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 a breakdown of the acceptance criteria and study details for the Creatinine assay based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a laboratory assay, so acceptance criteria are related to analytical performance characteristics compared to predicate devices, rather than clinical endpoints. The acceptance criteria are implied by the claim of "substantially equivalent" performance to the predicate devices. The key performance metrics are correlation, precision, linearity, and sensitivity (limit of quantitation).

Performance Metric	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (Creatinine Assay)	Comments
Method Comparison (Serum)	Acceptable correlation with Roche Cobas Mira Plus Creatinine assay	Correlation Coefficient: 0.9993Slope: 0.980Y-intercept: -0.150 mg/dL	Demonstrated strong linear correlation.
Method Comparison (Urine)	Acceptable correlation with Boehringer Mannheim Creatinine assay on Hitachi 717 Analyzer	Correlation Coefficient: 0.9995Slope: 1.060Y-intercept: 4.637 mg/dL	Demonstrated strong linear correlation.
Precision (Serum)	Acceptable (compared to predicate or established clinical standards)	Level 1/Panel 111 Total %CV: 4.5%Level 2/Panel 112 Total %CV: 2.2%	Within acceptable analytical variability.
Precision (Urine)	Acceptable (compared to predicate or established clinical standards)	Level 1/Panel 131 Total %CV: 2.1%Level 2/Panel 132 Total %CV: 2.5%	Within acceptable analytical variability.
Linearity	Up to a certain clinically relevant concentration	Up to 42 mg/dL	Covers a broad range of creatinine concentrations.
Limit of Quantitation (Sensitivity)	Below a clinically relevant threshold	0.3 mg/dL	Indicates good sensitivity for low creatinine levels.

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

Sample Size for Test Set: Not explicitly stated for either the method comparison or precision studies. The document only mentions "Comparative performance studies were conducted" and "Precision studies were conducted using the Creatinine assay. Within-run, between-run, and between-day studies were performed using two levels of control material."
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they were conducted specifically for the 510(k) submission, comparing the new device against predicate devices and evaluating its performance characteristics.

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

This is a quantitative in vitro diagnostic assay. The "ground truth" for the test set is established by the measurements obtained from the predicate devices (Roche Cobas Mira Plus Creatinine assay for serum, and Boehringer Mannheim Creatinine assay on Hitachi 717 Analyzer for urine). No human experts were involved in establishing the "ground truth" for the numerical values. The validity of these predicate devices' measurements is assumed.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication or consensus on interpretations. The comparison is objective (numerical assays).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for imaging devices where human interpretation plays a significant role. This is a quantitative chemical assay.

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

Yes, this study is inherently a standalone performance evaluation of the Creatinine assay device. The performance characteristics (correlation, precision, linearity, sensitivity) are assessed for the device itself, without human intervention in the measurement process (beyond standard lab operation).

7. The Type of Ground Truth Used

The "ground truth" for evaluating the Creatinine assay's performance is the measurements provided by legally marketed and accepted predicate devices (Roche Cobas Mira Plus Creatinine assay for serum and Boehringer Mannheim Creatinine assay for urine), along with established analytical performance metrics (precision, linearity, sensitivity).

8. The Sample Size for the Training Set

Not applicable / Not stated. This is an in vitro diagnostic assay, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves chemical and engineering optimization during development, not data-driven model training.

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

Not applicable. As mentioned above, it's not a machine learning model requiring a training set with established ground truth. The "ground truth" in the context of developing such an assay would relate to physicochemical principles and analytical accuracy established through laboratory standards and controls.

Summary

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K981240

MAY 2 9 1998

510(k) Summary

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) 518-7861 Fax (972) 753-3367

Date of Preparation of this Summary:	April 2, 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 following devices:

Roche® Cobas Mira® Plus Automated Chemistry System Creatinine assay . (K941837) for the serum application
Creatinine 510(k) April 3, 1998 CreatE2.lwp

Section II Page 1

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Boehringer Mannheim® Creatinine assay on the Hitachi® 717 Analyzer . (K812095) for the urine application
These assays yield similar Performance Characteristics.

Similarities to Roche:

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

Differences to Roche:

There is a minor difference between the assay range. .
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 yield 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 ADCYON™ Analyzer. The Creatinine assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Creatinine assay for the serum application and the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the urine application. For the serum application, the correlation coefficient = 0.9993, Slope = 0.980, and Y-intercept = - 0.150 mg/dL. For the urine

Section II Page 2

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applications, the correlation coefficient = 0.9995, slope = 1.060, and

Y-intercept = 4.637 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 111 is 4.5% and Level 2/Panel 112 is 2.2%. For the urine application, the total %CV for Level 1/Panel 131 is 2.1% and Level 2/Panel 132 is 2.5%. The Creatinine assay is linear up to 42 mg/dL. The limit of quantitation (sensitivity) of the Creatinine assay is 0.3 mg/dL. These data demonstrate that the performance of the Creatinine assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Creatinine assay for the serum application and the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the urine application.

Conclusion:

The Creatinine assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Creatinine assay for the serum application and the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the urine application as demonstrated by results obtained in the studies.

Creatinine 510(k) April 3, 1998 CreatE2.lwp

Section II Page 3

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 9 1998

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

K981240 Re: Creatinine Regulatory Class: II Product Code: CGX Dated: April 3, 1998 Received: April 6, 1998

Dear Mr. Littlefield:

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 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 regulation (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 regulation 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 regulations.

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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 Sitman

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 Creatinine Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K 98/240
	0000007

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.