(112 days)
Not Found
Not Found
No
The summary describes a urine collection and transport device and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as image processing and performance studies typically associated with AI/ML devices.
No.
The device is described as a collection and transport device for urine samples, not for treating any medical condition.
No
The device description clearly states its purpose: "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." This indicates it's a sample collection and preservation device, not one that performs analysis or diagnosis itself.
No
The device description clearly indicates it is a "urine collection and transport device," which is a physical hardware product, not software.
Based on the provided information, the Urine Monovette® boric acid is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for "delayed microbiological urine analysis." This means the device is used to collect and transport a biological specimen (urine) for testing in vitro (outside the body) to obtain information about a patient's health status (specifically, the presence of microorganisms).
- Device Description: While simple, the description confirms it's a device used in the process of diagnostic testing.
The definition of an IVD device generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Urine Monovette® fits this description perfectly.
N/A
Intended Use / 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.
Product codes
JSM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around the symbol.
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).
1
Page 2 -
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 (301) 594-3084. 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,
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
2
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 (828) 465-4000 Corporate Telefax (828) 465-0718 Corporate Phone (800) 257-5101 Sales Telefax (828) 465-4003 Sales