COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE

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K070062 # Appendix C JUL 3 0 2007 # 510(k) Summary of Safety and Effectiveness | Name | DIESSE Diagnostica Senese SpA | |----------------|----------------------------------------------------------------------------------------| | Address | Via delle Rose 10, 53035 Monteriggioni SI<br>Tel. 39-0577-587111<br>Fax 39-0577-318690 | | Contact Person | Dr. Francesco Cocola | | Phone Number | 39-0577-587143 | | Fax Number | 39-0577-318379 | The Following section is included as required by the Safe Medical Device Act (SMDA) 1990. {1}------------------------------------------------ | Page | |--------| | 82/102 | # 510(k) Summary of Safety and Effectiveness This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The Assigned 510(k) Number is:________________________________________________________________________________________________________________________________________________ #### GENERAL INFORMATION 1 #### 1.1 Applicant | Date | September 19, 2006 | |----------------|-------------------------------------------------------------------------------------------------------| | Name | DIESSE Diagnostica Senese SpA | | Address | Via delle Rose 10, 53035 Monteriggioni SI, Italy<br>Tel. 011-39-0577-587111<br>Fax 011-39-0577-318690 | | Contact Person | Dr. Francesco Cocola | | Phone Number | 39-0577-587143 | | Fax Number | 39-0577-318379 | {2}------------------------------------------------ #### Device information 1.2 | Proprietary<br>Device Name | Coproset Shigella | Coproset Salmonella | Uriset Preservative tube | Swab Set General<br>Use | |-------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | Device model<br>number | 94052 | 94050 | 94026 | 94320 | | Type of<br>Submission | Third Party | Third Party | Third Party | Third Party | | Common Name<br>Or Classification<br>Name | Microbiological<br>specimen collection<br>and transport Device,<br>Coproset<br>(866.2900) | Microbiological<br>specimen collection<br>and transport Device,<br>Coproset<br>(866.2900) | Microbiological<br>specimen collection and<br>transport Device, Uriset<br>(866.2900) | Microbiological<br>specimen collection<br>and transport Device,<br>Swabset general use<br>(866.2900) | | Establishment<br>Registration<br>Number | 807.87 (b) 9615056 | 807.87 (b) 9615056 | 807.87 (b) 9615056 | 807.87 (b) 9615056 | | Facility Address | Via delle Rose 10<br>53035 Monteriggioni<br>SI, Italy<br>Tel.: 39-0577-587111<br>Fax: 39-0577-318690 | Via delle Rose 10<br>53035 Monteriggioni<br>SI, Italy<br>Tel.: 39-0577-587111<br>Fax: 39-0577-318690 | Via delle Rose 10<br>53035 Monteriggioni<br>SI, Italy<br>Tel.: 39-0577-587111<br>Fax: 39-0577-318690 | Via delle Rose 10<br>53035 Monteriggioni<br>SI, Italy<br>Tel.: 39-0577-587111<br>Fax: 39-0577-318690 | | Section 513<br>Device<br>Classification | 807.87 (C) Class I | 807.87 (C) Class I | 807.87 (C) Class I | 807.87 (C) Class I | | Product code | JTW | JTW | JSM | JTW | | Panel | Microbiology | Microbiology | Microbiology | Microbiology | | Reason For Pre-<br>market<br>Notification | New device | New device | New device | New device | #### 2 Predicate Device | | Coproset<br>Salmonella | Coproset<br>Shigella | Uriset preservative<br>tubes | Swab set<br>General use | |--------------------------------|-----------------------------|------------------------------|--------------------------------------------------------------------------|--------------------------| | Predicate<br>Device Name | BD Difco™<br>Selenite Broth | BD Difco™ GN<br>Broth, Hajna | BD Vacutainer™ PLUS Plastic<br>Urine C &S preservative Tubes and<br>Kits | BD Bacto™<br>Eugon Broth | | Predicate<br>Device 510(k) | K781304 | K781304 | K024240 | K781304 | | Product Code | JSN | JSN | JSM | JSN | | Predicate<br>Device<br>Company | BD Diagnostic<br>System | BD Diagnostic<br>System | BD Diagnostic System | BD Diagnostic<br>System | {3}------------------------------------------------ #### SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE 3 SUBSTANTIAL EQUIVALENCE #### Device Description 3.1 ## Coproset disposable in vitro diagnostic device for the collection and transportation of stool samples and the enrichment of pathogenic organisms present in the sample. Coproset Salmonella: In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp. Coproset Shigella: In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp. ## Uriset Preservative tubes with holder Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory. ## Swab set General use Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae. #### 3.2 Synopsis of Test methods # Coproset COPROSET has been designed for the collection and transport of stool samples and enrichment of the enteric pathogen which may be present. Stool samples are collected with the spoon and maintained in liquid medium in optimal conditions during transport. The same container is used for enrichment of the pathogen to be detected. , after subsequent streaking on agar plates and appropriated incubation. # Uriset Preservative tubes with holder URISET is a calibrated vacuum-filled