A creatinine test system is a device intended to measure creatinine levels in serum, 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.

Device Description

Creatinine is an in vitro diagnostic assay for the quantitative analysis of creatinine in human serum, plasma, or urine. At an alkaline pH, creatinine in the sample reacts with picrate in the reagent 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 concentration of creatinine in the sample.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, focusing on acceptance criteria and the supporting study:

The document describes a Special 510(k) submission for a modified Creatinine assay for urine application. The acceptance criteria for the modified assay are implicitly based on demonstrating substantial equivalence to a predicate device (Roche Creatinine assay urine application on the Hitachi 917 Analyzer) and a previously cleared version of the Creatinine assay (K061193) on the Abbott AEROSET® System and ARCHITECT® cSystems.

The primary study conducted is a comparative performance study.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (Implicit)	Predicate/Reference Performance (Roche Creatinine assay on Hitachi 917 Analyzer)	Modified Device Performance (AEROSET System creatinine assay)	Modified Device Performance (ARCHITECT c8000 System creatinine assay)	Meets Criteria?
Method Comparison	Correlation Coefficient (R) vs. Roche Creatinine assay on Hitachi 917 Analyzer	- (Reference)	0.9992	0.9990	Yes
Method Comparison	Slope vs. Roche Creatinine assay on Hitachi 917 Analyzer	- (Reference)	1.01	0.97	Yes
Method Comparison	Y-intercept (mg/dL) vs. Roche Creatinine assay on Hitachi 917 Analyzer	- (Reference)	-0.43	0.36	Yes
Method Comparison	Correlation Coefficient (R) vs. AEROSET System Creatinine assay (for ARCHITECT c8000 comparison)	0.9992 (AEROSET)	N/A	0.9992	Yes
Method Comparison	Slope vs. AEROSET System Creatinine assay (for ARCHITECT c8000 comparison)	1.01 (AEROSET)	N/A	0.96	Yes
Method Comparison	Y-intercept (mg/dL) vs. AEROSET System Creatinine assay (for ARCHITECT c8000 comparison)	-0.43 (AEROSET)	N/A	1.23	Yes
Linearity	Range	5.00 to 740.00 mg/dL (Implied predicate range is similar or within this)	5.00 to 740.00 mg/dL	5.00 to 740.00 mg/dL	Yes
Limit of Quantitation (Sensitivity)	Value (for urine application)	5.00 mg/dL (Implied predicate value is similar)	5.00 mg/dL	5.00 mg/dL	Yes
Precision	Total %CV for Level 1 (urine application on ARCHITECT c8000 System)	(Implied acceptable range)	N/A	1.34%	Yes
Precision	Total %CV for Level 2 (urine application on ARCHITECT c8000 System)	(Implied acceptable range)	N/A	1.27%	Yes

Note: The document states "acceptable correlation" and "similar Performance Characteristics," implying the reported values met predetermined acceptance criteria for substantial equivalence to the predicate and the previously cleared device. Specific quantitative acceptance thresholds for correlation coefficients, slopes, intercepts, or %CV are not explicitly listed, but the reported values are presented as meeting these criteria.

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

Sample Size: The document does not explicitly state the sample size (number of urine samples) used for the comparative performance studies. It mentions "Comparative performance studies were conducted" but does not quantify the number of samples.
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective. It only indicates that "Comparative performance studies were conducted."

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

This type of diagnostic device (Creatinine assay) does not rely on human experts to establish "ground truth" for individual test results in the way image analysis or clinical diagnosis devices do. The "ground truth" for the test set is established by the performance of the predicate device (Roche Creatinine assay urine application on the Hitachi 917 Analyzer) and the previously cleared device (Creatinine assay on the Abbott AEROSET® System). The performance metrics of the modified device are compared against the measurements obtained from these established methods.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative chemical assay, "adjudication" in the sense of multiple human readers resolving discrepancies is not relevant. The comparison is made directly between numerical measurements from different instruments/assays.

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 that involve human interpretation (e.g., radiologists reading images) where the AI assists the human. This 510(k) is for an in vitro diagnostic assay, which provides a direct quantitative measurement, not an interpretation aid.

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

Yes, in essence, standalone performance was assessed. The Creatinine assay itself is a standalone algorithm/method that directly measures creatinine levels. Its performance is evaluated by comparing its quantitative results against those of predicate methods. There is no "human-in-the-loop" once the sample is loaded and the assay begins to run.

7. The Type of Ground Truth Used

The ground truth for evaluating the modified Creatinine assay is the measurements obtained from the legally marketed predicate device (Roche Creatinine assay urine application on the Hitachi 917 Analyzer) and the previously cleared version of the same Creatinine assay (on the Abbott AEROSET® System). This is a form of comparative measurement ground truth, where the reference standard is another recognized and validated method.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an algorithm that learns from data. This submission is for an assay, not a machine learning algorithm that requires a separate training phase. The "modifications" were to calibration and assay parameters, implying adjustments based on known chemical principles and potentially internal studies, rather than a data-driven machine learning training set.

