(22 days)
Not Found
No
The device description focuses on the collection and transport of specimens using a buffered medium with antibiotics and stabilizers. There is no mention of AI or ML in the intended use, device description, or any other section of the summary.
No
This device is for the collection and transportation of specimens, not for treating any medical condition.
No
Explanation: The device is a collection and transport system for clinical specimens, designed to maintain the viability of microorganisms for subsequent laboratory analysis. It does not perform any diagnostic function itself.
No
The device description clearly describes a physical collection and transport system including a buffered medium, antibiotics, serum albumin, and sucrose, indicating it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "collection and transportation of Chlamydia, Mycoplasmas and viruses obtained from clinical specimens." This indicates the device is used to prepare biological samples for subsequent diagnostic testing.
- Device Description: The description details a "buffered medium" designed to "maintain the viability" of these microorganisms during transport to the laboratory. This medium is a key component in preserving the sample for in vitro analysis.
- Clinical Evaluation: The mention of a "Clinical evaluation... to ensure performance characteristics" further supports its role in the diagnostic process.
- Predicate Device: The predicate device (K962843; Multitrans) is also likely an IVD, as collection and transport systems for diagnostic samples are typically classified as such.
While the document doesn't describe the diagnostic test itself, the Starswab Multitrans Collection and Transport System is clearly intended to be used in conjunction with an in vitro diagnostic test by providing the necessary sample in a suitable condition. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
Multitrans is intended for the collection and transportation of viruses, chlamydia and mycoplasmas obtained from clinical specimens.
The Starswab Multitrans Collection and Transport System (Cat. No. S160) is intended for the collection and transportation of Chlamydia, Mycoplasmas and viruses obtained from clinical specimens.
Product codes (comma separated list FDA assigned to the subject device)
JSM
Device Description
Starswab Multitrans Collection and Transport System provides a safe and convenient way to collect and transport clinical specimens without leakage under optimum storage conditions. The osmotically balanced buffered medium will maintain the viability of viral, chlamydia and mycoplasma specimens during transportation to the laboratory. Antibiotics are incorporated into the medium to inhibit growth of competing bacteria and yeast. The addition of serum albumin provides a stabilizing effect. The high concentration of sucrose aids in the preservation of viruses and chlamydia if the specimens are frozen (-70℃) for prolonged storage.
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)
Clinical evaluation has been carried out by the Ontario Provincial Public Health Laboratory to ensure performance characteristics of the product held under new storage conditions is not compromised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 1 3 2003
510(k) SUMMARY
Starplex Scientific Inc. Sponsor: 50 Steinway Blvd. Etobicoke, Ontario, Canada M9W 6Y3
Sponsor Contact: Mehdi Karamchi, Director, QA/Regulatory Affairs Tel: 416-674-7474 ext. 3018 Fax: 416-674-6067 Email: mkaramch(@starplexscientific.com
Date Prepared: July 17, 2003
Device Classification Name
Transport System Aerobic
Common Name
Sterile swab culture collection and transport system for virus, chlamydia and mycoplasma.
Proprietory Name
Multitrans Culture Collection and Transport System
Legally marketed device. Multitrans (code S160) Docket # K962843
Device Description
Starswab Multitrans Collection and Transport System provides a safe and convenient way to collect and transport clinical specimens without leakage under optimum storage conditions. The osmotically balanced buffered medium will maintain the viability of viral, chlamydia and mycoplasma specimens during transportation to the laboratory. Antibiotics are incorporated into the medium to inhibit growth of competing bacteria and yeast. The addition of serum albumin provides a stabilizing effect. The high concentration of sucrose aids in the preservation of viruses and chlamydia if the specimens are frozen (-70℃) for prolonged storage.
1
Statement of Intended Use
Multitrans is intended for the collection and transportation of viruses, chlamydia and mycoplasmas obtained from clinical specimens.
Description of Change
The recommended storage condition prior to use has been changed from 2-8°C to 2-25°C.
Summary of Performance Data
Clinical evaluation has been carried out by the Ontario Provincial Public Health Laboratory to ensure performance characteristics of the product held under new storage conditions is not compromised.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The symbol in the center consists of three curved lines that resemble a stylized bird or abstract design. The text around the perimeter is partially obscured but appears to be related to health and human services.
AUG 1 3 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mehdi Karamchi, B.Sc. RM (CCM) Director, QA/Regulatory Starplex Scientific Inc. 50 Steinway Boulevard, Etobicoke Ontario, CANADA M9W 6Y3
K032246 Re:
Trade/Device Name: Starswab Multitrans Collection and Transport System (Cat. No. S160) Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I Product Code: JSM Dated: July 17, 2003 Received: July 24, 2003
Dear Mr. Karamchi:
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). Other general information on your responsibilities under the Act may be obtained 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
K032246 510(k) Number:
Device Name:
Starswab Multitrans Collection and Transport System (Cat. No. $160)
Indications of Use:
The Starswab Multitrans Collection and Transport System (Cat. No. S160) is intended for the collection and transportation of Chlamydia, Mycoplasmas and viruses obtained from clinical specimens.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sall, aHtyr 8/12/03.
K032246
Prescription Use Division Sign-Off
(Per 21 CFR 801.109)
OR
Office of In Vitro Diagnos.
Evaluation and Safety
Over-The-Counter Use __
510(k) K032246