(40 days)
Not Found
No
The 510(k) summary describes a transport medium and collection system, with no mention of AI or ML technology. The performance studies focus on the viability of organisms in the medium.
No
The device is described as a collection and transport system for clinical specimens, not for treating any medical condition.
No
This device is a transport medium and collection system for clinical specimens, not a diagnostic device itself. It facilitates the collection and transport of samples to a laboratory for diagnostic testing, but it does not perform any diagnostic analysis or interpretation.
No
The device description clearly outlines physical components including a universal transport medium, screw-cap tubes, and specimen collection swabs. There is no mention of software as a component of this system.
Based on the provided information, the Copan Universal Transport Medium (UTM-RT) System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for the "collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma or ureaplasma from the collection site to the testing laboratory." This is a key characteristic of IVD devices – they are used to collect and prepare samples for diagnostic testing.
- Processing in a Laboratory: The intended use also mentions it "can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture." This indicates the device is designed to be used in a laboratory setting for diagnostic purposes.
- Device Description: The description details a "universal transport medium" that "can sustain viability (and infectivity)" of organisms during transit to the "testing laboratory." This further reinforces its role in the diagnostic process.
- Performance Studies: The summary of performance studies mentions "Recovery studies" to "determine the ability of the products to maintain viability" and "Stability testing." These are typical studies conducted for IVD devices to demonstrate their performance for diagnostic use.
- Predicate Devices: The listing of predicate devices (K910526 Multi-Microbe Collection & Transport System, M4 Medium) which are also transport media for clinical specimens, strongly suggests that this device falls under the same regulatory category, which is IVD.
In summary, the device is designed to collect and transport clinical specimens for subsequent diagnostic testing in a laboratory, which aligns perfectly with the definition of 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 specimens 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.
Product codes
JSM
Device Description
The Copan UTM-RT System includes a universal transport medium that is room temperature stable and that can sustain viability (and infectivity) of a plurality of organisms that include clinically important viruses, chlamydiae, mycoplasma and ureaplasma during transit to the testing laboratory. The formulation of UTM-RT medium includes protein for stabilization, antibiotics to minimize bacterial and fungal contamination, and a buffer to maintain a neutral pH.
Copan UTM-RT System medium is provided in screw-cap tubes designed for transport of the clinical sample. Copan UTM-RT System is also supplied as a sample collection kit that comprises a package which contains one screw-cap tube of UTM-RT medium and a peel pouch incorporating one or two sterile specimen collection swabs. A range of UTM-RT sample collection kits are available which incorporate different types of shaft swabs which facilitate the collection of specimens from different sites of the patient.
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)
Studies were conducted to evaluate the performance characteristics of the Copan Universal Transport Medium (UTM-RT) System. Recovery studies were performed using the Copan UTM-RT System and a comparative product to determine the ability of the products to maintain viability of various strains of viruses, chlamydiae, mycoplasma and ureaplasma during storage and use. Stability testing was performed on aged Copan UTM-RT products to support the 12-month expiration date.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K042970
DEC - 7 2004
510(k) Summary
for
Copan Universal Transport Medium (UTM-RT) System
1. SPONSOR
Copan Diagnostics Inc. 2175 Sampson Avenue, Suite 124 Corona, CA 92879
Contact Person: Norman Sharples Telephone: 800-216-4016
Date Prepared: October 27, 2004
2. DEVICE NAME
Proprietary Name: Copan Universal Transport Medium (UTM-RT) System Common/Usual Name: Transport Culture Medium Devices Classification Name: Transport Culture Medium Devices
3. PREDICATE DEVICES
- . Multi-Microbe Collection & Transport System, M4 Medium MicroTest Inc. K910526
- MicroTest™ Multi-Microbe Collection & Transport System, M4 Medium . REMEL - Apogent [Covered by K910526 due to acquisition of MicroTest Inc. by REMEL-Apogent]
4. DEVICE DESCRIPTION
The Copan UTM-RT System includes a universal transport medium that is room temperature stable and that can sustain viability (and infectivity) of a plurality of organisms that include clinically important viruses, chlamydiae, mycoplasma and ureaplasma during transit to the testing laboratory. The formulation of UTM-RT medium includes protein for stabilization, antibiotics to minimize bacterial and fungal contamination, and a buffer to maintain a neutral pH.
1
Copan UTM-RT System medium is provided in screw-cap tubes designed for transport of the clinical sample. Copan UTM-RT System is also supplied as a sample collection kit that comprises a package which contains one screw-cap tube of UTM-RT medium and a peel pouch incorporating one or two sterile specimen collection swabs. A range of UTM-RT sample collection kits are available which incorporate different types of shaft swabs which facilitate the collection of specimens from different sites of the patient.
ડ. INTENDED USE
Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimens 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.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Copan Universal Transport Medium (UTM-RT) System products are substantially equivalent to the predicate transport medium devices. The Copan UTM-RT System product and the predicate devices are similar in design, intended use, and overall function.
The Copan and predicate devices are single-use products intended for the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma or ureaplasma. Both the Copan and predicate devices are offered in product configurations with medium supplied alone or in kit formats with medium and specimen collection swab options.
7. PERFORMANCE TESTING
Studies were conducted to evaluate the performance characteristics of the Copan Universal Transport Medium (UTM-RT) System. Recovery studies were performed using the Copan UTM-RT System and a comparative product to determine the ability of the products to maintain viability of various strains of viruses, chlamydiae, mycoplasma and ureaplasma during storage and use. Stability testing was performed on aged Copan UTM-RT products to support the 12-month expiration date.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 7 2004
Copan Diagnostics, Inc. c/o Cynthia A. Sinclair, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K042970
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 Product Code: JSM Dated: October 27, 2004 Received: October 28, 2004
Dear Ms. Sinclair:
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 (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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Salazar
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K042970 510(k) Number (if known):
Device Name: Copan Universal Transport Medium (UTM-RT) System
Copan Universal Transport Medium (UTM-RT) System is intended for the collection and Copan Onliversal Transport Neemaning viruses, chlamydiae, myoplasma or transport of cinnear specificals venus the testing laboratory. UTM-RT can be processed ureaplasma from the Il laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Las wth
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K042970 510(k) -