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

Not applicable. As noted above, this is an in vitro diagnostic assay based on chemical reactions, not a machine learning algorithm with a training set. The "ground truth" for the calibration and assay parameters would be based on the principles of the Jaffe reaction, and reference standards like NIST SRM 914 and NIST SRM 967, which are IDMS traceable.

Summary

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Special 510(k) Summary

APR - '7 2009

Submitter's Name/Address Abbott Laboratories 1921 Hurd Drive Irving, TX 75038

Contact Person Linda Morris Senior Regulatory Specialist, MS 2-11 Regulatory Affairs (972) 518-6711 Fax (972) 518-7479

Date of Preparation of this Summary:	December 15, 2008
Device Trade or Proprietary Name:	Creatinine
Device Common/Usual Name orClassification Name:	Creatinine Reagent
Classification Number/Class:	Class II 862.1225
Product Code:	CGX

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, 21 CFR 807.92, and the guidance document, "The New 510(k) Paradigm, Alternate Approaches to Demonstrating Substantial Equivalence in Pre-market Notification" dated March 20,1998.

The assigned 510(k) number is: KO83809

Test Description:

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Substantial Equivalence:

The modified Creatinine assay is substantially equivalent to the cleared Creatinine assay (K061193) on the Abbott AEROSET® System and ARCHITECT® cSystems. The modifications to the urine application include changes to the calibration and assay parameters. The Use-factor calibration has been changed to a Linear calibration that allows for a separate urine calibration curve. In addition, the modified Creatinine assay urine application uses NIST SRM 914 as the reference standard rather than the serum standard, NIST SRM 967, both of which are IDMS traceable standards. These modifications did not significantly change the safety and effectiveness profile of the device as demonstrated in the Performance Characteristics Summary.

The modified Creatinine assay urine application is substantially equivalent to the Roche Creatinine assay urine application (K941837) on the Hitachi 917 Analyzer. Both assays yield similar Performance Characteristics.

Similarities:

. Both assays can be used for the quantitation of creatinine.
Both assays yield similar results. .
. Both assays are based on the modified Jaffe (creatinine alkaline picrate) methodology.
. Both assays use serum, plasma, and urine

Differences:

None

Intended Use:

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

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Performance Characteristics:

Comparative performance studies were conducted using the AEROSET System and the ARCHITECT c8000 System. The Creatinine assay urine application method comparison yielded acceptable correlation with the Roche Creatinine assay urine application on the Hitachi 917 Analyzer. The urine application on the AEROSET System showed a correlation coefficient of 0.9992, slope of 1.01, and Y-intercept of -0.43 mg/dL when compared to the Roche Creatinine assay urine application on the Hitachi 917 Analyzer. The urine application on the ARCHITECT c8000 System showed a correlation coefficient of 0.9990, slope of 0.97, and Y-intercept of 0.36 mg/dL when compared to the Roche Creatinine assay urine application on the Hitachi 917 Analyzer. The urine application on the ARCHITECT c8000 System showed a correlation coefficient of 0.9992, slope of 0.96, and Y-intercept of 1.23 mg/dL when compared to the AEROSET System. The Creatinine assay method comparison yielded acceptable correlation between the AEROSET System and the ARCHITECT c8000 System for the urine application.

The Creatinine assay is linear from 5.00 to 740.00 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Creatinine assay is 5.00 mg/dL for the urine application.

Precision studies conducted using the Creatinine assay urine application on the ARCHITECT c8000 System showed the total %CV for Level 1 to be 1.34%, and for Level 2 to be 1.27% for the urine application.

These data demonstrate that the performance of the Creatinine assay urine application is substantially equivalent to the performance of the Roche Creatinine assay urine application on the Hitachi 917 Analyzer.

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Conclusion:

The Creatinine assay urine application on the AEROSET System and the ARCHITECT c8000 System is substantially equivalent to the Roche Creatinine assay urine application on the Hitachi 917 Analyzer as demonstrated by results obtained in these studies.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Abbott Laboratories c/o Linda Morris Senior Regulatory Specialist, 1921 Hurd Drive Irving, TX 75038

APR - 7 2009

Re: K083809

Trade/Device Name: Creatinine Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: CGX Dated: March 7, 2009 Received: March 10, 2009

Dear Linda Morris:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page - 2

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indication for Use

510(k) Number (if known): K08 3809

Device Name: Creatinine

Indication For Use:

Prescription Use_ X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Division Sign-Off

Office of the Vitro Diagnostic Device Evaluation and Safety

510(k) to83804

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.