(115 days)
None
Not Found
No
The summary describes a chemical reagent for laboratory testing and contains no mention of AI or ML.
No
The device is a reagent used for diagnostic purposes, not for therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the UREA reagent is used to "aid in the determination of liver and kidney functions and congestive heart failure and other diseases," which directly indicates its role in diagnosing or aiding in the diagnosis of various medical conditions.
No
The 510(k) summary describes a "UREA reagent (BUN)", which is a chemical substance used in laboratory testing, not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the UREA reagent is used "to aid in the determination of liver and kidney functions and congestive heart failure and other diseases associated with protein catabolism." This describes a test performed on biological samples (likely blood or urine) outside of the body to provide information about a patient's health status. This is the core definition of an in vitro diagnostic.
The lack of other information (Device Description, image processing, AI, etc.) does not negate the fact that the intended use places it squarely within the realm of IVDs.
N/A
Intended Use / Indications for Use
The UREA reagent (BUN) is to be used to aid in the determination of liver and kidney functions and congestive heart failure and other diseases associated with protein catabolism.
Product codes
CDQ
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Charles C. Allain, Ph.D. . Director Derma Media Lab, Inc ... .... 7245 Garden Grove Boulevard, Suite E Garden Grove, California 92641
AUG - 1 1997
K971309 Re : UREA Requlatory Class: II Product Code: CDQ Dated: May 22, 1997 May 28, 1997 Received:
Dear Dr. Allain:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 Requlations.
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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 (770) 488-7655.
This better 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
sincerely yours,
Steven Litman
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
2
510(k) Number (if known):
Device Name: UREA
Indications For Use: ---------------------------------------------------------------------------------------------------------------------------------------------------------
The UREA reagent (BUN) is to be used to aid in the determination of liver and kidney functions and congestive heart failure and other diseases associated with protein catabolism.
ivision Sign-Off)
ision of Clinical Laboratory, Degices,
(k) Number. 49711309
Labprotegic 09
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
ា វាយប្រជាជនា និ
OR
Over-The-Counter Use