical | ||
| specimens to the laboratory | ||
| for standard | ||
| diagnostic/identification | ||
| techniques. The Merit | ||
| Cultura Collection and | ||
| Transport System is a | ||
| culture-based media that | ||
| can be used for upper | ||
| respiratory viral diagnostic | ||
| assays including Severe | ||
| Acute Respiratory Syndrome | ||
| Coronavirus 2 (SARS-CoV- | ||
| 2), Influenza A, Influenza B, | ||
| Respiratory Syncytial Virus | ||
| (RSV), and Rhinovirus. | ||
| Tube and cap | ||
| material | Plastic | Same |
| Swab material | Various flocked nylon applicators | |
| on a plastic shaft with break point | Same | |
| Media Volume | 3 mL | Same |
| Single use device | Yes | Same |
| Principle of | ||
| operation | Culture-based medium for | |
| maintenance of target | ||
| microorganism viability and | ||
| integrity. The specimen can be | ||
| tested with culture- based | ||
| technique and with PCR-based | ||
| technique. | Same | |
| General Device Characteristic Differences | ||
| Shelf-life | 18 months | 12 months |
| Media list of | ||
| ingredients | Hank's Balanced Salt Solution, | |
| bovine serum albumin, L-cysteine, | ||
| gelatin, L-glutamic acid, HEPES | ||
| buffer, phenol red, sucrose, | ||
| vancomycin, amphotericin B and | ||
| colistin | Hank's Balanced Salt | |
| Solution (HBSS), Fetal | ||
| Bovine Serum (FBS), D- | ||
| glucose, Phenol Red, | ||
| Gentamicin sulfate and | ||
| Amphotericin B | ||
| Specimen transport | ||
| conditions and | ||
| storage time | Up to 96 hours at 2-25°C. | Up to 120 hours at 2-25°C. |
6. Table 1: Comparison to predicate device
5
7. Non-clinical Performance Data
Culture Performance Study
Data for preservation of viability of microorganisms (i.e., viruses, chlamydiae, mycoplasma, ureaplasma) was included in the original premarket notification (K042970). This part of the Intended Use remains unchanged in the candidate device.
Shelf-life (reagent) stability
Data supporting a shelf-life of 18 months for the UTM-RT medium was accepted for the original premarket notification (K042970) and no variable has further changed in the candidate device.
LoD Verification for Performance and Stability study
LoD for ATCC strains of representative viruses (i.e., Influenza A, Influenza B, Respiratory Syncytial virus) was evaluated to determine the lowest viral amount leading to ≥ 95% of the sample replicates amplified for the viral target. 3xLoD was used for conducting the Performance and Stability study.
Performance and Stability study
Performance and stability were evaluated to provide evidence about preservation of nucleic acids of respiratory viruses when specimen is stored in UTM-RT® at 2-25°C up to 96h throughout UTM-RT® shelf life.
To support the candidate device's performance in preserving viral nucleic acids throughout the claimed shelf-life (i.e., 18 months) for the product, the tests were performed on a set of UTM-RT® lots within one-to-four months of manufacture, a set of UTM-RT® lots dated approximately a year after manufacture, and a third set of UTM-RT® lots aged beyond 18 months (applicable to UTM-RT® tubes with or without glass beads inside).
For each UTM-RT® lot and ATCC strain of representative respiratory viruses (i.e., Influenza A, Influenza B, Respiratory Syncytial virus), 5 replicates were tested at baseline / time 0 (i.e., To) and then at 72 hours (Tz2) and 96 hours (Tgs) of sample storage in the cold (2-8°C) and room temperature (22–28°C). Tests were performed using the Xpert® Xpress CoV-2/Flu/RSV plus assay in combination with GeneXpert® Dx.
The cycle threshold (Ct) values obtained from the molecular assay were used to assess performance and calculate the difference in Ct values (ΔCt) at tested time points relative to baseline (Time 0). Results were considered acceptable if the ΔCt of