tube designed for the collection and transportation of urine samples for the detection of pathogenic agents. Using the tube with the holder, the urine sample can be collected in conditions of safety for the operator and for the sample itself. The tube fills with about 4 ml of urine and the preservative stabilizes the bacterial load. {4}------------------------------------------------ ## Swab set General use SWAB SET has been designed for the collection and transportation of samples collected on bacteriological swabs, and enrichment of the pathogen which may be present. Samples are collected using the swab accessory and maintained in liquid medium in optimal conditions during transportation. #### Substantial Equivalence 3.3 As reported in M40-P NCCLS a Transport System is a device that ensures the integrity of the specimen and allows for a safe handling during the interval between specimen collection and processing the specimen in the laboratory. It consists of the liquid or semiliquid transport medium, the container of the transport system and in some cases, also sampling device. Transport medium: Liquid or semisolid medium designed to preserve and maintain the integrity of the specimen for the time period between specimen collection and laboratory processing of the sample. Following this definition and considering that Diesse Coproset and Swabset devices ad their respective predicate devices have similar Intended use, indication for use, similar features and that the media are the same , we can consider DIESSE Device Substantially equivalent to their respective predicate device. Performance evaluation, further demonstrate the substantial equivalence and the safety and effectiveness of Diesse Devices when compared with the respective Predicate Device: in the case of Coproset devices and Swab set device viability of pathogen is maintained and the results obtained are comparable with those obtained for predicate device; Uriset preservative tubes with holder have the same intended use, Indication for use, material and design than its predicate device and thus it possible to conclude that they are substantially equivalent. The results obtained in the comparison between Uriset preservative tube and Vacutainer demonstrate that DIESSE Uriset give a good performance in terms of sample preservation and data are comparable with those obtained for the predicate device. Signature Date: Dr. Francesco Cocola Director of Quality Unit/ Regulatory Affairs Director, Research and Development {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Coproset Salmonella, Coproset Shigella, Uriset preservative tubes, Swab set General Use Indications For Use: Coproset Salmonella In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp. ### Coproset Shigella In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp ### Uriset preservative tubes Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory. ### Swab set General Use Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae. | Prescription Use <span style="text-decoration: underline;"><b>✓</b></span> | AND/OR | Over-The-Counter | |----------------------------------------------------------------------------|--------|------------------| | (Part 21 CFR 801 Subpart D) | | (21 CFR 8) | ounter Use 01 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Lede Division Sign-Off Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD). Office of In Vitro Diagnostic Device Evaluation and Safety sin(k) KD7 {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the left. The eagle is black and has a sleek, modern design. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A.", arranged in a circular fashion around the eagle. The text is in all capital letters and is also black. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Diesse Diagnostica Senese S.P.A. c/o Casey Conroy Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road Melville, New York 11747 JUL 3 0 2007 Re: k070062 Trade/Device Name: Coproset Salmonella, Coproset Shigella, Uriset Preservative Tubes, Swab Set General Use Regulation Number: 21 CFR 866.2900 Regulation Name: Microbiological Specimen Collection and Transport Device Regulatory Class: Class I Product Code: LIO, JTW Dated: July 16, 2007 Received: July 18, 2007 Dear Mr. Conroy: 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). {7}------------------------------------------------ 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 vou 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)276-0450. 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, Sally, anton 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 {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Coproset Salmonella, Coproset Shigella, Uriset preservative tubes, Swab set General Use Indications For Use: Coproset Salmonella In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp. ### Coproset Shigella In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp #### Uriset preservative tubes Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory. ### Swab set General Use Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety KD7006. 11/16/2)