URINE MONOVETTE BORIC ACID

K024237 · Sarstedt, Inc. · JSM · Apr 14, 2003 · Microbiology

Device Facts

• Record ID: K024237
• Device Name: URINE MONOVETTE BORIC ACID
• Applicant: Sarstedt, Inc.
• Product Code: JSM · Microbiology
• Decision Date: Apr 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

Indications for Use

The Urine Monovette® boric acid is intended for use as a urine collection and transport device that maintains the integrity of the urine for delayed microbiological urine analysis

Device Story

Urine Monovette® boric acid is a specimen collection and transport device; functions as a container for urine samples; contains boric acid additive to preserve specimen integrity for delayed microbiological analysis; used in clinical settings by healthcare professionals; facilitates transport of samples to laboratories; ensures sample stability for accurate diagnostic testing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Urine collection tube containing boric acid preservative; Class I device; manual operation; non-electronic; non-software.

Indications for Use

Indicated for urine collection and transport to maintain specimen integrity for delayed microbiological analysis in patients requiring urine testing.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 4 2003

Mr. Peter Rumswinkel VP/General Manager Sarstedt, Inc. P.O. Box 468 Newton, NC 28658-0468

k024237 Re:

Trade/Device Name: Urine Monovette® boric acid Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I Product Code: JSM Dated: March 7, 2003 Received: March 10, 2003

Dear Mr. Rumswinkel:

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 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 [phone]. 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 [phone] or [phone] 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

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Sarstedt, Inc. · P.O. Box 468 · Newton, NC 28658-0468

Instruments and Disposables for Medicine and Science

Indications for Use Statement

510(k) Number: K024237

Device Name: Urine Monovette® boric acid

Indications For Use:

The Urine Monovette® boric acid is intended for use as a urine collection and transport device that maintains the integrity of the urine for delayed microbiological urine analysis

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Ruddie Lu Poole

(Division Sign-Off) Division of Clinical 510(k) Number J

Sarstedt, Inc. P.O. Box 468 Newton, NC 28658-0468

Phone [phone] Corporate Telefax [phone] Corporate Phone [phone] Sales Telefax [phone] Sales

K024237