(106 days)
Not Found
No
The description details a chemical reaction-based assay and mentions no AI/ML components or methodologies.
No.
This device is an in vitro diagnostic assay used to measure creatinine levels, which aids in diagnosis and treatment monitoring. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Creatinine measurements are used in the diagnosis and treatment of renal diseases." The "Device Description" also refers to it as an "in vitro diagnostic assay."
No
The device description clearly states it is an "in vitro diagnostic assay" that measures creatinine levels through a chemical reaction and absorbance measurement, indicating it is a physical test kit or system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure creatinine levels in serum, plasma and urine" and that these 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." This clearly indicates that the device is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description states that it is an "in vitro diagnostic assay for the quantitative analysis of creatinine in human serum, plasma, or urine." This directly identifies it as an in vitro diagnostic device.
- Method of Operation: The description details a chemical reaction that occurs in vitro (outside the body) to measure the analyte.
- Regulatory Context: The presence of a Predicate Device with a K number (K061193) and a Reference Device with a K number (K941837) strongly suggests that this device is subject to regulatory review as an IVD.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Creatinine assay is used for the quantitation of creatinine in human serum, plasma, or urine.
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.
Product codes
CGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Correlation coefficient, slope, Y-intercept, linearity, limit of quantitation (sensitivity), total %CV.
Correlation coefficients: 0.9992, 0.9990, 0.9992
Slopes: 1.01, 0.97, 0.96
Y-intercepts: -0.43 mg/dL, 0.36 mg/dL, 1.23 mg/dL
Linearity: 5.00 to 740.00 mg/dL for the urine application
Limit of quantitation (sensitivity): 5.00 mg/dL for the urine application
Total %CV for Level 1: 1.34%
Total %CV for Level 2: 1.27%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 or | |
| Classification 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:
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.
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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.
.
3
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.
.
4
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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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:
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.
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