(20 days)
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No
The 510(k) summary describes a reagent for a clinical chemistry analyzer, which is a chemical assay and does not typically involve AI/ML. There are no mentions of AI, ML, image processing, or data training/testing sets.
No
The device is a reagent for diagnostic testing and does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" states that "The results are used in the diagnosis and treatment of certain renal and metabolic diseases," indicating its role in diagnosis.
No
The 510(k) summary describes a reagent (BUN Reagent) used with a clinical system (Beckman SYNCHRON CX Clinical Systems) for the quantitative determination of urea nitrogen. This clearly indicates a chemical reagent and a hardware system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the BUN Reagent is for the "quantitative determination of urea nitrogen in serum." This involves testing a sample taken from the human body (serum) outside of the body (in vitro).
- Purpose: The results are used "in the diagnosis and treatment of certain renal and metabolic diseases." This aligns with the purpose of IVDs, which are used to provide information for diagnostic purposes.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures. This description fits the BUN Reagent.
N/A
Intended Use / Indications for Use
BUN Reagent is intended for the quantitative determination of urea nitrogen in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of certain renal and metabolic diseases.
Product codes
CDQ
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 17 1997
Cynthia Shuqart · President Carolina Liquid Chemistries Corporation 451 West Lambert Road, Suite 207 Brea, California 92821
- K971967 Re : BUN Reagent Requlatory Class: II Product Code: CDQ Dated: May 26, 1997 May 28, 1997 Received:
Dear Ms. Shugart:
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. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 requlation (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 general 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
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K971967 510(k) Number (if known):
Device Name: Blood Urea Nitrogen (BUN) Reagent
Indications For Use:
BUN Reagent is intended for the quantitative determination of urea nitrogen in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of certain renal and metabolic diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Veronica Calvin for Dr Montameus.f
(Division Sign-Off)
Division of Clinical Laborat
ces
510(k) Number 297961
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
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