CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K

K993812 · Hardy Diagnostics · JSM · Dec 21, 1999 · Microbiology

Device Facts

• Record ID: K993812
• Device Name: CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
• Applicant: Hardy Diagnostics
• Product Code: JSM · Microbiology
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

Indications for Use

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.

Device Story

CVM Transport Media consists of plastic centrifuge tubes containing transport medium; used for collection and transport of clinical specimens; facilitates recovery of viral, chlamydial, and mycoplasmal agents; used in clinical laboratory settings; operated by healthcare professionals; maintains specimen viability during transit to laboratory for analysis; supports diagnostic testing for various respiratory and systemic pathogens.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Plastic centrifuge tubes containing transport media for biological specimens. Non-electronic, non-powered device.

Indications for Use

Indicated for the collection and transport of clinical specimens for the recovery of viral, chlamydial, and mycoplasmal agents (e.g., HSV, CMV, Influenza, RSV, Chlamydia, Mycoplasma, Ureaplasma) from patients requiring diagnostic testing for these pathogens.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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: [e-mail] Website: Hardydiagnostics com

> anta Maria, California 430 West MrCovlane Santa Maria, CA 93455 Tel: [phone]x 18051 346-7760

6

alt Lake Citv. Utah 254 W. Cottage Ave. Sandy, UT 84070 Tel: [phone] Fax: [phone]

Phoenix, Arizona 35 W. Iron Ave., #105 Mesa, AZ 85210 Tel: [phone] Fax: [phone]

## 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)