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.

Device Description

Coproset: disposable in vitro diagnostic device for the collection and transportation of stool samples and the enrichment of pathogenic organisms present in the sample.

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.

AI/ML Overview

The provided text describes a 510(k) summary for several microbiological specimen collection and transport devices, namely Coproset Salmonella, Coproset Shigella, Uriset Preservative tubes, and Swab set General Use. The document details the device descriptions and general information but does not contain detailed information regarding acceptance criteria, specific study designs, or performance data in the format requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes for test/training sets, ground truth establishment, expert involvement, adjudication methods, or MRMC studies.

The document states: "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."

This statement indicates that performance evaluations were conducted, and the results were found to be "comparable" with predicate devices, suggesting the device does meet certain performance expectations. However, the specific metrics, criteria, and detailed study results demonstrating this comparison are not included in this summary.

In summary, the input text lacks the specific details required to answer your questions about acceptance criteria, study design, and performance metrics.

Summary

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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 SITel. 39-0577-587111Fax 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.

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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, ItalyTel. 011-39-0577-587111Fax 011-39-0577-318690
Contact Person	Dr. Francesco Cocola
Phone Number	39-0577-587143
Fax Number	39-0577-318379

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Device information 1.2

ProprietaryDevice Name	Coproset Shigella	Coproset Salmonella	Uriset Preservative tube	Swab Set GeneralUse
Device modelnumber	94052	94050	94026	94320
Type ofSubmission	Third Party	Third Party	Third Party	Third Party
Common NameOr ClassificationName	Microbiologicalspecimen collectionand transport Device,Coproset(866.2900)	Microbiologicalspecimen collectionand transport Device,Coproset(866.2900)	Microbiologicalspecimen collection andtransport Device, Uriset(866.2900)	Microbiologicalspecimen collectionand transport Device,Swabset general use(866.2900)
EstablishmentRegistrationNumber	807.87 (b) 9615056	807.87 (b) 9615056	807.87 (b) 9615056	807.87 (b) 9615056
Facility Address	Via delle Rose 1053035 MonteriggioniSI, ItalyTel.: 39-0577-587111Fax: 39-0577-318690	Via delle Rose 1053035 MonteriggioniSI, ItalyTel.: 39-0577-587111Fax: 39-0577-318690	Via delle Rose 1053035 MonteriggioniSI, ItalyTel.: 39-0577-587111Fax: 39-0577-318690	Via delle Rose 1053035 MonteriggioniSI, ItalyTel.: 39-0577-587111Fax: 39-0577-318690
Section 513DeviceClassification	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-marketNotification	New device	New device	New device	New device

2 Predicate Device

	CoprosetSalmonella	CoprosetShigella	Uriset preservativetubes	Swab setGeneral use
PredicateDevice Name	BD Difco™Selenite Broth	BD Difco™ GNBroth, Hajna	BD Vacutainer™ PLUS PlasticUrine C &S preservative Tubes andKits	BD Bacto™Eugon Broth
PredicateDevice 510(k)	K781304	K781304	K024240	K781304
Product Code	JSN	JSN	JSM	JSN
PredicateDeviceCompany	BD DiagnosticSystem	BD DiagnosticSystem	BD Diagnostic System	BD DiagnosticSystem

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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.

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.

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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

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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

Prescription Use ✓	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

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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).

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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 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

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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

Coproset Shigella

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

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)

Regulation Number and Section

§ 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.