(41 days)
CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral, chlamydial, and mycoplasmal agents including: Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Influenzae A. Influenzae B, Respiratory Synctial Virus (RSV), Echovirus, Adenovirous, Chlamydia trachomatis, C. pneumoniae, Mycoplasma hominis, M. pneumoniae and Ureaplasma urealvticum.
Viral Transport Media: CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents including: Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Respiratory Synctial Virus (RSV), Echovirus, and Adenovirous.
CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral, chlamydial, and mycoplasmal agents.
I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Hardy Diagnostics for their CVM Transport Media. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device and does not contain the detailed study information you've requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot extract the information required to populate the table and answer your questions directly from this document.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 | 1999
Ms. Melissa Traylor, RAC Technical Services Director/Regulatory Affairs Hardy Diagnostics, Inc. 1430 West McCoy Lane Santa Maria, California 93455
Re: K993812 Trade Name: CVM Transport Media Regulatory Class: I Product Code: JSM Dated: November 9, 1999 Received: November 10, 1999
Dear Ms. Traylor:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Hardy Diagnostics. The logo consists of a circular graphic on the left and the text "HARDY DIAGNOSTICS" on the right. The circular graphic is composed of several diagonal lines within a circle. The word "HARDY" is stacked on top of the word "DIAGNOSTICS".
Email: Sales@Hardydiagnostics.com Website: Hardydiagnostics com
anta Maria, California 430 West MrCovlane Santa Maria, CA 93455 Tel: 18051 346-7766 1x 18051 346-7760
6
alt Lake Citv. Utah 254 W. Cottage Ave. Sandy, UT 84070 Tel: 18001 995-4273 Fax: 18011562-3214
Phoenix, Arizona 35 W. Iron Ave., #105 Mesa, AZ 85210 Tel: (800) 995-8456 Fax: 16021 464-9828
Indications for Use (from labeling):
CVM Transport Media:
CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral, chlamydial, and mycoplasmal agents including: Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Influenzae A. Influenzae B, Respiratory Synctial Virus (RSV), Echovirus, Adenovirous, Chlamydia trachomatis, C. pneumoniae, Mycoplasma hominis, M. pneumoniae and Ureaplasma urealvticum.
Viral Transport Media:
CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents including: Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Respiratory Synctial Virus (RSV), Echovirus, and Adenovirous.
Woody Dubois
510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)
§ 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).