The Creatinine assay is used for the quantitation of creatinine in human serum, plasma, or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Device Description

Creatinine is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma, or urine. The Creatinine assay is a clinical chemistry assay in which the creatinine in the sample, at an alkaline pH, reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the amount of creatinine in the sample.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, broken down to address your specific questions about acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance for Crea Creatinine Assay

This 510(k) summary details the substantial equivalence of the Abbott Laboratories Crea Creatinine assay to the Boehringer Mannheim® Creatinine assay on the Hitachi® 717 Analyzer. The acceptance criteria are implicitly defined by achieving "acceptable correlation" and "similar performance characteristics" compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit - based on predicate)	Reported Device Performance (Crea Creatinine Assay)
Method Comparison (Serum)	Acceptable correlation with predicate	Correlation coefficient = 0.9997, slope = 0.873, Y-intercept = 0.078 mg/dL (vs. Boehringer Mannheim Creatinine assay on Hitachi 717)
Method Comparison (Urine)	Acceptable correlation with predicate	Correlation coefficient = 0.9947, slope = 1.056, Y-intercept = -2.410 mg/dL (vs. Boehringer Mannheim Creatinine assay on Hitachi 717)
Precision (Serum - Level 1)	Acceptable precision	Total %CV for Level 1/Panel 101 is 3.0%
Precision (Serum - Level 2)	Acceptable precision	Total %CV for Level 2/Panel 102 is 2.6%
Precision (Urine - Level 1)	Acceptable precision	Total %CV for Level 1/Panel 201 is 1.6%
Precision (Urine - Level 2)	Acceptable precision	Total %CV for Level 2/Panel 202 is 2.1%
Linearity (Serum)	Acceptable linearity up to a certain concentration	Linear up to 38.7 mg/dL
Linearity (Urine)	Acceptable linearity up to a certain concentration	Linear up to 757.0 mg/dL
Limit of Quantitation (Sensitivity)	Acceptable sensitivity	0.10 mg/dL
Assay Range	Similar to predicate, minor difference acceptable	Minor difference between assay range compared to Boehringer Mannheim

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size used for the comparative performance studies (method comparison, precision, linearity, sensitivity).

The data provenance is not explicitly stated in terms of country of origin. The studies were conducted internally by Abbott Laboratories ("Comparative performance studies were conducted using the AEROSET™ System"). The studies appear to be prospective, as they involve testing the new Crea assay and comparing its performance against a legally marketed predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of in vitro diagnostic device (IVD) submission. The "ground truth" for a quantitative chemical assay like creatinine is established by the reference method (the predicate device in this case) and traceable standards, not by expert consensus or interpretation of images. The performance is measured against objective chemical measurements.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative IVD device. Adjudication methods (e.g., 2+1, 3+1) are typically used in imaging studies where human interpretation is involved to establish ground truth or resolve discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation of medical images or data, not for automated quantitative chemical assays.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, this study is inherently a standalone performance study. The Crea Creatinine assay is an automated in vitro diagnostic assay. Its performance characteristics (correlation, precision, linearity, sensitivity) are measured directly from the device's output, without human intervention in the result generation process itself. The comparison is against another automated device (the predicate).

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance of the legally marketed predicate device, the Boehringer Mannheim® Creatinine assay on the Hitachi® 717 Analyzer, as well as established analytical standards for linearity and sensitivity. The goal is to demonstrate "substantial equivalence" to this predicate, meaning the new device performs similarly.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in the same way it would be for AI/ML-based devices. For an IVD like this, "training" typically refers to the development and optimization process, not a distinct dataset used for machine learning. The studies described are validation (test set) studies.

9. How the Ground Truth for the Training Set Was Established

As explained above, the concept of a "training set" with ground truth in the AI/ML sense doesn't directly apply here. The device was likely developed and optimized through standard chemical and engineering principles to accurately measure creatinine, with its performance then validated against the predicate device and analytical standards.

Summary

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510(k) Summary

K981799
July 22, 1998

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive

Irving, Texas 75038

Contact Person

Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs (972) 518-6062 Fax (972) 753-3367

Date of Preparation of this Summary:	May 20, 1998
Device Trade or Proprietary Name:	Crea
Device Common/Usual Name or Classification Name:	Creatinine
Classification Number/Class:	75C6X/Class II

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

Test Description:

Substantial Equivalence:

The Creatinine assay is substantially equivalent to the Boehringer Mannheim® Creatinine assay on the Hitachi® 717 Analyzer (K812095) for the serum, plasma, or urine applications .

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These assays vield similar Performance Characteristics.

Similarities to Boehringer Mannheim:

Both assays are in vitro clinical chemistry methods. .
Both assays can be used for the quantitative determination of creatinine. .
Both assays vield similar clinical results. .

Differences to Boehringer Mannheim:

. There is a minor difference between the assay range.

Intended Use:

The Creatinine assay is used for the quantitation of creatinine in human serum, plasma, or urine.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ System. The Creatinine assay method comparison yielded acceptable correlation with the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the serum and urine applications. For the serum application, the correlation coefficient = 0.9997, slope = 0.873, and Y-intercept = 0.078 mg/dL. For the urine applications, the correlation coefficient = 0.9947, slope = 1.056, and Y-intercept = -2.410 mg/dL. Precision studies were conducted using the Creatinine assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 101 is 3.0% and Level 2/Panel 102 is 2.6%. For the urine application, the total %CV for Level 1/Panel 201 is 1.6% and Level 2/Panel 202 is 2.1%. The Creatinine assay is linear up to 38.7 mg/dL for the serum application, and 757.0 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Creatinine assay is 0.10 mg/dL. These data demonstrate that the performance of the Creatinine assay is

Creatinine 510(k) May 20, 1998 Creatflwp

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substantially equivalent to the performance of the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the serum and urine applications.

Conclusion:

The Creatinine assay is substantially equivalent to the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the serum and urine applications as demonstrated by results obtained in the studies

Creatinine 510(k)
May 20, 1998 Creatf.lwp

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 22 1998

Mark Littlefield Mark British Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

K981799 Re : Crea Requlatory Class: II Product Code: CGX Dated: May 20, 1998 Received: May 21, 1998

Dear Mr. Littlefield:

We have reviewed your Section 510(k) notification of intent to we have reviewed jeeferenced above and we have determined the market 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 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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 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 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.gov/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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Creatinine Device Name:

Indications For Use:

Sign-Off)
Clinical Laboratory Devices
O(k) Number K981799

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concarrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use ----OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.