CHOLESTECH BUN/CREATININE TEST SYSTEM by CHOLESTECH CORP.

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.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "Cholestech BUN/Creatinine Test System II". This document does not contain the detailed information necessary to answer all the questions about acceptance criteria and study design as typically found in a clinical study report or a more comprehensive summary of safety and effectiveness.

However, based on the information available in the document, here's what can be deduced, along with what cannot be provided:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in this document. 510(k) clearances are based on substantial equivalence, meaning the new device performs as well as, or better than, a legally marketed predicate device. The specific performance criteria (e.g., accuracy, precision targets) that Cholestech had to meet are not detailed here. They would typically be found in the 510(k) submission itself.
Reported Device Performance: Not detailed in this clearance letter. The letter only states that the FDA "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This implies that performance data was submitted and found acceptable, but the actual data (e.g., bias, CV, correlation) is not presented.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this is an in vitro diagnostic device, not an imaging device requiring expert interpretation for ground truth. For IVD devices, ground truth is typically established using a reference method or a well-characterized predicate device. The number and qualifications of individuals performing these reference tests are not in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for an in vitro diagnostic device in the context of expert consensus/adjudication. If adjudication refers to discrepancy resolution between the new device and a reference method, that detail is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as this is an in vitro diagnostic device, not an AI-powered diagnostic imaging interpretation device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is an in vitro diagnostic test system that provides quantitative results. Its "standalone performance" would be its analytical performance (accuracy, precision, linearity, etc.) when tested in a laboratory setting. The specific results of such standalone performance are not detailed in this document. The indications for use state "For professional in vitro diagnostic use only," implying it's used by human operators, but the "performance" is of the device/reagent system itself, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For an in vitro diagnostic device like the Cholestech BUN/Creatinine Test System II, the "ground truth" for determining its performance (e.g., accuracy) would typically be established by:
- Reference laboratory methods: Assays performed in a high-complexity laboratory using established, often more expensive or time-consuming, gold standard methods for BUN and Creatinine.
- Predicate device comparison: Directly comparing results from the new device with a legally marketed predicate device on the same patient samples.
The document does not specify which type of ground truth was used for their submission.

8. The sample size for the training set

This information is not available in the provided document. The concept of a "training set" is more directly relevant to machine learning/AI development, though IVD systems also involve extensive development and testing with samples.

9. How the ground truth for the training set was established

This information is not available in the provided document. Similar to point 7, it would likely involve reference methods or predicate device comparison if a training phase (e.g., for algorithm development in a more complex IVD) was explicitly conducted.

Summary of available information from the document:

Device Name: Cholestech BUN/Creatinine Test System II
Intended Use: 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.
Regulatory Outcome: Found "Substantially Equivalent" (K972012) to a predicate device.
Regulatory Class: Not explicitly stated in the letter, but implied as a general controls device with potential for additional controls if Class II or III.
Product Code: CDN, JFY
Date of Clearance: July 24, 1997

To obtain the detailed information requested, one would typically need to refer to the full 510(k) submission document or a summary of safety and effectiveness (SSE) for K972012, which are sometimes publicly available through the FDA website but are not part of this clearance letter.

Summary

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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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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)

Regulation Number and Section

§ 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.