(55 days)
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No
The summary describes a device for quantitative determination of blood analytes, which is a standard laboratory technique. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is for quantitative determination of Blood Urea Nitrogen and creatinine in whole blood for diagnostic purposes, not for treating or rehabilitating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For the quantitative determination of Blood Urea Nitrogen and creatinine in whole blood," and that these values "are valuable in the diagnosis of renal diseases." It also specifies "For professional in vitro diagnostic use only," which is a hallmark of diagnostic devices.
No
The intended use describes the quantitative determination of analytes in whole blood, which strongly suggests a physical device (e.g., a blood analyzer or test strip reader) is involved, not just software. The lack of a device description prevents definitive confirmation, but the nature of the test points away from a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For the quantitative determination of Blood Urea Nitrogen and creatinine in whole blood."
- "For professional in vitro diagnostic use only."
This clearly indicates that the device is intended to be used outside of the body (in vitro) to diagnose or provide information about a person's health status by analyzing a biological sample (whole blood).
N/A
Intended Use / Indications for Use
For the quantitative determination of Blood Urea Nitrogen and creatinine in whole blood. Creatinine values are used as indications of renal function. Blood Urea Nitrogen values are valuable in the diagnosis of renal diseases. For professional in vitro diagnostic use only.
Product codes
CDN, JFY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.
JUL 2 4 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Gary Hewett Cholestech Corporation 3347 Investment Boulevard Havward, California 94545-3808
K972012 Re : Cholestech BUN/Creatinine Test System II Requlatory Class: Product Code: CDN, JFY Dated: May 28, 1997 Received: May 30, 1997
Dear Mr. Hewett:
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, Drug, and Cosmetic Act (Act). 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 (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. ਬੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 letter 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Ditman
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
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Page_of_of_l
10(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ evice Name: ( Chatestech; LOX ( BUN / Chestimise Panel
dications For-Use: .. . . . . . . . .
For the evantitative determination of Blood uven Nitrogen and crestining in while bloog). Creekinne values are used as inclications of renal function . Blood Unen Nitrogen values are valuable in the blaginosis of remal disocrees. For protessional in Urlus diagnostic ise only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K972012 |
Prescription Use V OR Over-The-Counter Use_
(Per 21 CFR 801.109) (Optional Format 1-2-96)