(44 days)
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No
The device is a specimen collection and transport system, which is a physical product and does not involve data processing or analysis using AI/ML. The description focuses on the components and function of the collection kit and transport medium.
No
The device is described as a collection and transport system for clinical specimens, intended to maintain the viability of bacteria for diagnostic testing, not to treat a condition or disease.
No
The device is a collection and transport system for clinical specimens, designed to maintain the viability of bacteria for later processing in a laboratory, not to perform a diagnosis itself.
No
The device description clearly outlines physical components: a plastic tube, liquid transport medium, and a nylon flocked swab. This is a hardware-based collection and transport system, not software.
Based on the provided information, 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 specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory." It also mentions that "In the laboratory, ESwab specimens are processed using standard clinical laboratory operating procedures for bacterial culture." This clearly indicates that the device is intended for use in the collection and transport of samples for in vitro diagnostic testing (bacterial culture).
- Device Description: The description details a system designed to maintain the viability of bacteria for laboratory testing. The components (swab and transport medium) are specifically designed for this purpose.
- Performance Studies: The summary of performance studies mentions evaluating the ability of the product to "maintain viability of various strains of aerobic, anaerobic and fastidious bacteria during storage and use." This is a key performance characteristic for a device used in the collection and transport of samples for diagnostic testing.
- Predicate Devices: The listed predicate devices (BBL™ Port-A-Cul™ Specimen Collection and Transport Products and Copan Venturi Transystem® Amies Medium Without Charcoal) are also IVD devices used for specimen collection and transport for diagnostic purposes.
While the document doesn't explicitly state "IVD," the intended use, device description, and performance studies strongly indicate that this device is intended for use in the collection and transport of specimens for in vitro diagnostic procedures.
N/A
Intended Use / Indications for Use
Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory. In the laboratory, ESwab specimens are processed using standard clinical laboratory operating procedures for bacterial culture.
Product codes
JTW, JTX
Device Description
Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is supplied in a collection kit format. Each collection kit consists of a sterile package containing a plastic screw-cap tube with conical shaped bottom filled with 1 ml of Liquid Amies transport medium and a small sterile peel pouch containing one of two sizes of a specimen collection swab that has a tip flocked with soft nylon fiber.
The Liquid Amies transport medium is a maintenance medium comprising inorganic phosphate buffer, calcium and magnesium salts and sodium chloride with a reduced environment due to the presence of sodium thioglycollate. The medium is designed to maintain the viability of aerobic bacteria, anaerobic bacteria and fastidious bacteria such as Neisseria gonorrhoeae during transit to the testing laboratory.
The nylon flocked specimen collection swabs provided with the Copan ESwab Collection and Transport System have a solid plastic shaft with a molded breakpoint site. Copan ESwab Collection and Transport System kits are available with two different size nylon flocked swab options to facilitate the collection of specimens from various sites on a patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 ESwab System components as well as the complete ESwab collection kit formats. Recovery studies were performed using the Copan ESwab and the predicate devices to determine the ability of the products to maintain viability of various strains of aerobic, anaerobic and fastidious bacteria during storage and use. Stability testing was performed on aged Copan ESwab products to support the 15month expiration date.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
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510(k) Summary for Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System
1. SPONSOR
JUN 2 3 2006
Copan Diagnostics Inc. 2175 Sampson Avenue, Suite 124 Corona, CA 92879
Contact Person: Norman Sharples Telephone: 800-216-4016
Date Prepared: May 8, 2006
2. DEVICE NAME
Proprietary Name: Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System Common/Usual Name: Transport Culture Medium Devices Classification Name: Transport Culture Medium Devices
3. PREDICATE DEVICES
- BBL™ Port-A-Cul™ Specimen Collection and Transport Products . (Port-A-Cul™) Becton, Dickinson and Company K854986
Copan . Venturi Transystem® Amies Medium Without Charcoal (Venturi Transystem®) Copan Diagnostics Inc. K972448 and K946287
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4. DEVICE DESCRIPTION
Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is supplied in a collection kit format. Each collection kit consists of a sterile package containing a plastic screw-cap tube with conical shaped bottom filled with 1 ml of Liquid Amies transport medium and a small sterile peel pouch containing one of two sizes of a specimen collection swab that has a tip flocked with soft nylon fiber.
The Liquid Amies transport medium is a maintenance medium comprising inorganic phosphate buffer, calcium and magnesium salts and sodium chloride with a reduced environment due to the presence of sodium thioglycollate. The medium is designed to maintain the viability of aerobic bacteria, anaerobic bacteria and fastidious bacteria such as Neisseria gonorrhoeae during transit to the testing laboratory.
The nylon flocked specimen collection swabs provided with the Copan ESwab Collection and Transport System have a solid plastic shaft with a molded breakpoint site. Copan ESwab Collection and Transport System kits are available with two different size nylon flocked swab options to facilitate the collection of specimens from various sites on a patient.
ട. INTENDED USE
Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory. In the laboratory, ESwab specimens are processed using standard clinical laboratory operating procedures for bacterial culture.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Copan ESwab products are substantially equivalent to the predicate transport culture medium devices. The Copan ESwab products and the predicate devices are similar in intended use and overall function.
The proposed and predicate devices are single-use products intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria. Both the Copan ESwab and the predicate devices are offered in collection kit formats with specimen collection swab options.
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7. PERFORMANCE TESTING
Studies were conducted to evaluate the performance characteristics of the Copan ESwab System components as well as the complete ESwab collection kit formats. Recovery studies were performed using the Copan ESwab and the predicate devices to determine the ability of the products to maintain viability of various strains of aerobic, anaerobic and fastidious bacteria during storage and use. Stability testing was performed on aged Copan ESwab products to support the 15month expiration date.
Copan Diagnostics Inc. 510(k) May 8, 2006 Copan ESwab Collection and Transport System
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 3 2006
Copan Diagnostics, Inc. c/o Ms. Cynthia A. Sinclair, RAC Principal Consultant, Regulatory Services Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K061301
Trade/Device Name: Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System Regulation Number: 21 CFR§866.2900 Regulation Name: Microbiological specimen collection and transport device Regulatory Class: Class I Product Code: JTW. JTX Dated: May 8, 2006 Received: May 10, 2006
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, Or to 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 drive, 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).
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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 (240)276-0484. 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/industry/support/index.html
Sincerely yours.
Sally a Form
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
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Indications for Use
KO 61301 510(k) Number (if known):
Copan Liquid Amies Elution Swab (ESwab) Collection and Transport Device Name: System
Indications for Use:
Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory. In the laboratory, ESwab specimens are processed using standard clinical laboratory operating procedures for bacterial culture.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR '
Over-the-Counter Use (21 CFR 807 Subpart C) ﺗ
(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)
Ferdinande Parke
Division Sign-Off
Office of In Vit-o Diagnostic Device Evaluation and suffity