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.

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.

AI/ML Overview

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 < 3 for viral targets at 72 hours and 96 hours relative to baseline (Time 0) when stored at 2-8°C and 22-28°C, across different lot ages.	Flu A1 (UTM-RT® tube): ΔCt at 96 hrs (T96 – T0): 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 < 3, meeting the acceptance criterion.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: The performance and stability study was conducted using specific "sets" of UTM-RT® lots.
- Lot Ages: Lots within one-to-four months of manufacture ("Freshly produced (new)"), lots approximately a year after manufacture ("Middle-Aged"), and lots aged beyond 18 months ("Old/Expired").
- Lot Age Ranges: New (0.8–4.2 months), Middle-aged (11.1-13.5 months), Old/Expired (18.7-22.7 months).
- Test Setup: For each UTM-RT® lot and ATCC strain of representative respiratory viruses (Influenza A, Influenza B, Respiratory Syncytial virus), 5 replicates were tested at each time point.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a premarket notification for a CE-marked device originating from Italy, the studies were likely conducted by the manufacturer. It appears to be a prospective experimental study conducted in a lab setting rather than real-world clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of device and study. The "ground truth" for this study is not established by human experts in the sense of image interpretation or diagnostic performance. Instead, it's based on objective molecular assay results (Ct values) indicating viral nucleic acid presence and stability.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication. The results are quantitative (Ct values) and objectively measured by the Xpert® Xpress CoV-2/Flu/RSV plus assay.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is not relevant for this device, which is a transport medium, not an AI or imaging diagnostic device that human readers interact with.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a transport medium. The "performance" is its ability to preserve nucleic acids, measured by a molecular assay, not an algorithm's standalone diagnostic capability.

7. The Type of Ground Truth Used

The "ground truth" for the performance and stability study was established by molecular assay results (Ct values) from a reference molecular diagnostic test (Xpert® Xpress CoV-2/Flu/RSV plus assay) on known ATCC strains of viruses. This acts as an objective measure of the integrity and concentration of viral nucleic acids, which is the performance characteristic being evaluated.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of a physical transport medium, not an AI/machine learning model that would require a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for this device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K232357

Device Name

Copan Universal Transport Medium (UTM-RT) System

Indications for Use (Describe)

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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April 2024

510(k) SUMMARY

1. General Information

Submitter name	COPAN ITALIA S.p.A.
Address	Via F. Perotti 1025125 Brescia, Italy
Telephone number	+39 030 2687212
Contact person	Ms. Silvia CapriniE-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

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.

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Device &PredicateDevices:	Device (K232357)	Predicate (K201674)
Device TradeName	Copan Universal TransportMedium (UTM-RT) System	Merit Medical SystemsCultura Collection andTransport System
Manufacturer	Copan Italia S.p.A.	Merit Medical Systems, Inc.
	General Device Characteristic Similarities
IntendedUse/Indications ForUse	Copan Universal TransportMedium (UTM-RT) System isintended for the collection andtransport of clinical specimencontaining viruses, chlamydiae,mycoplasma or ureaplasma fromthe collection site to the testinglaboratory. UTM-RT can beprocessed using standard clinicallaboratory operating procedures forviral, chlamydial, mycoplasma andureaplasma culture. UTM-RT isintended for the stabilization andtransportation of an unprocessedupper respiratory clinical specimensuspected of containing respiratoryviruses' nucleic acids. UTM-RT isintended for use with compatiblemolecular assays.	The Merit Cultura Collectionand Transport System isintended for collection andtransport of clinicalspecimens to the laboratoryfor standarddiagnostic/identificationtechniques. The MeritCultura Collection andTransport System is aculture-based media thatcan be used for upperrespiratory viral diagnosticassays including SevereAcute Respiratory SyndromeCoronavirus 2 (SARS-CoV-2), Influenza A, Influenza B,Respiratory Syncytial Virus(RSV), and Rhinovirus.
Tube and capmaterial	Plastic	Same
Swab material	Various flocked nylon applicatorson a plastic shaft with break point	Same
Media Volume	3 mL	Same
Single use device	Yes	Same
Principle ofoperation	Culture-based medium formaintenance of targetmicroorganism viability andintegrity. The specimen can betested with culture- basedtechnique and with PCR-basedtechnique.	Same
	General Device Characteristic Differences
Shelf-life	18 months	12 months
Media list ofingredients	Hank's Balanced Salt Solution,bovine serum albumin, L-cysteine,gelatin, L-glutamic acid, HEPESbuffer, phenol red, sucrose,vancomycin, amphotericin B andcolistin	Hank's Balanced SaltSolution (HBSS), FetalBovine Serum (FBS), D-glucose, Phenol Red,Gentamicin sulfate andAmphotericin B
Specimen transportconditions andstorage time	Up to 96 hours at 2-25°C.	Up to 120 hours at 2-25°C.

6. Table 1: Comparison to predicate device

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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 < 3 was observed. RSV, Flu A and Fly B target nucleic acids were amplified acceptably with stable ΔCt values relative to baseline after storage in UTM-RT® for up to 96 hours at both room temperature (22–28°C) and refrigerated temperature (2–8°C), demonstrating medium stability during the product shelf life of 18 months, as summarized in Table 2 below.

Virus	Beads	Lot age of UTM-RT at testing*	ΔCt at 96 hrs. (T96 – T0)PASS criterion: ΔCt <3
			2–8°C	Result	22–28°C	Result
Flu A1	UTM-RT® tube	Freshly	0–0.9	PASS	0.3–1.4	PASS
Flu A2	With beads	produced (new),	0–0.8	PASS	0.3–1.1	PASS
Flu B	or	Middle-Aged, or	-1–0.4	PASS	-0.8–1	PASS
RSV	without beads	Old/Expired	-0.4–1	PASS	-0.1–1.1	PASS

Table 2: Summary of data demonstrating stability of viral nucleic acids during storage up to 96 hours in UTM-RT®

*Lot age (in months from production) at testing was in the following range: New (0.8–4.2), Middle-aged (11.1-13.5) and Old/Expired (18.7-22.7).

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8. Conclusion

Copan Universal Transport Medium (UTM-RT®) system demonstrated acceptable stability of nucleic acids from representative respiratory viruses (i.e., Influenza A, two (2) targets A1 and A2; Influenza B; Respiratory Syncytial virus) when the specimen is stored in the cold (2-8°C) or at room temperature (20–25ºC) for up to 96 hours in UTM-RT® medium.

Based on the indications for use, technological characteristics, safety, and performance testing, the candidate device (Copan Universal Transport Media (UTM-RT®) system) is substantially equivalent to the legally marketed predicate device, Merit Medical Systems Cultura Collection and Transport System (K201674).

Regulation Number and Section

§ 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).